Status:
COMPLETED
Continuous Glucose Monitors (CGM) for Type 2 Diabetes (T2D) Risk Evaluation
Lead Sponsor:
Mary Ellen Vajravelu, MD
Conditions:
Overweight and Obesity
PreDiabetes
Eligibility:
All Genders
8-18 years
Phase:
NA
Brief 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 stan...
Detailed Description
Youth-onset type 2 diabetes (T2D), an increasingly common and aggressive disease that disproportionately impacts racial and ethnic minorities, presents several diagnostic challenges. The rapid loss of...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05404711
Start Date
October 11 2022
End Date
December 14 2023
Last Update
September 25 2024
Active Locations (1)
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1
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224