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The Insulin-Only Bionic Pancreas Bridging Study

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: NCT03565666
Recruitment Status : Completed
First Posted : June 21, 2018
Results First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Steven J. Russell, MD, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type1 Diabetes Mellitus
Interventions Device: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
Drug: iLet Bionic Pancreas insulin-only configuration with Fiasp
Other: Usual care
Enrollment 36
Recruitment Details 18 participants were recruited at MGH and 18 participants at Stanford
Pre-assignment Details This study consisted of a test-run period followed by an RCT
Arm/Group Title Usual Care Then Either iLet/Novolog/Humalog or iLet/Fiasp iLet/Novolog/Humalog Then Either iLet/Fiasp or Usual Care iLet/Fiasp Then Either iLet With Novolog/Humalog or Usual Care
Hide Arm/Group Description Participants first started the usual care arm (managing their diabetes with either multiple daily injections or insulin pump) for 7 days, then switched to either the insulin-only iLet using Novolog or Humalog for 7 days, or the insulin-only iLet using Fiasp for 7 days. No washout period was required between arms Participants first started using the insulin-only iLet with either Novolog or Humalog for 7 days then switched to either the usual care arm (managing their diabetes with multiple daily injections or insulin pump) for 7 days, or the insulin-only iLet arm using Fiasp for 7 days. No washout period was required between arms. Participants first started the insulin-only iLet using Fiasp for 7 days, then switched to either the insulin-only iLet arm using Novolog or Humalog for 7 days or the usual care arm, (managing their diabetes with either multiple daily injections or insulin pump) for 7 days. No washout period was required between arms
Period Title: Overall Study
Started 12 12 12
Completed 12 12 11
Not Completed 0 0 1
Arm/Group Title All Study Participants
Hide Arm/Group Description

36 adult patients with type 1 diabetes will complete 3 arms in a random-order crossover fashion. Participants in the usual care arm (UC) will manage their diabetes with either multiple daily injections or continuous subcutaneous insulin infusion (pump therapy). All subjects will wear Dexcom G5 continuous glucose monitor (CGM) and half of all subjects will also wear a senseonics CGM.

Each arm is 7 days, no washout between arms

Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
  91.4%
>=65 years
3
   8.6%
[1]
Measure Analysis Population Description: 1 participant was not analysed as they discontinued the study after 1 day and did not meet the criteria for their results to be included in the analyses (according to the protocol)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
41  (18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
19
  52.8%
Male
17
  47.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White non-hispanic Number Analyzed 36 participants
28
  77.8%
Bklack/African-American Number Analyzed 36 participants
1
   2.8%
Asian Number Analyzed 36 participants
5
  13.9%
American Indian/Alaskan Native Number Analyzed 36 participants
1
   2.8%
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 35 participants
35
 100.0%
[1]
Measure Analysis Population Description: 1 participant was not analysed as they discontinued the study after 1 day and did not meet the criteria for their results to be included in the analyses (according to the protocol)
1.Primary Outcome
Title Mean CGM Glucose
Hide Description [Not Specified]
Time Frame Days 3–7 for the RCT Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Arm iLet With Insulin Analogue (Novolog/Humalog) Arm iLet Using Fiasp Arm
Hide Arm/Group Description:
Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm
Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm
Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Overall Number of Participants Analyzed 35 34 35
Mean (Standard Deviation)
Unit of Measure: mg/dl
144.3  (9.5) 162  (26) 155  (12)
2.Primary Outcome
Title Percentage of Time Where Glucose is Less Than 54 mg/dL
Hide Description [Not Specified]
Time Frame Days 3–7 for the RCT Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Arm iLet With Insulin Analogue (Novolog/Humalog) Arm iLet Using Fiasp Arm
Hide Arm/Group Description:
Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm
Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm
Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Overall Number of Participants Analyzed 35 34 35
Median (Inter-Quartile Range)
Unit of Measure: percentage of time
0.58
(0.39 to 0.93)
0.53
(0.18 to 0.98)
0.56
(0.17 to 1.12)
3.Other Pre-specified Outcome
Title Episodes of Severe Hypoglycemia
Hide Description Pre-specified to report the total number of episodes summed across all participants
Time Frame Days 3–7 for the RCT Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Arm iLet With Insulin Analogue (Novolog/Humalog) Arm iLet Using Fiasp Arm
Hide Arm/Group Description:
Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm
Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm
Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Overall Number of Participants Analyzed 35 34 36
Measure Type: Number
Unit of Measure: number of episodes
0 0 1
4.Other Pre-specified Outcome
Title Episodes of Diabetic Ketoacidosis (DKA)
Hide Description pre-specified to report the total number of episodes summed across all participants
Time Frame Days 3–7 for the RCT Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Arm iLet With Insulin Analogue (Novolog/Humalog) Arm iLet Using Fiasp Arm
Hide Arm/Group Description:
Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm
Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm
Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Overall Number of Participants Analyzed 35 34 35
Measure Type: Number
Unit of Measure: number of episodes
0 0 0
5.Other Pre-specified Outcome
Title Percentage of Time Where Glucose is Less Than 70 mg/dL
Hide Description [Not Specified]
Time Frame Days 3–7 for the RCT Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Arm iLet Using Humalog/Novolog Arm iLet Using Fiasp Arm
Hide Arm/Group Description:
Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm
Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm
Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Overall Number of Participants Analyzed 35 34 35
Median (Inter-Quartile Range)
Unit of Measure: percentage of time
5.09
(3.73 to 5.5)
3.2
(1.3 to 5.2)
2.7
(1.5 to 3.9)
6.Other Pre-specified Outcome
Title Percentage of Time in the Glucose Target Range of 70-180 mg/dl
Hide Description [Not Specified]
Time Frame Days 3–7 for the RCT Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Arm iLet Using Humalog/Novolog Arm iLet Using Fiasp Arm
Hide Arm/Group Description:
Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm
Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm
Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Overall Number of Participants Analyzed 35 34 35
Mean (Standard Deviation)
Unit of Measure: percentage of time
73.3  (7.35) 62.2  (16.2) 69.2  (9.2)
7.Other Pre-specified Outcome
Title Percentage of Time Where Glucose is Greater Than 180 mg/dL
Hide Description [Not Specified]
Time Frame Days 3–7 for the RCT Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Arm iLet Using Humalog/Novolog Arm iLet Using Fiasp Arm
Hide Arm/Group Description:
Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm
Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm
Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Overall Number of Participants Analyzed 35 34 35
Mean (Standard Deviation)
Unit of Measure: percentage of time
21.8  (7.6) 34.4  (16.9) 27.96  (8.9)
8.Other Pre-specified Outcome
Title Percentage of Time Where Glucose is Less Than 60 mg/dL
Hide Description [Not Specified]
Time Frame Days 3–7 for the RCT Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Arm iLet Using Humalog/Novolog Arm iLet Using Fiasp Arm
Hide Arm/Group Description:
Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm
Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm
Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Overall Number of Participants Analyzed 35 34 35
Mean (Standard Deviation)
Unit of Measure: percentage of time
1.67  (0.73) 1.3  (1.23) 1.19  (0.93)
9.Other Pre-specified Outcome
Title Percentage of Time Where Glucose is Greater Than 250 mg/dL
Hide Description [Not Specified]
Time Frame Days 3–7 for the RCT Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Arm iLet Using Humalog/Novolog Arm iLet Using Fiasp Arm
Hide Arm/Group Description:
Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm
Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm
Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Overall Number of Participants Analyzed 35 34 35
Mean (Standard Deviation)
Unit of Measure: percentage of time
3.64  (3.03) 10.42  (10.43) 7.73  (4.99)
10.Other Pre-specified Outcome
Title Percentage Time in the Glucose Target Range of 70-120mg/dL
Hide Description [Not Specified]
Time Frame Days 3–7 for the RCT Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Arm iLet Using Humalog/Novolog Arm iLet Using Fiasp Arm
Hide Arm/Group Description:
Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm
Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm
Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Overall Number of Participants Analyzed 35 34 35
Mean (Standard Deviation)
Unit of Measure: percentage of time
30.65  (4.17) 25.65  (12.36) 28.24  (7.98)
11.Other Pre-specified Outcome
Title Mean Absolute Relative Difference Between Dexcom G5 CGM and Contour Next One Glucose Meter
Hide Description The MARD is calculated as the mean value of individual absolute relative differences (ARD). The ARD is calculated as follows: 100*(CGM-reference glucose)/reference glucose
Time Frame Days 3–7 for the RCT Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RCT Period Days 1-7
Hide Arm/Group Description:
36 adult patients with type 1 diabetes will complete 3 arms in a random-order crossover fashion. Half of the subjects (n=18) will wear the Dexcom G5 continuous glucose monitor (CGM) and the other half will wear a Senseonics Eversense CGM.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: MARD (CGMG-meter glucose)/meter glucose)
18.8  (8.2)
12.Other Pre-specified Outcome
Title Mean Absolute Relative Difference Between Senseonics Eversense CGM and Contour Next One Glucose Meter
Hide Description The MARD is calculated as the mean value of individual absolute relative differences (ARD). The ARD is calculated as follows: 100*(CGM-reference glucose)/reference glucose
Time Frame Days 1-7 of the Adult RCT period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Days 1-7 of RCT
Hide Arm/Group Description:
36 adult patients with type 1 diabetes will complete 3 arms in a random-order crossover fashion. Half of the subjects (n=18) will wear the Dexcom G5 continuous glucose monitor (CGM) and the other half will wear a Senseonics Eversense CGM.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: MARD: Mean of all [(CGMG − PG)/PG]
13.3  (5)
Time Frame Up to 2 months for the RCT
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Care Arm iLet With Humalog/Novolog Arm iLet Using Fiasp Arm
Hide Arm/Group Description

Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm

Usual care: Usual care

Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
All-Cause Mortality
Usual Care Arm iLet With Humalog/Novolog Arm iLet Using Fiasp Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)      0/36 (0.00%)      0/36 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care Arm iLet With Humalog/Novolog Arm iLet Using Fiasp Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/36 (0.00%)      0/36 (0.00%)      1/36 (2.78%)    
Endocrine disorders       
Serious adverse event  [1]  0/36 (0.00%)  0/36 (0.00%)  1/36 (2.78%)  1
Indicates events were collected by systematic assessment
[1]
Severe hypoglycemia defined as hypoglycemia necessitating the aid of a third party for recovery
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care Arm iLet With Humalog/Novolog Arm iLet Using Fiasp Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/36 (11.11%)      15/36 (41.67%)      16/36 (44.44%)    
Endocrine disorders       
Non-serious adverse event  [1]  0/36 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0
Non-serious adverse event  [2]  4/36 (11.11%)  10 14/36 (38.89%)  19 15/36 (41.67%)  27
Gastrointestinal disorders       
Non serious adverse event  [3]  0/36 (0.00%)  0 1/36 (2.78%)  1 1/36 (2.78%)  1
Indicates events were collected by systematic assessment
[1]
Elevated ketones >1.0 mmol/L (no DKA)
[2]
Hypoglycemia For the test run, data for hypos is collected from RedCap surveys and for RCT data is collected from CGM downloads
[3]
Nausea without vomiting
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Steven J. Russell
Organization: Mass. General Hospital
Phone: 617-726-8722
EMail: sjrussell@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Steven J. Russell, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03565666     History of Changes
Other Study ID Numbers: 2018P000853
First Submitted: May 29, 2018
First Posted: June 21, 2018
Results First Submitted: April 15, 2019
Results First Posted: September 4, 2019
Last Update Posted: September 4, 2019