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

Completed · Not applicable

Conditions studied: Overweight and Obesity, PreDiabetes, Insulin Resistance

In brief

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.

Key facts

Study ID

NCT05404711

Run by

Mary Ellen Vajravelu, MD

People needed

40

Starts

2022-10-11

Expected to finish

2023-12-14

Last updated by the study team

2024-09-25

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Any gender, age 8-18 years
• Tanner 2 or higher pubertal development
• Overweight or obese (BMI ≥85th percentile for age/sex, or ≥ 25 kg/m2 for participants =18 years)
• A) No previously documented abnormal HbA1c or glucose but at higher risk for T2D based on race/ethnicity (Black, Hispanic, Asian, Native American, Pacific Islander), diagnosis with dyslipidemia, hypertension, polycystic ovary syndrome, presence of acanthosis nigricans, or first degree relative with T2D; or B) previously documented (within 6 months) HbA1c 5.7-7.0%, fasting glucose ≥100 mg/dL, or 2-hour plasma glucose on OGTT of ≥140 mg/dL
• Consent (adult subjects), parental/guardian permission (if applicable), assent (if applicable)
• Willingness to wear ActiGraph watch and CGM continuously for 10 day study duration

You may not qualify if…

• Current or recent (within 1 month) use of diabetes-related medication
• Current use of hydroxyurea (due to interference with CGM)
• Known type 1, cystic fibrosis-related, or medication-induced diabetes
• Potential subject unable to speak or read in English
• Severe cognitive impairment
• Current or previous pregnancy

Where it is running

• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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