CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance

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.

Study Overview

• Status: Recruiting
• Conditions: Impaired Glucose Tolerance
• Intervention / Treatment: Device: CGM

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Larry Fox, MD; Phone Number: 9046973674; Email: larry.fox@nemours.org
• Study Contact Backup: Name: Liezel Riego; Phone Number: 9046973431; Email: Liezel.Riego@nemours.org

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Nemours Children's Clinic
      • Principal Investigator: Larry A Fox, MD
      • Contact: Liezel Riego; Phone Number: 904-697-3431; Email: liezel.riego@nemours.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children 10 to <17 years old (i.e., before their 17th birthday)
2. Impaired glucose tolerance based on standardized oral glucose tolerance test (OGTT) or fasting glucose per American Diabetes Association criteria,
3. Overweight or obese (BMI ≥85th percentile for age/sex)
4. Patients are pubertal, defined as females with breast Tanner stage II or above, or males with testicular volume ≥4 mL

Exclusion Criteria:

1. Existing diagnosis of type 1 or type 2 diabetes
2. Prepubertal
3. Taking medications that affect insulin sensitivity (e.g.,chronic corticosteroids whether systemic or inhaled). Metformin allowed if stable dose.
4. Patients and/or families not willing to wear the CGM for the duration of the study period or lack of compliance after recruitment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGM intervention; Continuous glucose monitoring with real-time glucose data using Dexcom G6.	Device: CGM; Dexcom G6 sensor, transmitter and supplies will be provided to family for use. Participants will wear G6 and have real-time glucose data throughout the study.; Other Names: Dexcom G6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QUICKI insulin sensitivity	Change in insulin sensitivity as measured by QUICKI	Baseline to 3 months
QUICKI insulin sensitivity	Change in insulin sensitivity as measured by QUICKI	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.	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)	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).	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)	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)	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)	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.	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.	3 and 6 months

Collaborators and Investigators

• Sponsor: Nemours Children's Clinic
• Investigators: Principal Investigator: Larry A Fox, MD, Nemours Children's Health

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Estimated): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: obesity; adolescents; impaired glucose tolerance
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: lfox051622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes