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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02299479
The ClinicalTrials.gov registry entry for NCT02299479 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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