Trial Outcomes & Findings for Four Way Crossover Closed Loop With Exercise Detection (NCT NCT02862730)
NCT ID: NCT02862730
Last Updated: 2018-09-14
Results Overview
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
entire 84 hour study
Results posted on
2018-09-14
Participant Flow
Participant milestones
| Measure |
SAP, PLGS, DH, SH
The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), predictive low glucose suspend (PLGS), dual hormone (DH) and single hormone (SH). Each visit was 84 hours and included inpatient and outpatient portions.
|
SAP, DH, SH, PLGS
The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), dual hormone (DH), single hormone (SH) and predictive low glucose suspend (PLGS). Each visit was 84 hours and included inpatient and outpatient portions.
|
DH, SH, SAP, PLGS
The randomization order for subjects in this arm was dual hormone (DH), single hormone (SH), open loop (Sensor Augmented Pump SAP), and predictive low glucose suspend (PLGS). Each visit was 84 hours and included inpatient and outpatient portions.
|
SH, SAP, PLGS, DH
The randomization order for subjects in this arm was single hormone (SH), open loop (Sensor Augmented Pump SAP), predictive low glucose suspend (PLGS) and dual hormone (DH). Each visit was 84 hours and included inpatient and outpatient portions.
|
PLGS, DH, SH, SAP
The randomization order for subjects in this arm was predictive low glucose suspend (PLGS), dual hormone (DH), single hormone (SH), and open loop (Sensor Augmented Pump SAP). Each visit was 84 hours and included inpatient and outpatient portions.
|
PLGS, SAP, SH, DH
The randomization order for subjects in this arm was predictive low glucose suspend (PLGS), open loop (Sensor Augmented Pump SAP), single hormone (SH), and dual hormone (DH). Each visit was 84 hours and included inpatient and outpatient portions.
|
SAP, DH, PLGS, SH
The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), dual hormone (DH), predictive low glucose suspend (PLGS), and single hormone (SH). Each visit was 84 hours and included inpatient and outpatient portions.
|
|---|---|---|---|---|---|---|---|
|
Second Intervention (84 Hours)
STARTED
|
4
|
1
|
7
|
5
|
5
|
1
|
1
|
|
Second Intervention (84 Hours)
COMPLETED
|
3
|
1
|
7
|
5
|
5
|
1
|
1
|
|
Second Intervention (84 Hours)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Rest Period (7-45 Days)
STARTED
|
3
|
1
|
7
|
5
|
5
|
1
|
1
|
|
Third Rest Period (7-45 Days)
COMPLETED
|
3
|
1
|
6
|
5
|
4
|
1
|
1
|
|
Third Rest Period (7-45 Days)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Third Intervention (84 Hours)
STARTED
|
3
|
1
|
6
|
5
|
4
|
1
|
1
|
|
Third Intervention (84 Hours)
COMPLETED
|
3
|
1
|
6
|
4
|
4
|
1
|
1
|
|
Third Intervention (84 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Fourth Rest Period (7-45 Days)
STARTED
|
3
|
1
|
6
|
4
|
4
|
1
|
1
|
|
Fourth Rest Period (7-45 Days)
COMPLETED
|
3
|
1
|
6
|
4
|
4
|
1
|
1
|
|
Fourth Rest Period (7-45 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fourth Intervention (84 Hours)
STARTED
|
3
|
1
|
6
|
4
|
4
|
1
|
1
|
|
Fourth Intervention (84 Hours)
COMPLETED
|
3
|
1
|
6
|
4
|
4
|
1
|
1
|
|
Fourth Intervention (84 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Tslim Training Visit (2 Weeks)
STARTED
|
4
|
1
|
8
|
5
|
5
|
1
|
1
|
|
Tslim Training Visit (2 Weeks)
COMPLETED
|
4
|
1
|
7
|
5
|
5
|
1
|
1
|
|
Tslim Training Visit (2 Weeks)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
First Rest Period (1-12 Weeks)
STARTED
|
4
|
1
|
7
|
5
|
5
|
1
|
1
|
|
First Rest Period (1-12 Weeks)
COMPLETED
|
4
|
1
|
7
|
5
|
5
|
1
|
1
|
|
First Rest Period (1-12 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Intervention (84 Hours)
STARTED
|
4
|
1
|
7
|
5
|
5
|
1
|
1
|
|
First Intervention (84 Hours)
COMPLETED
|
4
|
1
|
7
|
5
|
5
|
1
|
1
|
|
First Intervention (84 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Rest Period (7-45 Days)
STARTED
|
4
|
1
|
7
|
5
|
5
|
1
|
1
|
|
Second Rest Period (7-45 Days)
COMPLETED
|
4
|
1
|
7
|
5
|
5
|
1
|
1
|
|
Second Rest Period (7-45 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
SAP, PLGS, DH, SH
The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), predictive low glucose suspend (PLGS), dual hormone (DH) and single hormone (SH). Each visit was 84 hours and included inpatient and outpatient portions.
|
SAP, DH, SH, PLGS
The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), dual hormone (DH), single hormone (SH) and predictive low glucose suspend (PLGS). Each visit was 84 hours and included inpatient and outpatient portions.
|
DH, SH, SAP, PLGS
The randomization order for subjects in this arm was dual hormone (DH), single hormone (SH), open loop (Sensor Augmented Pump SAP), and predictive low glucose suspend (PLGS). Each visit was 84 hours and included inpatient and outpatient portions.
|
SH, SAP, PLGS, DH
The randomization order for subjects in this arm was single hormone (SH), open loop (Sensor Augmented Pump SAP), predictive low glucose suspend (PLGS) and dual hormone (DH). Each visit was 84 hours and included inpatient and outpatient portions.
|
PLGS, DH, SH, SAP
The randomization order for subjects in this arm was predictive low glucose suspend (PLGS), dual hormone (DH), single hormone (SH), and open loop (Sensor Augmented Pump SAP). Each visit was 84 hours and included inpatient and outpatient portions.
|
PLGS, SAP, SH, DH
The randomization order for subjects in this arm was predictive low glucose suspend (PLGS), open loop (Sensor Augmented Pump SAP), single hormone (SH), and dual hormone (DH). Each visit was 84 hours and included inpatient and outpatient portions.
|
SAP, DH, PLGS, SH
The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), dual hormone (DH), predictive low glucose suspend (PLGS), and single hormone (SH). Each visit was 84 hours and included inpatient and outpatient portions.
|
|---|---|---|---|---|---|---|---|
|
Tslim Training Visit (2 Weeks)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Second Intervention (84 Hours)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Rest Period (7-45 Days)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Third Intervention (84 Hours)
diagnosis of gastroparesis
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Four Way Crossover Closed Loop With Exercise Detection
Baseline characteristics by cohort
| Measure |
All Study Participants
n=25 Participants
All study participants were randomized to complete four 84 hour study visits using either standard of care insulin pump therapy, 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
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: entire 84 hour studyPopulation: All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms.
Outcome measures
| Measure |
Predictive Low Glucose Suspend Arm
n=23 Participants
The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it 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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery command
|
Dual Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled
|
Single Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
|
Sensor Augmented Pump Therapy Arm
n=22 Participants
Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.
Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.
|
|---|---|---|---|---|
|
Percent of Time With Sensed Glucose < 3.9 mmol/L
|
1.8 percentage of 84 hours
Standard Deviation 1.5
|
1.2 percentage of 84 hours
Standard Deviation 1.0
|
2.7 percentage of 84 hours
Standard Deviation 1.7
|
3.0 percentage of 84 hours
Standard Deviation 3.1
|
PRIMARY outcome
Timeframe: From 14:00-18:00 for each 12 hour inpatient visitPopulation: All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms.
Outcome measures
| Measure |
Predictive Low Glucose Suspend Arm
n=23 Participants
The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it 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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery command
|
Dual Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled
|
Single Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
|
Sensor Augmented Pump Therapy Arm
n=22 Participants
Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.
Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.
|
|---|---|---|---|---|
|
Percent of Time With Sensed Glucose < 3.9 mmol/L
|
6.9 percentage of 4 hours after exercise
Standard Deviation 8.0
|
3.5 percentage of 4 hours after exercise
Standard Deviation 4.9
|
7.5 percentage of 4 hours after exercise
Standard Deviation 12.2
|
4.0 percentage of 4 hours after exercise
Standard Deviation 6.6
|
PRIMARY outcome
Timeframe: entire 84 hour studyPopulation: All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms.
Outcome measures
| Measure |
Predictive Low Glucose Suspend Arm
n=23 Participants
The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it 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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery command
|
Dual Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled
|
Single Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
|
Sensor Augmented Pump Therapy Arm
n=22 Participants
Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.
Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.
|
|---|---|---|---|---|
|
Percent of Time With Sensed Glucose Between 3.9-10 mmol/L
|
62.9 percentage of 84 hours
Standard Deviation 14.5
|
72.7 percentage of 84 hours
Standard Deviation 10.5
|
75.6 percentage of 84 hours
Standard Deviation 8.7
|
63.1 percentage of 84 hours
Standard Deviation 17.6
|
PRIMARY outcome
Timeframe: From 14:00-18:00 for each 12 hour inpatient visitPopulation: All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms.
Outcome measures
| Measure |
Predictive Low Glucose Suspend Arm
n=23 Participants
The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it 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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery command
|
Dual Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled
|
Single Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
|
Sensor Augmented Pump Therapy Arm
n=22 Participants
Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.
Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.
|
|---|---|---|---|---|
|
Percent of Time With Sensed Glucose Between 3.9-10 mmol/L
|
78.0 percentage of 4 hours after exercise
Standard Deviation 20.1
|
84.6 percentage of 4 hours after exercise
Standard Deviation 16.1
|
84.4 percentage of 4 hours after exercise
Standard Deviation 16.3
|
79.4 percentage of 4 hours after exercise
Standard Deviation 25.3
|
SECONDARY outcome
Timeframe: entire 84 hour studyPopulation: All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.
Assess the mean sensor glucose using Dexcom sensor downloads across all four arms.
Outcome measures
| Measure |
Predictive Low Glucose Suspend Arm
n=23 Participants
The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it 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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery command
|
Dual Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled
|
Single Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
|
Sensor Augmented Pump Therapy Arm
n=22 Participants
Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.
Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.
|
|---|---|---|---|---|
|
Mean Sensed Glucose
|
165.9 mg/dL
Standard Deviation 21.8
|
154.1 mg/dL
Standard Deviation 15.8
|
146.8 mg/dL
Standard Deviation 12
|
161.9 mg/dL
Standard Deviation 29
|
SECONDARY outcome
Timeframe: entire 84 hour studyPopulation: All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.
Assess the number of rescue carbohydrate treatments per day across all four arms.
Outcome measures
| Measure |
Predictive Low Glucose Suspend Arm
n=23 Participants
The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it 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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery command
|
Dual Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled
|
Single Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
|
Sensor Augmented Pump Therapy Arm
n=22 Participants
Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.
Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.
|
|---|---|---|---|---|
|
Number of Carbohydrate Treatments
|
1.3 number of carbohydrate treatments/day
Standard Deviation 1.3
|
0.8 number of carbohydrate treatments/day
Standard Deviation 0.7
|
1.6 number of carbohydrate treatments/day
Standard Deviation 1.4
|
1.4 number of carbohydrate treatments/day
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: entire 84 hour studyPopulation: All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.0 mmol/L using Dexcom sensor downloads across all four arms.
Outcome measures
| Measure |
Predictive Low Glucose Suspend Arm
n=23 Participants
The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it 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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery command
|
Dual Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled
|
Single Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
|
Sensor Augmented Pump Therapy Arm
n=22 Participants
Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.
Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.
|
|---|---|---|---|---|
|
Percent of Time With Sensed Glucose < 3.0 mmol/L
|
0.2 percentage of 84 hours
Standard Deviation 0.3
|
0.2 percentage of 84 hours
Standard Deviation 0.4
|
0.6 percentage of 84 hours
Standard Deviation 0.6
|
0.3 percentage of 84 hours
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: entire 84 hour studyPopulation: All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values greater than 10 mmol/L using Dexcom sensor downloads across all four arms
Outcome measures
| Measure |
Predictive Low Glucose Suspend Arm
n=23 Participants
The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it 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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery command
|
Dual Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled
|
Single Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
|
Sensor Augmented Pump Therapy Arm
n=22 Participants
Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.
Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.
|
|---|---|---|---|---|
|
Percent of Time With Sensed Glucose > 10 mmol/L
|
35.2 percentage of 84 hours
Standard Deviation 15.1
|
26.1 percentage of 84 hours
Standard Deviation 10.9
|
21.7 percentage of 84 hours
Standard Deviation 9.1
|
33.9 percentage of 84 hours
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: entire 84 hour studyPopulation: All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.
Assess number of events with capillary blood glucose \< 3.9 mmol/L using downloads from a Contour Next blood glucose meter across all four arms. .
Outcome measures
| Measure |
Predictive Low Glucose Suspend Arm
n=23 Participants
The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it 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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery command
|
Dual Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled
|
Single Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
|
Sensor Augmented Pump Therapy Arm
n=22 Participants
Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.
Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.
|
|---|---|---|---|---|
|
Number of Events With Capillary Blood Glucose < 3.9 mmol/L
|
0.8 number of events
Standard Deviation 0.7
|
0.7 number of events
Standard Deviation 0.5
|
1.1 number of events
Standard Deviation 0.7
|
0.9 number of events
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: entire 84 hour studyPopulation: All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.
Assess number of events with capillary blood glucose \< 3.0 mmol/L using downloads from a Contour Next blood glucose meter across all four arms.
Outcome measures
| Measure |
Predictive Low Glucose Suspend Arm
n=23 Participants
The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it 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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery command
|
Dual Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled
|
Single Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
|
Sensor Augmented Pump Therapy Arm
n=22 Participants
Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.
Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.
|
|---|---|---|---|---|
|
Number of Events With Capillary Blood Glucose < 3.0 mmol/L
|
0.1 number of events
Standard Deviation 0.1
|
0.1 number of events
Standard Deviation 0.2
|
0.2 number of events
Standard Deviation 0.3
|
0.1 number of events
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.
Assess the average amount of insulin delivered per day in units/kg as documented through the artificial pancreas controller across all four arms.
Outcome measures
| Measure |
Predictive Low Glucose Suspend Arm
n=23 Participants
The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it 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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery command
|
Dual Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled
|
Single Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
|
Sensor Augmented Pump Therapy Arm
n=22 Participants
Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.
Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.
|
|---|---|---|---|---|
|
Mean Amount of Insulin Delivered
|
43.8 units/kg
Standard Deviation 17.5
|
44.2 units/kg
Standard Deviation 16.0
|
42.6 units/kg
Standard Deviation 14.1
|
44.1 units/kg
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.
Assess the average amount of insulin delivered per day in units/kg as documented through the artificial pancreas controller in dual hormone arm.
Outcome measures
| Measure |
Predictive Low Glucose Suspend Arm
n=23 Participants
The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it 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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery command
|
Dual Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled
|
Single Hormone Closed-loop Arm
n=22 Participants
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
|
Sensor Augmented Pump Therapy Arm
n=22 Participants
Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.
Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.
|
|---|---|---|---|---|
|
Mean Amount of Glucagon Delivered
|
516.1 mcg/kg
Standard Deviation 201.1
|
0 mcg/kg
Standard Deviation 0
|
0 mcg/kg
Standard Deviation 0
|
0 mcg/kg
Standard Deviation 0
|
Adverse Events
Predictive Low Glucose Suspend Arm
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Dual Hormone Closed-loop Arm
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Single Hormone Closed-loop Arm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sensor Augmented Pump Therapy Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Tslim Training
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Predictive Low Glucose Suspend Arm
n=23 participants at risk
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
|
Dual Hormone Closed-loop Arm
n=22 participants at risk
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
|
Single Hormone Closed-loop Arm
n=22 participants at risk
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. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
|
Sensor Augmented Pump Therapy Arm
n=22 participants at risk
Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.
Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.
|
Tslim Training
n=25 participants at risk
Subjects used the tslim and Dexcom G4 Share of G5 sensor for two weeks at home to allow subjects to become familiar with the devices.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
GI upset
|
13.0%
3/23 • Number of events 6 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
18.2%
4/22 • Number of events 8 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
4.5%
1/22 • Number of events 1 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/25 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Number of events 2 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
4.5%
1/22 • Number of events 1 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/25 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
|
Skin and subcutaneous tissue disorders
mild edema
|
4.3%
1/23 • Number of events 1 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
9.1%
2/22 • Number of events 2 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/25 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/23 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
4.5%
1/22 • Number of events 1 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
4.5%
1/22 • Number of events 1 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
4.0%
1/25 • Number of events 1 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
|
Endocrine disorders
Hyperglycemia
|
4.3%
1/23 • Number of events 1 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
4.0%
1/25 • Number of events 1 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
|
Gastrointestinal disorders
Sore throat
|
0.00%
0/23 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
4.5%
1/22 • Number of events 1 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/25 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
|
Endocrine disorders
device induced symptomatic hypoglycemia
|
0.00%
0/23 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
4.5%
1/22 • Number of events 1 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/25 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/23 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
4.5%
1/22 • Number of events 2 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/25 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
|
Cardiac disorders
Presyncope
|
0.00%
0/23 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
4.5%
1/22 • Number of events 1 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/22 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
0.00%
0/25 • 12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
|
Additional Information
Dr. Jessica Castle
Oregon Health and Science University
Phone: 503-494-7072
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place