Trial Outcomes & Findings for Three-way, Cross-over Closed-loop Exercise Study (NCT NCT02241889)
NCT ID: NCT02241889
Last Updated: 2017-05-22
Results Overview
Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 70 mg/dl using Dexcom sensor downloads.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
from start of exercise (~hour 12) until study completion (hour 21)
Results posted on
2017-05-22
Participant Flow
Participant milestones
| Measure |
SAP, APN, APX (21 Hours)
The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), closed loop (APN) and closed loop with exercise announcement (APX). Each visit was 21 hours.
|
SAP, APX, APN (21 Hours)
The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), closed loop with exercise announcement (APX), and closed loop (APN). Each visit was 21 hours.
|
APN, SAP and APX (21 Hours)
The randomization order for subjects in this arm was closed loop (APN), open loop (Sensor Augmented Pump SAP), and closed loop with exercise announcement (APX). Each visit was 21 hours.
|
APN, APX, SAP (21 Hours)
The randomization order for subjects in this arm was closed loop (APN), closed loop with exercise announcement (APX), and open loop (Sensor Augmented Pump SAP). Each visit was 21 hours.
|
APX, SAP, APN (21 Hours)
The randomization order for subjects in this arm was closed loop with exercise announcement (APX), open loop (Sensor Augmented Pump SAP) and closed loop (APN). Each visit was 21 hours.
|
APX, APN, SAP (21 Hours)
The randomization order for subjects in this arm was closed loop with exercise announcement (APX), closed loop (APN) and open loop (Sensor Augmented Pump SAP). Each visit was 21 hours.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
3
|
3
|
5
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
2
|
3
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
SAP, APN, APX (21 Hours)
The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), closed loop (APN) and closed loop with exercise announcement (APX). Each visit was 21 hours.
|
SAP, APX, APN (21 Hours)
The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), closed loop with exercise announcement (APX), and closed loop (APN). Each visit was 21 hours.
|
APN, SAP and APX (21 Hours)
The randomization order for subjects in this arm was closed loop (APN), open loop (Sensor Augmented Pump SAP), and closed loop with exercise announcement (APX). Each visit was 21 hours.
|
APN, APX, SAP (21 Hours)
The randomization order for subjects in this arm was closed loop (APN), closed loop with exercise announcement (APX), and open loop (Sensor Augmented Pump SAP). Each visit was 21 hours.
|
APX, SAP, APN (21 Hours)
The randomization order for subjects in this arm was closed loop with exercise announcement (APX), open loop (Sensor Augmented Pump SAP) and closed loop (APN). Each visit was 21 hours.
|
APX, APN, SAP (21 Hours)
The randomization order for subjects in this arm was closed loop with exercise announcement (APX), closed loop (APN) and open loop (Sensor Augmented Pump SAP). Each visit was 21 hours.
|
|---|---|---|---|---|---|---|
|
Overall Study
device issues
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Three-way, Cross-over Closed-loop Exercise Study
Baseline characteristics by cohort
| Measure |
All Study Participants
n=23 Participants
All study participants underwent three 21 hour study visits using either standard of care insulin pump therapy, closed loop control, or closed loop control with adjustments to insulin and glucagon after exercise announcement. 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 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from start of exercise (~hour 12) until study completion (hour 21)Population: Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.
Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 70 mg/dl using Dexcom sensor downloads.
Outcome measures
| Measure |
Standard Insulin Pump Therapy
n=21 Participants
Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose.
|
Closed-loop Without Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
Closed-loop With Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
|---|---|---|---|
|
Percent of Time With Sensed Glucose < 70 mg/dl
|
0.9 percentage of time
Interval 0.2 to 1.6
|
3.2 percentage of time
Interval 0.9 to 5.5
|
0.3 percentage of time
Interval 0.0 to 0.8
|
PRIMARY outcome
Timeframe: from start of exercise (~hour 12) until study completion (hour 21)Population: Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.
Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values between 70-180 mg/dl using Dexcom sensor downloads.
Outcome measures
| Measure |
Standard Insulin Pump Therapy
n=21 Participants
Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose.
|
Closed-loop Without Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
Closed-loop With Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
|---|---|---|---|
|
Percent of Time With Sensed Glucose Between 70-180 mg/dl
|
67.6 percent of time
Interval 59.5 to 75.7
|
72.5 percent of time
Interval 66.3 to 78.8
|
67.3 percent of time
Interval 60.2 to 74.5
|
SECONDARY outcome
Timeframe: Entire 21 hour study duration excluding the first four hoursPopulation: Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.
Assess the mean sensed glucose per participant using Dexcom sensor downloads.
Outcome measures
| Measure |
Standard Insulin Pump Therapy
n=21 Participants
Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose.
|
Closed-loop Without Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
Closed-loop With Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
|---|---|---|---|
|
Mean of the Mean Sensed Glucose Per Participant
|
8.6 mg/dl
Interval 7.9 to 9.2
|
8.0 mg/dl
Interval 7.8 to 8.3
|
8.6 mg/dl
Interval 8.1 to 9.1
|
SECONDARY outcome
Timeframe: Entire 21 hour study duration excluding the first four hoursPopulation: Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.
Assess the number of rescue carbohydrate treatments.
Outcome measures
| Measure |
Standard Insulin Pump Therapy
n=21 Participants
Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose.
|
Closed-loop Without Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
Closed-loop With Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
|---|---|---|---|
|
Number of Carbohydrate Treatments
|
0.33 carbohydrate treatments
Interval 0.09 to 0.58
|
0.43 carbohydrate treatments
Interval 0.15 to 0.71
|
0.29 carbohydrate treatments
Interval 0.06 to 0.51
|
SECONDARY outcome
Timeframe: Entire 21 hour study duration excluding the first four hoursPopulation: Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.
Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 50 mg/dl using Dexcom sensor downloads.
Outcome measures
| Measure |
Standard Insulin Pump Therapy
n=21 Participants
Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose.
|
Closed-loop Without Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
Closed-loop With Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
|---|---|---|---|
|
Percent of Time With Sensed Glucose < 50 mg/dl
|
0.001 percent of time
Interval 0.0 to 0.03
|
0.001 percent of time
Interval 0.0 to 0.002
|
0.0 percent of time
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Entire 21 hour study duration excluding the first four hoursPopulation: Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.
Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values greater than 180 mg/dl using Dexcom sensor downloads.
Outcome measures
| Measure |
Standard Insulin Pump Therapy
n=21 Participants
Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose.
|
Closed-loop Without Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
Closed-loop With Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
|---|---|---|---|
|
Percent of Time With Sensed Glucose > 180 mg/dl
|
26.9 percent of time
Interval 19.8 to 34.1
|
16.9 percent of time
Interval 13.2 to 20.6
|
25.2 percent of time
Interval 18.7 to 31.7
|
SECONDARY outcome
Timeframe: Entire 21 hour study duration excluding the first four hoursPopulation: Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.
Number of events measured with capillary blood glucose \<70 mg/dl.
Outcome measures
| Measure |
Standard Insulin Pump Therapy
n=21 Participants
Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose.
|
Closed-loop Without Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
Closed-loop With Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
|---|---|---|---|
|
Number of Events Capillary Blood Glucose (CBG) <70 mg/dl
|
0.43 occurrences of blood glucose < 70 mg/dl
Interval 0.15 to 0.71
|
0.33 occurrences of blood glucose < 70 mg/dl
Interval 0.09 to 0.58
|
0.24 occurrences of blood glucose < 70 mg/dl
Interval 0.03 to 0.45
|
SECONDARY outcome
Timeframe: Entire 21 hour study duration excluding the first four hoursPopulation: Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.
Assess the number of events that the Contour Next BG meter reported blood glucose values between 70-180 mg/dl using meter downloads.
Outcome measures
| Measure |
Standard Insulin Pump Therapy
n=21 Participants
Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose.
|
Closed-loop Without Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
Closed-loop With Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
|---|---|---|---|
|
Number of Events With CBG Between 70 - 180 mg/dl
|
1.6 # of events
Interval 1.3 to 1.9
|
3.1 # of events
Interval 2.7 to 3.5
|
3.0 # of events
Interval 2.6 to 3.4
|
SECONDARY outcome
Timeframe: Entire 21 hour study duration excluding the first four hoursPopulation: Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.
Assess the total number of events that the Contour Next BG meter reported blood glucose values less than 50 mg/dl across all participants in each group.
Outcome measures
| Measure |
Standard Insulin Pump Therapy
n=21 Participants
Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose.
|
Closed-loop Without Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
Closed-loop With Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
|---|---|---|---|
|
Number of Events With CBG <50 mg/dl
|
1 occurrences of blood glucose < 50 mg/dl
|
0 occurrences of blood glucose < 50 mg/dl
|
1 occurrences of blood glucose < 50 mg/dl
|
SECONDARY outcome
Timeframe: Entire 21 hour study duration excluding the first four hoursPopulation: Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.
Assess the percent of time that the Contour Next BG meter reported blood glucose values greater than 180 mg/dl using meter downloads.
Outcome measures
| Measure |
Standard Insulin Pump Therapy
n=21 Participants
Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose.
|
Closed-loop Without Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
Closed-loop With Adjustment
n=21 Participants
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
|---|---|---|---|
|
Percent of Time of CBG>180 mg/dl
|
1.1 percentage of time
Interval 0.7 to 1.4
|
0.7 percentage of time
Interval 0.4 to 1.0
|
1.1 percentage of time
Interval 0.6 to 1.6
|
Adverse Events
Standard Insulin Pump Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Closed-loop Without Adjustment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Closed-loop With Adjustment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Insulin Pump Therapy
n=23 participants at risk
Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose.
|
Closed-loop Without Adjustment
n=23 participants at risk
Subjects will undergo 21 study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
Closed-loop With Adjustment
n=23 participants at risk
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: 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.
|
|---|---|---|---|
|
Gastrointestinal disorders
nausea
|
4.3%
1/23 • Number of events 1 • 9 months
|
8.7%
2/23 • Number of events 2 • 9 months
|
8.7%
2/23 • Number of events 2 • 9 months
|
|
Skin and subcutaneous tissue disorders
mild edema
|
0.00%
0/23 • 9 months
|
4.3%
1/23 • Number of events 1 • 9 months
|
0.00%
0/23 • 9 months
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/23 • 9 months
|
4.3%
1/23 • Number of events 1 • 9 months
|
0.00%
0/23 • 9 months
|
|
Nervous system disorders
headache
|
0.00%
0/23 • 9 months
|
4.3%
1/23 • Number of events 1 • 9 months
|
4.3%
1/23 • Number of events 1 • 9 months
|
|
General disorders
chills
|
0.00%
0/23 • 9 months
|
0.00%
0/23 • 9 months
|
4.3%
1/23 • Number of events 1 • 9 months
|
|
Nervous system disorders
ligh headedness
|
0.00%
0/23 • 9 months
|
0.00%
0/23 • 9 months
|
4.3%
1/23 • Number of events 1 • 9 months
|
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