Trial Outcomes & Findings for A Multicenter Study of Outpatient Automated Blood Glucose Control With a Bihormonal Bionic Pancreas (NCT NCT02092220)
NCT ID: NCT02092220
Last Updated: 2017-11-22
Results Overview
Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 2 to 11 were averaged.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Days 2 to 11 of each period
Results posted on
2017-11-22
Participant Flow
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.
Participant milestones
| Measure |
Bionic Pancreas Then Usual Care
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 Then Bionic Pancreas
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 1
STARTED
|
21
|
22
|
|
Period 1
COMPLETED
|
21
|
20
|
|
Period 1
NOT COMPLETED
|
0
|
2
|
|
Period 2
STARTED
|
21
|
20
|
|
Period 2
COMPLETED
|
20
|
19
|
|
Period 2
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Bionic Pancreas Then Usual Care
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 Then Bionic Pancreas
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 1
Unrelated Illness
|
0
|
2
|
|
Period 2
Severe Hypoglycaemia
|
1
|
0
|
|
Period 2
Nausea, Anxiety, Inconvenience
|
0
|
1
|
Baseline Characteristics
A Multicenter Study of Outpatient Automated Blood Glucose Control With a Bihormonal Bionic Pancreas
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=39 Participants
All randomized participants who completed both periods of the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 11.0 • n=93 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Days 2 to 11 of each periodPopulation: All randomized participants who completed both periods of the study.
Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 2 to 11 were averaged.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11
|
141.2 milligrams/deciliter (mg/dL)
Standard Deviation 9.9
|
161.5 milligrams/deciliter (mg/dL)
Standard Deviation 28.7
|
PRIMARY outcome
Timeframe: Days 2 to 11 of each periodPopulation: All randomized participants who completed both periods of the study.
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.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11
|
0.6 percentage of time
Standard Deviation 0.6
|
1.9 percentage of time
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Day 1 and Days 1 to 11 in each periodPopulation: All randomized participants who completed both periods of the study.
Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 1 and Days 1 to 11 were averaged.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Mean CGMG Values
Day 1
|
145.3 mg/dL
Standard Deviation 17.6
|
161.9 mg/dL
Standard Deviation 45.2
|
|
Mean CGMG Values
Days 1 to 11
|
141.5 mg/dL
Standard Deviation 10.0
|
161.7 mg/dL
Standard Deviation 29.3
|
SECONDARY outcome
Timeframe: Day 1 of each periodPopulation: All randomized participants who completed both periods of the study.
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)
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Percentage of Time With CGMG Concentration by Ranges During Day 1
< 50 mg/dl (2.8 mmol/L)
|
0.1 percentage of time
Standard Deviation 0.3
|
0.9 percentage of time
Standard Deviation 1.5
|
|
Percentage of Time With CGMG Concentration by Ranges During Day 1
< 60 mg/dL (3.3 mmol/L)
|
0.5 percentage of time
Standard Deviation 0.9
|
2.3 percentage of time
Standard Deviation 3.4
|
|
Percentage of Time With CGMG Concentration by Ranges During Day 1
< 70 mg/dl (3.9 mmol/L)
|
1.5 percentage of time
Standard Deviation 2.3
|
5.0 percentage of time
Standard Deviation 6.5
|
|
Percentage of Time With CGMG Concentration by Ranges During Day 1
70 to 120 mg/dL (3.9 to 6.7 mmol/L)
|
39.4 percentage of time
Standard Deviation 13.6
|
28.5 percentage of time
Standard Deviation 18.6
|
|
Percentage of Time With CGMG Concentration by Ranges During Day 1
70-180 mg/dl (3.9 to 10.0 mmol/L)
|
76.8 percentage of time
Standard Deviation 11.5
|
62.1 percentage of time
Standard Deviation 22.2
|
|
Percentage of Time With CGMG Concentration by Ranges During Day 1
> 180 mg/dL (10.0 mmol/L)
|
21.7 percentage of time
Standard Deviation 11.2
|
32.9 percentage of time
Standard Deviation 24.0
|
|
Percentage of Time With CGMG Concentration by Ranges During Day 1
> 250 mg/dL (13.9 mmol/L)
|
6.0 percentage of time
Standard Deviation 7.4
|
12.3 percentage of time
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: Days 1 to 11 of each periodPopulation: All randomized participants who completed both periods of the study.
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)
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11
< 50 mg/dl (2.8 mmol/L)
|
0.1 percentage of time
Standard Deviation 0.1
|
0.6 percentage of time
Standard Deviation 0.6
|
|
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11
< 60 mg/dL (3.3 mmol/L)
|
0.6 percentage of time
Standard Deviation 0.5
|
1.9 percentage of time
Standard Deviation 1.8
|
|
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11
< 70 mg/dl (3.9 mmol/L)
|
1.8 percentage of time
Standard Deviation 1.4
|
4.6 percentage of time
Standard Deviation 3.9
|
|
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11
70 to 120 mg/dL (3.9 to 6.7 mmol/L)
|
40.6 percentage of time
Standard Deviation 8.0
|
27.5 percentage of time
Standard Deviation 11.3
|
|
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11
70-180 mg/dl (3.9 to 10.0 mmol/L)
|
78.3 percentage of time
Standard Deviation 6.0
|
61.9 percentage of time
Standard Deviation 14.5
|
|
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11
> 180 mg/dL (10.0 mmol/L)
|
19.9 percentage of time
Standard Deviation 6.0
|
33.5 percentage of time
Standard Deviation 16.5
|
|
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11
> 250 mg/dL (13.9 mmol/L)
|
4.4 percentage of time
Standard Deviation 2.7
|
11.0 percentage of time
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Days 2 to 11 of each periodPopulation: All randomized participants who completed both periods of the study.
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)
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11
< 50 mg/dl (2.8 mmol/L)
|
0.1 percentage of time
Standard Deviation 0.2
|
0.6 percentage of time
Standard Deviation 0.6
|
|
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11
< 70 mg/dl (3.9 mmol/L)
|
1.8 percentage of time
Standard Deviation 1.4
|
4.5 percentage of time
Standard Deviation 3.8
|
|
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11
70 to 120 mg/dL (3.9 to 6.7 mmol/L)
|
40.7 percentage of time
Standard Deviation 7.8
|
27.4 percentage of time
Standard Deviation 11.4
|
|
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11
70-180 mg/dl (3.9 to 10.0 mmol/L)
|
78.4 percentage of time
Standard Deviation 6.0
|
61.9 percentage of time
Standard Deviation 14.4
|
|
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11
> 180 mg/dL (10.0 mmol/L)
|
19.8 percentage of time
Standard Deviation 6.1
|
33.6 percentage of time
Standard Deviation 16.4
|
|
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11
> 250 mg/dL (13.9 mmol/L)
|
4.2 percentage of time
Standard Deviation 2.7
|
10.9 percentage of time
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Day 1, Days 2 to11, Days 1 to11 of each periodPopulation: All randomized participants who completed both periods of the study.
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%.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Mean CGMG < 154 mg/dl
Day 1
|
79 percentage of participants
|
59 percentage of participants
|
|
Percentage of Participants With Mean CGMG < 154 mg/dl
Days 1 to 11
|
92 percentage of participants
|
41 percentage of participants
|
|
Percentage of Participants With Mean CGMG < 154 mg/dl
Days 2 to 11
|
92 percentage of participants
|
41 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1-11A 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.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
<50 mg/dl
|
0.58 hypoglycemic events
Standard Deviation 0.87
|
1.0 hypoglycemic events
Standard Deviation 1.06
|
|
Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
<60 mg/dl
|
1.33 hypoglycemic events
Standard Deviation 1.31
|
2.88 hypoglycemic events
Standard Deviation 2.67
|
|
Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
<70 mg/dl
|
2.68 hypoglycemic events
Standard Deviation 2.4
|
5.28 hypoglycemic events
Standard Deviation 4.14
|
SECONDARY outcome
Timeframe: Days 1-11 of each periodPopulation: All randomized participants who completed both periods of the study. This outcome measure applies only to the Usual Care arm.
The percentage of days that participants reported the CGM device was being worn and working properly is reported.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
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.
|
|---|---|---|
|
Percentage of Days That CGM Was Used by Participants as Part of Their Usual Care
|
49 percentage of days
|
—
|
SECONDARY outcome
Timeframe: Day 12 of each periodPopulation: No data was collected for Glycated Albumin.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 12 of each periodPopulation: No data was collected for 1,5-anhydroglucitol.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 12 of each periodPopulation: No data was collected for Anti-Insulin and Anti-Glucagon Antibodies.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 11 days of each periodPopulation: All participants who completed both periods of the study.
A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Number of Participants With Severe Hypoglycemic Events
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1, Days 1 to 11 and Days 2 to 11 of each periodPopulation: All participants who completed both periods of the study.
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.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Number of Episodes of Symptomatic Hypoglycemia
Day 1
|
0.74 episodes per day
Standard Deviation 1.04
|
1.13 episodes per day
Standard Deviation 1.12
|
|
Number of Episodes of Symptomatic Hypoglycemia
Days 1 to 11
|
0.59 episodes per day
Standard Deviation 0.56
|
0.90 episodes per day
Standard Deviation 0.64
|
|
Number of Episodes of Symptomatic Hypoglycemia
Days 2 to 11
|
0.57 episodes per day
Standard Deviation 0.54
|
0.88 episodes per day
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Day 1, Days 1 to 11 and Days 2 to 11 of each periodPopulation: All participants who completed both periods of the study.
The number of carbohydrate interventions for hypoglycemia were reported daily by the participant. The average number of carbohydrate interventions per day is reported.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Number of Reported Carbohydrate Interventions for Hypoglycemia
Day 1
|
0.36 interventions per day
Standard Deviation 0.63
|
1.29 interventions per day
Standard Deviation 1.25
|
|
Number of Reported Carbohydrate Interventions for Hypoglycemia
Days 1 to 11
|
0.39 interventions per day
Standard Deviation 0.34
|
0.96 interventions per day
Standard Deviation 0.72
|
|
Number of Reported Carbohydrate Interventions for Hypoglycemia
Days 2 to 11
|
0.40 interventions per day
Standard Deviation 0.34
|
0.93 interventions per day
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Day 1, Days 1 to 11 and Days 2 to 11 of each periodPopulation: All participants who completed both periods of the study.
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.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Total Grams of Carbohydrate Taken for Hypoglycemia
Day 1
|
6.18 grams of carbohydrate per day
Standard Deviation 11.61
|
25.61 grams of carbohydrate per day
Standard Deviation 26.12
|
|
Total Grams of Carbohydrate Taken for Hypoglycemia
Days 1 to 11
|
22.04 grams of carbohydrate per day
Standard Deviation 13.62
|
34.8 grams of carbohydrate per day
Standard Deviation 16.21
|
|
Total Grams of Carbohydrate Taken for Hypoglycemia
Days 2 to 11
|
22.27 grams of carbohydrate per day
Standard Deviation 13.79
|
34.8 grams of carbohydrate per day
Standard Deviation 16.84
|
SECONDARY outcome
Timeframe: Day 1, Days 1 to 11, Days 2 to 11 of each periodPopulation: All participants who completed both periods of the study.
Insulin total daily dose is reported in units per kilogram per day (U/kg/day).
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Insulin Total Daily Dose
Days 1 to 11
|
0.66 U/kg/day
Standard Deviation 0.15
|
0.63 U/kg/day
Standard Deviation 0.18
|
|
Insulin Total Daily Dose
Day 1
|
0.64 U/kg/day
Standard Deviation 0.20
|
0.64 U/kg/day
Standard Deviation 0.21
|
|
Insulin Total Daily Dose
Days 2 to 11
|
0.66 U/kg/day
Standard Deviation 0.15
|
0.62 U/kg/day
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: Day 1, Days 2 to 11, Days 1 to 11 of each periodPopulation: All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.
Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
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.
|
|---|---|---|
|
Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm
Day 1
|
7.8 µg/kg/day
Standard Deviation 3.84
|
—
|
|
Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm
Days 1 to 11
|
6.9 µg/kg/day
Standard Deviation 2.34
|
—
|
|
Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm
Days 2 to 11
|
6.8 µg/kg/day
Standard Deviation 2.4
|
—
|
SECONDARY outcome
Timeframe: Day 1, Days 2 to 11, Days 1 to11, Overall, Daytime, Nighttime of each periodPopulation: All randomized participants who completed both periods of the study.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
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.
|
|---|---|---|
|
Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm
Day 1, Overall
|
101.2 mg/dL
Standard Deviation 2.0
|
—
|
|
Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm
Day 1, Daytime
|
101.3 mg/dL
Standard Deviation 1.6
|
—
|
|
Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm
Day 1, Nighttime
|
101.0 mg/dL
Standard Deviation 3.9
|
—
|
|
Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm
Day 2 to 11, Overall
|
101.9 mg/dL
Standard Deviation 5.0
|
—
|
|
Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm
Day 2 to 11, Daytime
|
102.0 mg/dL
Standard Deviation 5.1
|
—
|
|
Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm
Day 2 to 11, Nighttime
|
101.7 mg/dL
Standard Deviation 4.9
|
—
|
|
Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm
Day 1 to 11, Overall
|
101.8 mg/dL
Standard Deviation 4.6
|
—
|
|
Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm
Day 1 to 11, Daytime
|
101.9 mg/dL
Standard Deviation 4.7
|
—
|
|
Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm
Day 1 to 11, Nighttime
|
101.6 mg/dL
Standard Deviation 4.5
|
—
|
SECONDARY outcome
Timeframe: 11 daysPopulation: All randomized participants who completed both periods of the study. Reported for the Bionic pancreas arm only
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.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
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.
|
|---|---|---|
|
Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly
Insulin pump Lost Wireless Connectivity
|
3.9 percentage of time
Standard Deviation 2.5
|
—
|
|
Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly
Glucagon Pump Lost Wireless Connectivity
|
4.1 percentage of time
Standard Deviation 2.4
|
—
|
|
Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly
CGM Signal Unavailable
|
3.4 percentage of time
Standard Deviation 1.3
|
—
|
SECONDARY outcome
Timeframe: Day 1, Days 1 to 11, Days 2 to 11 and each individual day 2 to 11 of each periodPopulation: All randomized participants who completed both periods of the study.
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.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Day 1
|
0.79 cm
Standard Deviation 1.54
|
0.00 cm
Standard Deviation 0.00
|
|
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Days 1 to 11
|
0.51 cm
Standard Deviation 0.79
|
0.05 cm
Standard Deviation 0.17
|
|
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Days 2 to 11
|
0.48 cm
Standard Deviation 0.82
|
0.05 cm
Standard Deviation 0.18
|
|
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Day 2
|
0.46 cm
Standard Deviation 1.55
|
0.08 cm
Standard Deviation 0.48
|
|
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Day 3
|
0.56 cm
Standard Deviation 1.47
|
0.03 cm
Standard Deviation 0.16
|
|
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Day 4
|
0.41 cm
Standard Deviation 1.19
|
0.13 cm
Standard Deviation 0.47
|
|
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Day 5
|
0.33 cm
Standard Deviation 1.11
|
0.00 cm
Standard Deviation 0.00
|
|
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Day 6
|
0.56 cm
Standard Deviation 1.25
|
0.00 cm
Standard Deviation 0.00
|
|
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Day 7
|
0.49 cm
Standard Deviation 1.47
|
0.03 cm
Standard Deviation 0.16
|
|
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Day 8
|
0.67 cm
Standard Deviation 1.49
|
0.08 cm
Standard Deviation 0.35
|
|
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Day 9
|
0.44 cm
Standard Deviation 1.23
|
0.10 cm
Standard Deviation 0.50
|
|
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Day 10
|
0.59 cm
Standard Deviation 1.62
|
0.08 cm
Standard Deviation 0.35
|
|
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Day 11
|
0.28 cm
Standard Deviation 1.45
|
0.03 cm
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Baseline and Day 12 of each periodPopulation: All participants who completed both periods of the study.
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.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Change From Baseline in Body Weight
|
0.4 kilograms
Standard Deviation 0.95
|
0.1 kilograms
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline and Day 12 of each periodPopulation: All randomized participants who completed both periods of the study.
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.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Change From Baseline in Hemoglobin
|
-0.16 grams/deciliter (mg/dL)
Standard Deviation 0.68
|
0.14 grams/deciliter (mg/dL)
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: 11 days of each periodPopulation: All randomized participants who completed both periods of the study.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Number of Participants With Skin Rash
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 11 daysPopulation: All randomized participants who completed both periods.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM
|
96.6 percentage of possible values
Standard Deviation 1.4
|
96.3 percentage of possible values
Standard Deviation 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 11 daysPopulation: All randomized participants who completed both periods of the study. Glucagon infusion sets are not applicable to the Usual Care arm.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Number of Unscheduled Infusion Set Replacements
Glucagon Unscheduled Infusion Set Replacements
|
14 Infusion Set Relacements
|
—
|
|
Number of Unscheduled Infusion Set Replacements
Insulin Unscheduled Infusion Set Replacements
|
11 Infusion Set Relacements
|
15 Infusion Set Relacements
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Days 2 to 11, each individual day 2 to 11 of each periodPopulation: All randomized participants who completed both periods of the study.
Daily basal insulin dose reported in Units per kilogram per day (U/kg/day).
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Mean Daily Basal Insulin Dose
Day 1
|
0.3 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.1
|
|
Mean Daily Basal Insulin Dose
Days 2 to 11
|
0.3 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.002
|
|
Mean Daily Basal Insulin Dose
Day 2
|
0.3 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.1
|
|
Mean Daily Basal Insulin Dose
Day 3
|
0.3 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.1
|
|
Mean Daily Basal Insulin Dose
Day 4
|
0.3 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.1
|
|
Mean Daily Basal Insulin Dose
Day 5
|
0.3 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.1
|
|
Mean Daily Basal Insulin Dose
Day 6
|
0.3 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.1
|
|
Mean Daily Basal Insulin Dose
Day 7
|
0.3 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.1
|
|
Mean Daily Basal Insulin Dose
Day 8
|
0.3 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.1
|
|
Mean Daily Basal Insulin Dose
Day 9
|
0.3 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.1
|
|
Mean Daily Basal Insulin Dose
Day 10
|
0.3 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.1
|
|
Mean Daily Basal Insulin Dose
Day 11
|
0.3 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Days 1 to 11, Days 2 to 11, each individual day 2 to 11 of each periodPopulation: All randomized participants who completed both periods of the study.
Daily bolus insulin dose reported in Units per kilogram per day (U/kg/day).
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
Mean Daily Bolus Insulin Dose
Days 2 to 11
|
0.4 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.015
|
|
Mean Daily Bolus Insulin Dose
Day 1
|
0.4 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.2
|
|
Mean Daily Bolus Insulin Dose
Days 1 to 11
|
0.4 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.015
|
|
Mean Daily Bolus Insulin Dose
Day 2
|
0.4 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.2
|
|
Mean Daily Bolus Insulin Dose
Day 3
|
0.4 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.2
|
|
Mean Daily Bolus Insulin Dose
Day 4
|
0.4 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.3
|
|
Mean Daily Bolus Insulin Dose
Day 5
|
0.4 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.2
|
|
Mean Daily Bolus Insulin Dose
Day 6
|
0.4 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.2
|
|
Mean Daily Bolus Insulin Dose
Day 7
|
0.4 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.2
|
|
Mean Daily Bolus Insulin Dose
Day 8
|
0.4 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.2
|
|
Mean Daily Bolus Insulin Dose
Day 9
|
0.4 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.2
|
|
Mean Daily Bolus Insulin Dose
Day 10
|
0.4 U/kg/day
Standard Deviation 0.2
|
0.3 U/kg/day
Standard Deviation 0.2
|
|
Mean Daily Bolus Insulin Dose
Day 11
|
0.4 U/kg/day
Standard Deviation 0.1
|
0.3 U/kg/day
Standard Deviation 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 11 daysPopulation: All randomized participants who completed both periods.
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.
Outcome measures
| Measure |
Bionic Pancreas
n=39 Participants
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
n=39 Participants
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.
|
|---|---|---|
|
CGM Mean Absolute Relative Differences (MARD) Versus Time-stamped Blood Glucose (BG) Values From Meter Downloads
|
19.2 percent difference
Standard Deviation 31.4
|
18.0 percent difference
Standard Deviation 28.2
|
Adverse Events
Bionic Pancreas
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bionic Pancreas
n=41 participants at risk
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
n=41 participants at risk
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.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
100.0%
41/41 • Days 1 to 11
|
100.0%
41/41 • Days 1 to 11
|
|
Gastrointestinal disorders
Nausea
|
51.2%
21/41 • Days 1 to 11
|
12.2%
5/41 • Days 1 to 11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place