Trial Outcomes & Findings for Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas (NCT NCT03262116)
NCT ID: NCT03262116
Last Updated: 2022-12-09
Results Overview
The average glucose achieved by the bionic pancreas as measured by the continuous glucose monitor during each arm
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
20 participants
Primary outcome timeframe
7 days
Results posted on
2022-12-09
Participant Flow
20 subjects signed the consent form and screened into the study. 2 subjects were found to be ineligible after they were enrolled. 13 pariticpants were randomized. The numbers listed here, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No relevant data was collected from designated contacts.
Participant milestones
| Measure |
Insulin-only Bionic Pancreas With BC222 Lispro, Then Insulin Lispro, Then Insulin Aspart
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With BC222 Lispro, Then Insulin Aspart, Then Insulin Lispro
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Lispro, Then BC222 Lispro, Then Insulin Aspart
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Lispro, Then Insulin Aspart, Then BC222 Lispro
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Aspart, Then BC222 Lispro, Then Insulin Lispro
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Aspart, Then Insulin Lispro, Then BC222 Lispro
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
2
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
1
|
1
|
1
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Insulin-only Bionic Pancreas With BC222 Lispro, Then Insulin Lispro, Then Insulin Aspart
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With BC222 Lispro, Then Insulin Aspart, Then Insulin Lispro
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Lispro, Then BC222 Lispro, Then Insulin Aspart
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Lispro, Then Insulin Aspart, Then BC222 Lispro
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Aspart, Then BC222 Lispro, Then Insulin Lispro
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Aspart, Then Insulin Lispro, Then BC222 Lispro
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
2
|
1
|
1
|
1
|
2
|
Baseline Characteristics
Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas
Baseline characteristics by cohort
| Measure |
Insulin-only Bionic Pancreas With BC222 Lispro, Then Insulin Lispro, Then Insulin Aspart
n=2 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With BC222 Lispro, Then Insulin Aspart, Then Insulin Lispro
n=3 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Lispro, Then BC222 Lispro, Then Insulin Aspart
n=2 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Lispro, Then Insulin Aspart, Then BC222 Lispro
n=2 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Aspart, Then BC222 Lispro, Then Insulin Lispro
n=2 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Aspart, Then Insulin Lispro, Then BC222 Lispro
n=2 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30.0 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 17.6 • n=7 Participants
|
70.5 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
33.0 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
47.0 years
STANDARD_DEVIATION 14.1 • n=21 Participants
|
50.0 years
STANDARD_DEVIATION 15.6 • n=8 Participants
|
47.8 years
STANDARD_DEVIATION 15.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
13 participants
n=8 Participants
|
|
Hemoglobin A1c
|
6.7 percent of glycated hemoglobin
STANDARD_DEVIATION 0.8 • n=5 Participants
|
6.9 percent of glycated hemoglobin
STANDARD_DEVIATION 0.9 • n=7 Participants
|
6.9 percent of glycated hemoglobin
STANDARD_DEVIATION 0.2 • n=5 Participants
|
6.2 percent of glycated hemoglobin
STANDARD_DEVIATION 0.5 • n=4 Participants
|
7.2 percent of glycated hemoglobin
STANDARD_DEVIATION 0.8 • n=21 Participants
|
6.4 percent of glycated hemoglobin
STANDARD_DEVIATION 0.5 • n=8 Participants
|
6.7 percent of glycated hemoglobin
STANDARD_DEVIATION 0.6 • n=8 Participants
|
PRIMARY outcome
Timeframe: 7 daysThe average glucose achieved by the bionic pancreas as measured by the continuous glucose monitor during each arm
Outcome measures
| Measure |
Insulin-only Bionic Pancreas With BC222 Lispro
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Lispro
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Aspart
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
|---|---|---|---|
|
Average Continuous Glucose Monitor (CGM) Glucose
|
157.0 mg/dl
Standard Deviation 9.2
|
151.4 mg/dl
Standard Deviation 13.1
|
151.2 mg/dl
Standard Deviation 13.8
|
PRIMARY outcome
Timeframe: 7 daysThe amount of time the subject spent in the hypoglycemic range \< 54 mg/dl as measured by the continuous glucose monitor during each arm
Outcome measures
| Measure |
Insulin-only Bionic Pancreas With BC222 Lispro
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Lispro
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Aspart
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
|---|---|---|---|
|
Percentage of Time Spent With CGM Glucose < 54 mg/dl
|
0.30 percentage of CGM glucose values
Standard Deviation 0.53
|
0.55 percentage of CGM glucose values
Standard Deviation 0.26
|
1.01 percentage of CGM glucose values
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: 7 daysThe amount of time subject's spent in each of the listed glucose ranges as measured by the continuous glucose monitor during each bionic pancreas arm
Outcome measures
| Measure |
Insulin-only Bionic Pancreas With BC222 Lispro
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Lispro
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Aspart
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
|---|---|---|---|
|
Percentage of Time Spent Within Each of the Following Ranges:
% time CGM glcuose < 50 mg/dl
|
0.20 percentage of CGM glucose values
Standard Deviation 0.42
|
0.24 percentage of CGM glucose values
Standard Deviation 0.21
|
0.63 percentage of CGM glucose values
Standard Deviation 0.50
|
|
Percentage of Time Spent Within Each of the Following Ranges:
% time CGM glcuose < 60 mg/dl
|
0.80 percentage of CGM glucose values
Standard Deviation 0.88
|
1.31 percentage of CGM glucose values
Standard Deviation 0.55
|
1.85 percentage of CGM glucose values
Standard Deviation 1.05
|
|
Percentage of Time Spent Within Each of the Following Ranges:
% time CGM glcuose < 70 mg/dl
|
2.65 percentage of CGM glucose values
Standard Deviation 1.71
|
3.59 percentage of CGM glucose values
Standard Deviation 1.71
|
4.31 percentage of CGM glucose values
Standard Deviation 1.66
|
|
Percentage of Time Spent Within Each of the Following Ranges:
% time CGM glcuose 70-120 mg/dl
|
27.49 percentage of CGM glucose values
Standard Deviation 5.04
|
27.20 percentage of CGM glucose values
Standard Deviation 5.53
|
30.44 percentage of CGM glucose values
Standard Deviation 5.57
|
|
Percentage of Time Spent Within Each of the Following Ranges:
% time CGM glcuose 70-180 mg/dl
|
67.77 percentage of CGM glucose values
Standard Deviation 8.57
|
72.16 percentage of CGM glucose values
Standard Deviation 10.34
|
70.06 percentage of CGM glucose values
Standard Deviation 10.25
|
|
Percentage of Time Spent Within Each of the Following Ranges:
% time CGM glcuose >180 mg/dl
|
29.58 percentage of CGM glucose values
Standard Deviation 7.79
|
24.26 percentage of CGM glucose values
Standard Deviation 9.29
|
25.63 percentage of CGM glucose values
Standard Deviation 9.02
|
|
Percentage of Time Spent Within Each of the Following Ranges:
% time CGM glcuose > 250 mg/dl
|
7.67 percentage of CGM glucose values
Standard Deviation 3.55
|
5.21 percentage of CGM glucose values
Standard Deviation 5.24
|
7.11 percentage of CGM glucose values
Standard Deviation 6.41
|
SECONDARY outcome
Timeframe: 7 daysA measure of dispersion of glucose values around the mean
Outcome measures
| Measure |
Insulin-only Bionic Pancreas With BC222 Lispro
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Lispro
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Aspart
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
|---|---|---|---|
|
Within Day Coefficient of Variation
|
37.4 percentage of CGM glucose values
Standard Deviation 4.1
|
35.5 percentage of CGM glucose values
Standard Deviation 7.8
|
38.6 percentage of CGM glucose values
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: 7 daysDifference in CGMG from the beginning of the meal challenge to the peak CGMG in the 4 hours after the meal, for both mixed meal challenges.
Outcome measures
| Measure |
Insulin-only Bionic Pancreas With BC222 Lispro
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Lispro
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Aspart
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
|---|---|---|---|
|
Mean Post Prandial Excursion
|
95.06 mg/dl
Standard Deviation 37.49
|
103.13 mg/dl
Standard Deviation 47.37
|
104.07 mg/dl
Standard Deviation 36.60
|
SECONDARY outcome
Timeframe: 7 daysThe number of times subjects report experiencing symptoms of hypoglycemia during each bionic pancreas arm
Outcome measures
| Measure |
Insulin-only Bionic Pancreas With BC222 Lispro
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Lispro
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Aspart
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
|---|---|---|---|
|
Number of Symptomatic Hypoglycemic Events Per Day
|
0.73 number of events
Standard Deviation 0.43
|
0.60 number of events
Standard Deviation 0.43
|
1.02 number of events
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: 7 daysThe total amount of grams of carbohydrates subjects report having to take in for treatment of hypoglycemia
Outcome measures
| Measure |
Insulin-only Bionic Pancreas With BC222 Lispro
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Lispro
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Aspart
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
|---|---|---|---|
|
Grams of Carbohydrates Consumed to Treat Hypoglycemia Per Day
|
12.42 grams of carbohydrates
Standard Deviation 11.59
|
9.27 grams of carbohydrates
Standard Deviation 6.94
|
14.00 grams of carbohydrates
Standard Deviation 11.95
|
SECONDARY outcome
Timeframe: 7 daysThe average total amount of insulin delivered daily by the bionic pancreas during each bionic pancreas arm.
Outcome measures
| Measure |
Insulin-only Bionic Pancreas With BC222 Lispro
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Lispro
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
Insulin-only Bionic Pancreas With Insulin Aspart
n=8 Participants
Participants were randomized to complete three weeks using the insulin-only bionic pancreas. Participants would complete 7 days of each intervention in random order, including 7 days using the bionic pancreas with insulin lispro, 7 days with the bionic pancreas using insulin aspart and 7 days with the bionic pancreas using BC222 lispro. It was planned that all participants would complete all three interventions.
The numbers listed in the participant flow, and throughout the record only represent unique participants. Dyads, including designated contacts, are not used. No data was collected from designated contacts taht is relevant to this protocol.
The study had be terminated before all participants could complete all interventions. All available data are reported here.
|
|---|---|---|---|
|
Total Daily Dose of Insulin
|
0.71 units per kilogram per day
Standard Deviation 0.16
|
0.60 units per kilogram per day
Standard Deviation 0.21
|
0.61 units per kilogram per day
Standard Deviation 0.25
|
Adverse Events
Insulin-only Bionic Pancreas With BC222 Lispro
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Insulin-only Bionic Pancreas With Insulin Lispro
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Insulin-only Bionic Pancreas With Insulin-aspart
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Steven J. Russell, MD, PhD
Massachusetts General Hospital
Phone: 617.726.1848
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place