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

A Pilot Study Evaluating the Impact of Continuous Glucose Monitoring and Education Intervention on Glycemic Control and Behavioral Changes in Pre-Diabetic Adolescents

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pre Diabetes
• Intervention / Treatment: Device: FitBit and continuous glucose monitoring

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Sunil Sinha, MD; Phone Number: 5206865585; Email: sunil.sinha@bannerhealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• • 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
    • 2-hour glucose level on oral glucose tolerance test (OGTT):140-199 mg/dL
    • HbA1c 5.7%-6.4%

Exclusion Criteria:

• • 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

pre-diabetic patients aged 13-18

Device: FitBit and continuous glucose monitoring; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity	We will track physical activity as steps measured by the FitBit.	From enrollment to the end of the study at 20 weeks
Height, weight and BMI	We will measure height (m), weight (kg) and BMI (kg/m2)	From enrollment to the end of the study at 20 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic patterns	Glycemic patterns will be evaluated using continuous glucose monitor (CGM) data. We will measure area under the curve (AUC).	10-20 weeks

Collaborators and Investigators

• Sponsor: University of Arizona

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperglycemia; Nutritional and Metabolic Diseases; Glucose Intolerance; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: STUDY00007226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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