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Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use (CTR3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02137512
Recruitment Status : Completed
First Posted : May 13, 2014
Results First Posted : October 19, 2016
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Jaeb Center for Health Research

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Interventions Device: Closed-Loop Control System
Device: Sensor-Augmented Pump (SAP)
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Closed-Loop Control System
Hide Arm/Group Description

A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.

Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:

  • DiAs – a smart-phone medical platform;
  • Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
  • Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
  • Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
  • Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class
Period Title: 2-Week Baseline Sensor-Augmented Pump
Started 30
Completed 30
Not Completed 0
Period Title: 2-Week Overnight-Only Closed-Loop
Started 30
Completed 30
Not Completed 0
Period Title: 2-Week 24/7 Closed-Loop
Started 30
Completed 30
Not Completed 0
Period Title: 5-Month 24/7 Closed-Loop
Started 14
Completed 14
Not Completed 0
Arm/Group Title Closed-Loop Control System
Hide Arm/Group Description

A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.

Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:

  • DiAs – a smart-phone medical platform;
  • Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
  • Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
  • Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
  • Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
44
(18 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
13
  43.3%
Male
17
  56.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
24
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
5
  16.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
United States 15
Italy 5
Israel 5
France 5
Diabetes duration  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 30 participants
19
(13 to 28)
Body-mass index (BMI)  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 30 participants
25
(23 to 27)
Hemoglobin A1c (HbA1c)  
Median (Inter-Quartile Range)
Unit of measure:  Percent
Number Analyzed 30 participants
7.3
(7.1 to 7.7)
Daily total insulin dose  
Median (Inter-Quartile Range)
Unit of measure:  U/kg/day
Number Analyzed 30 participants
0.57
(0.42 to 0.72)
Daily basal insulin  
Median (Inter-Quartile Range)
Unit of measure:  U/kg/day
Number Analyzed 30 participants
0.27
(0.20 to 0.37)
1.Primary Outcome
Title Time Spent <70 mg/dL - Main Phase, Night Only
Hide Description Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, night only (23:00 to 07:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
3.0
(1.1 to 6.3)
1.1
(0.2 to 1.6)
0.4
(0.2 to 1.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments No adjustments were made for multiple comparisons.
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Time Spent <70 mg/dL - Main Phase, Day and Night
Hide Description Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
4.1
(2.0 to 7.8)
2.6
(1.6 to 3.6)
1.7
(1.1 to 2.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Time Spent <70 mg/dL - Main Phase, Day Only
Hide Description Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, day only (07:00 - 23:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
4.6
(2.0 to 7.0)
3.2
(2.1 to 4.6)
2.3
(1.3 to 3.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Time in Range 70-180 mg/dL - Main Phase, Day and Night
Hide Description Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
65
(59 to 69)
73
(65 to 78)
73
(68 to 76)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Time in Range 70-180 mg/dL - Main Phase, Night Only
Hide Description Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, night only (23:00 - 07:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
61
(53 to 73)
75
(69 to 80)
72
(65 to 80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Time in Range 70-180 mg/dL - Main Phase, Day Only
Hide Description Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, day only (07:00 - 23:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
65
(61 to 71)
70
(65 to 77)
72
(69 to 78)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Mean Sensor Glucose - Main Phase, Day and Night
Hide Description Mean CGM sensor glucose during study Main Phase
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Mean (Standard Deviation)
Unit of Measure: mg/dL
157  (18) 149  (12) 153  (12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Mean Sensor Glucose - Main Phase, Night Only
Hide Description Mean CGM sensor glucose during study Main Phase, night only (23:00 - 07:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Mean (Standard Deviation)
Unit of Measure: mg/dL
163  (23) 150  (12) 154  (13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Mean Sensor Glucose - Main Phase, Day Only
Hide Description Mean CGM sensor glucose during study Main Phase, day only (07:00 - 23:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Mean (Standard Deviation)
Unit of Measure: mg/dL
154  (19) 148  (15) 152  (14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Glucose Coefficient of Variation - Main Phase, Day and Night
Hide Description CGM Glucose Coefficient of Variation (CV) during study Main Phase
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage
38
(34 to 41)
35
(33 to 37)
34
(31 to 37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Glucose Coefficient of Variation - Main Phase, Night Only
Hide Description CGM Glucose Coefficient of Variation (CV) during study Main Phase, night only (23:00 - 07:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage
36
(32 to 40)
30
(29 to 34)
32
(27 to 36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title Glucose Coefficient of Variation - Main Phase, Day Only
Hide Description CGM Glucose Coefficient of Variation (CV) during study Main Phase, day only (07:00 - 23:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage
38
(34 to 42)
37
(34 to 39)
35
(31 to 37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
13.Secondary Outcome
Title Glucose Standard Deviation - Main Phase, Day and Night
Hide Description CGM Glucose Standard Deviation (SD) during study Main Phase
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
61
(53 to 69)
52
(48 to 58)
51
(47 to 55)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
14.Secondary Outcome
Title Glucose Standard Deviation - Main Phase, Night Only
Hide Description CGM Glucose Standard Deviation (SD) during study Main Phase, night only (23:00 - 07:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
61
(50 to 69)
47
(42 to 51)
48
(40 to 58)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
15.Secondary Outcome
Title Glucose Standard Deviation - Main Phase, Day Only
Hide Description CGM Glucose Standard Deviation (SD) during study Main Phase, day only (07:00 - 23:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
58
(53 to 65)
55
(49 to 60)
53
(47 to 54)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
16.Secondary Outcome
Title Time Spent >180 mg/dL - Main Phase, Day and Night
Hide Description Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
32
(25 to 36)
24
(20 to 31)
25
(22 to 28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
17.Secondary Outcome
Title Time Spent >180 mg/dL - Main Phase, Night Only
Hide Description Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase, night only (23:00 to 07:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
37
(24 to 45)
24
(19 to 28)
27
(19 to 34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
18.Secondary Outcome
Title Time Spent >180 mg/dL - Main Phase, Day Only
Hide Description Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase, day only (07:00 - 23:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
31
(23 to 35)
23
(19 to 32)
25
(21 to 29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
19.Secondary Outcome
Title Time Spent <50 mg/dL - Main Phase, Day and Night
Hide Description Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
0.8
(0.1 to 1.3)
0.2
(0.1 to 0.5)
0.2
(0.0 to 0.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
20.Secondary Outcome
Title Time Spent <50 mg/dL - Main Phase, Night Only
Hide Description Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase, night only (23:00 to 07:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
0.3
(0.0 to 1.0)
0.0
(0.0 to 0.1)
0.0
(0.0 to 0.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
21.Secondary Outcome
Title Time Spent <50 mg/dL - Main Phase, Day Only
Hide Description Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase, day only (07:00 - 23:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
0.9
(0.1 to 1.2)
0.2
(0.1 to 0.7)
0.2
(0.0 to 0.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
22.Secondary Outcome
Title Time Spent <60 mg/dL - Main Phase, Day and Night
Hide Description Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
2.2
(0.7 to 3.5)
1.1
(0.5 to 1.5)
0.7
(0.3 to 1.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
23.Secondary Outcome
Title Time Spent <60 mg/dL - Main Phase, Night Only
Hide Description Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase, night only (23:00 - 07:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
1.4
(0.4 to 2.9)
0.2
(0.0 to 0.6)
0.1
(0.0 to 0.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
24.Secondary Outcome
Title Time Spent <60 mg/dL - Main Phase, Day Only
Hide Description Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase, day only (07:00 - 23:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
2.4
(0.8 to 3.5)
1.4
(0.7 to 1.9)
0.7
(0.4 to 1.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
25.Secondary Outcome
Title LBGI - Main Phase, Day and Night
Hide Description Low Blood Glucose Index (LBGI) - Main Phase, Day and Night. The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: index scores
1.1
(0.6 to 1.9)
0.8
(0.6 to 0.9)
0.6
(0.4 to 0.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
26.Secondary Outcome
Title LBGI - Main Phase, Night Only
Hide Description Low Blood Glucose Index (LBGI) - Main Phase, night only (23:00 - 07:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: index scores
0.7
(0.4 to 1.6)
0.4
(0.3 to 0.5)
0.3
(0.2 to 0.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 1 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
27.Secondary Outcome
Title LBGI - Main Phase, Day Only
Hide Description Low Blood Glucose Index (LBGI) - Main Phase, day only (07:00 - 23:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: index scores
1.2
(0.8 to 1.7)
0.9
(0.7 to 1.2)
0.7
(0.4 to 0.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
28.Secondary Outcome
Title AOC 70 mg/dL - Main Phase, Day and Night
Hide Description Area Over the Curve (AOC) 70 mg/dL - Main Phase, Day and Night. The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
0.5
(0.2 to 0.9)
0.3
(0.1 to 0.4)
0.2
(0.1 to 0.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
29.Secondary Outcome
Title AOC 70 mg/dL - Main Phase, Night Only
Hide Description Area Over the Curve (AOC) 70 mg/dL - Main Phase, night only (23:00 - 07:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
0.3
(0.1 to 0.6)
0.1
(0.0 to 0.2)
0.0
(0.0 to 0.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
30.Secondary Outcome
Title AOC 70 mg/dL - Main Phase, Day Only
Hide Description Area Over the Curve (AOC) 70 mg/dL - Main Phase, day only (07:00 - 23:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
0.6
(0.2 to 0.9)
0.3
(0.2 to 0.5)
0.2
(0.1 to 0.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
31.Secondary Outcome
Title HBGI - Main Phase, Day and Night
Hide Description High Blood Glucose Index (HBGI) - Main Phase, Day and Night. The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: index scores
6.8
(5.9 to 7.8)
5.0
(4.3 to 6.2)
5.5
(4.6 to 6.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
32.Secondary Outcome
Title HBGI - Main Phase, Night Only
Hide Description High Blood Glucose Index (HBGI) - Main Phase, night only (23:00 - 07:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: index scores
7.5
(5.4 to 9.7)
5.1
(4.1 to 5.7)
5.4
(4.3 to 6.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
33.Secondary Outcome
Title HBGI - Main Phase, Day Only
Hide Description High Blood Glucose Index (HBGI) - Main Phase, day only (07:00 - 23:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: index scores
6.4
(5.2 to 8.0)
5.1
(4.4 to 7.1)
5.5
(4.7 to 6.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
34.Secondary Outcome
Title ADRR - Main Phase, Day and Night
Hide Description Average Daily Risk Range (ADRR) - Main Phase, Day and Night. ADRR is a metric that categorizes risk for hyper and hypoglycemic events. Low risk is scored 0-19, moderate risk is scored 20-40, and high risk is 40 and above.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: range scores
27
(25 to 34)
24
(21 to 28)
24
(19 to 27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
35.Secondary Outcome
Title AUC 180 mg/dL - Main Phase, Day and Night
Hide Description Area Under the Curve (AUC) 180 mg/dL - Main Phase, Day and Night. The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
15.0
(11.7 to 18.4)
9.2
(7.7 to 13.4)
11.3
(7.6 to 14.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
36.Secondary Outcome
Title AUC 180 mg/dL - Main Phase, Night Only
Hide Description Area Under the Curve (AUC) 180 mg/dL - Main Phase, night only (23:00 - 07:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
17.7
(7.9 to 26.4)
8.4
(5.7 to 11.0)
9.1
(6.4 to 14.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
37.Secondary Outcome
Title AUC 180 mg/dL - Main Phase, Day Only
Hide Description Area Under the Curve (AUC) 180 mg/dL - Main Phase, day only (07:00 - 23:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
13.6
(9.6 to 17.9)
10.0
(7.7 to 15.3)
9.8
(7.5 to 14.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
38.Secondary Outcome
Title Time Spent >250 mg/dL - Main Phase, Day and Night
Hide Description Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
7
(4 to 11)
4
(3 to 7)
5
(3 to 7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
39.Secondary Outcome
Title Time Spent >250 mg/dL - Main Phase, Night Only
Hide Description Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase, night only (23:00 to 07:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
8
(3 to 14)
3
(2 to 6)
4
(2 to 6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
40.Secondary Outcome
Title Time Spent >250 mg/dL - Main Phase, Day Only
Hide Description Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase, day only (07:00 - 23:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
6
(3 to 10)
5
(3 to 6)
5
(3 to 7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
41.Secondary Outcome
Title Time Spent >300 mg/dL - Main Phase, Day and Night
Hide Description Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
2
(1 to 3)
1
(0 to 2)
1
(0 to 2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments No adjustments were made for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
42.Secondary Outcome
Title Time Spent >300 mg/dL - Main Phase, Night Only
Hide Description Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase, night only (23:00 to 07:00)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded due to missing baseline CGM data
Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
Hide Arm/Group Description:
Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period
Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Overall Number of Participants Analyzed 29 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of CGM values
2
(0 to 6)
0
(0 to 1)
0
(0 to 2)
Hide Statistical Analysis 1
Statistical Analysis Overview