Trial Outcomes & Findings for The iLet Introduction Study: A Feasibility Study of the iLet, a Fully Integrated Bihormonal Bionic Pancreas (NCT NCT02701257)
NCT ID: NCT02701257
Last Updated: 2019-11-18
Results Overview
Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (aggregate of both insulin and glucagon doses) - primary outcome for iPhone-based BP using Lilly glucagon vs. iLet BP using Lilly glucagon
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
8 hours
Results posted on
2019-11-18
Participant Flow
Participant milestones
| Measure |
iPhone BP First, Then iLet BP (Lilly gLucagon)
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
|
iLet BP First, Then iPhone BP (Lilly Glucagon)
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set First, Then Contact Detach
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set First, Then iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
0
|
4
|
4
|
|
Overall Study
COMPLETED
|
6
|
3
|
0
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
0
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The iLet Introduction Study: A Feasibility Study of the iLet, a Fully Integrated Bihormonal Bionic Pancreas
Baseline characteristics by cohort
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=6 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed dailyy
|
iLet Bionic Pancreas - Lilly Glucagon
n=6 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set First, Then Contact Detach
n=4 Participants
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach First, Then iLet Infusion Set
n=4 Participants
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 22.3 • n=5 Participants
|
32.6 years
STANDARD_DEVIATION 17.9 • n=7 Participants
|
—
|
48.8 years
STANDARD_DEVIATION 14.7 • n=4 Participants
|
44.7 years
STANDARD_DEVIATION 17.7 • n=21 Participants
|
39.7 years
STANDARD_DEVIATION 17.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
—
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
—
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 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=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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=4 Participants
|
0 Participants
n=21 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=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
—
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
—
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
20 participants
n=8 Participants
|
|
Hemoglobin A1c
|
8.3 percent
STANDARD_DEVIATION 0.7 • n=5 Participants
|
7.6 percent
STANDARD_DEVIATION 1.8 • n=7 Participants
|
—
|
6.9 percent
STANDARD_DEVIATION 1.2 • n=4 Participants
|
8.1 percent
STANDARD_DEVIATION 1.8 • n=21 Participants
|
7.8 percent
STANDARD_DEVIATION 1.2 • n=8 Participants
|
PRIMARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.
Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (aggregate of both insulin and glucagon doses) - primary outcome for iPhone-based BP using Lilly glucagon vs. iLet BP using Lilly glucagon
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Aggregate of Both Insulin and Glucagon Doses)
|
94.6 percentage of doses delivered
Standard Deviation 9.2
|
95.0 percentage of doses delivered
Standard Deviation 12.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iLet BP using Lilly glucagon vs the iLet BP using Xerisol glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. Data for this outcome is reported for the iPhone BP and iLet BP arms using Lilly glucagon. This analysis does not apply to the infusion set sub study.
Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (glucagon doses) - - primary outcome for iLet BP using Lilly glucagon vs. iLet BP using Xeris Xerisol glucagon
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Glucagon Doses).
|
96.6 percentage of doses
Standard Deviation 6.8
|
100.0 percentage of doses
Standard Deviation 0.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3.5 hours following insulin bolusPopulation: This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.
This applies only to the infusion set sub-study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.
The average glucose according to continuous glucose monitor readings. This only applies to the iPhone vs. iLet BP experiments.
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Average Continuous Glucose Monitor (CGM) Glucose
|
179.2 mg/dl
Standard Deviation 37.5
|
251.2 mg/dl
Standard Deviation 80.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.
Percentage of time subjects spent in each of these ranges based on continuous glucose monitor readings. This only applies to the iPhone vs iLet BP visits.
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Percentage of Time in Each of the Following Ranges: < 50 mg/dl, < 60 mg/dl, <70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, >180 mg/dl, >250 mg/dl
CGM glucose < 60
|
0.0 percentage of time
Standard Deviation 0.0
|
0.36 percentage of time
Standard Deviation 1.07
|
—
|
—
|
—
|
|
Percentage of Time in Each of the Following Ranges: < 50 mg/dl, < 60 mg/dl, <70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, >180 mg/dl, >250 mg/dl
CGM glucose > 180
|
39.0 percentage of time
Standard Deviation 24.5
|
67.5 percentage of time
Standard Deviation 21.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.
The number of subjects who achieved a mean CGM glucose \< 154 mg/dl, which correlates to an estimated hemoglobin a1c of 7%, which is the ADA goal for therapy. This applies only to the iPhone vs iLet BP experiments
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Number of Subjects With Mean CGM Glucose < 154 mg/dl
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.
The number of severe hypoglycemic events subjects experience. This applies only to the iPhone vs iLet BP experiments.
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Number of Severe Hypoglycemic Events (Subject Unable to Self-treat, Requiring the Assistance of Another Person)
|
0 events
|
0 events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.
The average percentage of successfully delivered insulin doses. This applies only to the iPhone vs iLet BP experiments.
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
|
94.0 percentage of doses
Standard Deviation 10.7
|
95.8 percentage of doses
Standard Deviation 13.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.
The average percentage of successfully delivered glucagon doses. This applies only to the iPhone vs iLet BP experiments.
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
|
96.6 percentage of doses
Standard Deviation 6.8
|
100.0 percentage of doses
Standard Deviation 0.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.
The average percentage of successfully issued insulin doses that are then delivered successfully by the pump. This applies only to the iPhone vs iLet BP experiments.
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Average Percent Insulin Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
|
98.5 percentage of doses
Standard Deviation 5.5
|
96.1 percentage of doses
Standard Deviation 13.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.
The average percentage of successfully issued glucagon doses that are then delivered successfully by the pump. This applies only to the iPhone vs iLet BP experiments.
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Average Percent Glucagon Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That a Successfully Delivered by the Pump.
|
96.6 percentage of doses
Standard Deviation 6.8
|
100.0 percentage of doses
Standard Deviation 0.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted.
The percentage of time (measured in 5 minute "steps") that the bionic pancreas is working, indicated by the presence of a CGM reading, a successful dose calculation and successful issuing of a dose. This applies only to the iPhone vs iLet BP experiments.
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Average Percent of 5 Minute Steps During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time CGM Data (New CGM Glucose Reading Captured, Dose Calculated, Dose Issued to Pumps
|
88.9 percentage of 5 minute steps
Standard Deviation 0.073
|
75.1 percentage of 5 minute steps
Standard Deviation 0.196
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted.
The percentage of time (measured in 5 minute "steps") that the bionic pancreas is working even without a CGM reading being present, indicated by a successful dose calculation and successful issuing of a dose. This applies only to the iPhone vs iLet BP experiments.
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Average Percent of 5 Minute Steps During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured (Dose Calculated, Dose Issued to Pumps).
|
94.6 percentage of 5 minutes steps
Standard Deviation 0.054
|
99.8 percentage of 5 minutes steps
Standard Deviation 0.004
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted.
A measure of CGM reliability, indicating the percentage of values the CGM displayed out of the total values it should have displayed in that time. This applies only to the iPhone vs iLet BP experiments.
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
CGM Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM.
|
94.1 percentage of CGM values
Standard Deviation 0.06
|
75.1 percentage of CGM values
Standard Deviation 0.19
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.
The average total glucagon delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments.
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Glucagon Total Delivery Per kg of Body Mass.
|
0.60 mcg/kg
Standard Deviation 0.84
|
1.12 mcg/kg
Standard Deviation 1.71
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.
The average total insulin delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments.
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Insulin Total Delivery Per kg of Body Mass.
|
0.22 units/kg
Standard Deviation 0.07
|
0.23 units/kg
Standard Deviation 0.07
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.
Number of time subjects experienced symptoms of hypoglycemia and reported that to study staff. This applies only to the iPhone vs iLet BP experiments.
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Number of Episodes of Symptomatic Hypoglycemia.
|
0 number of episodes
|
0 number of episodes
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.
The total grams of carbohydrates given to subjects for treatment of hypoglycemia. This applies only to the iPhone vs iLet BP experiments.
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Total Grams of Carbohydrate Taken for Hypoglycemia.
|
0 number of grams of carbohydrates
|
0 number of grams of carbohydrates
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.
This applies only the iPhone vs. iLet BP experiments. Subjects were given a visual analog scale measuring 100 mm and asked to draw a line to indicate their level of nausea at timepoints during the study with 100 being the "worst possible nausea" and 0 being "no nausea".
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Difference in Mean Nausea From VAS During the Study
|
3.47 score on a scale
Standard Deviation 10.47
|
6.93 score on a scale
Standard Deviation 15.29
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: The experimental arm with the iLet BP using Xeris glucagon was never conducted. Analysis includes 9 subjects that completed both the BP visits and 4 subjects that completed both infusion set sub study visits.
This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments. Subjects were given a visual analog scale measuring 100 mm and asked to draw a line to indicate their level of pain at timepoints during the study with 100 being the "worst possible pain" and 0 being "no pain".
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
n=4 Participants
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
n=4 Participants
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Average Insulin Infusion Site Pain From VAS
|
1.49 score on a scale
Standard Deviation 3.06
|
6.61 score on a scale
Standard Deviation 13.04
|
—
|
0.54 score on a scale
Standard Deviation 2.61
|
2.42 score on a scale
Standard Deviation 9.98
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: The experimental arm with the iLet BP using Xeris glucagon was never conducted. Analysis includes 9 subjects that completed both the BP visits and 4 subjects that completed both infusion set sub study visits.
This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments. The draize scale assess erythema, eschar and edema using a score from 0-4, with 4 meaning a worse outcome.
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
n=4 Participants
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
n=4 Participants
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Difference in Local Erythema and Edema According to the Draize Scale
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
—
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: The experimental arm with the iLet BP using Xeris glucagon was never conducted. Analysis includes 9 subjects that completed both the BP visits and 4 subjects that completed both infusion set sub study visits.
This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments.
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
n=4 Participants
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
n=4 Participants
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Number of Unscheduled Infusion Set Replacements.
|
1 number of infusion set changes
|
0 number of infusion set changes
|
—
|
0 number of infusion set changes
|
0 number of infusion set changes
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.
This applies only to the iPhone vs. iLet BP experiments
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 Participants
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=9 Participants
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Number of Unscheduled CGM Sensor Changes.
|
0 number of sensor changes
|
0 number of sensor changes
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.
This applies only to the infusion set sub-study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 hoursPopulation: This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.
This applies only to the infusion set sub-study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 hoursPopulation: This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.
This applies only to the infusion set sub-study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 hoursPopulation: This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.
This applies only to the infusion set sub-study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 hoursPopulation: This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.
This applies only to the infusion set sub-study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 hoursPopulation: This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.
This applies only to the infusion set sub-study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 hoursPopulation: This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.
This applies only to the infusion set sub-study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 hoursPopulation: This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.
This applies only to the infusion set sub-study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 hoursPopulation: This outcome only applies to the infusion set sub study, the other arms were not analyzed.The infusion set sub study was terminated and the insulin assays were not completed.
This applies only to the infusion set sub-study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 hoursPopulation: This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.
This applies only to the infusion set sub-study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline Fasted State and 90 MinutesPopulation: This outcome only applies to the infusion set sub study, the other arms were not analyzed. The Overall Number of Participants Analyzed represents all Completed participants that received the intervention
This applies only to the infusion set sub-study
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
n=4 Participants
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
n=4 Participants
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Difference Between the Fasted PG Value and the PG Value at 90 Minutes
|
—
|
—
|
—
|
-3.7 mg/dl
Standard Deviation 28.7
|
-6.7 mg/dl
Standard Deviation 41.8
|
SECONDARY outcome
Timeframe: Pre-meal PG value and peak PG value during the 3.5 hours following the meal.Population: This outcome only applies to the infusion set sub study, the other arms were not analyzed. The Overall Number of Participants Analyzed represents all Completed participants that received the intervention
This applies only to the infusion set sub-study
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
n=4 Participants
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
n=4 Participants
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Difference in the PG Prior to the Meal and Peak Post-prandial Glucose
|
—
|
—
|
—
|
176.3 mg/dl
Standard Deviation 88.2
|
73.9 mg/dl
Standard Deviation 76.8
|
SECONDARY outcome
Timeframe: 3.5 hours following the mealPopulation: This outcome only applies to the infusion set sub study, the other arms were not analyzed. The Overall Number of Participants Analyzed represents all Completed participants that received the intervention
This applies only to the infusion set sub-study
Outcome measures
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
n=4 Participants
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach Infusion Set
n=4 Participants
The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
PG AUC in the 3.5 Hours Following the Meal
|
—
|
—
|
—
|
15512740 mg*min/dl
Standard Deviation 10050495
|
8359871 mg*min/dl
Standard Deviation 5458714
|
Adverse Events
iPhone Bionic Pancreas - Lilly Glucagon
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
iLet Bionic Pancreas - Lilly Glucagon
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
iLet Bionic Pancreas - Xerisol Glucagon
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
iLet Infusion Set
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Contact Detach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
iPhone Bionic Pancreas - Lilly Glucagon
n=9 participants at risk
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Lilly Glucagon
n=12 participants at risk
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily
|
iLet Bionic Pancreas - Xerisol Glucagon
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
|
iLet Infusion Set
n=5 participants at risk
iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
Contact Detach
n=7 participants at risk
Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
|
|---|---|---|---|---|---|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/9 • During study visits up to 8 hours long
There were no participants at risk for Serious Adverse Events, All-Cause Mortality and any other adverse events in the arm using the iLet bionic pancreas with Xerisol glucagon, because that arm was not conducted.
|
58.3%
7/12 • Number of events 7 • During study visits up to 8 hours long
There were no participants at risk for Serious Adverse Events, All-Cause Mortality and any other adverse events in the arm using the iLet bionic pancreas with Xerisol glucagon, because that arm was not conducted.
|
—
0/0 • During study visits up to 8 hours long
There were no participants at risk for Serious Adverse Events, All-Cause Mortality and any other adverse events in the arm using the iLet bionic pancreas with Xerisol glucagon, because that arm was not conducted.
|
0.00%
0/5 • During study visits up to 8 hours long
There were no participants at risk for Serious Adverse Events, All-Cause Mortality and any other adverse events in the arm using the iLet bionic pancreas with Xerisol glucagon, because that arm was not conducted.
|
0.00%
0/7 • During study visits up to 8 hours long
There were no participants at risk for Serious Adverse Events, All-Cause Mortality and any other adverse events in the arm using the iLet bionic pancreas with Xerisol glucagon, because that arm was not conducted.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place