Trial Outcomes & Findings for Hypoglycemia Prevention After Exercise in Adolescent T1DM Patients Using a Control to Range System (NCT NCT01390259)
NCT ID: NCT01390259
Last Updated: 2014-08-15
Results Overview
Number of hypoglycemic events below 70 mg/dL per patient per day Hypoglycemic event is defined as consecutive YSI plasma glucose measurements below 70 or moderate hypoglycemic symptoms
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
22 hours
Results posted on
2014-08-15
Participant Flow
Participant milestones
| Measure |
Open-Loop First, Then Closed-Loop
Open-Loop first, then Closed-Loop control (CLC)
Experimental, CLC admission: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:
1. monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
2. predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
Placebo Comparator: Open Loop admission. The subjects were in charge of their insulin treatment.
|
Closed-Loop Control First, Then Open-Loop
Closed-Loop control (CLC) first, then Open-Loop
Experimental, CLC admission: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:
1. monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
2. predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
Placebo Comparator: Open Loop admission. The subjects were in charge of their insulin treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hypoglycemia Prevention After Exercise in Adolescent T1DM Patients Using a Control to Range System
Baseline characteristics by cohort
| Measure |
Adolescents
n=11 Participants
Adolescents participated in both the Standard Control to Range (sCTR) Closed-Loop Control (CLC) Admission and the Open-Loop admission.
Experimental: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:
1. monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
2. predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
Placebo Comparator: Open Loop. The subjects were in charge of their insulin treatment.
|
|---|---|
|
Age, Continuous
|
14.5 years
STANDARD_DEVIATION 1.5 • n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
|
HbA1c
|
8.6 percent
STANDARD_DEVIATION 0.8 • n=93 Participants
|
PRIMARY outcome
Timeframe: 22 hoursNumber of hypoglycemic events below 70 mg/dL per patient per day Hypoglycemic event is defined as consecutive YSI plasma glucose measurements below 70 or moderate hypoglycemic symptoms
Outcome measures
| Measure |
Closed-Loop Control (CLC)
n=11 Participants
The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:
* monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
* predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
Closed-Loop: During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. Standard Control to Range (sCTR).
|
Open-Loop
n=11 Participants
The subjects were in charge of their insulin treatment.
Open-Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...).
|
|---|---|---|
|
Hypoglycemic Events
Overall (t=22h)
|
0.27 events/patient
Standard Error 0.19
|
1.0 events/patient
Standard Error 0.5
|
|
Hypoglycemic Events
Exercise (t=0.5h)
|
0.18 events/patient
Standard Error 0.12
|
0.18 events/patient
Standard Error 0.12
|
|
Hypoglycemic Events
Recovery (t=1h)
|
0 events/patient
Standard Error 0
|
0.18 events/patient
Standard Error 0.12
|
|
Hypoglycemic Events
Overnight (t=7h)
|
0 events/patient
Standard Error 0
|
0.18 events/patient
Standard Error 0.18
|
SECONDARY outcome
Timeframe: 22 hoursPercent of time the patient plasma glucose as measured by YSI is between 70mg/dl and 180mg/dl
Outcome measures
| Measure |
Closed-Loop Control (CLC)
n=11 Participants
The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:
* monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
* predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
Closed-Loop: During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. Standard Control to Range (sCTR).
|
Open-Loop
n=11 Participants
The subjects were in charge of their insulin treatment.
Open-Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...).
|
|---|---|---|
|
Percent Time in Euglycemia
Overall (t=22h)
|
65.1 percentage of time in range
Standard Error 6.8
|
50.2 percentage of time in range
Standard Error 9.7
|
|
Percent Time in Euglycemia
Day (t=15h)
|
74.0 percentage of time in range
Standard Error 5.2
|
57.0 percentage of time in range
Standard Error 8.9
|
|
Percent Time in Euglycemia
Night (t=7h)
|
56.0 percentage of time in range
Standard Error 11.8
|
43.6 percentage of time in range
Standard Error 13.3
|
SECONDARY outcome
Timeframe: 22 hoursAverage plasma glucose concentration in mg/dl
Outcome measures
| Measure |
Closed-Loop Control (CLC)
n=11 Participants
The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:
* monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
* predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
Closed-Loop: During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. Standard Control to Range (sCTR).
|
Open-Loop
n=11 Participants
The subjects were in charge of their insulin treatment.
Open-Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...).
|
|---|---|---|
|
Mean Glucose
Night (t=7)
|
177.29 mg/dL
Standard Error 8.23
|
193.04 mg/dL
Standard Error 22.08
|
|
Mean Glucose
Overall (t=22h)
|
166.24 mg/dL
Standard Error 7.23
|
176.1 mg/dL
Standard Error 18.04
|
|
Mean Glucose
Day (t=15h)
|
155.44 mg/dL
Standard Error 7.76
|
160.57 mg/dL
Standard Error 16.54
|
Adverse Events
Adolescents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place