N/A
Completed N=40
Continuous Glucose Monitors (CGM) for Type 2 Diabetes (T2D) Risk Evaluation
Overweight and Obesity · Prediabetes · Insulin Resistance
Source: ClinicalTrials.gov NCT05404711 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Feasibility of CGM Use to Determine Type 2 Diabetes Risk — 33; 5 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of CGM Use to Determine Type 2 Diabetes Risk |
33; 5 | — |
| SECONDARY Acceptability of CGM Use for At-home T2D Risk Evaluation in Youth |
33; 3 | — |
| SECONDARY Sensitivity of At-home CGM-measured Glucose Challenge |
80 | — |
| SECONDARY Specificity of At-home CGM-measured Glucose Challenge |
25 | — |
| SECONDARY Positive Predictive Value of At-home, CGM-measured Glucose Challenge |
18.2 | — |
| SECONDARY Negative Predictive Value of At-home, CGM-measured Glucose Challenge |
85.7 | — |
| SECONDARY Sensitivity of At-home CGM-measured Fasting Glucose |
100 | — |
| SECONDARY Specificity of At-home CGM-measured Fasting Glucose |
10 | — |
| SECONDARY Positive Predictive Value of At-home CGM-measured Fasting Glucose |
3.6 | — |
| SECONDARY Negative Predictive Value of At-home CGM-measured Fasting Glucose |
100 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05404711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.