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

NCT05404711 | Completed Results FDA Device

• 1 other identifier: STUDY22030082
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Overweight and Obesity; PreDiabetes; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Feasibility of CGM Use to Determine Type 2 Diabetes Risk

  Completeness of CGM data (≥ 80% of days with data)

  10 days

Secondary Outcomes (9)

• Acceptability of CGM Use for At-home T2D Risk Evaluation in Youth

  30 minutes

• Sensitivity of At-home CGM-measured Glucose Challenge

  2 Hour Point of Home-OGTT

• Specificity of At-home CGM-measured Glucose Challenge

  2 Hour Point of Home-OGTT

• Positive Predictive Value of At-home, CGM-measured Glucose Challenge

  2 Hour Point of Home-OGTT

• Negative Predictive Value of At-home, CGM-measured Glucose Challenge

  2 Hour Point of Home-OGTT

Other Outcomes (3)

• Laboratory-measured HbA1c

  Measured at Research Visit

• Laboratory-measured Fasting Glucose

  Start of Lab-OGTT

• Laboratory-measured 2-hour Glucose

  2 Hour Point of Lab-OGTT

Study Arms (1)

CGM use for T2D risk evaluation

OTHER

All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation.

Device: CGM

Interventions

CGM DEVICE

Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.

CGM use for T2D risk evaluation

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Mary Ellen Vajravelu, MD: lead

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Prediabetic State; Insulin Resistance

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Results Point of Contact

• Title: Mary Ellen Vajravelu, MD,MSHP
• Organization: University of Pittsburgh School of Medicine

vajravelume@upmc.edu

412-692-6533

Study Officials

• Mary Ellen Vajravelu, MD, MSHP

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Subjects will wear a continuous glucose monitor (CGM) to determine the feasibility and acceptability of the device to evaluate risk of youth developing Type 2 Diabetes (T2D).

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 3, 2022
• Study Start: October 11, 2022
• Primary Completion: November 21, 2023
• Study Completion: December 14, 2023
• Last Updated: September 25, 2024
• Results First Posted: September 25, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)