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

NCT07569185 — Not yet recruiting, 25 participants, University of Arizona

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

Registry	NCT07569185, acronym PreDiA-CGM
Status	Not yet recruiting
Study type	Observational
Enrollment	25 (Estimated)
Sponsor	University of Arizona (Other)
Conditions	Pre Diabetes
Interventions	FitBit and continuous glucose monitoring (Device)
Dates	start 2026-06-01 (estimated), primary completion 2027-01-30 (estimated), completion 2027-07-30 (estimated), first posted 2026-05-06, last updated 2026-05-06

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
pre-diabetic patients aged 13-18		Device: FitBit and continuous glucose monitoring

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

+Outcome measures

Primary outcomes

Behavioral Changes as measured by questionnaires [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 [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 [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 [10-20 weeks]: Glycemic patterns will be evaluated using continuous glucose monitor (CGM) data. We will measure area under the curve (AUC).

+Eligibility

Sex: All, ages: 13 Years to 18 Years

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