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NCT02047643 · ClinicalTrials.gov registry record · NA
Accelerometer Use in the Prevention of Exercise-Associated Hypoglycemia in Type 1 Diabetes: Outpatient Exercise Protocol
A NA study, sponsored by Stanford University.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT02047643: Completed NA study, sponsored by Stanford University.
NCT02047643 is a NA study that has completed, run by Stanford University. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02047643, a NA study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study Summary
Manually suspending an insulin pump at the beginning of aerobic exercise reduces the risk of exercise-associated hypoglycemia (low blood sugar) in patients with type 1 diabetes (T1D). However, since patients with T1D often do not make exercise-related adjustments to their insulin regimen, our group has developed an algorithm to initiate pump suspension in a user-independent manner upon projecting exercise-associated hypoglycemia. The current study seeks to test the efficacy of this algorithm by asking users to participate in a sports camp while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which will communicate electronically to a pump shutoff algorithm. On one of the days the algorithm will be used, while on the other day their normal insulin rate will continue for comparative purposes. The investigators hypothesize that the use of an accelerometer-augmented computer algorithm for insulin pump suspension during exercise will result in significantly fewer episodes of hypoglycemia (both during exercise and in post-exercise monitoring) than in exercise without a pump suspension algorithm.
Primary Outcome
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
Interventions
- DEVICE Computer algorithm to initiate pump suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2014-03-12 |
| Est. Completion | 2014-05-01 |
| Phase | NA |
What the finished NCT02047643 record still lists
NCT02047643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Computer algorithm to initiate pump suspension is the first listed.
NCT02047643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02047643 about?
NCT02047643 is a clinical study titled "Accelerometer Use in the Prevention of Exercise-Associated Hypoglycemia in Type 1 Diabetes: Outpatient Exercise Protocol". Manually suspending an insulin pump at the beginning of aerobic exercise reduces the risk of exercise-associated hypoglycemia (low blood sugar) in patients with type 1 diabetes (T1D). However, since patients with T1D often do not make exercise-related adjustments to their insulin regimen, our group ...
What is the current status of trial NCT02047643?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2014-03-12. Estimated completion is 2014-05-01.
What interventions are being tested in trial NCT02047643?
The interventions under investigation include: Computer algorithm to initiate pump suspension (DEVICE).
Who is sponsoring clinical trial NCT02047643?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02047643's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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