A Pilot Study Evaluating the Impact of Continuous Glucose Monitoring and Education Intervention on Glycemic Control and Behavioral Changes in Pre-Diabetic Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- Behavioral Changes as measured by questionnaires
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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%
排除标准
- •• 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
研究组 & 干预措施
pre-diabetic patients aged 13-18
干预措施: FitBit and continuous glucose monitoring (Device)
结局指标
主要结局
Behavioral Changes as measured by questionnaires
时间窗: 20 weeks
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.
次要结局
- Physical Activity(From enrollment to the end of the study at 20 weeks)
- Height, weight and BMI(From enrollment to the end of the study at 20 weeks)