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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized type 2 diabetes care. | Experimental | Remote, personalized type 2 diabetes clinic provided by an endocrinologist using frequent remote contacts for medication adjustments. |
|
| Usual Endocrine Care | Active Comparator | Usual Endocrine care will be provided by an endocrinologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote, personalized type 2 diabetes care. | Other | Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline A1C (glycated hemoglobin) at 12 months | Measure of long-term blood glucose control and efficacy of intervention | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline lipids at 12 months | Measure of total cholesterol, LDL, and Triglycerides | 12 months |
| Change in baseline blood pressure at 12 months | Systolic and diastolic blood pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Clinic retention | Missed visits, missed phone calls, lost to follow up and drops outs will be recorded for both groups | 12 months |
| Cost | Resource utilization and cost for both groups |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Israel Hodish, MD, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28793967 | Background | Klingeman H, Funnell M, Jhand A, Lathkar-Pradhan S, Hodish I. Type 2 diabetes specialty clinic model for the accountable care organization era. J Diabetes Complications. 2017 Oct;31(10):1521-1526. doi: 10.1016/j.jdiacomp.2017.05.011. Epub 2017 May 25. |
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Experimental group patients informed of A1C results.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Usual Endocrine care. | Other | Diabetes and comorbidities management will provided by an endocrinologist |
|
| 12 months |
| All cause mortality | Record deaths due to any cause | 12 months |
| Acute complications | Cardiovascular events, cerebrovascular events, peripheral vascular events, limb ulcers and amputations, severe hypoglycemia, and other unscheduled emergency department and hospital visits | 12 months |
| Change in baseline Quality of life at 12 months | Short Form-36 | 12 months |
| Change in baseline insulin satisfaction at 12 months | Insulin Therapy Satisfaction Questionnaire | 12 months |
| 12 months |
| D004700 | Endocrine System Diseases |