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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Canadian REgistry of Chronic Kidney Disease in Diabetes Outcomes (CREDO) Study

Conditions
-----------------
Chronic Kidney Disease in Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: The physician's prescription in routine clinical practice


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with T2D<br>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. | Drug: The physician's prescription in routine clinical practice<br>* This is an Observational study that will not involve prescription of the drugs.<br>|
| Healthcare providers<br>Healthcare providers caring for patients with CKD and T2D. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with CKD in a large T2D population | The data will be retrieved from the LMC Diabetes Registry, a Pan-Canadian registry of diabetes community-based specialist practices and used to develop a renal registry to investigate the primary objectives of the study | Retrospectively analysis between January 1, 2019 and December 31, 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients using the different therapies | The therapies are: ACEi, ARBs, ACEi/ARBs, MRAs, GLP-1 RA and SGLT2i | Retrospectively analysis between January 1, 2019 and December 31, 2019 | 
| Proportion of patients with stage 1 CKD with moderate or greater albuminuria, stage 2 CKD with moderate or greater albuminuria, stage 3a CKD, stage 3b CKD, stage 4 CKD and stage 5 CKD in accordance with Canadian clinical practice guidelines | Stage 1 CKD: eGFR (estimated glomerular filtration rate) ≥ 90 ml/min/1.73 m^2 Stage 2 CKD: eGFR between 60-89 ml/min/1.73 m^2 Stage 3a CKD: eGFR between 45-59 ml/min/1.73 m^2 Stage 3b CKD: eGFR between 30-44 ml/min/1.73 m^2 Stage 4 CKD: eGFR between 15-29 ml/min/1.73 m^2 Stage 5 CKD: eGFR <15 ml/min/1.73 m^2 | Retrospectively analysis between January 1, 2019 and December 31, 2019 | 
| Proportion of patients with microalbuminuria and macroalbuminuria, in accordance with Canadian clinical practice guidelines | Microalbuminuria: uACR (urine albumin-to-creatinine ratio) 2-20 mg/mmol Macroalbuminuria: uACR > 20 mg/mmol | Retrospectively analysis between January 1, 2019 and December 31, 2019 | 
| Proportion of patients within each albuminuria category (A1, A2 or A3), in accordance with KDIGO clinical practice guidelines | KDIGO = Kidney Disease: Improving Global Outcomes | Retrospectively analysis between January 1, 2019 and December 31, 2019 | 
| Laboratory values for patients using either no therapy or using a therapy for ≥ 6 months | Laboratory values including glucose, glycated hemoglobin (HbA1c), lipids, creatinine, electrolytes, eGFR, and uACR | Retrospectively analysis between January 1, 2019 and December 31, 2019 | 
| Proportion of patients with different comorbidities | Comorbidities like hypertension, dyslipidemia, microvascular disease, macrovascular disease | Retrospectively analysis between January 1, 2019 and December 31, 2019 | 
| Proportion of healthcare provider prescriptions of RAS therapies (ACEi/ARB) used to treat hypertension, heart failure, coronary artery disease, CKD, or other condition | RAS: renin angiotensin system ACEi: angiotensin converting enzyme inhibitors ARB: angiotensin receptor blocker Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D | On the day of healthcare provider completes a questionnaire | 
| Proportion of healthcare provider prescriptions of GLP-1 RA used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition | GLP-1 RA: glucagon-like peptide-1 receptor agonist Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D | On the day of healthcare provider completes a questionnaire | 
| Proportion of healthcare provider prescriptions of MRAs used to treat hypertension, heart failure, coronary artery disease, CKD or other condition | MRAs: mineralocorticoid receptor antagonists Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D | On the day of healthcare provider completes a questionnaire | 
| Proportion of healthcare provider prescriptions of SGLT2i used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition | SGLT2i: sodium-glucose co-transporter-2 inhibitors Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D | On the day of healthcare provider completes a questionnaire |