A Study Using the LMC Diabetes Registry to Learn More About Chronic Kidney Disease (CKD) in Canadian Patients With Type 2 Diabetes (T2D)

Bayer

Status: Completed

Conditions: Chronic Kidney Disease in Type 2 Diabetes

Treatments: Drug: The physician's prescription in routine clinical practice

Study type: Observational

Funder types: Industry

Identifiers

NCT04445181

21190

Details and patient eligibility

About

In people with type 2 diabetes (T2D), the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels.

People with T2D are at a higher risk of having a condition called chronic kidney disease (CKD). In people with CKD, the kidneys become damaged and do not work as they should. People with CKD can have trouble breathing and often have swelling in their arms and legs, and high blood pressure.

People who have CKD and T2D are more likely to have other medical problems, such as heart disease.

There are many treatments available to patients who have CKD and T2D. But, researchers need more information about how doctors in Canada are deciding which treatment to give these patients.

In this study, the researchers will review health information from men and women with T2D who visited a doctor in 2019 and had check-ups for at least 6 months. The health information will be taken from a Canadian registry (or database) owned by LMC Diabetes & Endocrinology. The registry contains information from people that went to an LMC clinic. In this study, the researchers will learn how many of these people had T2D and CKD. They will learn the treatments these people received, and if they had other related medical problems. The researchers will also use surveys to ask the doctors about why they chose certain treatments.

Enrollment: 14,873 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of T2D as captured in the LMC EMR system
• Assessed by an LMC endocrinologist between January 1, 2019 and December 31, 2019
• Followed by an LMC endocrinologist for ≥ 6 months prior to inclusion in the cohort
• Informed consent to use patient medical record data for research purposes was provided

Among patients who meet the inclusion criteria, estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73 m^2 and/or urine albumin-to-creatinine ratio (uACR) ≥ 2 mg/mmol will be used to identify the cohort of patients with T2D and CKD

Exclusion criteria

• Any patients with documented non-diabetic etiology for renal disease will be excluded from the numerator (number of patients with CKD and T2D) when determining the primary endpoint

Trial design

14,873 participants in 2 patient groups

Patients with T2D

Description:

Active patients (defined as patients seen by an LMC endocrinologist between January 1, 2019 and December 31, 2019) with T2D (Type 2 Diabetes). Among the patients with T2D, those identified with CKD will be included in the renal registry.

Treatment:

Drug: The physician's prescription in routine clinical practice

Healthcare providers

Description:

Healthcare providers caring for patients with CKD and T2D.