iCaReMe Global Registry: Multinational Real-world Evidence in Cardiorenal and Metabolic Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Having a life-threatening co-morbidity with life expectancy below 1 year
Participating in an interventional trial requiring informed consent
Trial population
Adults with type 2 diabetes, Hypertension, Heart Failure and/or chronic kidney disease
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
35,000 Participants
are grouped into 4 trial groupsGroup A: T2DM Cohort
Group B: HTN Cohort
Group C: CKD Cohort
Group D: HF Cohort
Trial outcomes
Primary outcomes
1
1. Age of particpants
Age of participants at enrollment reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in years.
Time frame
At Baseline2
2. Percentage of Participants by Sex
Distribution of participants by sex (male/female) reported as counts and percentages.
Time frame
At baseline3
3. Percentage of Participants by Ethnicity
Distribution of participants by ethnicity reported as counts and percentages for each ethnic category.
Time frame
At Baseline4
4. Percentage of Participants by Education Level
Distribution of participants by education level reported as counts and percentages for each education category.
Time frame
At BaselineSecondary outcomes
1
1. Incidence of Level 1 Hypoglycemic Events (Blood Glucose <70 mg/dL)
Hypoglycemic events defined as blood glucose \<70 mg/dL (Level 1 - alert value) reported as counts, percentages of participants with at least one event, total number of events, and rate per 100 person-years.
Time frame
Average of 3 years2
2.Incidence of Level 2 Hypoglycemic Events (Blood Glucose <54 mg/dL)
Hypoglycemic events defined as blood glucose \<54 mg/dL (Level 2 - clinically significant) reported as counts, percentages of participants with at least one event, total number of events, and rate per 100 person-years.
Time frame
Average of 3 years3
3.Incidence of Level 3 Hypoglycemic Events (Requiring Third-Party Assistance)
Severe hypoglycemic events requiring third-party assistance (Level 3) reported as counts, percentages of participants with at least one event, total number of events, and rate per 100 person-years.
Time frame
Average of 3 years4
4.Incidence of Diabetic Ketoacidosis (DKA) Episodes
Diabetic ketoacidosis (DKA) episodes reported as counts, percentages of participants with at least one episode, and total number of episodes.
Time frame
Average of 3 yearsSponsors and contacts
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Source ClinicalTrials.gov