Trial Outcomes & Findings for Medtronic Treat to Range (TTR) Closed-Loop Control (NCT NCT01490151)
NCT ID: NCT01490151
Last Updated: 2017-09-29
Results Overview
A successful hospital admission was defined as requiring no more than 2 TTR closed-loop control system adjustments of algorithm tuning parameters after initial set up, and not meeting any stopping criteria. The system was considered feasible if 75% of hospital admissions were successful.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Day of hospital admission (12 hours)
Results posted on
2017-09-29
Participant Flow
Participant milestones
| Measure |
TTR Controller
The intervention will consist of using the Treat to Range (TTR) controller (Medtronic) for post-prandial glucose control following high and low glycemic meals
TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal or a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Medtronic Treat to Range (TTR) Closed-Loop Control
Baseline characteristics by cohort
| Measure |
TTR Controller
n=22 Participants
The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals
TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal or a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus.
|
|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day of hospital admission (12 hours)Population: A total of 25 admissions were completed. 1 participant was admitted twice in Cohort A1, and 2 participants were admitted first in Cohort A1 and then again in Cohort B.
A successful hospital admission was defined as requiring no more than 2 TTR closed-loop control system adjustments of algorithm tuning parameters after initial set up, and not meeting any stopping criteria. The system was considered feasible if 75% of hospital admissions were successful.
Outcome measures
| Measure |
Cohort A1 - Missed Bolus Meal
n=9 Admissions
The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals
TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal (Cohort A1) or a high glycemic index meal (Cohort A2) and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus (Cohort B).
|
Cohort A2 - Missed Bolus Meal
n=7 Admissions
The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals
TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will have a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home.
|
Cohort B - Overbolus Meal
n=9 Admissions
The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals
TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will receive an insulin dose which will be 120% of their usual insulin bolus. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home.
|
|---|---|---|---|
|
Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions
Unsuccessful Admission
|
2 Admissions
|
3 Admissions
|
2 Admissions
|
|
Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions
Successful Admission
|
7 Admissions
|
4 Admissions
|
7 Admissions
|
Adverse Events
TTR Controller
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TTR Controller
n=22 participants at risk
The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals
TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal or a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus.
|
|---|---|
|
Metabolism and nutrition disorders
Significant Post-Prandial Hyperglycemia
|
4.5%
1/22 • Number of events 1 • Day of hospital admission (12 hours)
Per protocol, adverse events were only collected during the hospital admission when participants were wearing the TTR controller (Medtronic) device
|
|
Metabolism and nutrition disorders
Hypoglycemia <50 mg/dL
|
9.1%
2/22 • Number of events 2 • Day of hospital admission (12 hours)
Per protocol, adverse events were only collected during the hospital admission when participants were wearing the TTR controller (Medtronic) device
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
27.3%
6/22 • Number of events 6 • Day of hospital admission (12 hours)
Per protocol, adverse events were only collected during the hospital admission when participants were wearing the TTR controller (Medtronic) device
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place