Team Support to Improve Glycemic Control Using CGM in Diverse Populations (TEAM CGM)

团队支持在不同人群中使用 CGM 改善血糖控制 (TEAM CGM)

• 批准号: 10659721
• 负责人: Ben Steven Gerber
• 金额: $ 72.54万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-05 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10659721
• 关键词: Address; Adoption; Affect; Behavioral; Black race; Blood Glucose; California; Caring; Child; Clinical Pharmacists; Community Health Aides; Continuous Glucose Monitor; Diabetes Mellitus; Disparity; Family Practice; Future; Glucose; Glycosylated hemoglobin A; Goals; Health; Healthcare Systems; Hispanic; Hyperglycemia; Hypoglycemia; Individual; Infusion procedures; Injections; Insulin; Insulin-Dependent Diabetes Mellitus; Insurance; Intercellular Fluid; Low Income Population; Low income; Massachusetts; Measures; Minority Groups; Modeling; Neighborhood Health Center; Non-Insulin-Dependent Diabetes Mellitus; Not Hispanic or Latino; Observational Study; Patient-Focused Outcomes; Patients; Persons; Pharmacists; Population; Population Heterogeneity; Primary Care; Quality of life; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Research; Research Design; Resources; Self Management; Sequential Multiple Assignment Randomized Trial; Specialist; Technology; Time; Translations; United States; Upper arm; Variant; Vulnerable Populations; Work; cardiovascular risk factor; cost; cost effective; cost effectiveness; cost estimate; diabetes control; diabetes management; effectiveness evaluation; effectiveness study; ethnic difference; glycemic control; health care service organization; improved; large datasets; mHealth; medication compliance; minority communities; monitoring device; patient population; primary care provider; primary care setting; racial difference; secondary outcome; sensor; social health determinants; subcutaneous; telehealth; tool; young adult

PROJECT SUMMARY Continuous glucose monitoring (CGM) has demonstrable benefits for people living with diabetes, including improvement in diabetes control and reduction in hypoglycemia. Randomized controlled trials have demonstrated that CGM can reduce hemoglobin A1c (HbA1c) and increase in the time in range (TIR) metric. Little is known about CGM use in the broader population with type 2 diabetes (T2DM) in low-income, minority populations not receiving insulin therapy. This proposed study will rigorously evaluate CGM in a diverse and vulnerable population with T2DM in the primary care setting. The proposed study will integrate CGM into our previously studied approach of mobile health (mHealth) diabetes management. Our prior research has leveraged mHealth tools and a community health worker (CHW)/clinical pharmacist team to manage low- income, minority populations with T2DM. Clinical pharmacists embedded in the healthcare system review patient glucose levels, promote medication adherence and collaboratively adjust therapy to help patients reach HbA1c goals. CHWs augment pharmacist-led efforts and address social determinants of health and provide individualized, contextual self-management support. In partnership with Baystate Community Health Centers and UMass Memorial Family Medicine Health Centers, we propose an effectiveness study of team-supported CGM using a Sequential Multiple Assignment Randomized Trial (SMART) study design. We plan to study a diverse population with 318 T2DM patients receiving pharmacist- and CHW-supported CGM delivered through community health centers (CHCs) in Massachusetts. The Specific Aims include: (1) Conduct a randomized, controlled trial to evaluate the effectiveness of pharmacist-supported CGM in a diverse patient population with T2DM in the primary care setting. We hypothesize that pharmacist-supported CGM will result in improved HbA1c, CGM metrics, and other secondary outcomes (e.g., quality of life) at 6 months compared with pharmacist-only care; (2) Re-randomize patients not at HbA1c goal after 6 months to receive or not receive CHW support beyond pharmacist-supported CGM. We hypothesize that adding CHWs will result in improved HbA1c, CGM metrics, and other secondary outcomes at 12 months compared with pharmacist-supported CGM alone; (3) Evaluate reach, effectiveness, adoption, implementation, and maintenance using the RE-AIM framework; and (4) Determine total cost and cost-effectiveness of CGM and the supportive components (e.g., clinical pharmacist and CHW) from the perspective of the healthcare organization. If this team support model of diabetes care is found to be cost-effective, such evidence may influence insurance restrictions on ambulatory CGM coverage in T2DM.

项目摘要 动态血糖监测（CGM）对糖尿病患者有明显的益处，包括 改善糖尿病控制和降低低血糖症。随机对照试验 表明CGM可降低血红蛋白A1 c（HbA 1c）并增加范围内时间（TIR）指标。 关于CGM在低收入、少数民族和其他2型糖尿病（T2 DM）患者中的应用知之甚少。 未接受胰岛素治疗的人群。这项拟议的研究将严格评估CGM在一个多样化的， 在初级保健环境中的T2 DM弱势人群。拟议的研究将把CGM纳入我们的 先前研究的移动的健康（mHealth）糖尿病管理方法。我们之前的研究 利用移动医疗工具和社区卫生工作者（CHW）/临床药剂师团队来管理低 收入，少数T2 DM人群。临床药师嵌入医疗系统审查 患者血糖水平，促进药物依从性，并协同调整治疗，以帮助患者达到 HbA 1c目标。社区卫生工作者加强药剂师领导的努力，解决健康的社会决定因素， 个性化的、情境化的自我管理支持。与Baystate社区健康中心合作 和马萨诸塞州纪念家庭医学健康中心，我们提出了一个团队支持的有效性研究 CGM采用序贯多重分配随机试验（SMART）研究设计。我们计划研究一个 多样化人群，318例T2 DM患者接受药剂师和CHW支持的CGM，通过 社区卫生中心（CHC）在马萨诸塞州。具体目的包括：（1）进行随机， 一项对照试验，旨在评价药剂师支持的CGM在不同患者人群中的有效性， 初级保健环境中的T2 DM。我们假设，药剂师支持的CGM将导致改善 HbA 1c、CGM指标和其他次要结局（例如，6个月时的生活质量）， 仅药剂师治疗;（2）6个月后未达到HbA 1c目标的患者重新随机接受或不接受治疗 CHW支持超出药剂师支持的CGM。我们假设添加CHW将导致改善 与药剂师支持的CGM相比，12个月时的HbA 1c、CGM指标和其他次要结局 （3）使用RE-AIM评估覆盖范围、有效性、采用、实施和维护 框架;以及（4）确定CGM和支持组件（例如， 临床药师和CHW）从医疗保健组织的角度。如果这种团队支持模式 糖尿病护理被认为是具有成本效益的，这些证据可能会影响对门诊的保险限制。 T2 DM的CGM覆盖率。