iCaReMe Global Registry

Study Overview
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Brief Summary
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To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases

Detailed Description
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The registry intends to provide real world data on patient management and quality of care for patients with T2DM, hypertension, heat failure and chronic kidney disease in clinical practice in many countries. To bridge this gap an observational voluntary registry is set up to capture real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart Failure and Chronic Kidney Disease. Multinational, observational registry utilizing a cloud-based eCRF, for prospective and retrospective data collection, accessible to investigators and Scientific Committee. This registry will be open to all physicians managing T2DM, HTN, HF or CKD across the world

Official Title
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Real-world Multinational Registry to Determine Management and Quality of Care of Patients With Type 2 Diabetes, Hypertension, Heart Failure and/or Chronic Kidney Diseases

Conditions
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Type 2 Diabetes, Hypertension, Chronic Kidney Disease, Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being 18 years or older Having type 2 diabetes, Hypertension, Heart Failure and/or chronic kidney disease Providing written informed consent to participate in the registry Exclusion Criteria: Having a life-threatening co-morbidity with life expectancy below 1 year Participating in an interventional trial requiring informed consent

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Provide real world data on patient characteristics | Disease control (e.g. achievement of glycated hemoglobin target and incidence of hypoglycemic events) Management of micro- and/or macrovascular complications Management of associated risk factors (e.g. hypercholesterolemia and hypertension) Current diabetes, CKD and HF treatments Concomitant medications | Average of 3 years through study completion | 
| 2. Provide real world data on disease management | Disease control (e.g. achievement of glycated hemoglobin target and incidence of hypoglycemic events) Management of micro- and/or macrovascular complications Management of associated risk factors (e.g. hypercholesterolemia and hypertension) Current diabetes treatments Concomitant medications | Average of 3 years through study completion | 
| 3. Provide real world data on healthcare utilization | Number of diabetes, Chronic Kidney Disease(CKD) and Heart Failure(HF)-related visits to a physician not at study site Number of urgent care visits for diabetes Number of diabetes, CKD and HF-related hospital emergency department visits and reason(s) for visits Number of hospitalizations, lengths of stay, and reasons for hospitalizations | Average of 3 years through study completion | 
| 4. Provide real world data on quality of care indicators | Smoking cessation Eye and foot examinations Dietary counselling | Average of 3 years through study completion | 
| Provide real world data on cardiovascular outcomes in patients with type 2 diabetes; Chronic Kidney Disease and Heart Failure | All-cause and cause-specific deaths and hospitalizations, including recurrent events | Average of 3 years through study completion | 
| 6. Provide real world data on renal outcomes and other microvascular complications in patients with type 2 diabetes and Heart Failure | All-cause and cause-specific deaths and hospitalizations, including recurrent events | Average of 3 years through study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Registry, Type 2 Diabetes, T2DM, Chronic Kidney Disease, CKD, Hypertension, HTN, Adult population, Heart Failure, HF, Early cardiorenal complications