NCT05404711Completed
Continuous Glucose Monitors (CGM) for Type 2 Diabetes (T2D) Risk Evaluation
Feasibility and Acceptability of Home Use Continuous Glucose Monitors for Type 2 Diabetes Risk Evaluation in Youth
Source: ClinicalTrials.gov · Last updated 25 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 25 May 2022
- Start date
- 11 Oct 2022
- Primary completion date
- 21 Nov 2023
- Lead sponsor
- Mary Ellen Vajravelu, MD
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT05404711
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 11 Oct 2022 to the primary completion date, 21 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous pregnancy
Other illness
- Current or recent (within 1 month) use of diabetes-related medication
- Known type 1, cystic fibrosis-related, or medication-induced diabetes
- Severe cognitive impairment
Other
- Current use of hydroxyurea (due to interference with CGM)
- Potential subject unable to speak or read in English
Who the study is looking for
- 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
Age in the registry: 8 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.