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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote, personalized type 2 diabetes care.
Usual Endocrine care.
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes focused on measuring Insulin therapy, Type 2 diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personalized type 2 diabetes care.

Usual Endocrine Care

Arm Description

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

Usual Endocrine care will be provided by an endocrinologist.

Outcomes

Primary Outcome Measures

Change in baseline A1C (glycated hemoglobin) at 12 months
Measure of long-term blood glucose control and efficacy of intervention

Secondary Outcome Measures

Change in baseline lipids at 12 months
Measure of total cholesterol, LDL, and Triglycerides
Change in baseline blood pressure at 12 months
Systolic and diastolic blood pressure
All cause mortality
Record deaths due to any cause
Acute complications
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
Short Form-36
Change in baseline insulin satisfaction at 12 months
Insulin Therapy Satisfaction Questionnaire

Full Information

First Posted
August 2, 2013
Last Updated
October 31, 2018
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01920256
Brief Title
Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care
Official Title
Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Insulin therapy, Type 2 diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalized type 2 diabetes care.
Arm Type
Experimental
Arm Description
Remote, personalized type 2 diabetes clinic provided by an endocrinologist using frequent remote contacts for medication adjustments.
Arm Title
Usual Endocrine Care
Arm Type
Active Comparator
Arm Description
Usual Endocrine care will be provided by an endocrinologist.
Intervention Type
Other
Intervention Name(s)
Remote, personalized type 2 diabetes care.
Intervention Description
Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely.
Intervention Type
Other
Intervention Name(s)
Usual Endocrine care.
Intervention Description
Diabetes and comorbidities management will provided by an endocrinologist
Primary Outcome Measure Information:
Title
Change in baseline A1C (glycated hemoglobin) at 12 months
Description
Measure of long-term blood glucose control and efficacy of intervention
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in baseline lipids at 12 months
Description
Measure of total cholesterol, LDL, and Triglycerides
Time Frame
12 months
Title
Change in baseline blood pressure at 12 months
Description
Systolic and diastolic blood pressure
Time Frame
12 months
Title
All cause mortality
Description
Record deaths due to any cause
Time Frame
12 months
Title
Acute complications
Description
Cardiovascular events, cerebrovascular events, peripheral vascular events, limb ulcers and amputations, severe hypoglycemia, and other unscheduled emergency department and hospital visits
Time Frame
12 months
Title
Change in baseline Quality of life at 12 months
Description
Short Form-36
Time Frame
12 months
Title
Change in baseline insulin satisfaction at 12 months
Description
Insulin Therapy Satisfaction Questionnaire
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Clinic retention
Description
Missed visits, missed phone calls, lost to follow up and drops outs will be recorded for both groups
Time Frame
12 months
Title
Cost
Description
Resource utilization and cost for both groups
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Israel Hodish, MD, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Experimental group patients informed of A1C results.
Citations:
PubMed Identifier
28793967
Citation
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.
Results Reference
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Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care

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