Impaired Glucose ToleranceNCT05387551
CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance
A study testing CGM in people with Impaired Glucose Tolerance and Prediabetes, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
The incidence of type 2 diabetes (T2D) in children is increasing, paralleling the rising incidence of obesity. Preventing children and adolescents from developing T2D is critical. The health benefits of lifestyle modifications are well documented in this population, but success rates are low. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Impaired Glucose Tolerance, Prediabetes
- What is being tested?
- CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 25 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children 10 to <18 years old (i.e., before their 18th birthday)
- Impaired glucose tolerance based on standardized oral glucose tolerance test (OGTT) or fasting glucose per American Diabetes Association criteria,
- Overweight or obese (BMI ≥85th percentile for age/sex)
- Patients are pubertal, defined as females with breast Tanner stage II or above, or males with testicular volume ≥4 mL
Who cannot join
- Existing diagnosis of type 1 or type 2 diabetes
- Prepubertal
- Taking medications that affect insulin sensitivity (e.g.,chronic corticosteroids whether systemic or inhaled). Metformin allowed if stable dose.
- Patients and/or families not willing to wear the CGM for the duration of the study period or lack of compliance after recruitment
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Clinic
Jacksonville, Florida, 32207
About this study
Official title: Effect of Adding Continuous Glucose Monitoring (CGM) to Lifestyle Changes on Insulin Sensitivity in Patients With Impaired Glucose Tolerance
The incidence of type 2 diabetes (T2D) in children is increasing, paralleling the rising incidence of obesity. Preventing children and adolescents from developing T2D is critical. The health benefits of lifestyle modifications are well documented in this population, but success rates are low. Obesity in children and adolescents increases the risk of not only T2D but other complications as well, such as hypertension, dyslipidemias and more. The investigators hypothesize that having real-time glucose data with the use of a continuous glucose monitor (CGM) in obese patients with impaired glucose tolerance will improve adherence to lifestyle modifications. As a result, a decrease in body mass index (BMI) is expected with subsequent improvement in insulin sensitivity, thus reducing risk of obesity-related complications later in childhood/adolescence and adulthood.
Read the detailed description
The purpose of this research is to evaluate if having blood sugar information from a continuous glucose monitor (CGM) during activities of daily living provides additional benefit to lifestyle modifications in reducing the risk of developing diabetes and achieving a healthier weight. A CGM is a small device often worn on the back of the arm that uses a very small needle to insert a small sensor just under the skin in the fatty tissue. The CGM device transmits the blood sugar level to either a smartphone or a special receiver.
The investigators expect patients will have an overall improvement in health by decreasing weight and therefore improving the way the child's insulin works in their body. This could result in decreased risk of obesity-related complications such as diabetes mellitus, cardiovascular disease, kidney disease, and loss of vision and/or limbs, among others.
- Conditions
- Impaired Glucose Tolerance, Prediabetes
- Being tested
- CGM
- Keywords
- impaired glucose tolerance, obesity, adolescents
- Medical subject headings
- Glucose Intolerance, Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGMDevice
Also called Dexcom G7
Dexcom G7 sensor, transmitter and supplies will be provided to family for use. Participants will wear G7 and have real-time glucose data throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| CGM intervention | Experimental | Continuous glucose monitoring with real-time glucose data using Dexcom G6. Receives: Device: CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity Score (ISS)
Change in insulin sensitivity as measured by insulin sensitivity Score (ISS). The ISS directly correlates with insulin sensitivity. Higher scores indicate higher insulin sensitivity; lower scores indicate more insulin resistance.
Measured: Baseline to 6 months
Secondary outcomes (10)
QUICKI insulin sensitivity
Change in insulin sensitivity as measured by QUICKI
Measured: Baseline to 3 months
QUICKI insulin sensitivity
Change in insulin sensitivity as measured by QUICKI
Measured: Baseline to 6 months
Insulin Sensitivity Score
Change in insulin sensitivity as measured by insulin sensitivity Score (ISS). The ISS directly correlates with insulin sensitivity. Higher scores indicate higher insulin sensitivity; lower scores indicate more insulin resistance.
Measured: Baseline to 3 months
Glycemic levels
Change in characteristics of glycemic levels obtained from the CGM data. This will include:
- mean, standard deviation of glucose levels
- time in range (glucose between 70-140 mg/dL)
- percent of time with hyperglycemia (>140 mg/dL)
- percent of time with hypoglycemia (<70 mg/dL)
Measured: Baseline to 3 and 6 months
Mean, standard deviation of sensor glucose levels
Change in characteristics of glycemic levels obtained from the CGM data, including mean and standard deviation of sensor glucose levels (mg/dL).
Measured: Baseline to 3 and 6 months
Time in range of sensor glucose levels
Change in glycemic levels obtained from the CGM data: Percent of time in range (glucose between 70-140 mg/dL)
Measured: Baseline to 3 and 6 months
Percent of sensor glucose levels in hypoglycemic range
Change in glycemic levels obtained from the CGM data: Percent of time with hypoglycemia (<70 mg/dL)
Measured: Baseline to 3 and 6 months
Percent of sensor glucose levels in hyperglycemic range
Change in glycemic levels obtained from the CGM data: Percent of time with hyperglycemia (>140 mg/dL)
Measured: Baseline to 3 and 6 months
Physical activity questionnaires
Questionnaires will be used to assess amount of time participants are active. Two questions regarding physical activity will be asked, with a scale set up as follows:
- How many minutes of continuous physical activity per week were completed? Possible answers will be <10, 11-20, 21-30, 31-60, 61-90, 91-120, or 121-150.
- How many days per week of physical activity longer than 30 minutes? Possible answers will be 0, 1, 2, 3, 4, 5, 6, or 7.
Measured: 3 and 6 months
Dietary compliance questionnaires
Questionnaires will be used to assess particpants' compliance witih dietary changes. Four questions regarding their diet will be asked, with a scale set up as follows:
- How many sugary drinks per week? Possible answers will be 0, 1-2, 3-5, or >5.
- How many unhealthy snacks per week? Possible answers will be 0, 1-2, 3-5, or >5.
- How many times junk food was consume in the past week? Possible answers will be 0, 1-2, 3-5, or >5.
- How often were the proper portion sizes followed (as per control plate)? Possible answers will be always, most days, occasionally, or never.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Dec 2022
- Primary completion25 Jun 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Glucose ToleranceStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry A. Fox, MD, Nemours Children's Clinic
- Investigators
- Larry A Fox, MD, Principal investigator, Nemours Children's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387551
- Sponsor's protocol ID
- lfox051622
- Status last verified
- Aug 2026
- First submitted
- 16 May 2022
- Last updated
- 7 Aug 2026
- Results posted
- No
- 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Continuous Glucose Monitoring (CGM) to Lifestyle Changes on Insulin Sensitivity in Patients With Impaired Glucose Tolerance
- ClinicalTrials.gov ID
- NCT05387551
- Acronym / sponsor ID
- lfox051622
- Conditions
- Impaired Glucose Tolerance, Prediabetes
- Keywords
- impaired glucose tolerance, obesity, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of type 2 diabetes (T2D) in children is increasing, paralleling the rising incidence of obesity. Preventing children and adolescents from developing T2D is critical. The health benefits of lifestyle modifications are well documented in this population, but success rates are low. Obesity in children and adolescents increases the risk of not only T2D but other complications as well, such as hypertension, dyslipidemias and more. The investigators hypothesize that having real-time glucose data with the use of a continuous glucose monitor (CGM) in obese patients with impaired glucose tolerance will improve adherence to lifestyle modifications. As a result, a decrease in body mass index (BMI) is expected with subsequent improvement in insulin sensitivity, thus reducing risk of obesity-related complications later in childhood/adolescence and adulthood.
Detailed description
The purpose of this research is to evaluate if having blood sugar information from a continuous glucose monitor (CGM) during activities of daily living provides additional benefit to lifestyle modifications in reducing the risk of developing diabetes and achieving a healthier weight. A CGM is a small device often worn on the back of the arm that uses a very small needle to insert a small sensor just under the skin in the fatty tissue. The CGM device transmits the blood sugar level to either a smartphone or a special receiver.
The investigators expect patients will have an overall improvement in health by decreasing weight and therefore improving the way the child's insulin works in their body. This could result in decreased risk of obesity-related complications such as diabetes mellitus, cardiovascular disease, kidney disease, and loss of vision and/or limbs, among others.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM intervention | Experimental | Device: CGMContinuous glucose monitoring with real-time glucose data using Dexcom G6. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children 10 to <18 years old (i.e., before their 18th birthday)
- Impaired glucose tolerance based on standardized oral glucose tolerance test (OGTT) or fasting glucose per American Diabetes Association criteria,
- Overweight or obese (BMI ≥85th percentile for age/sex)
- Patients are pubertal, defined as females with breast Tanner stage II or above, or males with testicular volume ≥4 mL
Key exclusion criteria (4 listed)
- Existing diagnosis of type 1 or type 2 diabetes
- Prepubertal
- Taking medications that affect insulin sensitivity (e.g.,chronic corticosteroids whether systemic or inhaled). Metformin allowed if stable dose.
- Patients and/or families not willing to wear the CGM for the duration of the study period or lack of compliance after recruitment
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 |
|---|---|---|
| CGMAlso: Dexcom G7Dexcom G7 sensor, transmitter and supplies will be provided to family for use. Participants will wear G7 and have real-time glucose data throughout the study. | Device | CGM intervention |
Primary outcome
Insulin Sensitivity Score (ISS)
Time frame: Baseline to 6 months
Change in insulin sensitivity as measured by insulin sensitivity Score (ISS). The ISS directly correlates with insulin sensitivity. Higher scores indicate higher insulin sensitivity; lower scores indicate more insulin resistance.
10 secondary outcomes
QUICKI insulin sensitivity
Time frame: Baseline to 3 months
QUICKI insulin sensitivity
Time frame: Baseline to 6 months
Insulin Sensitivity Score
Time frame: Baseline to 3 months
Glycemic levels
Time frame: Baseline to 3 and 6 months
Mean, standard deviation of sensor glucose levels
Time frame: Baseline to 3 and 6 months
Time in range of sensor glucose levels
Time frame: Baseline to 3 and 6 months
Percent of sensor glucose levels in hypoglycemic range
Time frame: Baseline to 3 and 6 months
Percent of sensor glucose levels in hyperglycemic range
Time frame: Baseline to 3 and 6 months
Physical activity questionnaires
Time frame: 3 and 6 months
Dietary compliance questionnaires
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- 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.
Larry A Fox, MD principal investigator
Nemours Children's Health
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 Impaired Glucose Tolerance and Prediabetes, run by Nemours Children's Clinic 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 4 inclusion and 4 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 7 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Insulin Sensitivity Score (ISS) (time frame: Baseline to 6 months). 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 7 Aug 2026.