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A Multicenter Study of Outpatient Automated Blood Glucose Control With a Bihormonal Bionic Pancreas

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ClinicalTrials.gov Identifier: NCT02092220
Recruitment Status : Completed
First Posted : March 20, 2014
Results First Posted : October 20, 2017
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
Boston University
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 Diabetes Mellitus Type 1
Interventions Device: Bionic Pancreas
Device: Insulin pump with or without CGM
Enrollment 48
Recruitment Details  
Pre-assignment Details 48 participants were enrolled in the trial, but only 43 participants actually participated. 2 participants were not eligible and 3 participants were not randomized because target enrollment was already met.
Arm/Group Title Bionic Pancreas Then Usual Care Usual Care Then Bionic Pancreas
Hide Arm/Group Description Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days in Period 1 followed by Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days in Period 2. There was a 3 to 10-day washout period between periods. Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days in Period 1 followed by Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days in Period 2. There was a 3 to 10-day washout period between periods.
Period Title: Period 1
Started 21 22
Completed 21 20
Not Completed 0 2
Reason Not Completed
Unrelated Illness             0             2
Period Title: Period 2
Started 21 20
Completed 20 19
Not Completed 1 1
Reason Not Completed
Severe Hypoglycaemia             1             0
Nausea, Anxiety, Inconvenience             0             1
Arm/Group Title All Randomized Participants
Hide Arm/Group Description All randomized participants who completed both periods of the study.
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
<=18 years
0
   0.0%
Between 18 and 65 years
39
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants
33.3  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
21
  53.8%
Male
18
  46.2%
1.Primary Outcome
Title Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11
Hide Description Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 2 to 11 were averaged.
Time Frame Days 2 to 11 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: milligrams/deciliter (mg/dL)
141.2  (9.9) 161.5  (28.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bionic Pancreas, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Repeated measures model.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -20.28
Confidence Interval (2-Sided) 95%
-28.00 to -12.56
Parameter Dispersion
Type: Standard Deviation
Value: 24.59
Estimation Comments Bionic Pancreas Arm - Usual Care Arm
2.Primary Outcome
Title Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11
Hide Description Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than 60 mg/dL [3.3 millimoles/liter (mmol/L)] during Days 2 to 11 was calculated.
Time Frame Days 2 to 11 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: percentage of time
0.6  (0.6) 1.9  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bionic Pancreas, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Repeated measures model.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.8 to 1.8
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean CGMG Values
Hide Description Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 1 and Days 1 to 11 were averaged.
Time Frame Day 1 and Days 1 to 11 in each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: mg/dL
Day 1 145.3  (17.6) 161.9  (45.2)
Days 1 to 11 141.5  (10.0) 161.7  (29.3)
4.Secondary Outcome
Title Percentage of Time With CGMG Concentration by Ranges During Day 1
Hide Description

Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated:

< 50 mg/dL (2.8 mmol/L) < 60 mg/dL (3.3 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)

Time Frame Day 1 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: percentage of time
< 50 mg/dl (2.8 mmol/L) 0.1  (0.3) 0.9  (1.5)
< 60 mg/dL (3.3 mmol/L) 0.5  (0.9) 2.3  (3.4)
< 70 mg/dl (3.9 mmol/L) 1.5  (2.3) 5.0  (6.5)
70 to 120 mg/dL (3.9 to 6.7 mmol/L) 39.4  (13.6) 28.5  (18.6)
70-180 mg/dl (3.9 to 10.0 mmol/L) 76.8  (11.5) 62.1  (22.2)
> 180 mg/dL (10.0 mmol/L) 21.7  (11.2) 32.9  (24.0)
> 250 mg/dL (13.9 mmol/L) 6.0  (7.4) 12.3  (17.7)
5.Secondary Outcome
Title Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11
Hide Description

Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated:

< 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)

Time Frame Days 1 to 11 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: percentage of time
< 50 mg/dl (2.8 mmol/L) 0.1  (0.1) 0.6  (0.6)
< 60 mg/dL (3.3 mmol/L) 0.6  (0.5) 1.9  (1.8)
< 70 mg/dl (3.9 mmol/L) 1.8  (1.4) 4.6  (3.9)
70 to 120 mg/dL (3.9 to 6.7 mmol/L) 40.6  (8.0) 27.5  (11.3)
70-180 mg/dl (3.9 to 10.0 mmol/L) 78.3  (6.0) 61.9  (14.5)
> 180 mg/dL (10.0 mmol/L) 19.9  (6.0) 33.5  (16.5)
> 250 mg/dL (13.9 mmol/L) 4.4  (2.7) 11.0  (10.3)
6.Secondary Outcome
Title Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11
Hide Description

Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated:

< 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)

Time Frame Days 2 to 11 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: percentage of time
< 50 mg/dl (2.8 mmol/L) 0.1  (0.2) 0.6  (0.6)
< 70 mg/dl (3.9 mmol/L) 1.8  (1.4) 4.5  (3.8)
70 to 120 mg/dL (3.9 to 6.7 mmol/L) 40.7  (7.8) 27.4  (11.4)
70-180 mg/dl (3.9 to 10.0 mmol/L) 78.4  (6.0) 61.9  (14.4)
> 180 mg/dL (10.0 mmol/L) 19.8  (6.1) 33.6  (16.4)
> 250 mg/dL (13.9 mmol/L) 4.2  (2.7) 10.9  (10.0)
7.Secondary Outcome
Title Percentage of Participants With Mean CGMG < 154 mg/dl
Hide Description Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Glycosylated Hemoglobin A1C of 7%.
Time Frame Day 1, Days 2 to11, Days 1 to11 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Measure Type: Number
Unit of Measure: percentage of participants
Day 1 79 59
Days 1 to 11 92 41
Days 2 to 11 92 41
8.Secondary Outcome
Title Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
Hide Description A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.
Time Frame Days 1-11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: hypoglycemic events
<50 mg/dl 0.58  (0.87) 1.0  (1.06)
<60 mg/dl 1.33  (1.31) 2.88  (2.67)
<70 mg/dl 2.68  (2.4) 5.28  (4.14)
9.Secondary Outcome
Title Percentage of Days That CGM Was Used by Participants as Part of Their Usual Care
Hide Description The percentage of days that participants reported the CGM device was being worn and working properly is reported.
Time Frame Days 1-11 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study. This outcome measure applies only to the Usual Care arm.
Arm/Group Title Usual Care
Hide Arm/Group Description:
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: percentage of days
49
10.Secondary Outcome
Title Glycated Albumin on Day 12
Hide Description [Not Specified]
Time Frame Day 12 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
No data was collected for Glycated Albumin.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title 1,5-anhydroglucitol on Day 12
Hide Description [Not Specified]
Time Frame Day 12 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
No data was collected for 1,5-anhydroglucitol.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Anti-Insulin and Anti-Glucagon Antibodies on Day 12
Hide Description [Not Specified]
Time Frame Day 12 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
No data was collected for Anti-Insulin and Anti-Glucagon Antibodies.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Number of Participants With Severe Hypoglycemic Events
Hide Description A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.
Time Frame 11 days of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   2.6%
14.Secondary Outcome
Title Number of Episodes of Symptomatic Hypoglycemia
Hide Description The number of episodes of symptomatic hypoglycemia were reported daily by the participant. The average number of episodes of symptomatic hypoglycemia per day was calculated.
Time Frame Day 1, Days 1 to 11 and Days 2 to 11 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: episodes per day
Day 1 0.74  (1.04) 1.13  (1.12)
Days 1 to 11 0.59  (0.56) 0.90  (0.64)
Days 2 to 11 0.57  (0.54) 0.88  (0.64)
15.Secondary Outcome
Title Number of Reported Carbohydrate Interventions for Hypoglycemia
Hide Description The number of carbohydrate interventions for hypoglycemia were reported daily by the participant. The average number of carbohydrate interventions per day is reported.
Time Frame Day 1, Days 1 to 11 and Days 2 to 11 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: interventions per day
Day 1 0.36  (0.63) 1.29  (1.25)
Days 1 to 11 0.39  (0.34) 0.96  (0.72)
Days 2 to 11 0.40  (0.34) 0.93  (0.72)
16.Secondary Outcome
Title Total Grams of Carbohydrate Taken for Hypoglycemia
Hide Description

The total grams of carbohydrate taken for hypoglycemia as reported daily by the participant were averaged.

The total number of grams of carbohydrate taken for hypoglycemia were reported daily by the participant. The total number of grams of carbohydrate taken are reported.

Time Frame Day 1, Days 1 to 11 and Days 2 to 11 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: grams of carbohydrate per day
Day 1 6.18  (11.61) 25.61  (26.12)
Days 1 to 11 22.04  (13.62) 34.8  (16.21)
Days 2 to 11 22.27  (13.79) 34.8  (16.84)
17.Secondary Outcome
Title Insulin Total Daily Dose
Hide Description Insulin total daily dose is reported in units per kilogram per day (U/kg/day).
Time Frame Day 1, Days 1 to 11, Days 2 to 11 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: U/kg/day
Day 1 0.64  (0.20) 0.64  (0.21)
Days 1 to 11 0.66  (0.15) 0.63  (0.18)
Days 2 to 11 0.66  (0.15) 0.62  (0.18)
18.Secondary Outcome
Title Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm
Hide Description Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).
Time Frame Day 1, Days 2 to 11, Days 1 to 11 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.
Arm/Group Title Bionic Pancreas
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: µg/kg/day
Day 1 7.8  (3.84)
Days 1 to 11 6.9  (2.34)
Days 2 to 11 6.8  (2.4)
19.Secondary Outcome
Title Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm
Hide Description [Not Specified]
Time Frame Day 1, Days 2 to 11, Days 1 to11, Overall, Daytime, Nighttime of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas
Hide Arm/Group Description:
All randomized participants who completed both periods of the study.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: mg/dL
Day 1, Overall 101.2  (2.0)
Day 1, Daytime 101.3  (1.6)
Day 1, Nighttime 101.0  (3.9)
Day 2 to 11, Overall 101.9  (5.0)
Day 2 to 11, Daytime 102.0  (5.1)
Day 2 to 11, Nighttime 101.7  (4.9)
Day 1 to 11, Overall 101.8  (4.6)
Day 1 to 11, Daytime 101.9  (4.7)
Day 1 to 11, Nighttime 101.6  (4.5)
20.Secondary Outcome
Title Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly
Hide Description Not functioning properly includes issues due to system crash, communication problems between CGM and bionic pancreas, communication problems between bionic pancreas and pumps and pump malfunction.
Time Frame 11 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study. Reported for the Bionic pancreas arm only
Arm/Group Title Bionic Pancreas
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: percentage of time
Insulin pump Lost Wireless Connectivity 3.9  (2.5)
Glucagon Pump Lost Wireless Connectivity 4.1  (2.4)
CGM Signal Unavailable 3.4  (1.3)
21.Secondary Outcome
Title Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Hide Description Participants rated their nausea using a 0 to 10 centimeter (cm) VAS where 0=least severe nausea to 10=most severe nausea. The average nausea index scores during Days 1 to 11 and Days 2 to 11 were calculated.
Time Frame Day 1, Days 1 to 11, Days 2 to 11 and each individual day 2 to 11 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: cm
Day 1 0.79  (1.54) 0.00  (0.00)
Days 1 to 11 0.51  (0.79) 0.05  (0.17)
Days 2 to 11 0.48  (0.82) 0.05  (0.18)
Day 2 0.46  (1.55) 0.08  (0.48)
Day 3 0.56  (1.47) 0.03  (0.16)
Day 4 0.41  (1.19) 0.13  (0.47)
Day 5 0.33  (1.11) 0.00  (0.00)
Day 6 0.56  (1.25) 0.00  (0.00)
Day 7 0.49  (1.47) 0.03  (0.16)
Day 8 0.67  (1.49) 0.08  (0.35)
Day 9 0.44  (1.23) 0.10  (0.50)
Day 10 0.59  (1.62) 0.08  (0.35)
Day 11 0.28  (1.45) 0.03  (0.16)
22.Secondary Outcome
Title Change From Baseline in Body Weight
Hide Description The change in body weight collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in body weight and a positive change from Baseline indicates an increase in body weight.
Time Frame Baseline and Day 12 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: kilograms
0.4  (0.95) 0.1  (1.1)
23.Secondary Outcome
Title Change From Baseline in Hemoglobin
Hide Description The change in the value of hemoglobin collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in hemoglobin and a positive change from Baseline indicates an increase in hemoglobin.
Time Frame Baseline and Day 12 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: grams/deciliter (mg/dL)
-0.16  (0.68) 0.14  (0.68)
24.Secondary Outcome
Title Number of Participants With Skin Rash
Hide Description [Not Specified]
Time Frame 11 days of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
25.Other Pre-specified Outcome
Title Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM
Hide Description [Not Specified]
Time Frame 11 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: percentage of possible values
96.6  (1.4) 96.3  (1.6)
26.Other Pre-specified Outcome
Title Number of Unscheduled Infusion Set Replacements
Hide Description [Not Specified]
Time Frame 11 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study. Glucagon infusion sets are not applicable to the Usual Care arm.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Measure Type: Number
Unit of Measure: Infusion Set Relacements
Glucagon Unscheduled Infusion Set Replacements Number Analyzed 39 participants 0 participants
14
Insulin Unscheduled Infusion Set Replacements Number Analyzed 39 participants 39 participants
11 15
27.Other Pre-specified Outcome
Title Mean Daily Basal Insulin Dose
Hide Description Daily basal insulin dose reported in Units per kilogram per day (U/kg/day).
Time Frame Day 1, Days 2 to 11, each individual day 2 to 11 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: U/kg/day
Day 1 0.3  (0.1) 0.3  (0.1)
Days 2 to 11 0.3  (0.1) 0.3  (0.002)
Day 2 0.3  (0.1) 0.3  (0.1)
Day 3 0.3  (0.1) 0.3  (0.1)
Day 4 0.3  (0.1) 0.3  (0.1)
Day 5 0.3  (0.1) 0.3  (0.1)
Day 6 0.3  (0.1) 0.3  (0.1)
Day 7 0.3  (0.1) 0.3  (0.1)
Day 8 0.3  (0.1) 0.3  (0.1)
Day 9 0.3  (0.1) 0.3  (0.1)
Day 10 0.3  (0.1) 0.3  (0.1)
Day 11 0.3  (0.1) 0.3  (0.1)
28.Other Pre-specified Outcome
Title Mean Daily Bolus Insulin Dose
Hide Description Daily bolus insulin dose reported in Units per kilogram per day (U/kg/day).
Time Frame Day 1, Days 1 to 11, Days 2 to 11, each individual day 2 to 11 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: U/kg/day
Day 1 0.4  (0.1) 0.3  (0.2)
Days 1 to 11 0.4  (0.1) 0.3  (0.015)
Days 2 to 11 0.4  (0.1) 0.3  (0.015)
Day 2 0.4  (0.1) 0.3  (0.2)
Day 3 0.4  (0.1) 0.3  (0.2)
Day 4 0.4  (0.1) 0.3  (0.3)
Day 5 0.4  (0.1) 0.3  (0.2)
Day 6 0.4  (0.1) 0.3  (0.2)
Day 7 0.4  (0.1) 0.3  (0.2)
Day 8 0.4  (0.1) 0.3  (0.2)
Day 9 0.4  (0.1) 0.3  (0.2)
Day 10 0.4  (0.2) 0.3  (0.2)
Day 11 0.4  (0.1) 0.3  (0.2)
29.Other Pre-specified Outcome
Title CGM Mean Absolute Relative Differences (MARD) Versus Time-stamped Blood Glucose (BG) Values From Meter Downloads
Hide Description This outcome measure compares the time stamped PG values from the glucose meter to the corresponding CGM glucose value to determine the overall accuracy of the CGM.
Time Frame 11 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: percent difference
19.2  (31.4) 18.0  (28.2)
Time Frame Days 1 to 11
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days. Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
All-Cause Mortality
Bionic Pancreas Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/41 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Bionic Pancreas Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/41 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bionic Pancreas Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   41/41 (100.00%)   41/41 (100.00%) 
Gastrointestinal disorders     
Nausea   21/41 (51.22%)  5/41 (12.20%) 
Metabolism and nutrition disorders     
Hypoglycemia   41/41 (100.00%)  41/41 (100.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Steven J Russell
Organization: Massachusetts General Hospital
Phone: 617-726-1848
EMail: sjrussell@partners.org
Layout table for additonal information
Responsible Party: Steven J. Russell, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02092220     History of Changes
Other Study ID Numbers: Multicenter Study
First Submitted: March 18, 2014
First Posted: March 20, 2014
Results First Submitted: November 1, 2016
Results First Posted: October 20, 2017
Last Update Posted: November 22, 2017