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.

项目概要 连续血糖监测 (CGM) 对糖尿病患者具有明显的好处，包括 改善糖尿病控制并减少低血糖。随机对照试验有 证明 CGM 可以降低糖化血红蛋白 (HbA1c) 并增加范围内时间 (TIR) 指标。 对于 CGM 在低收入少数族裔 2 型糖尿病 (T2DM) 患者中的使用知之甚少 未接受胰岛素治疗的人群。这项拟议的研究将从不同的角度严格评估 CGM 初级保健机构中患有 T2DM 的弱势群体。拟议的研究将把 CGM 纳入我们的 之前研究过移动健康（mHealth）糖尿病管理方法。我们之前的研究有 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，患有 T2DM 的少数群体。临床药剂师参与医疗保健系统审查 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 HbA1c 目标。社区卫生工作者加强药剂师主导的工作，解决健康的社会决定因素，并提供 个性化、情境化的自我管理支持。与 Baystate 社区健康中心合作 和麻省大学纪念家庭医学健康中心，我们提出了一项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 318 名 T2DM 患者接受药剂师和社区卫生工作者支持的 CGM 马萨诸塞州的社区卫生中心 (CHC)。具体目标包括： (1) 进行随机、 对照试验评估药剂师支持的 CGM 在不同患者群体中的有效性 初级保健机构中的 T2DM。我们假设药剂师支持的 CGM 将导致改善 6 个月时的 HbA1c、CGM 指标和其他次要结果（例如生活质量）与 仅限药剂师的护理； (2) 6 个月后将未达到 HbA1c 目标的患者重新随机分为接受或不接受治疗 CHW 支持超出药剂师支持的 CGM。我们假设增加 CHW 将改善 与药剂师支持的 CGM 相比，12 个月时的 HbA1c、CGM 指标和其他次要结果 独自的; (3) 使用 RE-AIM 评估范围、有效性、采用、实施和维护 框架; (4) 确定 CGM 和支持组件的总成本和成本效益（例如， 从医疗机构的角度来看，临床药剂师和社区卫生工作者（CHW）。如果这个团队支持模型 糖尿病护理被发现具有成本效益，此类证据可能会影响门诊保险的限制 CGM 在 T2DM 中的覆盖范围。