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NCT02714972 · ClinicalTrials.gov registry record · Phase 2
Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing in Children and Young Adolescents
A Phase 2 study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT02714972: Completed Phase 2 study, sponsored by Jaeb Center for Health Research.
NCT02714972 is a Phase 2 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02714972, a Phase 2 study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
Objective: to gain experience in children and younger adolescents with in-home use of an algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy data Study Design: randomized controlled trial, with randomization on a night level within subject Patient Population: Youth 6.0 - \<15 years old with type 1 diabetes treated with daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months who have HbA1c \< 10.0%. Sample Size: 30 subjects Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in activities followed by up to 90 days spent in clinical trial phase of study; clinic visits at enrollment, following CGM and system assessment run-in phases, at start of clinical trial phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use Major Efficacy Outcomes: * Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight. * Secondary: time spent in hypoglycemia (\<70 mg/dl, 3.9 mmol/L) and time spent in hyperglycemia (\>180 mg/dl, 10.0 mmol/L) overnight. Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and diabetic ketoacidosis
Primary Outcome
A single percentage calculated for each subject by pooling all CGM readings from the PLSG+HM nights will be compared with the corresponding percentage obtained by pooling all of the data from PLGS-only nights for the same subject. All CGM readings regardless of the amount of data will be weighted equally in the pooled percentage regardless of how they distribute across nights.
Interventions
- DEVICE Hyperglycemia Minimization Algorithm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2016-05 |
| Est. Completion | 2017-05 |
| Phase | Phase 2 |
What the finished NCT02714972 record still lists
NCT02714972 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which Hyperglycemia Minimization Algorithm is the first listed.
NCT02714972 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02714972 about?
NCT02714972 is a clinical study titled "Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing in Children and Young Adolescents". Objective: to gain experience in children and younger adolescents with in-home use of an algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy da...
What is the current status of trial NCT02714972?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2016-05. Estimated completion is 2017-05.
What interventions are being tested in trial NCT02714972?
The interventions under investigation include: Hyperglycemia Minimization Algorithm (DEVICE).
Who is sponsoring clinical trial NCT02714972?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02714972's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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