Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care

Completed · Not applicable

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT01920256

Run by

University of Michigan

People needed

60

Starts

2013-08-01

Expected to finish

2017-06-01

Last updated by the study team

2018-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Michigan Health System — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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