Trial Outcomes & Findings for Integration of Continuous Glucose Monitoring Into a BiHormonal Closed-Loop Artificial Pancreas (NCT NCT01161862)

NCT ID: NCT01161862

Last Updated: 2017-11-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2017-11-14

Participant Flow

Twelve adult and twelve pediatric subjects with type 1 diabetes and no endogenous insulin secretion participated in two 51-h experiments. The protocol was approved by the Massachusetts General Hospital (MGH) and Boston University Human Research Committees

Participant milestones

Measure	Bi-hormonal Bionic Pancreas With Meal-priming Bolus The first meal-priming bolus was solely based on weight (0.05 U/kg), after which meal-priming boluses were automatically adapted by the control system online targeting 75% of the anticipated insulin needed in the first four hours after the start of the meal.	Bi-hormonal Bionic Pancreas With no Meal-priming Bolus Bi-hormonal bionic pancreas with no meal-priming bolus. The controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Integration of Continuous Glucose Monitoring Into a BiHormonal Closed-Loop Artificial Pancreas

Baseline characteristics by cohort

Measure	Bi-hormonal Pancreas With Meal-priming Bolus n=12 Participants An automatically adapting meal priming bolus was given by the controller at the time each meal was presented	Bi-hormonal Pancreas Without Meal-priming Bolus n=12 Participants The insulin controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	30 years STANDARD_DEVIATION 17.7 • n=5 Participants	30.5 years STANDARD_DEVIATION 19.0 • n=7 Participants	30 years STANDARD_DEVIATION 18 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: Overall number of participants was 24, 12 in each arm

Outcome measures

Measure	Bionic Pancreas With Automated Meal-priming Bolus n=12 Participants Bi-hormonal bionic pancreas Bi-hormonal (insulin and glucagon) artificial pancreas	Bionic Pancreas Without Automated Meal-priming Bolus n=12 Participants
Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl) Adults	132 mg/dl Standard Deviation 3	146 mg/dl Standard Deviation 9
Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl) Adolescents	162 mg/dl Standard Deviation 6	175 mg/dl Standard Deviation 9

SECONDARY outcome

Timeframe: 48 hours

Population: Overall number of participants=24 (12 in each arm)

Outcome measures

Measure	Bionic Pancreas With Automated Meal-priming Bolus n=12 Participants Bi-hormonal bionic pancreas Bi-hormonal (insulin and glucagon) artificial pancreas	Bionic Pancreas Without Automated Meal-priming Bolus n=12 Participants
Percentage of Time Spent With Blood Glucose < 60 mg/dl Adults	2.3 percentage of total time Standard Deviation 3.9	1.4 percentage of total time Standard Deviation 2.7
Percentage of Time Spent With Blood Glucose < 60 mg/dl Adolescents	0.1 percentage of total time Standard Deviation 0.2	0.1 percentage of total time Standard Deviation 0.2

SECONDARY outcome

Timeframe: 48 hours

Population: Overall number of participants=24 (12 in each arm)

Outcome measures

Measure	Bionic Pancreas With Automated Meal-priming Bolus n=12 Participants Bi-hormonal bionic pancreas Bi-hormonal (insulin and glucagon) artificial pancreas	Bionic Pancreas Without Automated Meal-priming Bolus n=12 Participants
Percentage of Time Spent With Blood Glucose <70 mg/dl Adults	5.1 percentage of total time Standard Deviation 6.7	3.6 percentage of total time Standard Deviation 4.5
Percentage of Time Spent With Blood Glucose <70 mg/dl Adolescents	0.3 percentage of total time Standard Deviation 0.5	0.4 percentage of total time Standard Deviation 0.7

SECONDARY outcome

Timeframe: 48 hours

Population: Overall number of participants=24 (12 in each arm)

Outcome measures

Measure	Bionic Pancreas With Automated Meal-priming Bolus n=12 Participants Bi-hormonal bionic pancreas Bi-hormonal (insulin and glucagon) artificial pancreas	Bionic Pancreas Without Automated Meal-priming Bolus n=12 Participants
Percentage of Time Spent With Blood Glucose 70-180 mg/dl Adults	80 percentage of total time Standard Deviation 6	70 percentage of total time Standard Deviation 9
Percentage of Time Spent With Blood Glucose 70-180 mg/dl Adolescents	68 percentage of total time Standard Deviation 8	60 percentage of total time Standard Deviation 4

SECONDARY outcome

Timeframe: 48 hours

Population: Overall number of participants=24 (12 in each arm)

Outcome measures

Measure	Bionic Pancreas With Automated Meal-priming Bolus n=12 Participants Bi-hormonal bionic pancreas Bi-hormonal (insulin and glucagon) artificial pancreas	Bionic Pancreas Without Automated Meal-priming Bolus n=12 Participants
Insulin Total Daily Dose Adolescents	1.1 u/kg/day Standard Deviation 0.2	1.2 u/kg/day Standard Deviation 0.2
Insulin Total Daily Dose Adults	0.6 u/kg/day Standard Deviation 0.2	0.7 u/kg/day Standard Deviation 0.2

SECONDARY outcome

Timeframe: 48 hours

Population: Overall number of participants=24 (12 in each arm)

Outcome measures

Measure	Bionic Pancreas With Automated Meal-priming Bolus n=12 Participants Bi-hormonal bionic pancreas Bi-hormonal (insulin and glucagon) artificial pancreas	Bionic Pancreas Without Automated Meal-priming Bolus n=12 Participants
Number of Carbohydrate Interventions for Hypoglycemia	12 Carbohydrate Interventions	10 Carbohydrate Interventions

SECONDARY outcome

Timeframe: 48 hours

Outcome measures

Measure	Bionic Pancreas With Automated Meal-priming Bolus n=12 Participants Bi-hormonal bionic pancreas Bi-hormonal (insulin and glucagon) artificial pancreas	Bionic Pancreas Without Automated Meal-priming Bolus n=12 Participants
Number of Blood Glucose Events < 70 mg/dl	59 Number of events	48 Number of events

SECONDARY outcome

Timeframe: 48 hours

Outcome measures

Measure	Bionic Pancreas With Automated Meal-priming Bolus n=12 Participants Bi-hormonal bionic pancreas Bi-hormonal (insulin and glucagon) artificial pancreas	Bionic Pancreas Without Automated Meal-priming Bolus n=12 Participants
Nadir Blood Glucose in Each Arm	65.9 mg/dl Standard Deviation 17.4	66.4 mg/dl Standard Deviation 17.8

Adverse Events

Bi-hormonal With Meal Priming Bolus

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Bi-hormonal Without Meal Priming Bolus

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bi-hormonal With Meal Priming Bolus n=12 participants at risk Bi-hormonal with adaptive meal priming bolus	Bi-hormonal Without Meal Priming Bolus n=12 participants at risk Bi-hormonal with no meal announcements or meal priming boluses
General disorders Nausea	8.3% 1/12 • Number of events 1 • 51 hours per experiment	8.3% 1/12 • Number of events 1 • 51 hours per experiment

Additional Information

Edward R. Damiano

Department of Biomedical Engineering, Boston University, Boston, Massachusetts.

Phone: (617) 353-9493

Email: edamiano@bu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place