Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care
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|ClinicalTrials.gov Identifier: NCT01920256|
Recruitment Status : Active, not recruiting
First Posted : August 9, 2013
Last Update Posted : October 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Other: Remote, personalized type 2 diabetes care. Other: Usual Endocrine care.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||December 2018|
Experimental: Personalized type 2 diabetes care.
Remote, personalized type 2 diabetes clinic provided by an endocrinologist using frequent remote contacts for medication adjustments.
Other: Remote, personalized type 2 diabetes care.
Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely.
Active Comparator: Usual Endocrine Care
Usual Endocrine care will be provided by an endocrinologist.
Other: Usual Endocrine care.
Diabetes and comorbidities management will provided by an endocrinologist
- Change in baseline A1C (glycated hemoglobin) at 12 months [ Time Frame: 12 months ]Measure of long-term blood glucose control and efficacy of intervention
- Change in baseline lipids at 12 months [ Time Frame: 12 months ]Measure of total cholesterol, LDL, and Triglycerides
- Change in baseline blood pressure at 12 months [ Time Frame: 12 months ]Systolic and diastolic blood pressure
- All cause mortality [ Time Frame: 12 months ]Record deaths due to any cause
- Acute complications [ Time Frame: 12 months ]Cardiovascular events, cerebrovascular events, peripheral vascular events, limb ulcers and amputations, severe hypoglycemia, and other unscheduled emergency department and hospital visits
- Change in baseline Quality of life at 12 months [ Time Frame: 12 months ]Short Form-36
- Change in baseline insulin satisfaction at 12 months [ Time Frame: 12 months ]Insulin Therapy Satisfaction Questionnaire
- Clinic retention [ Time Frame: 12 months ]Missed visits, missed phone calls, lost to follow up and drops outs will be recorded for both groups
- Cost [ Time Frame: 12 months ]Resource utilization and cost for both groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920256
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Israel Hodish, MD, PhD||University of Michigan|