N/A
N=40
Continuous Glucose Monitors (CGM) for Type 2 Diabetes (T2D) Risk Evaluation
Overweight and Obesity · PreDiabetes · Insulin Resistance
Bottom Line
View on ClinicalTrials.gov: NCT05404711 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Feasibility of CGM Use to Determine Type 2 Diabetes Risk — 33; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CGM (Device)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- Mary Ellen Vajravelu, MD
- Primary completion
- Nov 2023
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 | — |
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.
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.