Behavioral Incentive Meal Dose Engagement in Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change in A1C (ΔA1C90-day) from baseline visit (visit 1) to 90-day visit (visit 2)
研究概览
简要总结
Type 1 Diabetes (T1D) is a serious disease that happens because the body cannot control blood glucose (sugar) levels. People with T1D need insulin shots because their body does not make insulin. Insulin lowers blood sugar levels. When blood sugar levels are too high or too low it causes medical problems.
Youth with T1D can really impact their own health if they follow their T1D treatment plan. However, even with the help of doctors, nurses, and family, most adolescents find it hard to follow their diabetes plan close enough to meet their A1C goal. It is very common for adolescents to forget to give an insulin bolus for meals. When insulin doses are missed, there is a greater chance for poor blood sugar control. When adolescents follow their diabetes plan closely, they have better blood sugar control and overall health.
Two behavioral economic interventions will be evaluated. COIN2DOSE (Cash-Only INcentive to promote mealtime insulin DOSE Engagement) and LOAN2DOSE (Behavioral Economic concept that uses an economic loss aversion approach to promote insulin dose engagement in adolescents with Type 1 Diabetes). These programs were designed to improve blood sugar control by decreasing the number of missed mealtime boluses. For COIN2DOSE, we will offer the opportunity for youth to earn a bonus reimbursement during which they achieve at least 5 days of 3 mealtime insulin boluses. Finally, we will pay youth up for sharing their insulin use data at least two times per week with the study team during the three-month treatment phase. For LOAN2DOSE, the participants will start with a monetary "balance" and will keep it if they bolus as instructed - at least 5 days of 3 mealtime insulin boluses. If they do not do this, their balance will decrease throughout the study.
详细描述
The long-term goal is to develop effective ways to improve glycemic control in youth with T1D. To that end, we propose to specifically evaluate the effectiveness, feasibility, and usability of two new behavioral economic interventions in diabetes care: an automated meal detection and patient engagement device to promote meal-time insulin dosing behavior (AIM2DOSE) and an economic incentive (COIN2DOSE) to promote patient engagement with mealtime insulin dosing behavior. If initially efficacious, our results will serve as the basis for an R01 submission(s) to conduct a fully powered efficacy trial of LOAN2DOSE and COIN2DOSE. This study is significant as omission of mealtime boluses is one of the common reasons for suboptimal diabetes control in youth. This project is highly innovative because it will: 1) target youth who are predicted by artificial intelligence to experience a worsening in glycemic control, 2) use a just-in-time intervention to improve mealtime insulin dosing behavior, and 3) use an economic incentive intervention to improve mealtime insulin dosing behavior.
Study Design The study is an unblinded, 3-arm, randomized, controlled trial. After successful screening and consent, individuals will wear a blinded Dexcom G6 Pro CGM inserted 1 week after consent. . At the baseline visit (visit 1; day 1), participants will be randomized to the LOAN2DOSE, COIN2DOSE, or control treatment arms and will be trained on the procedures appropriate to their treatment arm. Participants will also complete baseline measures by questionnaire. Participants will complete procedures specific to their treatment arm weekly. Visit 2 will occur after 12 weeks (90 days). Participants will stop any treatment interventions after this visit. A1C and questionnaire measures will be completed, and participants will again wear the Dexcom G6 Pro CGM for 10 days (the device will be returned by mail post-visit). Participants will receive no treatment intervention from week 13 to week 24. Participants will return for visit 3 at week 24. Again, A1C and questionnaire measures will be completed and participants will wear the Dexcom G6 Pro CGM for 10 days.
All study participants will also have the option to participate in a focus group discussion (FGD) on general AI ethical issues (control group) or intervention experiences (intervention group).
Parents of children who meet inclusion criteria may also elect to participate in a focus group.
Study Visits Study visits may occur in-person or remotely (i.e., from home). Procedures will be adapted to accommodate both scenarios.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 12-17.99 years
- •The youth must have been diagnosed with T1D for at least 6 months
- •The youth must have attended at least 2 routine T1D standard of care visits in the past 12 months
- •The youth must be using an insulin delivery device capable of recording, storing, and downloading insulin bolus behaviors (insulin pump or smart Bluetooth insulin pen that can be uploaded to standard clinic upload software).
- •The youth must have a current A1C >7.2% and/or be predicted to have a rise in A1C in of 0.3% or higher the next 90 days.
- •Not pregnant or planning to become pregnant by self-report.
排除标准
- •Participants with any type of diabetes mellitus other than T1D
- •Participant has any disease causing anemia or affecting red blood cell physiology (which would impact A1C)
- •Participant has a physical disability, which in the opinion of the investigator would interfere with individual's ability to feed themselves or use one's hands to facilitate eating
- •Participants with no internet access or ability to upload device(s) to data aggregation software that is accessible to study team.
- •For Focus Groups:
- •Any parent or legal guardian whose child is eligible for the study is invited to participate in a focus group discussion.
结局指标
主要结局
Change in A1C (ΔA1C90-day) from baseline visit (visit 1) to 90-day visit (visit 2)
时间窗: baseline and 90 days
A1C is a validated indicator of glycemic control.
次要结局
- Change in A1C (ΔA1C180-day) from baseline visit (visit 1) to 180-day visit (visit 3).(baseline and 180 days)
- Change in percent time in range 70-180 mg/dL (%TIR70-180) from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).(baseline, 90 and 180 days)
- Change in percent Time hypoglycemic (<70 mg/dL; %Hypo<70) from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).(baseline, 90 and 180 days)
- Change in mealtime insulin BOLUS score (BOLUS) from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).(baseline, 90 and 180 days)
- For COIN2DOSE treatment group, proportion of parents who endorse the feasibility of providing an economic incentive equivalent to that used in the intervention.(baseline, 90 and 180 days)
- Change in health-related empowerment from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).(baseline, 90 and 180 days)
- Change in percent Time severely hypoglycemic (<54 mg/dL) (%Hypo<54) from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).(baseline, 90 and 180 days)
- Change in perceived involvement in care from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).(baseline, 90 and 180 days)
- Change in percent time hyperglycemic (>180 mg/dL; %Hyper>180) from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).(baseline, 90 and 180 days)
- For LOAN2DOSE treatment group, proportion of participants who deliver insulin bolus doses within 10 minutes of >75% of mealtime bolus reminders.(baseline, 90 and 180 days)
- For LOAN2DOSE treatment group, proportion of participants wearing the apple watch throughout the 90-day intervention period >75% of days.(baseline, 90 and 180 days)
- For COIN2DOSE treatment group, >75% of participants will have a score of at least 14 out of a total possible 18 points on Diabetes Treatment Satisfaction Questionnaire (teen version).(baseline, 90 and 180 days)
- Change in trust in provider from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).(baseline, 90 and 180 days)
- For LOAN2DOSE treatment group, proportion of participants who complete >90% of study procedures throughout the intervention and post-intervention study procedures.(baseline, 90 and 180 days)
研究者
Sarah Tsai
Pediatric Endocrinologist
Children's Mercy Hospital Kansas City