Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in baseline A1C (glycated hemoglobin) at 12 months
研究概览
简要总结
Patients with type 2 diabetes can attain superior disease outcomes if multiple therapy goals are simultaneously achieved and maintained. In reality, therapy goals are seldom achieved, and patients become susceptible to devastating complications and greater health care expenses. Studies have shown that regular monitoring and therapy adjustments are a prerequisite to achieving and maintaining therapy goals. Unfortunately implementation of regular monitoring and therapy adjustments have been hindered by high clinic workload and shortage of endocrinologists. Due to this shortage, endocrine care is accessible to less than 20% of patients with type 2 diabetes. The overwhelming majority are managed by providers who may lack the necessary expertise or time to deliver optimal disease management, particularly when insulin is prescribed.
Objectives: We hypothesize that type 2 diabetes endocrine clinics for high-risk patients that complement primary care, personalize the frequency of remote disease interventions and employ infrequent face-to-face outpatient visits, will achieve comparable clinical outcomes and patient satisfaction compared to usual endocrine clinic care, while reducing workload and increasing the clinic capacity. The intervention clinic will employ regular remote communications initiated by the endocrinologists, based on tailored individual plans. Frequent remote monitoring and interventions will reinforce attainment of the therapy goals and allow a decrease in the frequency of outpatient visits. In turn, the clinic workload will decrease and it will be able to accommodate more patients with type 2 diabetes than traditional endocrine clinics. The aims of the study are to test this new endocrine clinic model in a clinical trial by monitoring clinical parameters, patient satisfaction and clinical workload. The long-term objectives are to modify the current model of endocrine care for patients with type 2 diabetes.
详细描述
Emerging data suggests that clinical interventions may be implemented successfully by a variety of remote communications. Thus far regular monitoring and treatment adjustments by remote communications have not yet been fully integrated into endocrine practice in a scalable fashion that can be readily disseminated. The PI proposes to test a new endocrine model care clinic for high-risk patients with type 2 diabetes that employs regular communications initiated by the provider, based on a tailored individual plan. Frequent monitoring and interventions will reinforce attainment of prespecified therapy goals, enhance patient engagement, and allow a significant decrease in the frequency of outpatient visits. In turn, the clinic will be able to accommodate more patients with type 2 diabetes than traditional endocrine clinics. Data management and day-to-day clinic operation will be computerized with technology that has been developed by the institution. The project is highly significant since it proposes a new model of endocrine care for high-risk patients with type 2 diabetes that may improved disease outcome in more patients and reduce medical expenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged ≥18 years of age;
- •Clinical diagnosis of type 2 diabetes (as defined by the American Diabetes Association 2);
- •Treated with insulin or at least two diabetes medications;
- •Have A1C ≥8.0% and ≤11.0%;
- •Able and willing to use telephone or other sorts of communication regularly between clinic visits.
排除标准
- •Do not speak English;
- •Unwilling or unable to provide informed consent;
- •Have any condition associated with life expectancy of less than 3 years;
- •Have an active mental illness or substance abuse
研究组 & 干预措施
Personalized type 2 diabetes care.
Remote, personalized type 2 diabetes clinic provided by an endocrinologist using frequent remote contacts for medication adjustments.
干预措施: Remote, personalized type 2 diabetes care. (Other)
Usual Endocrine Care
Usual Endocrine care will be provided by an endocrinologist.
干预措施: Usual Endocrine care. (Other)
结局指标
主要结局
Change in baseline A1C (glycated hemoglobin) at 12 months
时间窗: 12 months
Measure of long-term blood glucose control and efficacy of intervention
次要结局
- Change in baseline Quality of life at 12 months(12 months)
- Change in baseline lipids at 12 months(12 months)
- All cause mortality(12 months)
- Change in baseline blood pressure at 12 months(12 months)
- Acute complications(12 months)
- Change in baseline insulin satisfaction at 12 months(12 months)
研究者
Israel Hodish MD PhD
Assistant Professor
University of Michigan
