A Study to Learn More About Chronic Kidney Disease (CKD) in Patients With Type 2 Diabetes Mellitus (T2DM)

Study Overview
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Brief Summary
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In this observational study, data from the recent past of patients with type 2 diabetes mellitus and chronic kidney disease will be studied. Type 2 diabetes mellitus (T2DM) is a condition in which the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels. About half of people with T2DM also have a condition called chronic kidney disease (CKD). In people with CKD, the kidneys' ability to work as how it should decreases over time. In this study, researchers want to learn more about the CKD in T2DM patients in Alberta, Canada. This will help them to know the chances to improve the care of these patients. The researchers will look at the health information from adult men and women in Alberta who were diagnosed with T2DM before 2018 and visited a doctor to have check-ups in 2018. They will find out about how many of these people had CKD and how severe their CKD was. The researchers will collect data about the age and gender of these patients, how long they had T2DM and if they had other related medical problems. The researchers will also learn how these patients were treated based on their kidney condition and how much money was spent on these treatments. This study will collect information from the health records of about 270,000 patients with T2DM who were living in Alberta, Canada. This information will come from the Alberta Kidney Disease Network (AKDN) database. Besides this data collection, no further tests or examinations are planned in this study.

Official Title
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Chronic Kidney Disease in Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus, Chronic Kidney Disease

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A cohort of adults (18 years and older) with Type 2 Diabetes Mellitus (T2DM) who resided in Alberta on the index date (December 31, 2018) and were registered with Alberta Health will be included. All Alberta residents are eligible for Alberta Health Insurance Plan coverage and over 99% participate. Exclusion Criteria: Patients with type 1 DM (T1DM) (International Classification of Diseases, Ninth Revision [ICD-9] code: 250.x1 and 250.x3) in any of their previous records.

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 |
| --- | --- |
| Type 2 Diabetes Mellitus patients with Chronic Kidney Disease<br>Canadian patients with type 2 diabetes mellitus data will be collected retrospectively. | Other: No intervention<br>* Retrospective population-based study utilizing administrative data without any intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Type 2 Diabetes Mellitus (T2DM) patients with Chronic Kidney Disease (CKD) in database. | Percentage of T2DM patients with CKD as per hemoglobin A1C, and stage of CKD as defined by a) baseline Kidney Disease: Improving Global Outcomes (KDIGO) guidelines CKD category, and b) eGFR ≥25 to <75 mL/min/1.73 m2 and ACR ≥30 to ≤5,000 mg/g. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive analyses of clinical characteristics of patients in database. | Duration of diabetes, comorbities and slope of eGFR | Baseline | 
| Descriptive analyses of demographic data. | Age, sex, urban or rural residence. | Baseline | 
| Rate of decline in estimated glomerular filtration rate (eGFR) |  | Retrospectively 3 years | 
| Number of patients with CKD dispensed the medication or therapeutic class over a 1-year time period |  | from January 1, 2018 to December 31, 2018 | 
| The proportion of patients with CKD that experience a health outcome of interest over a 1-year time period |  | from January 1, 2018 to December 31, 2018 | 
| Health care resource utilization among patients |  | from January 1, 2018 to December 31, 2018 | 
| Annual average costs among patients |  | from January 1, 2018 to December 31, 2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular Diseases, Kidney Diseases, Renal Insufficiency, Chronic, Diabetes Mellitus , Type 1, Diabetes Mellitus, Type 2