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.

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Key information

Conditions

Pre Diabetes Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

Primary outcomes

Behavioral Changes as measured by questionnaires

Time frame: 20 weeks

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.

Secondary outcomes

Physical Activity

Time frame: From enrollment to the end of the study at 20 weeks

We will track physical activity as steps measured by the FitBit.
Height, weight and BMI

Time frame: From enrollment to the end of the study at 20 weeks

We will measure height (m), weight (kg) and BMI (kg/m2)

Other outcomes

Glycemic patterns

Time frame: 10-20 weeks

Glycemic patterns will be evaluated using continuous glucose monitor (CGM) data. We will measure area under the curve (AUC).

Study contacts

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

Sunil Sinha, MD

CONTACT

[email protected]

5206865585

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Acronym: PreDiA-CGM

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 6, 2026
Registry last updated: May 6, 2026

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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