Impact of Continuous Glucose Monitoring and Education Intervention on Glycemic Control and Behavioral Changes in Pre-Diabetic Adolescents (PreDiA-CGM)
A Pilot Study Evaluating the Impact of Continuous Glucose Monitoring and Education Intervention on Glycemic Control and Behavioral Changes in Pre-Diabetic Adolescents
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.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Sunil Sinha, MD
- 电话号码：5206865585
- 邮箱：sunil.sinha@bannerhealth.com
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
• 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%
Exclusion Criteria:
• 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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
pre-diabetic patients aged 13-18
|
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
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Behavioral Changes as measured by questionnaires
大体时间：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.
|
20 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physical Activity
大体时间：From enrollment to the end of the study at 20 weeks
|
We will track physical activity as steps measured by the FitBit.
|
From enrollment to the end of the study at 20 weeks
|
|
Height, weight and BMI
大体时间：From enrollment to the end of the study at 20 weeks
|
We will measure height (m), weight (kg) and BMI (kg/m2)
|
From enrollment to the end of the study at 20 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Glycemic patterns
大体时间：10-20 weeks
|
Glycemic patterns will be evaluated using continuous glucose monitor (CGM) data.
We will measure area under the curve (AUC).
|
10-20 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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