Real-time Engagement for Learning to Effectively Control Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Glucose coefficient of variability
研究概览
简要总结
The goal of this clinical trial is to learn if a new smartphone app that pairs glucose and exercise data will help adolescents and young adults with type 2 diabetes improve glycemic control. It will also study how changes in glycemic control are maintained over time. The main questions it aims to answer are:
- Does using the app help with short-term glycemic control?
- Does using the app help with longer-term glycemic control?
- Does using the app help increase physical activity?
Participants will:
- Wear a continuous glucose monitoring device for 6 months
- Wear a physical activity tracker for 6 months
- Use the study smartphone app for 6 months
- Complete 3 in-person study visits with fasting blood draws
- Report dietary intake intermittently throughout the study
详细描述
The objective of REFLECT2D (Real-time Engagement For Learning to Effectively Control Type 2 Diabetes) is to evaluate whether pairing real-time glycemic and health behavior data leads to improved glycemic control among adolescents and young adults with type 2 diabetes. Participants will use a mobile app that integrates continuous glucose monitor data, Fitbit activity tracker data, and diet logging, with the aim of increasing capability to interpret glycemic data (including impacts of physical activity and dietary intake), providing opportunity to plan and implement behavior change, and increasing motivation to engage in health behaviors. After an initial educational session and run-in period, a 90-day micro-randomized trial (MRT) period will involve once daily randomization of each participant to: 1) physical-activity focused prompt, 2) dietary intake-focused prompt, or 3) no prompt. After the MRT, a 90-day observation period without prompts but with ongoing availability of continuous glucose monitor data, Fitbit, and Healthmine app will examine persistence of glycemic and behavior changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes
- •English-speaking (app in English)
排除标准
- •Current pregnancy
- •Hydroxyurea use (CGM sensor inaccuracies)
- •Cognitive impairment or severe psychiatric condition that could interfere with participation in behavioral intervention for diabetes self-management
- •Current or previously diagnosed eating disorder
研究组 & 干预措施
Diet Focused App Prompt
The app prompts will ask participants what went well, or did not go well with their diet in the previous 24 hours in relation to their blood glucose numbers.
干预措施: Focused App Prompt (Behavioral)
No App Prompt
No app prompt will be sent to the participant
干预措施: No App Prompt (Behavioral)
Physical Activity Focused App Prompt
The app prompts will ask participants what went well, or did not go well with their physical activity in the previous 24 hours in relation to their blood glucose numbers.
干预措施: Focused App Prompt (Behavioral)
结局指标
主要结局
Glucose coefficient of variability
时间窗: daily during micro randomized trial, 90 days
measured using continuous glucose monitor
Mean daily glucose
时间窗: daily during micro randomized trial, 90 days
measured using continuous glucose monitor; mg/dL
Mean amplitude of glycemic excursions
时间窗: daily during micro randomized trial, 90 days
measured using continuous glucose monitor
Fasting glucose
时间窗: through study completion, 6 months average
lab-based measure to assess glycemic control, collected at study visit
Glucose time above 180mg/dL
时间窗: daily during micro randomized trial, 90 days
measured using continuous glucose monitor
Maximum daily glucose
时间窗: daily during micro randomized trial, 90 days
measured using continuous glucose monitor; mg/dL
Minimum daily glucose
时间窗: daily during micro randomized trial, 90 days
measured using continuous glucose monitor; mg/dL
Hemoglobin A1c
时间窗: through study completion, 6 months average
lab-based measure to assess longer-term glycemic control, collected at study visit
Objective physical activity (moderate-vigorous physical activity)
时间窗: daily during micro randomized trial, 90 days;
moderate-vigorous physical activity (\>100 steps per minute) will be measured using Fitbit activity tracker
Self-reported physical activity
时间窗: through study completion, 6 months average
assessed using PACE+ Adolescent Physical Activity Measure (PACE+) questionnaire to determine days with at least 60 minutes of moderate-vigorous physical activity per week. score ranges from 0-14; lower scores indicate less achievement of physical activity guidelines
Diet quality
时间窗: through study completion, 6 months average
24-hour dietary recall will be collected by study staff, who will use the Automated Self Administered 24 Hour Dietary Recall Assessment Tool (ASA24) to record data for diet quality assessment
Objective physical activity (step count)
时间窗: daily during micro randomized trial, 90 days;
step count measured using the Fitbit physical activity tracker
Capability
时间窗: through study completion, 6 months average
Assessed via the Diabetes Empowerment Scale (DES), a measure of self-efficacy. Average score ranges from 28-140; higher scores indicate greater diabetes empowerment
Healthmine app use
时间窗: during microrandomized trial, observational period
Percent of days with app use, per study period will be determined.
Continuous glucose monitor use use
时间窗: during microrandomized trial, observational period
Defined as percent of days with CGM data available, per study period.
Motivation to engage in diabetes self-management
时间窗: through study completion, 6 months average
Measured via Treatment Self-Regulation Questionnaire (TSRQ). score ranges from 15-105; scoring is based on and average between subscales of intrinsic vs. extrinsic motivation.
次要结局
- Body Mass Index (BMI)(through study completion, 6 months average)
- Diabetes distress(through study completion; 6 months average)
- Diabetes distress(through study completion; 6 months average)
研究者
Mary Ellen Vajravelu, MD
Assistant Professor
University of Pittsburgh