Thinking Outside the Clinic: A Digital Health Approach for Young Adults With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Percent Glycated Hemoglobin/6 Months
研究概览
简要总结
The study will test an app and web-delivered intervention designed to improve glycemic control (HbA1c) among young adults with Type 1 diabetes. All participants will receive the "core" digital intervention, the SweetGoals app, focused on self-monitoring and goal setting. Efficacy of two independent intervention components (incentives for adherence and web health coaching) will be tested
详细描述
ASSIGNMENT OF PARTICIPANTS:
Interested participants will download the SweetGoals app. Once all screening procedures are complete, including A1c verification via the mail in test kit, research staff will schedule a web video meeting to (1) randomize participants and inform them of their intervention condition assignment; (2)assist participants in setting up their Glooko account and uploading their devices and orient them to the Glooko data visualization hub; and (3) download the Glooko mobile app, which may be used by all participants and into which participants without a Glooko compatible pump will enter carb counts.
INTERVENTION DELIVERY:
All participants will receive the core intervention, the SweetGoals app. Those assigned to Incentives will receive the app plus incentives for meeting adherence goals. Those assigned to Coaching will receive web health coaching to increase motivation and skill in self-management as described below.
DIABETES CARE FOR ALL PARTICIPANTS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of T1D for >18 months
- •Have A1c ≥7.5%
- •Report a visit with physician managing type 1 diabetes (T1D) within the previous 6 months
- •Participants must use a glucometer or continuous glucose monitor compatible with Glooko.
排除标准
- •Pregnancy or breast feeding
- •Severe medical illness that would preclude participation (e.g., cystic fibrosis, developmental disability, severe cognitive impairment)
- •Psychiatric illness that would preclude participation
- •Diabetes diagnoses other than T1D (Type 2 Diabetes, Maturity Onset Diabetes of the Young/MODY)
- •Use of any medications known to impact glycemic control (oral or injectable corticosteroids, beta-blockers, antipsychotic medications such as risperidone).
- •A history of known hemoglobinopathy, anemia, or transfusion (which could alter the validity of HbA1c measurement)
- •Already being engaged in a psychological intervention targeting diabetes adherence.
研究组 & 干预措施
Sweetgoals app
干预措施: Sweetgoals app (Behavioral)
Sweetgoals app, incentives
干预措施: Incentives (Behavioral)
Sweetgoals app, incentives
干预措施: Sweetgoals app (Behavioral)
Sweetgoals app, coaching
干预措施: Coaching (Behavioral)
Sweetgoals app, coaching
干预措施: Sweetgoals app (Behavioral)
Sweetgoals app, incentives, coaching
干预措施: Coaching (Behavioral)
Sweetgoals app, incentives, coaching
干预措施: Incentives (Behavioral)
Sweetgoals app, incentives, coaching
干预措施: Sweetgoals app (Behavioral)
结局指标
主要结局
Percent Glycated Hemoglobin/6 Months
时间窗: From Baseline to Month 12
Estimated mean change (slope) in percent glycated hemoglobin per each 6 month interval from Baseline to Month 12 were obtained from a growth curve analysis using maximum likelihood estimation to account for missing data. All randomized participants were utilized in the model (ITT analysis).
Change in Hba1c at 12 Months, Main Effects of Each Intervention Component
时间窗: 12 months, controlling for baseline
Estimated mean change from Baseline to Month 12 were obtained from a maximum likelihood structural path model to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as the change in HbA1c at 12 months vs. baseline associated with the On level of the intervention condition relative to the Off level of the intervention condition.
次要结局
- Change in Percent Glycated Hemoglobin Per Day of Glucose Checking Goal Achievement(At 12 months, controlling for baseline)
- Change in Percent Glycated Hemoglobin Per Day of Mealtime Goal Achievement(At 12 months, controlling for baseline)
- Days Per Week Meeting Glucose Checking Goal During Intervention Period, Main Effects of Each Intervention Component(Baseline to 6 months)
- Days Per Week Meeting Mealtime Goal During Intervention Period, Main Effects of Each Intervention Component(Baseline to 6 months)
- Change in Percent Glycated Hemoglobin Due to Each Intervention Mediated by Days Met Glucose Checking Goal(Baseline to 12 months)
- Change in Percent Glycated Hemoglobin Due to Each Intervention Mediated by Days Met Mealtime Goal(Baseline to 12 months)
研究者
Catherine Stanger
Associate Professor
Trustees of Dartmouth College