Clinical trial NCT05004428: A Study to Learn More About Chronic Kidney Disease (CKD) in Patients With Type 2 Diabetes Mellitus (T2DM)
Official title: Chronic Kidney Disease in Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Chronic Kidney Disease
Keywords: Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus , Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2021-08-13
Enrollment: 336376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients medical history data from Alberta Kidney Disease Network (AKDN) with Type 2 diabetes by chronic kidney disease (CKD) stage and by rate of CKD progression will be collected retrospectively.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Type 2 Diabetes Mellitus (T2DM) patients with Chronic Kidney Disease (CKD) in database.
timeFrame: Baseline
Secondary outcomes:
measure: Descriptive analyses of clinical characteristics of patients in database.
timeFrame: Baseline
measure: Descriptive analyses of demographic data.
timeFrame: Baseline
measure: Rate of decline in estimated glomerular filtration rate (eGFR)
timeFrame: Retrospectively 3 years
measure: Number of patients with CKD dispensed the medication or therapeutic class over a 1-year time period
timeFrame: from January 1, 2018 to December 31, 2018
measure: The proportion of patients with CKD that experience a health outcome of interest over a 1-year time period
timeFrame: from January 1, 2018 to December 31, 2018
measure: Health care resource utilization among patients
timeFrame: from January 1, 2018 to December 31, 2018
measure: Annual average costs among patients
timeFrame: from January 1, 2018 to December 31, 2018
Other outcomes:
Locations:
city: Multiple Locations
country: Canada
facility: Many Locations
Study officials:
References: