- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01920256
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Health System
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Personalized type 2 diabetes care.
Remote, personalized type 2 diabetes clinic provided by an endocrinologist using frequent remote contacts for medication adjustments.
|
Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely.
|
|
Aktiv komparator: Usual Endocrine Care
Usual Endocrine care will be provided by an endocrinologist.
|
Diabetes and comorbidities management will provided by an endocrinologist
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in baseline A1C (glycated hemoglobin) at 12 months
Tidsramme: 12 months
|
Measure of long-term blood glucose control and efficacy of intervention
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in baseline lipids at 12 months
Tidsramme: 12 months
|
Measure of total cholesterol, LDL, and Triglycerides
|
12 months
|
|
Change in baseline blood pressure at 12 months
Tidsramme: 12 months
|
Systolic and diastolic blood pressure
|
12 months
|
|
All cause mortality
Tidsramme: 12 months
|
Record deaths due to any cause
|
12 months
|
|
Acute complications
Tidsramme: 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
Tidsramme: 12 months
|
Short Form-36
|
12 months
|
|
Change in baseline insulin satisfaction at 12 months
Tidsramme: 12 months
|
Insulin Therapy Satisfaction Questionnaire
|
12 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinic retention
Tidsramme: 12 months
|
Missed visits, missed phone calls, lost to follow up and drops outs will be recorded for both groups
|
12 months
|
|
Cost
Tidsramme: 12 months
|
Resource utilization and cost for both groups
|
12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Israel Hodish, MD, PhD, University of Michigan
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UMichigan
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Type 2 diabetes
-
Jin-Hee AhnAsan Medical CenterUkendtHER-2-genamplifikation | HER-2 Protein Overekspression
-
The University of Tennessee, KnoxvilleAfsluttetMatematiklærere (2-8 klassetrin) | Matematikstuderende (2-8 klassetrin)Forenede Stater
-
Instituto Nacional de Ciencias Medicas y Nutricion...Aktiv, ikke rekrutterende
-
Endogenex, Inc.Ikke rekrutterer endnuDiabetes mellitus, type 2 | Diabetes | Type 2 diabetes | Type 2 diabetes mellitus (T2DM) | Type 2 Diabetes
-
Tianjin Medical University Second HospitalJiangsu HengRui Medicine Co., Ltd.UkendtSolid tumor | HER-2-genamplifikation | HER2 genmutation | HER-2 Protein OverekspressionKina
-
PowderMedAfsluttet
-
Embecta Corp.Jaeb Center for Health ResearchTrukket tilbageType 2 diabetes | Type 2 diabetes mellitus (T2DM) | T2DM (Type 2 Diabetes Mellitus) | T2D | T2DM | Type 2 DM | T2DM med utilstrækkelig glykæmisk kontrolForenede Stater
-
Kaiser PermanenteThe Permanente Medical GroupTilmelding efter invitationType 2 diabetes | Type 2 diabetes mellitus (T2DM) | Type 2-diabetes (T2D)Forenede Stater
-
University of North Carolina, Chapel HillAmerican Heart AssociationRekrutteringType 2 diabetes | Ernæring | Diabetes type 2 | T2DM (Type 2 Diabetes Mellitus) | Diabetes Mellitis | T2DM | Diabetes uddannelseForenede Stater
-
Centre Hospitalier Universitaire DijonAfsluttet