Trial Outcomes & Findings for Three Way Crossover Closed Loop Study With Xeris Glucagon (NCT NCT03424044)
NCT ID: NCT03424044
Last Updated: 2020-05-27
Results Overview
Assess the percent of time that the Dexcom G5 or G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor across all three arms.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
4 hours post exercise on Day 1
Results posted on
2020-05-27
Participant Flow
Participant milestones
| Measure |
PLGS-SH-DH
The randomization order for subjects in this arm was predictive low glucose suspend (PLGS), single hormone (SH) and dual hormone (DH). Each visit was 76 hours and included inpatient and outpatient portions.
|
DH-PLGS-SH
The randomization order for subjects in this arm was dual hormone (DH), predictive low glucose suspend (PLGS), and single hormone (SH). Each visit was 76 hours and included inpatient and outpatient portions.
|
SH-DH-PLGS
The randomization order for subjects in this arm was single hormone (SH), dual hormone (DH) and predictive low glucose suspend (PLGS). Each visit was 76 hours and included inpatient and outpatient portions.
|
SH-PLGS-DH
The randomization order for subjects in this arm was single hormone (SH), predictive low glucose suspend (PLGS) and dual hormone (DH). Each visit was 76 hours and included inpatient and outpatient portions.
|
DH-SH-PLGS
The randomization order for subjects in this arm was dual hormone (DH), single hormone (SH) and predictive low glucose suspend (PLGS). Each visit was 76 hours and included inpatient and outpatient portions.
|
PLGS-DH-SH
The randomization order for subjects in this arm was predictive low glucose suspend (PLGS), dual hormone (DH) and single hormone (SH). Each visit was 76 hours and included inpatient and outpatient portions.
|
SH-SH-DH
The randomization order for this subject was single hormone (SH), dual hormone (DH) and predictive low glucose suspend (PLGS). The first SH visit wasn't completed due to technical issues and was repeated before continuing to the DH arm, which was not completed. Each visit was 76 hours and included inpatient and outpatient portions.
|
SH-SH-PLGS-DH
The randomization order for this subject was single hormone (SH), predictive low glucose suspend (PLGS) and dual hormone (DH). Due to device issues, the first SH study was not completed. A second SH study was completed before continuing to PLGS and DH arms. Each arm was 76 hours and included inpatient and outpatient portions.
|
DH-DH-PLGS-SH
The randomization order for this subject was dual hormone (DH), predictive low glucose suspend (PLGS) and single hormone (SH). Due to device issues, the first DH study was not completed. A second DH study was completed before continuing to PLGS and SH arms. Each arm was 76 hours and included inpatient and outpatient portions.
|
|---|---|---|---|---|---|---|---|---|---|
|
Dexcom Training Visit (1 Week)
STARTED
|
4
|
3
|
3
|
3
|
3
|
4
|
1
|
1
|
1
|
|
Dexcom Training Visit (1 Week)
COMPLETED
|
4
|
3
|
3
|
3
|
3
|
4
|
1
|
1
|
1
|
|
Dexcom Training Visit (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Rest Period (1-12 Weeks)
STARTED
|
4
|
3
|
3
|
3
|
3
|
4
|
1
|
1
|
1
|
|
First Rest Period (1-12 Weeks)
COMPLETED
|
4
|
3
|
2
|
3
|
3
|
4
|
1
|
1
|
1
|
|
First Rest Period (1-12 Weeks)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Intervention (76 Hours)
STARTED
|
4
|
3
|
2
|
3
|
3
|
4
|
1
|
1
|
1
|
|
First Intervention (76 Hours)
COMPLETED
|
4
|
3
|
2
|
3
|
2
|
4
|
0
|
0
|
0
|
|
First Intervention (76 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
1
|
|
Second Rest Period (7-45 Days)
STARTED
|
4
|
3
|
2
|
3
|
2
|
4
|
1
|
1
|
1
|
|
Second Rest Period (7-45 Days)
COMPLETED
|
4
|
3
|
2
|
3
|
2
|
4
|
1
|
1
|
1
|
|
Second Rest Period (7-45 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention (76 Hours)
STARTED
|
4
|
3
|
2
|
3
|
2
|
4
|
1
|
1
|
1
|
|
Second Intervention (76 Hours)
COMPLETED
|
4
|
3
|
2
|
3
|
2
|
4
|
1
|
1
|
1
|
|
Second Intervention (76 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Rest Period (7-45 Days)
STARTED
|
4
|
3
|
2
|
3
|
2
|
4
|
1
|
1
|
1
|
|
Third Rest Period (7-45 Days)
COMPLETED
|
4
|
3
|
2
|
3
|
2
|
4
|
1
|
1
|
1
|
|
Third Rest Period (7-45 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (76 Hours)
STARTED
|
4
|
3
|
2
|
3
|
2
|
4
|
1
|
1
|
1
|
|
Third Intervention (76 Hours)
COMPLETED
|
3
|
3
|
2
|
2
|
2
|
4
|
0
|
1
|
1
|
|
Third Intervention (76 Hours)
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Optional Fourth Rest Period (7-45 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Optional Fourth Rest Period (7-45 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Optional Fourth Rest Period (7-45 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fourth Intervention Repeat Visit (76 hr)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Fourth Intervention Repeat Visit (76 hr)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Fourth Intervention Repeat Visit (76 hr)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
PLGS-SH-DH
The randomization order for subjects in this arm was predictive low glucose suspend (PLGS), single hormone (SH) and dual hormone (DH). Each visit was 76 hours and included inpatient and outpatient portions.
|
DH-PLGS-SH
The randomization order for subjects in this arm was dual hormone (DH), predictive low glucose suspend (PLGS), and single hormone (SH). Each visit was 76 hours and included inpatient and outpatient portions.
|
SH-DH-PLGS
The randomization order for subjects in this arm was single hormone (SH), dual hormone (DH) and predictive low glucose suspend (PLGS). Each visit was 76 hours and included inpatient and outpatient portions.
|
SH-PLGS-DH
The randomization order for subjects in this arm was single hormone (SH), predictive low glucose suspend (PLGS) and dual hormone (DH). Each visit was 76 hours and included inpatient and outpatient portions.
|
DH-SH-PLGS
The randomization order for subjects in this arm was dual hormone (DH), single hormone (SH) and predictive low glucose suspend (PLGS). Each visit was 76 hours and included inpatient and outpatient portions.
|
PLGS-DH-SH
The randomization order for subjects in this arm was predictive low glucose suspend (PLGS), dual hormone (DH) and single hormone (SH). Each visit was 76 hours and included inpatient and outpatient portions.
|
SH-SH-DH
The randomization order for this subject was single hormone (SH), dual hormone (DH) and predictive low glucose suspend (PLGS). The first SH visit wasn't completed due to technical issues and was repeated before continuing to the DH arm, which was not completed. Each visit was 76 hours and included inpatient and outpatient portions.
|
SH-SH-PLGS-DH
The randomization order for this subject was single hormone (SH), predictive low glucose suspend (PLGS) and dual hormone (DH). Due to device issues, the first SH study was not completed. A second SH study was completed before continuing to PLGS and DH arms. Each arm was 76 hours and included inpatient and outpatient portions.
|
DH-DH-PLGS-SH
The randomization order for this subject was dual hormone (DH), predictive low glucose suspend (PLGS) and single hormone (SH). Due to device issues, the first DH study was not completed. A second DH study was completed before continuing to PLGS and SH arms. Each arm was 76 hours and included inpatient and outpatient portions.
|
|---|---|---|---|---|---|---|---|---|---|
|
First Rest Period (1-12 Weeks)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Intervention (76 Hours)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
First Intervention (76 Hours)
device issues
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Third Intervention (76 Hours)
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Third Intervention (76 Hours)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Three Way Crossover Closed Loop Study With Xeris Glucagon
Baseline characteristics by cohort
| Measure |
All Study Participants
n=23 Participants
All study participants were randomized to complete three 76 hour study visits using either dual hormone, single hormone or predictive low glucose suspend closed loop control. Treatment order was randomized
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hours post exercise on Day 1Population: Using an intent to treat analysis, all partial and completed studies were used in this analysis. 23 subjects were randomized. One subject did not start any studies.
Assess the percent of time that the Dexcom G5 or G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor across all three arms.
Outcome measures
| Measure |
Dual Hormone Closed-loop Arm
n=22 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.
Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
XeriSol glucagon: XeriSol glucagon is an investigational drug that is a stable, soluble liquid glucagon formulation that can be injected or administered through an insulin pump. XeriSol glucagon will be used to fill the Omnipod to deliver glucagon for the Artificial Pancreas Controller in Dual Hormone mode.
|
Single Hormone Closed-loop Arm
n=21 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.
Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
|
Predictive Low Glucose Suspend Arm
n=20 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient. The system will utilize the patient's optimized basal rates, correction factors and carb ratios as they would normally run but the mode will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event.
Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
|
|---|---|---|---|
|
Percent of Time With Sensed Glucose < 70 mg/dl
|
0 percentage 4 hrs post exercise on Day 1
Interval 0.0 to 4.2
|
8.3 percentage 4 hrs post exercise on Day 1
Interval 0.0 to 12.5
|
4.2 percentage 4 hrs post exercise on Day 1
Interval 0.0 to 9.4
|
SECONDARY outcome
Timeframe: entire 76 hour studyPopulation: Using an intent to treat analysis, all partial and completed studies were used in this analysis. 23 subjects were randomized. One subject did not start any studies.
Assess the percent of time that the Dexcom G5 or G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor across all three arms.
Outcome measures
| Measure |
Dual Hormone Closed-loop Arm
n=22 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.
Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
XeriSol glucagon: XeriSol glucagon is an investigational drug that is a stable, soluble liquid glucagon formulation that can be injected or administered through an insulin pump. XeriSol glucagon will be used to fill the Omnipod to deliver glucagon for the Artificial Pancreas Controller in Dual Hormone mode.
|
Single Hormone Closed-loop Arm
n=21 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.
Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
|
Predictive Low Glucose Suspend Arm
n=20 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient. The system will utilize the patient's optimized basal rates, correction factors and carb ratios as they would normally run but the mode will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event.
Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
|
|---|---|---|---|
|
Percent of Time With Sensed Glucose Between 70-180 mg/dl
|
71.0 percentage of 76 hours
Standard Deviation 9.2
|
72.6 percentage of 76 hours
Standard Deviation 9.2
|
63.4 percentage of 76 hours
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Using an intent to treat analysis, all partial and completed studies were used in this analysis. 23 subjects were randomized. One subject did not start any studies.
Assess the number of rescue carbohydrate treatments across all three arms per day.
Outcome measures
| Measure |
Dual Hormone Closed-loop Arm
n=22 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.
Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
XeriSol glucagon: XeriSol glucagon is an investigational drug that is a stable, soluble liquid glucagon formulation that can be injected or administered through an insulin pump. XeriSol glucagon will be used to fill the Omnipod to deliver glucagon for the Artificial Pancreas Controller in Dual Hormone mode.
|
Single Hormone Closed-loop Arm
n=21 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.
Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
|
Predictive Low Glucose Suspend Arm
n=20 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient. The system will utilize the patient's optimized basal rates, correction factors and carb ratios as they would normally run but the mode will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event.
Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
|
|---|---|---|---|
|
Number of Carbohydrate Treatments
|
0.6 number of carbohydrate treatments/day
Standard Deviation 0.9
|
1.7 number of carbohydrate treatments/day
Standard Deviation 2.0
|
1.4 number of carbohydrate treatments/day
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: entire 76 hour studyPopulation: Using an intent to treat analysis, all partial and completed studies were used in this analysis. 23 subjects were randomized. One subject did not start any studies.
Assess the percent of time that the Dexcom G5 or G6 reported sensor glucose values less than 54 mg/dl using Dexcom sensor across all three arms.
Outcome measures
| Measure |
Dual Hormone Closed-loop Arm
n=22 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.
Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
XeriSol glucagon: XeriSol glucagon is an investigational drug that is a stable, soluble liquid glucagon formulation that can be injected or administered through an insulin pump. XeriSol glucagon will be used to fill the Omnipod to deliver glucagon for the Artificial Pancreas Controller in Dual Hormone mode.
|
Single Hormone Closed-loop Arm
n=21 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.
Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
|
Predictive Low Glucose Suspend Arm
n=20 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient. The system will utilize the patient's optimized basal rates, correction factors and carb ratios as they would normally run but the mode will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event.
Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
|
|---|---|---|---|
|
Percent of Time With Sensed Glucose < 54 mg/dl
|
0 percentage of 76 hours
Interval 0.0 to 0.2
|
0.2 percentage of 76 hours
Interval 0.0 to 0.8
|
0.1 percentage of 76 hours
Interval 0.0 to 0.8
|
SECONDARY outcome
Timeframe: entire 76 hour studyPopulation: Using an intent to treat analysis, all partial and completed studies were used in this analysis. 23 subjects were randomized. One subject did not start any studies.
Assess the percent of time that the Dexcom G5 or G6 reported sensor glucose values greater than 180 mg/dl using Dexcom sensor across all three arms.
Outcome measures
| Measure |
Dual Hormone Closed-loop Arm
n=22 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.
Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
XeriSol glucagon: XeriSol glucagon is an investigational drug that is a stable, soluble liquid glucagon formulation that can be injected or administered through an insulin pump. XeriSol glucagon will be used to fill the Omnipod to deliver glucagon for the Artificial Pancreas Controller in Dual Hormone mode.
|
Single Hormone Closed-loop Arm
n=21 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.
Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
|
Predictive Low Glucose Suspend Arm
n=20 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient. The system will utilize the patient's optimized basal rates, correction factors and carb ratios as they would normally run but the mode will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event.
Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
|
|---|---|---|---|
|
Percent of Time With Sensed Glucose > 180 mg/dl
|
28.2 percentage of 76 hours
Standard Deviation 9.4
|
25.1 percentage of 76 hours
Standard Deviation 9.0
|
34.7 percentage of 76 hours
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Using an intent to treat analysis, all partial and completed studies were used in this analysis. 23 subjects were randomized. One subject did not start any studies.
Assess the mean amount of insulin delivered in units/kg as documented through the artificial pancreas controller across all three arms.
Outcome measures
| Measure |
Dual Hormone Closed-loop Arm
n=22 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.
Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
XeriSol glucagon: XeriSol glucagon is an investigational drug that is a stable, soluble liquid glucagon formulation that can be injected or administered through an insulin pump. XeriSol glucagon will be used to fill the Omnipod to deliver glucagon for the Artificial Pancreas Controller in Dual Hormone mode.
|
Single Hormone Closed-loop Arm
n=21 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.
Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
|
Predictive Low Glucose Suspend Arm
n=20 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient. The system will utilize the patient's optimized basal rates, correction factors and carb ratios as they would normally run but the mode will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event.
Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
|
|---|---|---|---|
|
Mean Amount of Insulin Delivered in One Day
|
42.3 units/kg/day
Standard Deviation 16.9
|
41.1 units/kg/day
Standard Deviation 16.4
|
44.0 units/kg/day
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Using an intent to treat analysis, all partial and completed studies were used in this analysis. 23 subjects were randomized. One subject did not start any studies.
Assess the mean amount of XeriSol glucagon delivered in mcg/kg as documented through the artificial pancreas controller in dual hormone arm.
Outcome measures
| Measure |
Dual Hormone Closed-loop Arm
n=22 Participants
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.
Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
XeriSol glucagon: XeriSol glucagon is an investigational drug that is a stable, soluble liquid glucagon formulation that can be injected or administered through an insulin pump. XeriSol glucagon will be used to fill the Omnipod to deliver glucagon for the Artificial Pancreas Controller in Dual Hormone mode.
|
Single Hormone Closed-loop Arm
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.
Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
|
Predictive Low Glucose Suspend Arm
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient. The system will utilize the patient's optimized basal rates, correction factors and carb ratios as they would normally run but the mode will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event.
Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
|
|---|---|---|---|
|
Mean Amount of Glucagon Delivered in One Day
|
4.5 mcg/kg/day
Standard Deviation 1.9
|
—
|
—
|
Adverse Events
Dual Hormone Closed-loop Arm
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Single Hormone Closed-loop Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Predictive Low Glucose Suspend Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dexcom Training Period Arm
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 |
Dual Hormone Closed-loop Arm
n=22 participants at risk
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.
Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
XeriSol glucagon: XeriSol glucagon is an investigational drug that is a stable, soluble liquid glucagon formulation that can be injected or administered through an insulin pump. XeriSol glucagon will be used to fill the Omnipod to deliver glucagon for the Artificial Pancreas Controller in Dual Hormone mode.
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Single Hormone Closed-loop Arm
n=21 participants at risk
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.
Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
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Predictive Low Glucose Suspend Arm
n=20 participants at risk
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient. The system will utilize the patient's optimized basal rates, correction factors and carb ratios as they would normally run but the mode will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event.
Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.
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Dexcom Training Period Arm
n=23 participants at risk
Subjects used the Dexcom G6 CGM along with the APC app. Subjects attended a training visit on using the Dexcom G6. Subjects used the G6 at home over the next 7 days.
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Gastrointestinal disorders
GI upset
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18.2%
4/22 • Number of events 5 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
4.8%
1/21 • Number of events 1 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
0.00%
0/20 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
0.00%
0/23 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
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Skin and subcutaneous tissue disorders
Burning at glucagon site
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4.5%
1/22 • Number of events 1 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
0.00%
0/21 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
0.00%
0/20 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
0.00%
0/23 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
|
Skin and subcutaneous tissue disorders
Irritation at zephyr site
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4.5%
1/22 • Number of events 1 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
0.00%
0/21 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
10.0%
2/20 • Number of events 2 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
0.00%
0/23 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
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Musculoskeletal and connective tissue disorders
Bruised tailbone
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0.00%
0/22 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
0.00%
0/21 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
5.0%
1/20 • Number of events 1 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
0.00%
0/23 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
|
Infections and infestations
upper respiratory infection
|
4.5%
1/22 • Number of events 1 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
4.8%
1/21 • Number of events 1 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
0.00%
0/20 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
0.00%
0/23 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
|
Nervous system disorders
headache
|
9.1%
2/22 • Number of events 2 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
0.00%
0/21 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
0.00%
0/20 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
0.00%
0/23 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
|
Skin and subcutaneous tissue disorders
Swelling at sensor site
|
0.00%
0/22 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
4.8%
1/21 • Number of events 1 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
0.00%
0/20 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
|
0.00%
0/23 • 13 months
All participants that began/started the Dexcom training visit or a PLGS, SH, or DH arm are included in the adverse events. The numbers from the participant flow indicate that 23 subjects began the Dexcom training visit, 20 subjects began a PLGS visit, 21 subjects began a SH visit and 22 subjects began a DH visit.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place