Impact of Continuous Glucose Monitoring and Education Intervention on Glycemic Control and Behavioral Changes in Pre-Diabetic Adolescents

NCT07569185 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00007226
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prediabetes is a condition wherein blood sugar levels are elevated but not sufficiently high enough to diagnose type 2 diabetes mellitus (T2D). Prediabetes is a critical risk factor for the development of T2D in pediatric populations. This progression can occur over a short period of time, limiting the efficacy and impact of existing interventions and recommendations targeting this population. There is growing evidence on the use of continuous glucose monitors (CGMs) in adult prediabetic populations to prevent the development of T2D, though this intervention has not been thoroughly investigated in pediatric populations. The investigators are proposing a pilot study of 25 prediabetic adolescents enrolled in a 20-week study. For the initial 10 weeks of the study, the participants will go without CGMs and undergo clinically recommended education on their condition as standard of care. In the 10 weeks following, participants will be given a CGM to wear and instructions on its use. Surveys will be issued to all participants over the entirety of the study to follow behaviors surrounding food and physical activity.

Conditions

Pre Diabetes

Outcome Measures

Primary Outcomes (1)

• Behavioral Changes as measured by questionnaires

  Participants will complete a standardized questionnaire assessing dietary intake and physical activity every two weeks throughout the study period. Responses will be recorded using Likert-scale measures. Questionnaire results will be compared across study phases, including before and after continuous glucose monitor (CGM) use, to evaluate changes over time.

  20 weeks

Secondary Outcomes (2)

• Physical Activity

  From enrollment to the end of the study at 20 weeks

• Height, weight and BMI

  From enrollment to the end of the study at 20 weeks

Other Outcomes (1)

• Glycemic patterns

  10-20 weeks

Study Arms (1)

pre-diabetic patients aged 13-18

Device: FitBit and continuous glucose monitoring

Interventions

FitBit and continuous glucose monitoring DEVICE

The purpose of this pilot study is to evaluate the effectiveness of CGMs in assisting prediabetic adolescents to make appropriate lifestyle changes aimed at preventing the development of T2D. The investigators hypothesize that the use of CGMs over 10 weeks will result in beneficial lifestyle changes, relative to a period without CGM. The investigators will evaluate beneficial lifestyle changes by following eating habits, physical activity levels, and biometric measurements

pre-diabetic patients aged 13-18

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Sudy population includes patients seen at Banner Hospital University Medical Center, Tucson.

You may qualify if:

• At least 13 years of age
• No older than 17 years of age (up to 18th birthday)
• Access to a smart-device compatible with a continuous glucose monitor application and wearable biosensor
• Diagnosed prediabetes, defined as any of the following:
• Fasting plasma glucose of 100- 125 mg/dL
• hour glucose level on oral glucose tolerance test (OGTT):140-199 mg/dL
• HbA1c 5.7%-6.4%

You may not qualify if:

• Previous diagnosis of Prader Willi Syndrome
• Previous diagnosis of hypothalamic obesity
• Previous diagnosis of intellectual disability
• Previous or planned bariatric surgery
• Current use of medication is known to impact weight
• Previous diagnosis of diabetes mellitus
• Hemoglobin A1c \>6.5%
• Non-English speaking

Sponsors & Collaborators

• University of Arizona: lead

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Central Study Contacts

Sunil Sinha, MD

CONTACT

5206865585; sunil.sinha@bannerhealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2025-11