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Determining Rates of Cardiovascular Complications Among Patients of a Managed Diabetes Care Program

Does Managed Diabetes Care Decrease Cardiovascular Complications of Diabetes?

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00498147
Acronym
DECIDE
Enrollment
1213
Registered
2007-07-09
Start date
2007-07-31
Completion date
2010-07-31
Last updated
2009-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Complications, Diabetic Nephropathy, Diabetic Neuropathy, Diabetic Retinopathy, Diabetic Vascular Complications, Disease Management

Keywords

amputation, angina, angiography, angioplasty, arterial disease, artery disease, bypass, CABG, cad, carotid, cerebral accident, CHF, CRF, CVA, endarterectomy, heart attack, heart failure, infarct, kidney disease, kidney failure, laser, nephropathy, neuropathy, pad, PCI, percutaneous coronary, percutaneous transluminal, pvd, renal failure, retinopathy, revascularization, schemia, stenosis, stent, stroke, transient, ulcer, vascular disease

Brief summary

The primary objective of this study is to identify whether cardiovascular complication rates are lower in patients who participate in managed diabetes care, in comparison to provincial and national rates. This study will involve an electronic medical record (EMR) chart audit, augmented by a manual review of hospital and other pertinent medical records, as necessary.

Detailed description

The DECIDE study will identify whether cardiovascular complication rates (the composite rate of myocardial infarction (MI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG), stroke, carotid endarterectomy, peripheral revascularization, and peripheral amputation) are lower in patients who participate in managed diabetes care by ADEC in comparison to provincial and national rates. Comparison statistics will be provided by the Institute of Evaluative Sciences (ICES) Atlas 2003 and other Diabetes studies such as the 2005 DICE study. Complications such as nephropathy and retinopathy will be documented, along with hospitalization rates and all cause mortality. Clinical outcomes relevant to diabetes management such as blood pressure and lipids will also be compared.

Interventions

OTHERADEC Program

Interventions (managed diabetes care) employed by the ADEC Program include: diabetes education, nutrition care, individual and group counseling sessions, foot care, and insulin and oral diabetes medication adjustments with a signed medical directive. ADEC Diabetes Educators (Registered Dietitians and Registered Nurses) will use adult education principles throughout the education process and promote self-care by encouraging responsibility and promoting a positive attitude towards acceptance of diabetes. All patients will be encouraged to self-monitor their blood glucose at home. Team member collaboration and with other agencies to promote a total client care approach to diabetes management will be employed.

Sponsors

Pfizer
CollaboratorINDUSTRY
Group Health Centre
Lead SponsorOTHER

Study design

Observational model
COHORT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Ambulatory patients over the age of 18 years with diabetes mellitus. 2. Current enrolment in ADEC program (\>6 months)or new enrolment in ADEC program (\<6 months). 3. Confirmed diagnosis of diabetes mellitus, according to the current Canadian Diabetes Guidelines. 4. Informed consent provided

Exclusion criteria

1. History of only gestational diabetes. 2. Non-GHC member. 3. GHC patients with diabetes who do not attend the ADEC program. 4. Unable to give informed consent. 5. Any conditions/circumstances that prevent the patient from attending ADEC sessions or participating fully in the program. 6. Refusal to allow research staff access to medical records, including hospital charts.

Design outcomes

Primary

MeasureTime frame
Rates of cardiovascular events and other complications of diabetes compared to provincial and national rates1 year

Secondary

MeasureTime frame
The secondary outcomes will be total mortality, CV- related events, and other selected complications of diabetes.1 year

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026