Trial Outcomes & Findings for Feasibility Study of Closed Loop Control in Type 1 Diabetes Using Heart Rate Monitoring as an Exercise Marker (NCT NCT01582139)
NCT ID: NCT01582139
Last Updated: 2014-08-15
Results Overview
Plasma glucose based number of hypoglycemic events, defined as consecutive plasma readings below 70mg/dl to measure the capacity of the system to protect patients against the risk of hypoglycemia. Two events separated by only one Yellow Springs Instrument (YSI) value over 70 are considered to form a single event.
COMPLETED
NA
12 participants
26 hours (x2 admissions)
2014-08-15
Participant Flow
Participant milestones
| Measure |
Control First, Then Experimental
Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate
|
Experimental First, Then Control
Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility Study of Closed Loop Control in Type 1 Diabetes Using Heart Rate Monitoring as an Exercise Marker
Baseline characteristics by cohort
| Measure |
Control First, Then Experimental
n=6 Participants
Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate
|
Experimental First, Then Control
n=6 Participants
Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 26 hours (x2 admissions)Population: Twelve subjects completed the study. The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented below.
Plasma glucose based number of hypoglycemic events, defined as consecutive plasma readings below 70mg/dl to measure the capacity of the system to protect patients against the risk of hypoglycemia. Two events separated by only one Yellow Springs Instrument (YSI) value over 70 are considered to form a single event.
Outcome measures
| Measure |
Experimental: Heart-Rate Informed SSM+HMM
n=10 Participants
An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate
Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes.
|
Control: SSM+HMM
n=10 Participants
A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
|
|---|---|---|
|
Hypoglycemic Events
During Exercise (t=0.5h)
|
0 hypoglycemic events
|
2 hypoglycemic events
|
|
Hypoglycemic Events
Overnight (t=8h)
|
0 hypoglycemic events
|
1 hypoglycemic events
|
|
Hypoglycemic Events
During Recovery (t=2.5h)
|
1 hypoglycemic events
|
2 hypoglycemic events
|
SECONDARY outcome
Timeframe: 26 hours (x2 admissions)Population: Twelve subjects completed the study. The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented below.
A measure of the risk of hypoglycemia. It quantifies the frequency and the extent of low BG readings. A LBGI \< 2.5 is associated with a low-risk of hypoglycemia, LBGI 2.5-5 is associated with a moderate risk of hypoglycemia, and LBGI \> 5 is associated with a high-risk of hypoglycemia.
Outcome measures
| Measure |
Experimental: Heart-Rate Informed SSM+HMM
n=10 Participants
An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate
Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes.
|
Control: SSM+HMM
n=10 Participants
A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
|
|---|---|---|
|
Low Blood Glucose Index
During Exercise (t=0.5h)
|
0.84 index score
Standard Error 0.60
|
2.72 index score
Standard Error 1.61
|
|
Low Blood Glucose Index
During Recovery (t=2.5h)
|
1.81 index score
Standard Error 1.2
|
1.83 index score
Standard Error 1.4
|
|
Low Blood Glucose Index
Overnight (t=8h)
|
0.98 index score
Standard Error 0.41
|
0.49 index score
Standard Error 0.21
|
SECONDARY outcome
Timeframe: 26 hours (2x admissions)Population: The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented.
Average glucose drops at specific time points after the onset of exercise; defined as the difference between plasma glucose at onset of exercise and the glucose values reached at 40 and 60 min post onset of exercise.
Outcome measures
| Measure |
Experimental: Heart-Rate Informed SSM+HMM
n=10 Participants
An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate
Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes.
|
Control: SSM+HMM
n=10 Participants
A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
|
|---|---|---|
|
Average Glucose Drop
60 min since exercise onset
|
-3.4 mg/dL
Standard Deviation 12
|
-27.7 mg/dL
Standard Deviation 10
|
|
Average Glucose Drop
40 min since exercise onset
|
-5 mg/dL
Standard Deviation 10
|
-29 mg/dL
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 26 hours (x2 admissions)Population: Twelve subjects completed the study. The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented below.
Percent time spent within target (70-180 mg/dL) range.
Outcome measures
| Measure |
Experimental: Heart-Rate Informed SSM+HMM
n=10 Participants
An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate
Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes.
|
Control: SSM+HMM
n=10 Participants
A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
|
|---|---|---|
|
Time in Range
Overall
|
81 percentage of time spent in range
Standard Error 3.9
|
75 percentage of time spent in range
Standard Error 4.3
|
|
Time in Range
During Exercise (t=0.5h)
|
91 percentage of time spent in range
Standard Error 7.3
|
85 percentage of time spent in range
Standard Error 10.3
|
|
Time in Range
During Recovery (t=2.5h)
|
86 percentage of time spent in range
Standard Error 9.3
|
84 percentage of time spent in range
Standard Error 7.9
|
|
Time in Range
Overnight (t=8h)
|
89 percentage of time spent in range
Standard Error 7.1
|
84 percentage of time spent in range
Standard Error 9.2
|
Adverse Events
Control: SSM+HMM
Experimental: Heart Rate Informed SSM+HMM
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control: SSM+HMM
n=12 participants at risk
A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
|
Experimental: Heart Rate Informed SSM+HMM
n=12 participants at risk
Experimental:
An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate
Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
8.3%
1/12 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Mild Erythema
|
8.3%
1/12 • Number of events 5
|
0.00%
0/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place