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

项目总结 这款R01符合PAS-20-160(小型R01)，用于针对特派团内疾病的临床试验 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(BEI)在一种新颖的半自动干预中针对患有糖尿病的青少年的每日胰岛素推注分数 使用不理想的胰岛素。迫切需要以自我为目标的有效且易于实施的干预措施 青少年1型糖尿病患者的管理行为研究这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)的目标，从而使 他们中的大多数人患严重急性和长期并发症的风险增加。BEI干预有效 促进青少年健康行为，包括自我监测血糖(SMBG)频率。此外， 有证据表明，BEI可以相对容易地实现，特别是在使用非应急BEI时。但 随着集成的胰岛素泵和连续血糖监测(CGM)系统的采用以及新的FDA 批准让年轻人仅根据CGM服用胰岛素，我们相信靶向的长期价值 仅SMBG在BEI干预中是有限的，每日胰岛素使用是下一个合乎逻辑的自我管理目标。 在我们先前工作的基础上，胰岛素推注评分提供了一个特定的、可测量的和有效的治疗目标。 对于日常胰岛素使用，这与糖化血红蛋白的关系也比SMBG或每天总胰岛素推注更密切。因此， 我们的目标是：1)检查我们半自动BEI干预(称为 Coin2Dose)针对青少年的每日团注评分，以及2)检查Coin2Dose的初步疗效 与标准护理对照组(SC组)相比，青年每日推注评分、HbA1c和血糖时间范围 (TIR)。我们还包括一个探索性目标，以检查使用应急措施与非应急措施的增量影响 我们Coin2中的或有BEI对青年的团注分数、HbA1c和TIR进行干预。Coin2Dose将 发送自动短信，提示青少年注射胰岛素，外加BEI每日注射活动。至 为了提高R01的科学严谨性，我们将使用轨道模型进行行为干预开发。 根据这一模式，我们将招募180名青少年和一名家长参加1-a远程医疗焦点 小组(轨道阶段1a：定义；n=20)，2--队形预试(轨道阶段1b：完善；n=10)，或3--飞行员 随机临床试验(轨道阶段2：随机对照试验；n=150)。我们的随机对照试验将对青少年进行随机化 使用胰岛素(根据试点数据，约70%的青少年使用胰岛素)或2种Coin2版本中的1种。 只有基于我们对个性化(或有)和非个性化(非或有)BEI的使用的不同。 青少年将参加为期12周的积极治疗，外加12周的随访期。这款小型R01是 对其潜在收益具有重要意义：1-初步数据检查我们针对每日推注的新BEI干预 分数，这也可能提高青年HbA1c，2-探索或有V。 非或有BEI，这对Coin2Dose以及对BEI干预的更广泛接受具有影响。

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.