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

University of Arizona

Status: Begins enrollment this month

Conditions: Pre Diabetes

Treatments: Device: FitBit and continuous glucose monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT07569185

STUDY00007226

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 1 patient group

pre-diabetic patients aged 13-18

Treatment:

Device: FitBit and continuous glucose monitoring