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Continuous Glucose Monitors (CGM) for Type 2 Diabetes (T2D) Risk Evaluation

NCT05404711 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-09-25

Study results available
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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.

Conditions

Interventions

DEVICE

CGM

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.

Sponsors & Collaborators

  • Mary Ellen Vajravelu, MD

    lead OTHER

Principal Investigators

  • Mary Ellen Vajravelu, MD, MSHP · University of Pittsburgh

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-11
Primary Completion
2023-11-21
Completion
2023-12-14
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05404711 on ClinicalTrials.gov