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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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109
- University of Michigan Health System
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Personalized type 2 diabetes care.
Remote, personalized type 2 diabetes clinic provided by an endocrinologist using frequent remote contacts for medication adjustments.
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Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely.
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Actieve vergelijker: Usual Endocrine Care
Usual Endocrine care will be provided by an endocrinologist.
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Diabetes and comorbidities management will provided by an endocrinologist
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in baseline A1C (glycated hemoglobin) at 12 months
Tijdsspanne: 12 months
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Measure of long-term blood glucose control and efficacy of intervention
|
12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in baseline lipids at 12 months
Tijdsspanne: 12 months
|
Measure of total cholesterol, LDL, and Triglycerides
|
12 months
|
|
Change in baseline blood pressure at 12 months
Tijdsspanne: 12 months
|
Systolic and diastolic blood pressure
|
12 months
|
|
All cause mortality
Tijdsspanne: 12 months
|
Record deaths due to any cause
|
12 months
|
|
Acute complications
Tijdsspanne: 12 months
|
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
Tijdsspanne: 12 months
|
Short Form-36
|
12 months
|
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Change in baseline insulin satisfaction at 12 months
Tijdsspanne: 12 months
|
Insulin Therapy Satisfaction Questionnaire
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12 months
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Clinic retention
Tijdsspanne: 12 months
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Missed visits, missed phone calls, lost to follow up and drops outs will be recorded for both groups
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12 months
|
|
Cost
Tijdsspanne: 12 months
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Resource utilization and cost for both groups
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12 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Israel Hodish, MD, PhD, University of Michigan
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UMichigan
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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