Continuous Glucose Monitors (CGM) for Type 2 Diabetes (T2D) Risk Evaluation
Primary Purpose
Overweight and Obesity, PreDiabetes, Insulin Resistance
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CGM
Sponsored by
About this trial
This is an interventional diagnostic trial for Overweight and Obesity
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
Sites / Locations
- Children's Hospital of PittsburghRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CGM use for T2D risk evaluation
Arm Description
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.
Outcomes
Primary Outcome Measures
Feasibility of CGM use to determine Type 2 Diabetes Risk
Completeness of CGM data (≥ 80% of days with data)
Secondary Outcome Measures
Sensitivity of at-home CGM-measured glucose challenge
Sensitivity of CGM-glucose 2 hours after at-home glucose beverage ingestion to predict OGTT-2h≥140 mg/dL
Specificity of at-home CGM-measured glucose challenge
Specificity of CGM-glucose 2 hours after at-home glucose beverage ingestion to predict OGTT-2h≥140 mg/dL
Positive predictive value of at-home, CGM-measured glucose challenge
Positive predictive value of CGM-glucose 2 hours after at-home glucose beverage ingestion to predict OGTT-2h≥140 mg/dL
Negative predictive value of at-home, CGM-measured glucose challenge
Negative predictive value of CGM-glucose 2 hours after at-home glucose beverage ingestion to predict OGTT-2h≥140 mg/dL
Acceptability of CGM use for at-home T2D risk evaluation in youth
Interview-based
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05404711
Brief Title
Continuous Glucose Monitors (CGM) for Type 2 Diabetes (T2D) Risk Evaluation
Official Title
Feasibility and Acceptability of Home Use Continuous Glucose Monitors for Type 2 Diabetes Risk Evaluation in Youth
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mary Ellen Vajravelu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
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 glycemic control soon after T2D diagnosis makes early identification an important goal in pediatrics, and risk-based screening has been recommended for children for over two decades. However, the screening tests currently used in practice, including hemoglobin A1c (HbA1c), fasting glucose, and 2-hour oral glucose tolerance test (OGTT), have significant drawbacks. Real-time continuous glucose monitors (CGM) are promising new tools for risk stratification in individuals with dysglycemia. These patient-worn medical devices measure interstitial glucose every 5 minutes and offer glimpses into an individual's everyday life, which may include consumption of carbohydrates in amounts larger than that assessed in an OGTT, enhancing test sensitivity. Whether use of CGMs to evaluate type 2 diabetes risk in free-living youth is feasible and acceptable to patients and families is unknown. Assessment of CGM with standardized, but practical, home-based glucose and mixed-meal challenges is needed to determine facilitators and barriers to use of this technology-driven approach in clinical practice. Without advancement in the approach to screening for youth-onset T2D, there is ongoing risk of failure to understand which individuals are at highest risk for complications and could benefit the most from intervention early in the disease process.
In this single-arm prospective study, participants will attend one in-person study visit to complete 2-hour oral glucose tolerance test after overnight fast. Participants will wear a continuous glucose monitor and a wrist-worn actigraphy device for physical activity and sleep measurement for 10 days beginning on the day of the study visit, then return the monitors by mail. During the 10 day wear period, participants will respond to text message-based surveys to document food intake, physical activity, and sleep times and will complete two at-home challenges: 1) glucose challenge using study-provided glucose beverage that is identical to that they consume during clinical oral glucose tolerance test; and 2) food challenge with mixed carbohydrate/fat/protein-containing food of their choice. Glucose trends during these at-home challenges will be compared with oral glucose tolerance test obtained during the study visit. Individual interviews will be conducted upon completion of CGM wear to assess acceptability of the use of at-home glucose challenge and CGM wear as a strategy to evaluate diabetes risk in youth.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, PreDiabetes, Insulin Resistance
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CGM use for T2D risk evaluation
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CGM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of CGM use to determine Type 2 Diabetes Risk
Description
Completeness of CGM data (≥ 80% of days with data)
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Sensitivity of at-home CGM-measured glucose challenge
Description
Sensitivity of CGM-glucose 2 hours after at-home glucose beverage ingestion to predict OGTT-2h≥140 mg/dL
Time Frame
2 Hours
Title
Specificity of at-home CGM-measured glucose challenge
Description
Specificity of CGM-glucose 2 hours after at-home glucose beverage ingestion to predict OGTT-2h≥140 mg/dL
Time Frame
2 Hours
Title
Positive predictive value of at-home, CGM-measured glucose challenge
Description
Positive predictive value of CGM-glucose 2 hours after at-home glucose beverage ingestion to predict OGTT-2h≥140 mg/dL
Time Frame
2 Hours
Title
Negative predictive value of at-home, CGM-measured glucose challenge
Description
Negative predictive value of CGM-glucose 2 hours after at-home glucose beverage ingestion to predict OGTT-2h≥140 mg/dL
Time Frame
2 Hours
Title
Acceptability of CGM use for at-home T2D risk evaluation in youth
Description
Interview-based
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Ellen Vajravelu, MD, MSHP
Phone
412-692-6533
Email
vajravelume@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brianna Hewitt, MPH
Phone
412-692-8418
Email
hewittbl2@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Ellen Vajravelu, MD, MSHP
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Ellen Vajravelu, MD,MSHP
Phone
412-692-6533
Email
vajravelume@upmc.edu
First Name & Middle Initial & Last Name & Degree
Brianna Hewitt, MPH
Phone
412-692-8418
Email
hewittbl2@upmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Continuous Glucose Monitors (CGM) for Type 2 Diabetes (T2D) Risk Evaluation
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