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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Remote, personalized type 2 diabetes care.; Other: Usual Endocrine care.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	12 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Israel Hodish, MD, PhD, University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: August 2, 2013
• First Submitted That Met QC Criteria: August 7, 2013
• First Posted (Estimate): August 9, 2013

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: October 31, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Insulin therapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: UMichigan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Experimental group patients informed of A1C results.