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Burden of Chronic Kidney Disease (CKD), Type 2 Diabetes Mellitus (T2DM), and Comorbid T2DM/CKD in Alberta, Canada

Burden of Disease of Chronic Kidney Disease (CKD), Type 2 Diabetes Mellitus (T2DM), and Comorbid T2DM/CKD in Alberta, Canada: A Non-interventional Study Using Administrative Health Data

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04417725
Enrollment
588170
Registered
2020-06-05
Start date
2008-04-01
Completion date
2022-08-31
Last updated
2023-10-31

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

Conditions

Chronic Kidney Diseases, Type 2 Diabetes

Brief summary

The purpose of the research study is to describe the burden of disease among three different cohorts of patients: (1) patients diagnosed with CKD, (2) those with T2DM; and (3) those with T2DM and comorbid CKD.

Detailed description

Chronic kidney disease (CKD) has been ranked as the 10th leading cause of death in Canada as of 2013, while type 2 diabetes mellitus (T2DM) is one of the fastest growing diseases in Canada. There is a growing body of evidence that has examined these populations in real-world settings in Canada. The study described below will add to the growing body of literature that has examined CKD patients in Alberta and will contribute to an understanding of the epidemiology of CKD by stage, as well as healthcare resource utilization (HCRU) and costs. Furthermore, this study will contribute to a more nuanced understanding of the epidemiology, treatment patterns, HCRU and costs, and adverse events for T2DM patients with and without comorbid CKD in Alberta.

Interventions

OTHERNot applicable - this is a non-interventional, observational study.

Not applicable - this is a non-interventional, observational study.

Sponsors

Medlior Health Outcomes Research Ltd
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

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

Inclusion criteria

(either of the following): * Chronic kidney disease identified using laboratory test and health administrative data * Type 2 diabetes mellitus identified using health administrative data

Exclusion criteria

* Age \< 18 years

Design outcomes

Primary

MeasureTime frameDescription
Incidence and prevalence2010 to 2018 fiscal yearsIncidence and prevalence of CKD (by stage), T2DM, and comorbid T2DM/CKD, including 1-, 4-, and 5-year period prevalence and incidence

Secondary

MeasureTime frameDescription
Comorbidity and complication profiles and rates2010 to 2019 fiscal yearsFor all three cohorts, comorbidities and complications of interest include: 1. Diabetic: hypoglycemia, lower limb amputations, diabetic ketoacidosis 2. Renal: acute kidney injury, acute renal failure, anemia, urogenital tract infections, albuminuria, hematuria, fast estimated glomerular filtration rate decline, CKD progression, continuous renal replacement therapy, dialysis initiation 3. Cardiovascular: CV events (atrial fibrillation, coronary artery disease, chronic heart failure, hypertension, myocardial infarction, hospitalization for heart failure (specific and broad), peripheral artery disease, stroke/transient ischemic attack (TIA)), CV hospitalization, CV mortality 4. Other: fractures and all-cause mortality 5. Any event: Composite outcome to capture any of the above For the CKD cohort, results will also be stratified by T2DM status. Comorbidity/complication rates between the T2DM and T2DM/CKD comorbid populations will be compared.
Factors that influence the progression of CKD in patients2010 to 2019 fiscal yearsLogistic regression model to assess association of variables of interest (age, sex, health region, comorbidities (Charlson Comorbidity Index as well as conditions in outcome 2), ACR, HbA1c, medication use. This will be performed for all patients with CKD and stratified by T2DM status.
Healthcare resource use (HCRU) and associated costs for CKD patients2010 to 2019 fiscal yearsHCRU include: inpatient hospitalizations, hospital length of stay, emergency department visits, general practitioner and specialist visits. Costs include: hospital costs, emergency department costs, physician costs, medication costs. This will be performed for all patients with CKD and stratified by T2DM status.
Stage-to-stage progression of CKD across the follow-up years in patients with CKD2010 to 2019 fiscal yearsThis will be performed for all patients with CKD and stratified by T2DM status.
Treatment patterns2010 to 2019 fiscal years1. Treatment patterns by year for all three cohorts 2. Drug treatment patterns in patients with T2DM and comorbid CKD versus current guidelines, 3. Treatment patterns for the CKD cohort will also be stratified by T2DM status.

Outcome results

None listed

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