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

ConditionPre Diabetes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13-18
SponsorUniversity of Arizona

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 volunteers

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 population

Sudy population includes patients seen at Banner Hospital University Medical Center, Tucson.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: pre-diabetic patients aged 13-181 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
20 weeks

Secondary outcomes

1

Physical Activity

We will track physical activity as steps measured by the FitBit.

Time frame
From enrollment to the end of the study at 20 weeks
2

Height, weight and BMI

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

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

Other outcomes

1

Glycemic patterns

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

Time frame
10-20 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: