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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04417725
• Other study ID #: 1245.217
• Status: Completed
• Start date: April 1, 2008
• Est. completion date: August 31, 2022

Study information

• Verified date: October 2023
• Source: Medlior Health Outcomes Research Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 588170
• Est. completion date: August 31, 2022
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medlior Health Outcomes Research Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and prevalence	Incidence and prevalence of CKD (by stage), T2DM, and comorbid T2DM/CKD, including 1-, 4-, and 5-year period prevalence and incidence	2010 to 2018 fiscal years
Secondary	Comorbidity and complication profiles and rates	For all three cohorts, comorbidities and complications of interest include: Diabetic: hypoglycemia, lower limb amputations, diabetic ketoacidosis; 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; 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; Other: fractures and all-cause mortality; 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.	2010 to 2019 fiscal years
Secondary	Factors that influence the progression of CKD in patients	Logistic 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.	2010 to 2019 fiscal years
Secondary	Healthcare resource use (HCRU) and associated costs for CKD patients	HCRU 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.	2010 to 2019 fiscal years
Secondary	Stage-to-stage progression of CKD across the follow-up years in patients with CKD	This will be performed for all patients with CKD and stratified by T2DM status.	2010 to 2019 fiscal years
Secondary	Treatment patterns	Treatment patterns by year for all three cohorts; Drug treatment patterns in patients with T2DM and comorbid CKD versus current guidelines,; Treatment patterns for the CKD cohort will also be stratified by T2DM status.	2010 to 2019 fiscal years