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Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller

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ClinicalTrials.gov Identifier: NCT02280863
Recruitment Status : Completed
First Posted : November 3, 2014
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Bruce A. Buckingham, Stanford University

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: Medtronic Hybrid Closed-loop System - Android Platform
Device: Medtronic Hybrid Closed-loop Integrated System
Enrollment 24

Recruitment Details Adults were recruited in the first 2 cohorts. Following analysis of the adult cohorts, adolescents were recruited in the third cohort.
Pre-assignment Details  
Arm/Group Title Adult Cohort Adolescent Cohort
Hide Arm/Group Description

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Period Title: Android Platform
Started 8 0
Completed 8 0
Not Completed 0 0
Period Title: Integrated Platform
Started 9 [1] 15
Completed 9 14
Not Completed 0 1
Reason Not Completed
Met stopping criteria             0             1
[1]
One additional participant was enrolled for part 2.
Arm/Group Title Adult Cohort Adolescent Cohort Total
Hide Arm/Group Description

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Total of all reporting groups
Overall Number of Baseline Participants 9 15 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 15 participants 24 participants
0-12 year
0
   0.0%
0
   0.0%
0
   0.0%
13-17 years
0
   0.0%
15
 100.0%
15
  62.5%
18-64 years
9
 100.0%
0
   0.0%
9
  37.5%
65 year and older
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 15 participants 24 participants
Female
8
  88.9%
9
  60.0%
17
  70.8%
Male
1
  11.1%
6
  40.0%
7
  29.2%
1.Primary Outcome
Title Count of Participants With no More Than One Meter Glucose Value <50 mg/dL and no Values <40 mg/dL, no More Than Two Episodes With Meter Glucose Values Remaining >300 mg/dL for More Than 1 Hour, and no Ketonemia, Seizures, or Loss of Consciousness
Hide Description

Our definition of a subject successfully participating in a cohort is:

  1. No more than one meter glucose value <50 mg/dL and no values <40 mg/dL
  2. No more than two episodes with meter glucose values remaining >300 mg/dL for more than 1 hour that are unrelated to an infusion set failure
  3. No ketonemia >1.0 mmol/L, while the system is functional unless related to an intercurrent illness or infusion set failure
  4. No seizures or loss of consciousness while system is on and functional
Time Frame Up to 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adult Cohort - Medtronic Android Interface Adult Cohort - Integrated System Interface Adolescent Cohort
Hide Arm/Group Description:

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Overall Number of Participants Analyzed 8 9 15
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   6.7%
2.Secondary Outcome
Title Mean Glucose Values
Hide Description Mean glucose values are reported as assessed by continuous glucose monitoring (CGM; subcutaneous sensor, day and night values).
Time Frame Up to 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol were included in the analysis.
Arm/Group Title Adult Cohort - Medtronic Android Interface Adult Cohort - Integrated System Interface Adolescent Cohort
Hide Arm/Group Description:

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Overall Number of Participants Analyzed 8 9 14
Mean (Standard Deviation)
Unit of Measure: mg/dL
Day (open loop) 151  (14) 144  (15) 171  (30)
Day (closed loop) 156  (14) 152  (14) 153  (17)
Night (open loop) 156  (26) 142  (18) 168  (39)
Night (closed loop) 155  (22) 148  (20) 144  (19)
3.Secondary Outcome
Title Mean Glucose Values, Fingerstick Glucose Meter Value, Adult Cohorts
Hide Description Mean glucose values are reported as assessed by fingerstick glucose meter value.
Time Frame Up to 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data are presented for adult cohorts only.
Arm/Group Title Adult Cohort - Medtronic Android Interface Adult Cohort - Integrated System Interface
Hide Arm/Group Description:

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: mg/dL
Open loop 148  (31) 164  (41)
Closed loop 127  (14) 151  (36)
4.Secondary Outcome
Title Median Glucose Values, Fingerstick Glucose Meter Value, Adolescent Cohort
Hide Description Median an glucose values are reported as assessed by fingerstick glucose meter value.
Time Frame Up to 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data are presented for the adolescent cohort only. Participants who completed the protocol were included in the analysis.
Arm/Group Title Adolescent Cohort
Hide Arm/Group Description:

Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Open loop
181
(121 to 191)
Closed loop
132
(121 to 138)
5.Secondary Outcome
Title Percentage of Time Within Glucose Range of 70-180 mg/dL
Hide Description [Not Specified]
Time Frame Up to 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol were included in the analysis.
Arm/Group Title Adult Cohort - Medtronic Android Interface Adult Cohort - Integrated System Interface Adolescent Cohort
Hide Arm/Group Description:

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Overall Number of Participants Analyzed 8 9 14
Mean (Standard Deviation)
Unit of Measure: percentage of time in range
Open loop 71.9  (10.6) 67.7  (8.1) 55.2  (14.2)
Closed loop 71.0  (12.4) 71.8  (12.5) 69.8  (9.7)
6.Secondary Outcome
Title Percentage of Fingerstick Meter Glucose Value Tests <70 mg/dL
Hide Description [Not Specified]
Time Frame Up to 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol were included in the analysis.
Arm/Group Title Adult Cohort - Medtronic Android Interface Adult Cohort - Integrated System Interface Adolescent Cohort
Hide Arm/Group Description:

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Overall Number of Participants Analyzed 8 9 14
Mean (Standard Deviation)
Unit of Measure: percentage of tests
Open loop 4.7  (5.1) 13.0  (9.7) 11.7  (9.9)
Closed loop 1.4  (1.7) 7.6  (2.9) 13.5  (13.9)
7.Secondary Outcome
Title Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts
Hide Description [Not Specified]
Time Frame Up to 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data are presented for adult cohorts only.
Arm/Group Title Adult Cohort - Medtronic Android Interface Adult Cohort - Integrated System Interface
Hide Arm/Group Description:

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: percentage of time
Day (open loop) 2.7  (1.3) 7.6  (5.4)
Day (closed loop) 1.4  (1.8) 2.0  (1.4)
Night (open loop) 3.5  (4.3) 8.2  (8.7)
Night (closed loop) 1.9  (3.4) 1.2  (1.7)
8.Secondary Outcome
Title Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort
Hide Description [Not Specified]
Time Frame Up to 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data are presented for the adolescent cohort only. Participants who completed the protocol were included in the analysis.
Arm/Group Title Adolescent Cohort
Hide Arm/Group Description:

Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: percentage of time
Day (open loop)
2.7
(0.8 to 9.2)
Day (closed loop)
2.5
(1.7 to 3.5)
Night (open loop)
2.5
(0.5 to 4.7)
Night (closed loop)
0.7
(0.0 to 4.2)
9.Secondary Outcome
Title Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Medtronic Android Interface
Hide Description [Not Specified]
Time Frame Up to 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data are presented for the Adult Cohort - Medtronic Android Interface only
Arm/Group Title Adult Cohort - Medtronic Android Interface
Hide Arm/Group Description:

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Overall Number of Participants Analyzed 8
Median (Inter-Quartile Range)
Unit of Measure: percentage of readings
Open loop
0.0
(0.0 to 3.3)
Closed loop
0.7
(0.0 to 3.6)
10.Secondary Outcome
Title Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Integrated System Interface and Adolescent Cohort
Hide Description [Not Specified]
Time Frame Up to 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data are presented for the Adult Cohort - Integrated System Interface and the Adolescent Cohort only. Participants who completed the protocol were included in the analysis.
Arm/Group Title Adult Cohort - Integrated System Interface Adolescent Cohort
Hide Arm/Group Description:

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Overall Number of Participants Analyzed 9 14
Mean (Standard Deviation)
Unit of Measure: percentage of readings
Open loop 3.0  (4.3) 8.9  (9.8)
Closed loop 3.1  (2.5) 6.7  (9.2)
Time Frame Up to 10 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adult Cohort Adolescent Cohort
Hide Arm/Group Description

In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.

Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.

All-Cause Mortality
Adult Cohort Adolescent Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adult Cohort Adolescent Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adult Cohort Adolescent Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      1/15 (6.67%)    
Endocrine disorders     
Hypoglycaemia  [1]  0/9 (0.00%)  0 1/15 (6.67%)  2
Indicates events were collected by systematic assessment
[1]
Hypoglycaemia defined as blood glucose <50 mg/dL
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Name/Title: Dr. Bruce Buckingham, MD
Organization: Stanford University
Responsible Party: Bruce A. Buckingham, Stanford University
ClinicalTrials.gov Identifier: NCT02280863     History of Changes
Other Study ID Numbers: IDE: G140086
1-SRA-2014-238- ( Other Grant/Funding Number: JDRF Grant Key: 1-SRA-2014-238-M-R )
IRB 29973 ( Other Identifier: Stanford University )
First Submitted: July 9, 2014
First Posted: November 3, 2014
Results First Submitted: March 2, 2018
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018