Coin2Dose: Behavioral economics to promote insulin BOLUS activity and improve HbA1c in teens

Coin2Dose：促进胰岛素 BOLUS 活性并改善青少年 HbA1c 的行为经济学

• 批准号: 10597657
• 负责人: Susana R Patton
• 金额: $ 29.52万
• 依托单位: NEMOURS CHILDREN'S CLINIC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10597657
• 关键词: Acute; Adherence; Adolescent; Aftercare; Behavior; Behavioral Model; Blood Glucose Self-Monitoring; Bolus Infusion; Childhood; Clinic; Clinical; Clinical Trials; Complex; Complications of Diabetes Mellitus; Conflict (Psychology); Continuous Glucose Monitor; Control Groups; Cues; Data; Diabetes Mellitus; Disease; Distress; Dose; Failure; Focus Groups; Frequencies; Future; Glucose; Glycosylated Hemoglobin; Health Promotion; Health behavior; Health behavior change; Hemoglobin concentration result; Hypoglycemia; Incentives; Incidence; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Intervention; Maintenance; Measurable; Methodology; Mission; Modeling; Modernization; National Institute of Diabetes and Digestive and Kidney Diseases; Parents; Phase; Public Health; Randomized; Reporting; Research; Research Personnel; Risk; Running; Self Management; System; Teenagers; Testing; Time; Vascular Diseases; Work; Youth; acceptability and feasibility; active method; automated intervention; automated text message; behavioral economics; data registry; design; diabetes distress; diabetes mellitus therapy; diabetes self-management; economic incentive; efficacious intervention; feasibility testing; follow-up; improved; innovation; novel; post intervention; primary outcome; programs; randomized, clinical trials; recruit; response; secondary outcome; standard care; telehealth; therapy development; treatment duration; treatment group; uptake

PROJECT SUMMARY This R01 responds to PAS-20-160 (Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK). Our objective is to test the feasibility, acceptability, and initial efficacy of using behavioral economics incentives (BEI) in a novel, semi-automated intervention to target daily insulin BOLUS scores in adolescents with suboptimal insulin use. There is a critical need for efficacious and easy-to-implement interventions targeting self- management behaviors in adolescents with type 1 diabetes (T1D). This is because national registry data suggest that only between 15-28% of adolescents achieve their glycated hemoglobin (HbA1c) target, thereby placing the majority of them at increased risk for serious acute and long-term complications. BEI interventions are efficacious for promoting health behaviors including frequency of self-monitoring blood glucose (SMBG) in youth. Moreover, there is evidence that BEI can be relatively easy to implement, especially when using Non-Contingent BEI. But with the uptake of integrated insulin pump and continuous glucose monitor (CGM) systems and the new FDA approval enabling youth to dose for insulin based solely on CGM, we believe the long-term value of targeting SMBG alone in BEI interventions is limited and that daily insulin use is the next logical self-management target. Building off of our prior work, the insulin BOLUS score offers a specific, measurable, and valid treatment target for daily insulin use that is also more closely related to HbA1c than SMBG or Total insulin boluses per day. Thus our Aims are: 1) examine the feasibility and acceptability of our semi-automated BEI intervention (called Coin2Dose) targeting daily BOLUS scores in adolescents and 2) examine the preliminary efficacy of Coin2Dose versus a standard care control (SC) group on youth daily BOLUS scores, HbA1c, and glucose time in range (TIR). We also include an exploratory aim to examine the incremental impact of using Contingent versus Non- Contingent BEI within our Coin2Dose intervention on youth’s BOLUS scores, HbA1c, and TIR. Coin2Dose will deliver automated text messages to cue adolescents to bolus for insulin, plus BEI for daily BOLUS activity. To enhance the scientific rigor of this R01, we will use the ORBIT Model for behavioral intervention development. Consistent with this model, we will recruit 180 adolescents and a parent to participate in 1- a telehealth focus group (ORBIT Phase 1a: Define; n= 20), 2- a formative pre-test (ORBIT Phase 1b: Refine; n=10), or 3- a pilot randomized clinical trial (ORBIT Phase 2: RCT Pilot; n=150). Our RCT Pilot will randomize teens with suboptimal insulin use (BOLUS score <2.5; ~70% of teens based on pilot data) to SC or 1 of 2 versions of Coin2Dose that only differ based on our use of personalized (Contingent) v. non-personalized (Non-Contingent) BEI. Adolescents will participate in 12-weeks of active treatment, plus a 12-week follow-up period. This small R01 is Significant for its potential to yield: 1- preliminary data examining our new BEI intervention targeting daily BOLUS scores, which may also improve youth HbA1c, 2- novel data exploring the incremental impact of Contingent v. Non-Contingent BEI, which has implications for Coin2Dose as well as the broader uptake of BEI interventions.

项目概要 该 R01 响应 PAS-20-160（针对疾病临床试验的小 R01） NIDDK）。我们的目标是测试使用行为经济学的可行性、可接受性和初步效果。 激励措施（BEI），一种新颖的半自动干预措施，旨在针对青少年的每日胰岛素 BOLUS 分数 迫切需要针对自我的有效且易于实施的干预措施。 1 型糖尿病 (T1D) 青少年的管理行为是因为国家登记数据表明。 只有 15-28% 的青少年达到糖化血红蛋白 (HbA1c) 目标，从而将 其中大多数患有严重急性和长期并发症的风险较高，BEI 干预措施是有效的。 促进健康行为，包括青少年自我监测血糖（SMBG）的频率。 有证据表明 BEI 相对容易实施，特别是在使用非条件 BEI 时。 随着集成胰岛素泵和连续血糖监测 (CGM) 系统以及新 FDA 的采用 批准使青少年能够仅根据 CGM 来注射胰岛素，我们相信目标的长期价值 单独使用 SMBG 在 BEI 干预中效果有限，每日胰岛素使用量是下一个合乎逻辑的自我管理目标。 在我们之前的工作的基础上，胰岛素 BOLUS 评分提供了具体的、可测量的和有效的治疗目标 每日胰岛素使用量与 HbA1c 的关系比 SMBG 或每日总胰岛素推注量更密切。 我们的目标是：1）检查我们的半自动 BEI 干预（称为 Coin2Dose）针对青少年每日 BOLUS 评分，2）检查 Coin2Dose 的初步功效 与标准护理对照组 (SC) 组相比，青少年每日 BOLUS 评分、HbA1c 和葡萄糖时间在范围内 （TIR）。我们还包括一个探索性目标，以检查使用偶然与非的增量影响。 我们的 Coin2Dose 干预中的或有 BEI 对青少年的 BOLUS 分数、HbA1c 和 Coin2Dose 进行干预。 发送自动短信提示青少年推注胰岛素，并添加 BEI 进行每日推注活动。 为了增强这个R01的科学严谨性，我们将使用ORBIT模型进行行为干预开发。 根据此模型，我们将招募 180 名青少年和一名家长参加 1- 远程医疗焦点 组（ORBIT 阶段 1a：定义；n= 20），2- 形成性预测试（ORBIT 阶段 1b：细化；n=10），或 3- 试点 随机临床试验（ORBIT 第 2 期：RCT 试点；n=150）我们的 RCT 试点将随机分配表现不佳的青少年。 胰岛素使用（BOLUS 评分 <2.5；基于试点数据约 70% 的青少年）转为 SC 或 Coin2Dose 的 2 个版本中的 1 个 仅根据我们对个性化（或有）与非个性化（非或有）BEI 的使用而有所不同。 青少年将参加12周的积极治疗，加上12周的随访期。这个小R01是。 对其产生潜力具有重要意义：1-初步数据检查我们针对每日 BOLUS 的新 BEI 干预措施 分数，这也可能改善青少年 HbA1c，2- 探索 Contingent v. 的增量影响的新颖数据。 非偶然 BEI，这对 Coin2Dose 以及 BEI 干预措施的更广泛采用具有影响。

项目成果

Cash-Only INcentives to promote insulin DOSE engagement: A protocol paper for the pilot randomized controlled trial of COIN2DOSE.

促进胰岛素剂量参与的仅现金激励：COIN2DOSE 试点随机对照试验的方案文件。

• 发表时间: 2022-12
• 影响因子: 2.2
• 作者: Patton, Susana R;Fox, Larry;Cushing, Christopher C;McDonough, Ryan;Clements, Mark A
• 通讯作者: Clements, Mark A

Applying Behavioral Economics Theories to Interventions for Persons with Diabetes.

将行为经济学理论应用于糖尿病患者的干预措施。

• 发表时间: 2022-05
• 影响因子: 4.2
• 作者: Patton, Susana R;Cushing, Christopher C;Lansing, Amy Hughes
• 通讯作者: Lansing, Amy Hughes