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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of CGM Use to Determine Type 2 Diabetes Risk | Completeness of CGM data (≥ 80% of days with data) | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of CGM Use for At-home T2D Risk Evaluation in Youth | Interview-based assessment. Participants rated their experience with CGM-OGTT using a Likert-like scale from 1-5 (1= terrible, 2=bad, 3=neutral, 4=good, 5=excellent). Acceptability was defined as a pre-specified threshold of ≥80% of participants providing a neutral or higher rating. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory-measured HbA1c | HbA1c will be measured in the laboratory at baseline to investigate associations with CGM indices obtained during at-home glucose challenge. | Measured at Research Visit |
| Laboratory-measured Fasting Glucose |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Ellen Vajravelu, MD, MSHP | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CGM Use for T2D Risk Evaluation | 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. CGM: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Completed Study Visit |
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| ||||||||||||||||||
| Completed 75-gram, 2-hour CGM-OGTT |
| |||||||||||||||||||
| Valid 75-gram, 2-hour CGM-OGTT |
| |||||||||||||||||||
| Completed, Valid Lab-OGTT and CGM-OGTT |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CGM Use for T2D Risk Evaluation | 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. CGM: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of CGM Use to Determine Type 2 Diabetes Risk | Completeness of CGM data (≥ 80% of days with data) | Of the 39 participants who completed the study visit, 38 returned their CGM for analysis. | Posted | Count of Participants | Participants | 10 days |
|
Adverse event information was collected for the study duration of 10 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CGM Use for T2D Risk Evaluation | 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. CGM: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash due to CGM adhesive | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Ellen Vajravelu, MD,MSHP | University of Pittsburgh School of Medicine | 412-692-6533 | vajravelume@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2023 | Jul 25, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 8, 2023 | Dec 15, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D011236 | Prediabetic State |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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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).
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| 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 | 2 Hour Point of Home-OGTT |
| 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 | 2 Hour Point of Home-OGTT |
| 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 | 2 Hour Point of Home-OGTT |
| 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 | 2 Hour Point of Home-OGTT |
| Sensitivity of At-home CGM-measured Fasting Glucose | Sensitivity of baseline CGM-glucose at the time of at-home glucose beverage ingestion to predict fasting OGTT ≥100 mg/dL | 5 Minute Point of Home-OGTT |
| Specificity of At-home CGM-measured Fasting Glucose | Specificity of baseline CGM-glucose at the time of at-home glucose beverage ingestion to predict fasting OGTT ≥100 mg/dL | 5 Minute Point of Home-OGTT |
| Positive Predictive Value of At-home CGM-measured Fasting Glucose | Positive predictive value of baseline CGM-glucose at the time of at-home glucose beverage ingestion to predict fasting OGTT ≥100 mg/dL | 5 Minute Point of Home-OGTT |
| Negative Predictive Value of At-home CGM-measured Fasting Glucose | Negative predictive value of baseline CGM-glucose at the time of at-home glucose beverage ingestion to predict fasting OGTT ≥100 mg/dL | 5 Minute Point of Home-OGTT |
Fasting glucose will be measured in the laboratory at baseline to investigate associations with CGM indices obtained during at-home glucose challenge.
| Start of Lab-OGTT |
| Laboratory-measured 2-hour Glucose | 2-hour OGTT glucose will be measured in the laboratory at baseline to investigate associations with CGM indices obtained during at-home glucose challenge. | 2 Hour Point of Lab-OGTT |
|
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| BMI | Median | Inter-Quartile Range | kg/m^2 |
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|
|
| Secondary | Acceptability of CGM Use for At-home T2D Risk Evaluation in Youth | Interview-based assessment. Participants rated their experience with CGM-OGTT using a Likert-like scale from 1-5 (1= terrible, 2=bad, 3=neutral, 4=good, 5=excellent). Acceptability was defined as a pre-specified threshold of ≥80% of participants providing a neutral or higher rating. | Of the 39 participants enrolled in the study, only 36 completed the exit interview. | Posted | Count of Participants | Participants | 30 minutes |
|
|
|
| Secondary | 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 | Posted | Number | percentage of true positives | 2 Hour Point of Home-OGTT |
|
|
|
|
| Secondary | 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 | Posted | Number | percentage of true negatives | 2 Hour Point of Home-OGTT |
|
|
|
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| Secondary | 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 | Posted | Number | percent accuracy of positive tests | 2 Hour Point of Home-OGTT |
|
|
|
|
| Secondary | 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 | Posted | Number | percent accuracy of negative tests | 2 Hour Point of Home-OGTT |
|
|
|
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| Secondary | Sensitivity of At-home CGM-measured Fasting Glucose | Sensitivity of baseline CGM-glucose at the time of at-home glucose beverage ingestion to predict fasting OGTT ≥100 mg/dL | Of the 35 participants completing the 2-hr CGM-OGTT, 31 had valid data for baseline fasting glucose. | Posted | Number | percentage of true positives | 5 Minute Point of Home-OGTT |
|
|
|
|
| Secondary | Specificity of At-home CGM-measured Fasting Glucose | Specificity of baseline CGM-glucose at the time of at-home glucose beverage ingestion to predict fasting OGTT ≥100 mg/dL | Of the 35 participants completing the 2-hr CGM-OGTT, 31 had valid data for baseline fasting glucose. | Posted | Number | percentage of true negatives | 5 Minute Point of Home-OGTT |
|
|
|
|
| Secondary | Positive Predictive Value of At-home CGM-measured Fasting Glucose | Positive predictive value of baseline CGM-glucose at the time of at-home glucose beverage ingestion to predict fasting OGTT ≥100 mg/dL | Of the 35 participants completing the 2-hr CGM-OGTT, 31 had valid data for baseline fasting glucose. | Posted | Number | percent accuracy of positive tests | 5 Minute Point of Home-OGTT |
|
|
|
|
| Secondary | Negative Predictive Value of At-home CGM-measured Fasting Glucose | Negative predictive value of baseline CGM-glucose at the time of at-home glucose beverage ingestion to predict fasting OGTT ≥100 mg/dL | Of the 35 participants completing the 2-hr CGM-OGTT, 31 had valid data for baseline fasting glucose. | Posted | Number | percent accuracy of negative tests | 5 Minute Point of Home-OGTT |
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| Other Pre-specified | Laboratory-measured HbA1c | HbA1c will be measured in the laboratory at baseline to investigate associations with CGM indices obtained during at-home glucose challenge. | Posted | Median | Inter-Quartile Range | percent | Measured at Research Visit |
|
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|
|
| Other Pre-specified | Laboratory-measured Fasting Glucose | Fasting glucose will be measured in the laboratory at baseline to investigate associations with CGM indices obtained during at-home glucose challenge. | Posted | Median | Inter-Quartile Range | mg/dL | Start of Lab-OGTT |
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| Other Pre-specified | Laboratory-measured 2-hour Glucose | 2-hour OGTT glucose will be measured in the laboratory at baseline to investigate associations with CGM indices obtained during at-home glucose challenge. | Posted | Median | Inter-Quartile Range | mg/dL | 2 Hour Point of Lab-OGTT |
|
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|
| 0 |
| 39 |
| 0 |
| 39 |
| 3 |
| 39 |
| Emesis due to OGTT beverage | General disorders | Systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| Spearman correlation |
| 0.005 |
| Spearman correlation rho |
| 0.50 |
| 2-Sided |
| Other |
Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT glucose and HbA1c. | Spearman correlation | 0.01 | Spearman correlation rho | 0.46 | 2-Sided | Other | Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and HbA1c. | Spearman correlation | 0.2 | Spearman correlation rho | 0.23 | 2-Sided | Other | Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and HbA1c. | Spearman correlation | 0.5 | Spearman correlation rho | 0.14 | 2-Sided | Other | Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between CGM mean glucose (mg/dL) and HbA1c. | Spearman correlation | 0.1 | Spearman correlation rho | 0.29 | 2-Sided | Other | Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between CGM correlation of variability (CV) and HbA1c. | Spearman correlation | 0.4 | Spearman correlation rho | -0.15 | 2-Sided | Other | Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between CGM standard deviation and HbA1c. | Spearman correlation | 0.7 | Spearman correlation rho | -0.06 | 2-Sided | Other | Spearman correlation analysis |
Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and lab-OGTT fasting glucose.
| Spearman correlation |
| 0.3 |
| Spearman correlation rho |
| 0.19 |
| 2-Sided |
| Other |
Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT and lab-OGTT fasting glucose. | Spearman correlation | 0.6 | Spearman correlation rho | -0.10 | 2-Sided | Other | Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and lab-OGTT fasting glucose. | Spearman correlation | 0.3 | Spearman correlation rho | 0.19 | 2-Sided | Other | Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and lab-OGTT fasting glucose. | Spearman correlation | 0.6 | Spearman correlation rho | 0.09 | 2-Sided | Other | Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between CGM mean glucose and lab-OGTT fasting glucose. | Spearman correlation | 0.05 | Spearman correlation rho | 0.35 | 2-Sided | Other | Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between CGM coefficient of variability (CV) and lab-OGTT fasting glucose. | Spearman correlation | 0.3 | Spearman correlation rho | -0.18 | 2-Sided | Other | Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between CGM standard deviation (SD) and lab-OGTT fasting glucose. | Spearman correlation | 0.7 | Spearman correlation rho | -0.07 | 2-Sided | Other | Spearman correlation analysis |
Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and lab-OGTT 2-hour glucose.
| Spearman correlation |
| 0.1 |
| Spearman correlation rho |
| 0.31 |
| 2-Sided |
| Other |
Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT glucose and lab-OGTT 2-hour glucose. | Spearman correlation | 0.2 | Spearman correlation rho | 0.25 | 2-Sided | Other | Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and lab-OGTT 2-hour glucose. | Spearman correlation | 0.2 | Spearman correlation rho | 0.26 | 2-Sided | Other | Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and lab-OGTT 2-hour glucose. | Spearman correlation | 0.2 | Spearman correlation rho | 0.27 | 2-Sided | Other | Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between CGM mean glucose and lab-OGTT 2-hour glucose. | Spearman correlation | 0.08 | Spearman correlation rho | 0.31 | 2-Sided | Other | Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between CGM coefficient of variability (CV) and lab-OGTT 2-hour glucose. | Spearman correlation | 0.4 | Spearman correlation rho | 0.15 | 2-Sided | Other | Spearman correlation analysis |
| Correlation analyses were performed to assess the relationship between CGM standard deviation (SD) and lab-OGTT 2-hour glucose. | Spearman correlation | 0.1 | Spearman correlation rho | 0.28 | 2-Sided | Other | Spearman correlation analysis |