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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство FitBit and continuous glucose monitoring
  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

Первичные конечные точки

• Behavioral Changes as measured by questionnaires [Срок оценки: 20 weeks]

Вторичные конечные точки (2)

• Physical Activity [Срок оценки: From enrollment to the end of the study at 20 weeks]
• Height, weight and BMI [Срок оценки: From enrollment to the end of the study at 20 weeks]

Критерии участия

Критерии включения

• • 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%

Критерии исключения

• • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07569185 · STUDY00007226

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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