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NCT05387551 · ClinicalTrials.gov registry record · NA
CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance
A NA study of PreDiabetes and Impaired Glucose Tolerance, sponsored by Nemours Children's Clinic.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05387551: Recruiting NA study of PreDiabetes and Impaired Glucose Tolerance, sponsored by Nemours Children's Clinic.
NCT05387551 is a NA study of PreDiabetes and Impaired Glucose Tolerance that is actively recruiting participants, run by Nemours Children's Clinic. The registered enrollment target is 15 participants, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05387551, a NA study of PreDiabetes and Impaired Glucose Tolerance, is actively recruiting participants, sponsored by Nemours Children's Clinic.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
The incidence of type 2 diabetes (T2D) in children is increasing, paralleling the rising incidence of obesity. Preventing children and adolescents from developing T2D is critical. The health benefits of lifestyle modifications are well documented in this population, but success rates are low. Obesity in children and adolescents increases the risk of not only T2D but other complications as well, such as hypertension, dyslipidemias and more. The investigators hypothesize that having real-time glucose data with the use of a continuous glucose monitor (CGM) in obese patients with impaired glucose tolerance will improve adherence to lifestyle modifications. As a result, a decrease in body mass index (BMI) is expected with subsequent improvement in insulin sensitivity, thus reducing risk of obesity-related complications later in childhood/adolescence and adulthood.
Primary Outcome
Change in insulin sensitivity as measured by insulin sensitivity Score (ISS). The ISS directly correlates with insulin sensitivity. Higher scores indicate higher insulin sensitivity; lower scores indicate more insulin resistance.
Conditions Studied
Interventions
- DEVICE CGM
Study Locations (1)
Florida
- Nemours Children's Clinic - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-12-01 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT05387551 shows while recruiting
NCT05387551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with PreDiabetes appearing as the primary indexed condition, and to 1 intervention - of which CGM is the first listed.
NCT05387551 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05387551 about?
NCT05387551 is a clinical study titled "CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance". The incidence of type 2 diabetes (T2D) in children is increasing, paralleling the rising incidence of obesity. Preventing children and adolescents from developing T2D is critical. The health benefits of lifestyle modifications are well documented in this population, but success rates are low. Obesit...
What is the current status of trial NCT05387551?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2022-12-01. Estimated completion is 2026-12.
What conditions does trial NCT05387551 study?
This clinical trial studies the following conditions: PreDiabetes, Impaired Glucose Tolerance.
What interventions are being tested in trial NCT05387551?
The interventions under investigation include: CGM (DEVICE).
Who is sponsoring clinical trial NCT05387551?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05387551 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for PreDiabetes
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 NCT05387551's enrollment target sits among peer trials
15 141st of 149 higher than 4 of 149 other PreDiabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PreDiabetes 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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