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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Israel Hodish MD PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01920256
First received: August 2, 2013
Last updated: September 23, 2013
Last verified: September 2013

August 2, 2013
September 23, 2013
August 2013
September 2015   (final data collection date for primary outcome measure)
Change in baseline A1C (glycated hemoglobin) at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Measure of long-term blood glucose control and efficacy of intervention
Same as current
Complete list of historical versions of study NCT01920256 on ClinicalTrials.gov Archive Site
  • Change in baseline lipids at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measure of total cholesterol, LDL, and Triglycerides
  • Change in baseline blood pressure at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Systolic and diastolic blood pressure
  • All cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Record deaths due to any cause
  • Acute complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Short Form-36
  • Change in baseline insulin satisfaction at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Insulin Therapy Satisfaction Questionnaire
  • Change in baseline lipids at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measure of total cholesterol, LDL, and Triglycerides
  • Change in baseline blood pressure at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Systolic and diastolic blood pressure
  • All cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Record deaths due to any cause
  • Acute complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Quality of Well-being Index
  • Change in baseline insulin satisfaction at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Insulin Therapy Satisfaction Questionnaire
  • Clinic retention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Missed visits, missed phone calls, lost to follow up and drops outs will be recorded for both groups
  • Cost [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Resource utilization and cost for both groups
Same as current
 
Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Type 2 Diabetes
  • Other: Remote, personalized type 2 diabetes care.
    Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely.
  • Other: Usual Endocrine care.
    Diabetes and comorbidities management will provided by an endocrinologist
  • Experimental: Personalized type 2 diabetes care.
    Remote, personalized type 2 diabetes clinic provided by an endocrinologist using frequent remote contacts for medication adjustments.
    Intervention: Other: Remote, personalized type 2 diabetes care.
  • Active Comparator: Usual Endocrine Care
    Usual Endocrine care will be provided by an endocrinologist.
    Intervention: Other: Usual Endocrine care.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
September 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Israel Hodish, MD, PhD (734) 936-5505 ihodish@umich.edu
Contact: Martha Funnell, MS, RN, CDE (734) 936-9237 mfunnell@umich.edu
United States
 
NCT01920256
UMichigan
Yes
Israel Hodish MD PhD, University of Michigan
University of Michigan
Not Provided
Principal Investigator: Israel Hodish, MD, PhD University of Michigan
University of Michigan
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP