Trial Outcomes & Findings for Closed Loop Control in Adolescents Using Heart Rate as Exercise Indicator (NCT NCT01945060)
NCT ID: NCT01945060
Last Updated: 2023-08-21
Results Overview
The Low Blood Glucose Index, which quantifies the risk for hypoglycemia, and the hypoglycemic count (number sequences of blood glucose less than 70 mg/dL). The LBGI is a metric of the frequency and severity of hypoglycemia, based on an increasing weighting of progressively low glucose readings. The LBGI is measured on a scale from 0 to 100 and a higher score indicates a worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
24 hours
Results posted on
2023-08-21
Participant Flow
Participants were recruited at the University of Virginia and Virginia Commonwealth University from July 2013 through April 2015.
Of the 22 enrolled participants, 20 met inclusion criteria and were randomized to treatment. During the study, one participant withdrew from the trial because of distress related to intravenous access, and one participant did not finish the second admission within the allowed time window.
Participant milestones
| Measure |
hrCTR THEN No hrCTR
The experimental admission (hrCTR) was defined as having the participant complete a exercise session where the Diabetes Assistant (DiAs) Control-to-Range system is notified of heart rate. The study team member activated and deactivated a heart rate button when the subject's heart rate exceeded and then returned below 140 beats per minute.
The control admission (No hrCTR) had participants complete an exercise session where the closed loop is not informed about heart rate.
Each admission was about 24-hour in duration with at least 2 days of wash-out in between. Admission had to be completed within a 2-month window.
|
No hrCTR THEN hrCTR
The control admission (No hrCTR) had participants complete an exercise session where the closed loop is not informed about heart rate.
The experimental admission (hrCTR) was defined as having the participant complete a exercise session where the Diabetes Assistant (DiAs) Control-to-Range system is notified of heart rate. The study team member activated and deactivated a heart rate button when the subject's heart rate exceeded and then returned below 140 beats per minute.
Each admission was about 24-hour in duration with at least 2 days of wash-out in between. Admission had to be completed within a 2-month window.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
hrCTR THEN No hrCTR
The experimental admission (hrCTR) was defined as having the participant complete a exercise session where the Diabetes Assistant (DiAs) Control-to-Range system is notified of heart rate. The study team member activated and deactivated a heart rate button when the subject's heart rate exceeded and then returned below 140 beats per minute.
The control admission (No hrCTR) had participants complete an exercise session where the closed loop is not informed about heart rate.
Each admission was about 24-hour in duration with at least 2 days of wash-out in between. Admission had to be completed within a 2-month window.
|
No hrCTR THEN hrCTR
The control admission (No hrCTR) had participants complete an exercise session where the closed loop is not informed about heart rate.
The experimental admission (hrCTR) was defined as having the participant complete a exercise session where the Diabetes Assistant (DiAs) Control-to-Range system is notified of heart rate. The study team member activated and deactivated a heart rate button when the subject's heart rate exceeded and then returned below 140 beats per minute.
Each admission was about 24-hour in duration with at least 2 days of wash-out in between. Admission had to be completed within a 2-month window.
|
|---|---|---|
|
Overall Study
Lost to follow up
|
1
|
0
|
|
Overall Study
Distress related to IV access
|
0
|
1
|
Baseline Characteristics
Closed Loop Control in Adolescents Using Heart Rate as Exercise Indicator
Baseline characteristics by cohort
| Measure |
hrCTR Then No hrCTR
n=9 Participants
The experimental admission (hrCTR) was defined as having the participant complete a exercise session where the Diabetes Assistant (DiAs) Control-to-Range system is notified of heart rate. The study team member activated and deactivated a heart rate button when the subject's heart rate exceeded and then returned below 140 beats per minute.
The admission was about 24-hour in duration with at least 2 days of wash-out in between. Admission had to be completed within a 2-month window.
heart rate Control to Range System (hrCTR) using DiAs Platform: Diabetes Assistant (DiAs) Medical Platform System
* A smart-phone medical platform (DiAs);
* Continuous Glucose Monitor;
* Insulin pump;
* Bluetooth connection;
* Remote Monitoring Server.
The control admission (no hrCTR) had participants complete an exercise session where the closed loop is not informed about heart rate.
The admission was about 24-hour in duration with at least 2 days of wash-out in between. Admission had to be completed within a 2-month window.
|
No hrCTR Then hrCTR
n=9 Participants
The control admission (no hrCTR) had participants complete an exercise session where the closed loop is not informed about heart rate.
The admission was about 24-hour in duration with at least 2 days of wash-out in between. Admission had to be completed within a 2-month window.
The experimental admission (hrCTR) was defined as having the participant complete a exercise session where the Diabetes Assistant (DiAs) Control-to-Range system is notified of heart rate. The study team member activated and deactivated a heart rate button when the subject's heart rate exceeded and then returned below 140 beats per minute.
The admission was about 24-hour in duration with at least 2 days of wash-out in between. Admission had to be completed within a 2-month window.
heart rate Control to Range System (hrCTR) using DiAs Platform: Diabetes Assistant (DiAs) Medical Platform System
* A smart-phone medical platform (DiAs);
* Continuous Glucose Monitor;
* Insulin pump;
* Bluetooth connection;
* Remote Monitoring Server.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
14 years
n=5 Participants
|
14 years
n=7 Participants
|
14 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
diabetes duration [y]
|
10 years
n=5 Participants
|
9 years
n=7 Participants
|
10 years
n=5 Participants
|
|
HbA1c [%]
|
9.2 percentage of glycated hemoglobin
n=5 Participants
|
8.7 percentage of glycated hemoglobin
n=7 Participants
|
9.1 percentage of glycated hemoglobin
n=5 Participants
|
|
Total daily insulin [U]
|
62.5 Units per day
n=5 Participants
|
75 Units per day
n=7 Participants
|
65.1 Units per day
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursThe Low Blood Glucose Index, which quantifies the risk for hypoglycemia, and the hypoglycemic count (number sequences of blood glucose less than 70 mg/dL). The LBGI is a metric of the frequency and severity of hypoglycemia, based on an increasing weighting of progressively low glucose readings. The LBGI is measured on a scale from 0 to 100 and a higher score indicates a worse outcome.
Outcome measures
| Measure |
hrCTR
n=18 Participants
The experimental admission (hrCTR) was defined as having the participant complete a exercise session where the Diabetes Assistant (DiAs) Control-to-Range system is notified of heart rate. The study team member activated and deactivated a heart rate button when the subject's heart rate exceeded and then returned below 140 beats per minute.
The admission was about 24-hour in duration with at least 2 days of wash-out in between. Admission had to be completed within a 2-month window.
|
No hrCTR
n=18 Participants
The control admission (No hrCTR) had participants complete an exercise session where the closed loop is not informed about heart rate.
The admission was about 24-hour in duration with at least 2 days of wash-out in between. Admission had to be completed within a 2-month window.
|
|---|---|---|
|
Low Blood Glucose Index (LBGI)
|
1.4 index score
Standard Deviation 0.91
|
1.9 index score
Standard Deviation 1.85
|
Adverse Events
hrCTR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No hrCTR
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