NCT05404711

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

Completed NA Results posted Last updated 25 September 2024

What this trial tests

NA trial testing CGM in Overweight and Obesity in 40 participants. Completed in 14 December 2023.

Timeline

11 October 2022

Primary endpoint
21 November 2023

14 December 2023

Quick facts

Lead sponsor	Mary Ellen Vajravelu, MD
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	40
Start date	11 October 2022
Primary completion	21 November 2023
Estimated completion	14 December 2023
Sites	1 location across United States

Drugs / interventions tested

• CGM

Conditions studied

• Overweight and Obesity — all drugs for Overweight and Obesity →
• PreDiabetes — all drugs for PreDiabetes →
• Insulin Resistance — all drugs for Insulin Resistance →

Sponsor

Mary Ellen Vajravelu, MD

Who can join

Adults 8 to 18, any sex, with Overweight and Obesity or PreDiabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of CGM Use to Determine Type 2 Diabetes Risk Primary · 10 days

Completeness of CGM data (≥ 80% of days with data)

Group	Value	95% CI
CGM Use for T2D Risk Evaluation	33
CGM Use for T2D Risk Evaluation	5

Acceptability of CGM Use for At-home T2D Risk Evaluation in Youth Secondary · 30 minutes

Interview-based assessment. Participants rated their experience with CGM-OGTT using a Likert-like scale from 1-5 (1= terrible, 2=bad, 3=neutral, 4=good, 5=excellent). Acceptability was defined as a pre-specified threshold of ≥80% of participants providing a neutral or higher rating.

Group	Value	95% CI
CGM Use for T2D Risk Evaluation	33
CGM Use for T2D Risk Evaluation	3

Sensitivity of At-home CGM-measured Glucose Challenge Secondary · 2 Hour Point of Home-OGTT

Sensitivity of CGM-glucose 2 hours after at-home glucose beverage ingestion to predict OGTT-2h≥140 mg/dL

Group	Value	95% CI
CGM Use for T2D Risk Evaluation	80

Specificity of At-home CGM-measured Glucose Challenge Secondary · 2 Hour Point of Home-OGTT

Specificity of CGM-glucose 2 hours after at-home glucose beverage ingestion to predict OGTT-2h≥140 mg/dL

Group	Value	95% CI
CGM Use for T2D Risk Evaluation	25

Positive Predictive Value of At-home, CGM-measured Glucose Challenge Secondary · 2 Hour Point of Home-OGTT

Positive predictive value of CGM-glucose 2 hours after at-home glucose beverage ingestion to predict OGTT-2h≥140 mg/dL

Group	Value	95% CI
CGM Use for T2D Risk Evaluation	18.2

Negative Predictive Value of At-home, CGM-measured Glucose Challenge Secondary · 2 Hour Point of Home-OGTT

Negative predictive value of CGM-glucose 2 hours after at-home glucose beverage ingestion to predict OGTT-2h≥140 mg/dL

Group	Value	95% CI
CGM Use for T2D Risk Evaluation	85.7

Sensitivity of At-home CGM-measured Fasting Glucose Secondary · 5 Minute Point of Home-OGTT

Sensitivity of baseline CGM-glucose at the time of at-home glucose beverage ingestion to predict fasting OGTT ≥100 mg/dL

Group	Value	95% CI
CGM Use for T2D Risk Evaluation	100

Specificity of At-home CGM-measured Fasting Glucose Secondary · 5 Minute Point of Home-OGTT

Specificity of baseline CGM-glucose at the time of at-home glucose beverage ingestion to predict fasting OGTT ≥100 mg/dL

Group	Value	95% CI
CGM Use for T2D Risk Evaluation	10

Positive Predictive Value of At-home CGM-measured Fasting Glucose Secondary · 5 Minute Point of Home-OGTT

Positive predictive value of baseline CGM-glucose at the time of at-home glucose beverage ingestion to predict fasting OGTT ≥100 mg/dL

Group	Value	95% CI
CGM Use for T2D Risk Evaluation	3.6

Negative Predictive Value of At-home CGM-measured Fasting Glucose Secondary · 5 Minute Point of Home-OGTT

Negative predictive value of baseline CGM-glucose at the time of at-home glucose beverage ingestion to predict fasting OGTT ≥100 mg/dL

Group	Value	95% CI
CGM Use for T2D Risk Evaluation	100

Laboratory-measured HbA1c Secondary · Measured at Research Visit

HbA1c will be measured in the laboratory at baseline to investigate associations with CGM indices obtained during at-home glucose challenge.

Group	Value	95% CI
CGM Use for T2D Risk Evaluation	5.7	5.4 – 5.9

Laboratory-measured Fasting Glucose Secondary · Start of Lab-OGTT

Fasting glucose will be measured in the laboratory at baseline to investigate associations with CGM indices obtained during at-home glucose challenge.

Group	Value	95% CI
CGM Use for T2D Risk Evaluation	84	80 – 91

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event information was collected for the study duration of 10 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CGM Use for T2D Risk Evaluation

Serious: 0/39 (0%)

Deaths: 0/39

Other adverse events (2 terms — click to expand)

Reaction	System	CGM Use for T2D Risk Evalu…
Rash due to CGM adhesive	Skin and subcutaneous tissue disorders	—
Emesis due to OGTT beverage	General disorders	—

Data from ClinicalTrials.gov NCT05404711 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility, Acceptability, and Validity of Home Continuous Glucose Monitoring-Based Oral Glucose Tolerance Test in Youth.
   Rodriguez Gonzalez A, Harrison C, Hewitt B, Mejier JL, et al · · 2025 · cited 1× · PMID 39657252 · DOI 10.1210/clinem/dgae845