Trial Outcomes & Findings for Accelerometer Use in the Prevention of Exercise-Associated Hypoglycemia in Type 1 Diabetes: Outpatient Exercise Protocol (NCT NCT02047643)
NCT ID: NCT02047643
Last Updated: 2019-12-27
Results Overview
The primary outcome will be a hypoglycemic event defined as (1) any meter blood glucose (BG) reading of ≤60 mg/dl, (2) two consecutive meter BG readings ≤70 mg/dl done within one hour, or (3) any instance in which carbohydrates were given at a subject's request for symptoms of hypoglycemia
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Measurements occurring during exercise (up to 8 hours)
Results posted on
2019-12-27
Participant Flow
Participant milestones
| Measure |
On-algorithm First, Then Off-algorithm
Users participated in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm was turned on; on the other day, the algorithm was turned off. If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump.
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Off-algorithm First, Then On-algorithm
Users participated in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm was turned on; on the other day, the algorithm was turned off. If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump.
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|---|---|---|
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Overall Study
STARTED
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9
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9
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Overall Study
COMPLETED
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9
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9
|
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Accelerometer Use in the Prevention of Exercise-Associated Hypoglycemia in Type 1 Diabetes: Outpatient Exercise Protocol
Baseline characteristics by cohort
| Measure |
All Participants
n=18 Participants
Users participated in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm was turned on; on the other day, the algorithm was turned off. If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump.
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|---|---|
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Age, Continuous
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13.4 years
STANDARD_DEVIATION 3.7 • n=93 Participants
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Sex: Female, Male
Female
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8 Participants
n=93 Participants
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Sex: Female, Male
Male
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10 Participants
n=93 Participants
|
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Region of Enrollment
United States
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18 participants
n=93 Participants
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Hemoglobin A1c
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8.0 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.1 • n=93 Participants
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Insulin pump type
Medtronic
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11 Participants
n=93 Participants
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Insulin pump type
OmniPod
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4 Participants
n=93 Participants
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Insulin pump type
Animas
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2 Participants
n=93 Participants
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Insulin pump type
Tandem
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1 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Measurements occurring during exercise (up to 8 hours)The primary outcome will be a hypoglycemic event defined as (1) any meter blood glucose (BG) reading of ≤60 mg/dl, (2) two consecutive meter BG readings ≤70 mg/dl done within one hour, or (3) any instance in which carbohydrates were given at a subject's request for symptoms of hypoglycemia
Outcome measures
| Measure |
On-algorithm
n=18 Participants
Users participated in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm was turned on; on the other day, the algorithm was turned off. If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump.
|
Off-algorithm
n=18 Participants
Users participated in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm was turned on; on the other day, the algorithm was turned off. If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump.
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|---|---|---|
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Count of Participants Experiencing a Hypoglycemic Event During Scheduled Exercise
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3 Participants
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6 Participants
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SECONDARY outcome
Timeframe: In the time following exercise until the following morning (up to 24 hours)A hypoglycemic event was defined as (1) any meter blood glucose (BG) reading of ≤60 mg/dl, (2) two consecutive meter BG readings ≤70 mg/dl done within one hour, or (3) any instance in which carbohydrates were given at a subject's request for symptoms of hypoglycemia
Outcome measures
| Measure |
On-algorithm
n=18 Participants
Users participated in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm was turned on; on the other day, the algorithm was turned off. If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump.
|
Off-algorithm
n=18 Participants
Users participated in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm was turned on; on the other day, the algorithm was turned off. If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump.
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|---|---|---|
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Count of Participants With Hypoglycemia in the Post Exercise Period
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2 Participants
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4 Participants
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Adverse Events
On-algorithm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Off-algorithm
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 |
On-algorithm
n=18 participants at risk
Users participated in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm was turned on; on the other day, the algorithm was turned off. If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump.
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Off-algorithm
n=18 participants at risk
Users participated in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm was turned on; on the other day, the algorithm was turned off. If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump.
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|---|---|---|
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Metabolism and nutrition disorders
Hypoglycemia
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16.7%
3/18 • Two 24-hour periods
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33.3%
6/18 • Two 24-hour periods
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place