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NCT Number: NCT05387551

CGM and Lifestyle Changes 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.

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Key information

Conditions

Impaired Glucose Tolerance Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location status: Recruiting

Location contact

Larry A Fox, MD

PRINCIPAL_INVESTIGATOR

Liezel Riego

CONTACT

[email protected]

904-697-3431

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CGM

Device

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.

Other names: Dexcom G7

Primary outcomes

  1. 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.

Secondary outcomes

  1. QUICKI insulin sensitivity

    Time frame: Baseline to 3 months

    Change in insulin sensitivity as measured by QUICKI

  2. QUICKI insulin sensitivity

    Time frame: Baseline to 6 months

    Change in insulin sensitivity as measured by QUICKI

  3. Insulin Sensitivity Score

    Time frame: Baseline to 3 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.

  4. Glycemic levels

    Time frame: Baseline to 3 and 6 months

    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)

  5. Mean, standard deviation of sensor glucose levels

    Time frame: Baseline to 3 and 6 months

    Change in characteristics of glycemic levels obtained from the CGM data, including mean and standard deviation of sensor glucose levels (mg/dL).

  6. Time in range of sensor glucose levels

    Time frame: Baseline to 3 and 6 months

    Change in glycemic levels obtained from the CGM data: Percent of time in range (glucose between 70-140 mg/dL)

  7. Percent of sensor glucose levels in hypoglycemic range

    Time frame: Baseline to 3 and 6 months

    Change in glycemic levels obtained from the CGM data: Percent of time with hypoglycemia (<70 mg/dL)

  8. Percent of sensor glucose levels in hyperglycemic range

    Time frame: Baseline to 3 and 6 months

    Change in glycemic levels obtained from the CGM data: Percent of time with hyperglycemia (>140 mg/dL)

  9. Physical activity questionnaires

    Time frame: 3 and 6 months

    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.

  10. Dietary compliance questionnaires

    Time frame: 3 and 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Larry Fox, MD

CONTACT

[email protected]

9046973674

Liezel Riego

CONTACT

[email protected]

9046973431

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Official study title

Effect of Adding Continuous Glucose Monitoring (CGM) to Lifestyle Changes on Insulin Sensitivity in Patients With Impaired Glucose Tolerance

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 24, 2022
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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