About this trial
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.
Eligibility criteria
Qualifiers
• 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
Fasting plasma glucose of 100- 125 mg/dL
Disqualifiers
• Previous diagnosis of Prader Willi Syndrome
Previous diagnosis of hypothalamic obesity
Previous diagnosis of intellectual disability
Previous or planned bariatric surgery
Trial design
Treatments tested in this trial
- FitBit and continuous glucose monitoring