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

项目摘要 本R01响应PAS-20 - 160（针对以下使命内疾病的临床试验的小型R01） NIDDK）。我们的目标是检验使用行为经济学的可行性、可接受性和初步功效 在一种新型的半自动干预中， 次优胰岛素使用。迫切需要有效和易于实施的干预措施， 青少年1型糖尿病（T1D）的管理行为。这是因为国家登记数据表明 只有15 - 28%的青少年达到了他们的糖化血红蛋白（HbA1c）目标， 他们中的大多数人发生严重急性和长期并发症的风险增加。BEI干预有效 促进健康行为，包括自我监测血糖（SMBG）的年轻人的频率。此外，委员会认为， 有证据表明，BEI可以相对容易地实现，特别是当使用非应急BEI时。但 随着集成胰岛素泵和动态血糖监测（CGM）系统的采用，以及FDA新的 批准使年轻人能够仅基于CGM给药胰岛素，我们相信靶向的长期价值 在BEI干预中单独使用SMBG是有限的，每日使用胰岛素是下一个合理的自我管理目标。 在我们先前工作的基础上，胰岛素BOLUS评分提供了一个具体、可测量和有效的治疗目标 对于每日胰岛素使用量，其与HbA1c的相关性也比SMBG或每日总胰岛素推注量更密切。因此 我们的目标是：1）检查我们的半自动BEI干预（称为 Coin2Dose）针对青少年的每日推注评分和2）检查Coin2Dose的初步疗效 与标准治疗对照（SC）组相比，青年每日BOLUS评分、HbA1c和血糖时间在范围内 （TIR）。我们还包括一个探索性的目标，以检查使用应急与非应急的增量影响， Coin2Dose干预中的应急BEI对青少年的BOLUS评分、HbA1c和TIR的影响。Coin2Dose将 提供自动短信提示青少年进行胰岛素推注，以及每日推注活动的BEI。到 为了提高R01的科学严谨性，我们将使用ORBIT模型进行行为干预开发。 与此模式相一致，我们将招募180名青少年和一名家长参加1-a远程保健焦点 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 II期：RCT先导试验; n = 150）。我们的随机对照试验将随机选择青少年， 胰岛素使用（BOLUS评分<2.5;根据试点数据，约70%的青少年）改为SC或Coin2Dose的2个版本之一， 仅根据我们使用的个性化（应急）与非个性化（非应急）BEI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。这款小R01 其潜在收益显著：1-初步数据检查我们针对每日推注的新BEI干预措施 分数，这也可能改善青年HbA1c，2-探索偶然性v. 非应急BEI，这对Coin2Dose以及更广泛的BEI干预措施具有影响。

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.