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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Kidney Diseases, Type 2 Diabetes

Intervention / Treatment
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* Other: Not applicable - this is a non-interventional, observational study.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic kidney disease<br>Adult patients (≥18 years of age) with CKD were identified in Alberta during the case ascertainment period (April 1, 2010, to March 31, 2019), based on a validated algorithm incorporating ICD-9-CM/ICD-10-CA coding, estimated glomerular filtration rate, and albuminuria laboratory tests. This is a non-interventional, observational study, and thus, no intervention was administered. | Other: Not applicable - this is a non-interventional, observational study.<br>* Not applicable - this is a non-interventional, observational study.<br>|
| Type 2 diabetes mellitus<br>Adult patients with T2DM were identified in Alberta during the case ascertainment period (April 1, 2010 to March 31, 2018), based on a validated algorithm incorporating ICD-9-CM and ICD-10-CA codes. This is a non-interventional, observational study, and thus, no intervention was administered. | Other: Not applicable - this is a non-interventional, observational study.<br>* Not applicable - this is a non-interventional, observational study.<br>|
| Comorbid type 2 diabetes mellitus and chronic kidney disease<br>The derived T2DM cohort was used to identify patients with comorbid T2DM/CKD (stages 1-3) during the same case ascertainment period (April 1, 2010 to May 31, 2018). The study cohort included T2DM patients with comorbid CKD (stages 1-3) identified in Alberta within the two years prior or after their T2DM index date, using the T2DM index date as the index date for this cohort. This is a non-interventional, observational study, and thus, no intervention was administered. | Other: Not applicable - this is a non-interventional, observational study.<br>* Not applicable - this is a non-interventional, observational study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |