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)

基本信息

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
项目类别：
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

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

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项目摘要

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.

项目摘要连续葡萄糖监测（CGM）对患有糖尿病的患者具有可观的好处，包括改善糖尿病控制和低血糖的减少。随机对照试验具有证明CGM可以减少血红蛋白A1C（HBA1C）并增加范围（TIR）度量的时间。关于CGM在更广泛的人群中使用2型糖尿病（T2DM）的CGM知之甚少种群未接受胰岛素治疗。这项拟议的研究将严格评估各种各样的CGM，在初级保健环境中具有T2DM的脆弱人群。拟议的研究将将CGM整合到我们的先前研究的移动健康方法（MHealth）糖尿病管理方法。我们先前的研究已经利用MHealth工具和社区卫生工作者（CHW）/临床药剂师团队管理低 - 收入，T2DM的少数族裔人口。临床药剂师嵌入了医疗保健系统评论中患者葡萄糖水平，促进药物依从性并协作调整治疗以帮助患者达到 HBA1C目标。 CHW扩大药剂师主导的努力，并针对健康的社会决定因素，并提供个性化的，上下文的自我管理支持。与Baystate社区卫生中心合作以及UMass Memorial Family Medicine Health Centers，我们提出了一项对团队支持的有效研究 CGM使用顺序多重分配随机试验（SMART）研究设计。我们计划研究通过318名T2DM患者接受药剂师和CHW支持的CGM的人群多样化马萨诸塞州的社区卫生中心（CHC）。具体目的包括：（1）进行随机，对照试验评估药剂师支持的CGM在多元化患者人群中的有效性 T2DM在初级保健环境中。我们假设药剂师支持的CGM将改善 HBA1C，CGM指标和其他次要结果（例如，生活质量）在6个月时仅药剂师的护理；（2）6个月后不以HBA1C目标重新将患者重新运送以接受或不接受除药剂师支持的CGM之外，CHW支持。我们假设添加CHW会改善与药剂师支持的CGM相比独自的; （3）使用Re-Aim评估覆盖范围，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，从医疗组织的角度来看，临床药剂师和CHW）。如果这个团队支持模型的糖尿病护理被发现具有成本效益，这种证据可能会影响对卧床的保险限制 T2DM中的CGM覆盖范围。