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
This trial does not accept healthy volunteersQualifiers
• 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 population
Sudy population includes patients seen at Banner Hospital University Medical Center, Tucson.
Trial design
Cohort
Prospective
Treatments tested in this trial
FitBit and continuous glucose monitoring
DeviceThe 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
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Physical Activity
We will track physical activity as steps measured by the FitBit.
Height, weight and BMI
We will measure height (m), weight (kg) and BMI (kg/m2)
Other outcomes
Glycemic patterns
Glycemic patterns will be evaluated using continuous glucose monitor (CGM) data. We will measure area under the curve (AUC).
Locations
Sponsors and contacts
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