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NCT02299479 · ClinicalTrials.gov registry record · NA
Adjusting Insulin Delivery to Activity
A NA study of Diabetes and Nocturnal Hypoglycemia, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT02299479: Completed NA study of Diabetes and Nocturnal Hypoglycemia, sponsored by Boston Children's Hospital.
NCT02299479 is a NA study of Diabetes and Nocturnal Hypoglycemia that has completed, run by Boston Children's Hospital. The registered enrollment target is 20 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02299479, a NA study of Diabetes and Nocturnal Hypoglycemia, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Increased daytime activity in children and adolescents with type I diabetes is known to be associated with overnight hypoglycemia. We therefore wish to perform a prospective clinical study to assess the feasibility of using activity monitor data to adjust insulin pump basal rates and see whether we can help prevent overnight hypoglycemia or decrease related interventions following high activity days. We plan to carry this out by enrolling 20 subjects (10 subjects 1 to \<7 years old and 10 subjects 7 to 17 years old) with type 1 diabetes managed on insulin pump therapy and having them wear activity monitors and CGMs for up to 3 months. After an initial two-week period to establish activity baselines, we will recommend nighttime basal insulin rate adjustments based on activity monitor, CGM and insulin pump data.
Primary Outcome
Median and inter-quartile range (IQR) of supplemental carbohydrate (SC) interventions (number of SC given by parent divided by the number of days the SC were given) to prevent hypoglycemia during the study period will be compared to those given during the baseline period for each subject. The median and IQR of all subjects will then be calculated.
Conditions Studied
Interventions
- DEVICE Dexcom G4 Platinum CGM
- DEVICE Activity monitor
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-07 |
| Est. Completion | 2017-06-27 |
| Phase | NA |
What the finished NCT02299479 record still lists
NCT02299479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Dexcom G4 Platinum CGM is the first listed.
NCT02299479 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02299479 about?
NCT02299479 is a clinical study titled "Adjusting Insulin Delivery to Activity". Increased daytime activity in children and adolescents with type I diabetes is known to be associated with overnight hypoglycemia. We therefore wish to perform a prospective clinical study to assess the feasibility of using activity monitor data to adjust insulin pump basal rates and see whether we ...
What is the current status of trial NCT02299479?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2015-07. Estimated completion is 2017-06-27.
What conditions does trial NCT02299479 study?
This clinical trial studies the following conditions: Diabetes, Nocturnal Hypoglycemia.
What interventions are being tested in trial NCT02299479?
The interventions under investigation include: Dexcom G4 Platinum CGM (DEVICE), Activity monitor (DEVICE).
Who is sponsoring clinical trial NCT02299479?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02299479 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02299479's enrollment target sits among peer trials
20 305th of 338 higher than 25 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes 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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