Overweight and ObesityNCT05404711
Continuous Glucose Monitors (CGM) for Type 2 Diabetes (T2D) Risk Evaluation
A study testing CGM in people with Overweight and Obesity and PreDiabetes, run by Mary Ellen Vajravelu, MD at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, PreDiabetes, Insulin Resistance
- What is being tested?
- CGM
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2022to 14 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Feasibility and Acceptability of Home Use Continuous Glucose Monitors for Type 2 Diabetes Risk Evaluation in Youth
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.
Read the 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.
- Conditions
- Overweight and Obesity, PreDiabetes, Insulin Resistance
- Being tested
- CGM
- Medical subject headings
- Overweight, Obesity, Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of CGM Use to Determine Type 2 Diabetes Risk
Completeness of CGM data (≥ 80% of days with data)
Measured: 10 days
Secondary outcomes (9)
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.
Measured: 30 minutes
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 Minute Point of Home-OGTT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start11 Oct 2022
- Primary completion21 Nov 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary Ellen Vajravelu, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mary Ellen Vajravelu, MD, University of Pittsburgh
- Investigators
- Mary Ellen Vajravelu, MD, MSHP, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404711
- Sponsor's protocol ID
- STUDY22030082
- Status last verified
- Aug 2024
- First submitted
- 25 May 2022
- Last updated
- 25 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Home Use Continuous Glucose Monitors for Type 2 Diabetes Risk Evaluation in Youth
- ClinicalTrials.gov ID
- NCT05404711
- Acronym / sponsor ID
- STUDY22030082
- Conditions
- Overweight and Obesity, PreDiabetes, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mary Ellen Vajravelu, MDUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Posted 25 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| CGM use for T2D risk evaluation | Other | Device: CGMAll 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGMParticipants 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. | Device | CGM use for T2D risk evaluation |
Primary outcome
Feasibility of CGM Use to Determine Type 2 Diabetes Risk
Time frame: 10 days
Completeness of CGM data (≥ 80% of days with data)
9 secondary outcomes
Acceptability of CGM Use for At-home T2D Risk Evaluation in Youth
Time frame: 30 minutes
Sensitivity of At-home CGM-measured Glucose Challenge
Time frame: 2 Hour Point of Home-OGTT
Specificity of At-home CGM-measured Glucose Challenge
Time frame: 2 Hour Point of Home-OGTT
Positive Predictive Value of At-home, CGM-measured Glucose Challenge
Time frame: 2 Hour Point of Home-OGTT
Negative Predictive Value of At-home, CGM-measured Glucose Challenge
Time frame: 2 Hour Point of Home-OGTT
Sensitivity of At-home CGM-measured Fasting Glucose
Time frame: 5 Minute Point of Home-OGTT
Specificity of At-home CGM-measured Fasting Glucose
Time frame: 5 Minute Point of Home-OGTT
Positive Predictive Value of At-home CGM-measured Fasting Glucose
Time frame: 5 Minute Point of Home-OGTT
Negative Predictive Value of At-home CGM-measured Fasting Glucose
Time frame: 5 Minute Point of Home-OGTT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Ellen Vajravelu, MD, MSHP principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM in people with Overweight and Obesity and PreDiabetes, run by Mary Ellen Vajravelu, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of CGM Use to Determine Type 2 Diabetes Risk (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.