CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
CGMdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05404711
NCT05404711N/ACompleted

Feasibility and Acceptability of Home Use Continuous Glucose Monitors for Type 2 Diabetes Risk Evaluation in Youth

Mary Ellen Vajravelu, MD·interventional·Posted Jun 3, 2022·Updated Sep 25, 2024

In Brief

A clinical study evaluating CGM for Overweight and Obesity and 2 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this research study is to determine whether continuous glucose monitors (CGM) are a safe, effective, and acceptable way to evaluate type 2 diabetes risk in youth as compared to the standard 2-hour oral glucose tolerance test (OGTT). This study will involve wearing a CGM, wearing a physical activity tracker, responding to surveys, and completing at-home glucose and mixed food challenge while wearing the CGM. Subjects will also be asked to complete an interview by phone or videoconference after wearing the CGM.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedJun 3, 2022
Enrollment StartOct 11, 2022
Primary CompletionNov 21, 2023
Study CompletionDec 14, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.1 years ago

Interventions

CGMdevice

Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.