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

NCT01920256 | Completed DMC

• 1 other identifier: UMichigan
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Insulin therapy; Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Change in baseline A1C (glycated hemoglobin) at 12 months

  Measure of long-term blood glucose control and efficacy of intervention

  12 months

Secondary Outcomes (6)

• Change in baseline lipids at 12 months

  12 months

• Change in baseline blood pressure at 12 months

  12 months

• All cause mortality

  12 months

• Acute complications

  12 months

• Change in baseline Quality of life at 12 months

  12 months

Other Outcomes (2)

• Clinic retention

  12 months

• Cost

  12 months

Study Arms (2)

Personalized type 2 diabetes care.

EXPERIMENTAL

Remote, personalized type 2 diabetes clinic provided by an endocrinologist using frequent remote contacts for medication adjustments.

Other: Remote, personalized type 2 diabetes care.

Usual Endocrine Care

ACTIVE COMPARATOR

Usual Endocrine care will be provided by an endocrinologist.

Other: Usual Endocrine care.

Interventions

Remote, personalized type 2 diabetes care. OTHER

Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely.

Personalized type 2 diabetes care.

Usual Endocrine care. OTHER

Diabetes and comorbidities management will provided by an endocrinologist

Usual Endocrine Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 28793967 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Israel Hodish, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 9, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2017
• Last Updated: November 2, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)