Type 2 DiabetesiCaReMeNCT03549754
iCaReMe Global Registry: Multinational Real-world Evidence in Cardiorenal and Metabolic Diseases
An observational study of Type 2 Diabetes and Hypertension, run by AstraZeneca at 76 sites in 20 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Hypertension, Chronic Kidney Disease
- How many people
- 35,000 participants
- Where
- 76 sitesin 20 countries
- Study dates
- 17 Feb 2018to 31 Dec 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with type 2 diabetes, Hypertension, Heart Failure and/or chronic kidney disease
Who may be able to join
- 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
Who cannot join
- Having a life-threatening co-morbidity with life expectancy below 1 year
- Participating in an interventional trial requiring informed consent
Trial locations and contacts
76 sites in 20 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
76 sites in 20 countries
Brazil15 sites, 15 recruiting
- Recruiting
Research Site
Bragança Paulista, São Paulo, 12916-542
- Recruiting
Research Site
Brasília, Federal District, 70673-623
- Recruiting
Research Site
Campina Grande do Sul, Paraná, 83430-000
- Recruiting
Research Site
Colatina, Espírito Santo (ES), 29707-035
- Recruiting
Research Site
Curitiba, Paraná, 80230-020
- Recruiting
Research Site
Fortaleza, Ceará, 60840-285
- Recruiting
Research Site
Goiânia, State of Goias, 74453-200
- Recruiting
Research Site
Joinville, State of Santa Catarina, 89204-248
- Recruiting
Research Site
Poços de Caldas, Minas Gerais, 37706-106
- Recruiting
Research Site
Salvador, Estado de Bahia, 40730-220
- Recruiting
Research Site
Santa Cruz do Sul, Rio Grande Do Sul (RS), 96835-090
- Recruiting
Research Site
São Caetano do Sul, São Paulo, 09521-160
- Recruiting
Research Site
São Paulo, 05403-000
- Recruiting
Research Site
São Paulo, 05403-900
- Recruiting
Research Site
Teresina, Piauí (PI), 64001-450
Philippines10 sites, 10 recruiting
- Not yet recruiting
Research Site
Bulacan
- Recruiting
Research Site
Cebu City
- Not yet recruiting
Research Site
Iloilo City
- Not yet recruiting
Research Site
Laguna
- Not yet recruiting
Research Site
Mandaluyong
- Not yet recruiting
Research Site
Manila
- Not yet recruiting
Research Site
Mindoro
- Not yet recruiting
Research Site
Pampanga
- Not yet recruiting
Research Site
Quezon City
- Not yet recruiting
Research Site
Zamboanga City
Taiwan9 sites, 9 recruiting
- Recruiting
Research Site
Changhua, 500209
- Recruiting
Research Site
Kaohsiung City, 81301
- Recruiting
Research Site
Niaosong, 83301
- Recruiting
Research Site
Taichung, 40447
- Recruiting
Research Site
Taichung, 40705
- Recruiting
Research Site
Taichung
- Recruiting
Research Site
Tainan, 704
- Recruiting
Research Site
Taipei
- Recruiting
Research Site
Taoyuan City, 33305
Ukraine9 sites, 9 recruiting
- Recruiting
Research Site
Dnipro, Dnipropetrovsk Oblast, 49005
- Recruiting
Research Site
Kharkiv, Kharkiv Oblast, 61039
- Recruiting
Research Site
Kharkiv, Kharkiv Oblast
- Recruiting
Research Site
Kyiv, Kyiv Oblast, 3039
- Recruiting
Research Site
Kyiv, Kyiv Oblast, 4050
- Recruiting
Research Site
Lutsk, Volyn Oblast, 43024
- Recruiting
Research Site
Uzhhorod, Zakarpattia Oblast, 88000
- Recruiting
Research Site
Vinnytsia, Vinnytsia Oblast, 21000
- Recruiting
Research Site
Zaporizhzhya, Zaporizhzhia Oblast, 69035
Kazakhstan5 sites, 5 recruiting
- Recruiting
Research Site
Aktobe, 30019
- Recruiting
Research Site
Almaty, 50000
- Recruiting
Research Site
Almaty, 50006
- Recruiting
Research Site
Almaty, 50012
- Recruiting
Research Site
Almaty, 50054
Mexico5 sites, 5 recruiting
- Recruiting
Research Site
Iztapalapa
- Recruiting
Research Site
León, Guanajuato, 37549
- Recruiting
Research Site
México, 04530
- Recruiting
Research Site
Mexico City, 06720
- Recruiting
Research Site
Mexico City
South Africa4 sites, 4 recruiting
- Recruiting
Research Site
Florida, 1794
- Recruiting
Research Site
Parow, 7505
- Recruiting
Research Site
Umhlanga, 4319
- Recruiting
Research Site
Umhlanga, 4320
Egypt3 sites, 3 recruiting
- Recruiting
Research Site
Alexandria
- Recruiting
Research Site
Cairo
- Recruiting
Research Site
Giza
India3 sites, 3 recruiting
- Recruiting
Research Site
Ahmedabad
- Recruiting
Research Site
Kolkata, 700034
- Recruiting
Research Site
Mumbai, 400006
Nigeria3 sites, 3 recruiting
- Recruiting
Research Site
Enugu, 400001
- Recruiting
Research Site
Gwagwalada, 901002
- Recruiting
Research Site
Kano, 700233
Chile1 site, 1 recruiting
- Recruiting
Research Site
Providencia, Santiago Metropolitan, 7500922
United Arab Emirates1 site, 1 recruiting
- Recruiting
Research Site
Sharjah city
About this study
Official title: 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
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
Read the detailed description
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
- Conditions
- Type 2 Diabetes, Hypertension, Chronic Kidney Disease, Heart Failure
- Keywords
- Registry, Type 2 Diabetes, T2DM, Chronic Kidney Disease, CKD, Hypertension, HTN, Adult population, Heart Failure, HF, Early cardiorenal complications
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Renal Insufficiency, Chronic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T2DM Cohort | Patients with T2DM as enrollment motif or T2DM as comorbidity | |
| HTN Cohort | Patients with HTN as enrollment motif or HTN as comorbidity | |
| CKD Cohort | Patients with CKD as enrollment motif or CKD as comorbidity | |
| HF Cohort | Patients with HF as enrollment motif or HF as comorbidity |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Age of particpants
Age of participants at enrollment reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in years.
Measured: At Baseline
2. Percentage of Participants by Sex
Distribution of participants by sex (male/female) reported as counts and percentages.
Measured: At baseline
3. Percentage of Participants by Ethnicity
Distribution of participants by ethnicity reported as counts and percentages for each ethnic category.
Measured: At Baseline
4. Percentage of Participants by Education Level
Distribution of participants by education level reported as counts and percentages for each education category.
Measured: At Baseline
5. Percentage of Participants by Marital Status
Distribution of participants by marital status reported as counts and percentages for each marital status category.
Measured: At Baseline
6. Percentage of Participants with Family History of Cardiovascular and Renal-Metabolic Disease
Percentage of participants with a family history of cardiovascular, renal, or metabolic (CVRM) disease (yes/no) reported as counts and percentages.
Measured: At Baseline
7.Percentage of Participants by Physical Activity Level
Distribution of participants by physical activity level category reported as counts and percentages.
Measured: At Baseline
8. Percentage of Participants by Smoking Status
Distribution of participants by smoking status (current smoker/former smoker/never smoked) reported as counts and percentages.
Measured: At Baseline
9. Percentage of Participants by Alcohol Consumption
Distribution of participants by alcohol consumption category reported as counts and percentages.
Measured: At Baseline
10. Body Weight of Participants
Body weight of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kilograms (kg).
Measured: At Baseline
11. Height of Participants
Height of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in meters (m).
Measured: At Baseline
12. Body Mass Index (BMI) of Participants
Body mass index (BMI), calculated from weight and height, reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kg/m².
Measured: At Baseline
13. Waist Circumference of Participants
Waist circumference of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in centimeters (cm).
Measured: At Baseline
14. Waist-to-Hip Ratio of Participants
Waist-to-hip ratio of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
Measured: At Baseline
15. Waist-to-Height Ratio of Participants
Waist-to-height ratio of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
Measured: At Baseline
16. Percentage of Participants by Cardiac and Renal Functional Measurements Category
Distribution of participants by cardiac and renal functional measurement categories reported as counts and percentages.
Measured: At Baseline
17. Primary Disease Duration
Duration of primary disease (T2DM, HTN, HF, or CKD) from initial diagnosis to enrollment reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in years.
Measured: At Baseline
18. Percentage of Participants by Number and Types of Comorbidities
Distribution of participants by number and types of comorbidities reported as counts and percentages for each comorbidity category.
Measured: At Baseline
19. Percentage of Participants by NYHA Functional Class
Distribution of heart failure participants by New York Heart Association (NYHA) functional class (I, II, III, IV) reported as counts and percentages.
Measured: At Baseline
20. Percentage of Participants by Heart Failure Phenotype
Distribution of heart failure participants by phenotype (HFrEF: ejection fraction ≤40%, HFmrEF: 41-49%, HFpEF: ≥50%) reported as counts and percentages.
Measured: At Baseline
21. Percentage of Participants by Heart Failure Etiology
Distribution of heart failure participants by etiology (ischemic, non-ischemic, valvular, hypertensive, other) reported as counts and percentages.
Measured: At Baseline
22. Percentage of Participants by CKD Etiology
Distribution of chronic kidney disease participants by etiology (diabetic nephropathy, hypertensive nephrosclerosis, glomerulonephritis, other) reported as counts and percentages.
Measured: At Baseline
23. Percentage of Participants by Hypertension Stage
Distribution of hypertension participants by stage (Stage 1, Stage 2, Stage 3) reported as counts and percentages.
Measured: At Baseline
24. Percentage of Participants by Secondary Hypertension Etiology
Distribution of participants with secondary hypertension by etiology reported as counts and percentages for each etiology category.
Measured: At Baseline
25. Office Systolic and Diastolic Blood Pressure
Office blood pressure reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
Measured: At Baseline
26. Home Blood Pressure Monitoring (HBPM) Systolic and Diastolic Values
Home blood pressure monitoring (HBPM) values reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
Measured: At Baseline
27. Ambulatory Blood Pressure Monitoring (ABPM) Systolic and Diastolic Values
Ambulatory blood pressure monitoring (ABPM) values reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
Measured: At Baseline
28. Blood HbA1c
HbA1c values reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in %
Measured: Average of 3 years
29. Fasting Glucose
Fasting Glucose reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL
Measured: Average of 3 years
30. Lipid Profile Testing
Total cholesterol, LDL-C, HDL-C, triglycerides reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL
Measured: Average of 3 years
31. Serum Creatinine
Serum creatinine value reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL.
Measured: Average of 3 years
32. Estimated Glomerular Filtration Rate (eGFR)
Estimated glomerular filtration rate (eGFR) reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mL/min/1.73m².
Measured: Average of 3 years
33. Urine Albumin-to-Creatinine Ratio (UACR)
Urine albumin-to-creatinine ratio (UACR) reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/g.
Measured: Average of 3 years
34. Serum Electrolyte Values
Serum electrolyte values (sodium, potassium, chloride, bicarbonate) reported individually as mean ± standard deviation (SD) and median with interquartile range (IQR) in mmol/L.
Measured: Avergae of 3 years
35. Frequency of HbA1c Testing
Frequency of glycated hemoglobin (HbA1c) testing reported as counts and percentages of participants tested per monitoring period.
Measured: Average of 3 years
36. Frequency of Fasting Glucose Testing
Frequency of fasting glucose testing reported as counts and percentages of participants tested per monitoring period.
Measured: Average of 3 years
37. Frequency of Lipid Profile Testing
Frequency of lipid profile testing (total cholesterol, LDL-C, HDL-C, triglycerides) reported as counts and percentages of participants tested per monitoring period.
Measured: Average of 3 years
38. Frequency of Serum Creatinine Testing
Frequency of serum creatinine testing reported as counts and percentages of participants tested per monitoring period.
Measured: Average of 3 years
39. Frequency of eGFR Assessment
Frequency of estimated glomerular filtration rate (eGFR) assessment reported as counts and percentages of participants assessed per monitoring period.
Measured: Average of 3 years
40. Frequency of Urine Albumin-to-Creatinine Ratio Testing
Frequency of urine albumin-to-creatinine ratio (UACR) testing reported as counts and percentages of participants tested per monitoring period.
Measured: Average of 3 years
41. Echocardiography
Frequency of echocardiography abnormalities reported as counts and percentages
Measured: Average of 3 years
42. Electrocardiogram (ECG)
Frequency of electrocardiogram (ECG) abnormalities reported as counts and percentages
Measured: Average of 3 years
43. Participants Receiving Dietary Modification Counseling
Percentage of participants receiving dietary modification counseling or intervention reported as counts and percentages.
Measured: Average of 3 years
44. Participants Enrolled in Exercise Programs
Percentage of participants enrolled in or recommended exercise programs reported as counts and percentages.
Measured: Average of 3 years
45. Participants Receiving Weight Management Interventions
Percentage of participants receiving weight management interventions or counseling reported as counts and percentages.
Measured: Average of 3 years
46. Participants Receiving Smoking Cessation Counseling
Percentage of participants receiving smoking cessation counseling or interventions reported as counts and percentages.
Measured: Average of 3 years
47. Participants Receiving Alcohol Reduction Counseling
Percentage of participants receiving alcohol reduction counseling or interventions reported as counts and percentages.
Measured: Average of 3 years
48. Percentage of Participants by Line of Treatment
Distribution of participants by line of pharmacological treatment (first-line, second-line, third-line or higher) reported as counts and percentages.
Measured: Average of 3 years
49. Percentage of Participants by Drug Class
Distribution of participants by drug class prescribed (e.g., SGLT2i, GLP-1RA, ACEi, ARBs, beta-blockers, MRAs, CCBs, diuretics, metformin, DPP-4i, sulfonylureas, insulin) reported as counts and percentages.
Measured: Average of 3 years
50. Percentage of Participants Undergoing Cardiac Surgeries (CABG or PCI)
Percentage of participants undergoing coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) reported as counts and percentages for each procedure type.
Measured: Average of 3 years
51. Percentage of Participants Receiving Dialysis
Percentage of participants receiving dialysis procedures (hemodialysis or peritoneal dialysis) reported as counts and percentages.
Measured: Average of 3 years
52. Percentage of Participants with Cardiac Device Implantation
Percentage of participants with cardiac device implantation (pacemaker, implantable cardioverter-defibrillator [ICD], or cardiac resynchronization therapy [CRT]) reported as counts and percentages for each device type.
Measured: Average of 3 years
53. Mean Duration of Pharmacological Treatments
Duration of pharmacological treatments reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in months for each drug class.
Measured: Average of 3 years
54. Drug Dose of Pharmacological Treatments
Drug dose of pharmacological treatments prescribed reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in milligrams (mg) for each drug class.
Measured: Average of 3 years
55. Number of Primary Care Visits per Participant
Total number of primary care visits reported as total visits and mean visits per participant ± standard deviation (SD).
Measured: Average of 3 years
56. Number of Tertiary Care Hospital Visits per Participant
Total number of tertiary care hospital visits reported as total visits and mean visits per participant ± standard deviation (SD).
Measured: Average of 3 years
57. Number of Specialist Care Visits per Participant
Total number of specialist care visits reported as total visits and mean visits per participant ± standard deviation (SD).
Measured: Average of 3 years
58.Number of Emergency Department Visits per Participant
Total number of emergency department visits reported as total visits and mean visits per participant ± standard deviation (SD).
Measured: Average of 3 years
59. All-Cause Hospitalizations
All-cause hospitalizations reported as counts, percentages of participants with at least one hospitalization, total hospitalizations, and rate per 100 person-years.
Measured: Average of 3 years
60. Disease-Specific Hospitalizations
Disease-specific hospitalizations (related to T2DM, HTN, HF, or CKD) reported as counts, percentages of participants with at least one hospitalization, total hospitalizations, and rate per 100 person-years.
Measured: Average of 3 years
61. All-Cause Emergency Department Visits
All-cause emergency department visits reported as counts, percentages of participants with at least one visit, total visits, and rate per 100 person-years.
Measured: Average of 3 years
62. Disease-Specific Emergency Department Visits
Disease-specific emergency department visits (related to T2DM, HTN, HF, or CKD) reported as counts, percentages of participants with at least one visit, total visits, and rate per 100 person-years.
Measured: Average of 3 years
63. Length of Hospital Stay
Length of hospital stay reported as median with interquartile range (IQR) and mean ± standard deviation (SD) in days.
Measured: Average of 3 years
Secondary outcomes (56)
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.
Measured: Average of 3 years
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.
Measured: Average of 3 years
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.
Measured: Average of 3 years
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.
Measured: Average of 3 years
5. Percentage of Participants with Uncontrolled Type 2 Diabetes (HbA1c ≥7%)
Percentage of participants with uncontrolled type 2 diabetes mellitus defined as HbA1c ≥7% reported as counts and percentages.
Measured: Average of 3 years
6. Percentage of Participants with Uncontrolled Hypertension (BP ≥140/90 mmHg)
Percentage of participants with uncontrolled hypertension defined as blood pressure ≥140/90 mmHg or ≥130/80 mmHg (per applicable guideline threshold) reported as counts and percentages.
Measured: Average of 3 years
7. Incidence of Retinopathy
Incidence of retinopathy reported as counts, percentages of participants with new-onset retinopathy, and incidence per 100 person-years.
Measured: Average of 3 years
8. Incidence of Nephropathy
Incidence of nephropathy reported as counts, percentages of participants with new-onset nephropathy, and incidence per 100 person-years.
Measured: Average of 3 years
9. Incidence of Neuropathy
Incidence of neuropathy reported as counts, percentages of participants with new-onset neuropathy, and incidence per 100 person-years.
Measured: Average of 3 years
10. Incidence of Myocardial Infarction (MI)
Incidence of myocardial infarction (MI) reported as counts, percentages of participants with at least one event, and incidence per 100 person-years.
Measured: Average of 3 years
11. Incidence of Stroke
Incidence of stroke reported as counts, percentages of participants with at least one event, and incidence per 100 person-years.
Measured: Average of 3 years
12. Incidence of Peripheral Arterial Disease (PAD)
Incidence of peripheral arterial disease (PAD) reported as counts, percentages of participants with new-onset PAD, and incidence per 100 person-years.
Measured: Average of 3 years
13. Incidence of Coronary Revascularization
Incidence of coronary revascularization procedures reported as counts, percentages of participants undergoing revascularization, and incidence per 100 person-years.
Measured: Average of 3 years
14. Incidence of New-Onset Heart Failure
Incidence of new-onset heart failure diagnosis reported as counts, percentages of participants with new HF diagnosis, and incidence per 100 person-years.
Measured: Average of 3 years
15. Incidence of New-Onset Chronic Kidney Disease
Incidence of new-onset chronic kidney disease defined as eGFR <60 mL/min/1.73m² or urine albumin-to-creatinine ratio (UACR) ≥30 mg/g reported as counts, percentages of participants, and incidence per 100 person-years.
Measured: Average of 3 years
16. Percentage of Participants Developing Anemia
Percentage of participants developing anemia as a cardio-renal complication reported as counts and percentages.
Measured: Average of 3 years
17. Percentage of Participants Developing Hyperkalemia
Percentage of participants developing hyperkalemia as a cardio-renal complication reported as counts and percentages.
Measured: Average of 3 years
18. Percentage of Participants with Heart Failure Hospitalization
Percentage of participants with at least one heart failure hospitalization reported as counts and percentages.
Measured: Average of 3 years
19. Percentage of Participants with eGFR Decline
Percentage of participants experiencing a clinically significant decline in estimated glomerular filtration rate (eGFR) reported as counts and percentages.
Measured: Average of 3 years
20. Percentage of Participants with RRT Initiation or ESRD Progression
Percentage of participants initiating renal replacement therapy (RRT) or progressing to end-stage renal disease (ESRD) reported as counts and percentages.
Measured: Average of 3 years
21. Incidence of Renal Replacement Therapy Initiation or ESRD Progression
Incidence of renal replacement therapy (RRT) initiation or progression to end-stage renal disease (ESRD) reported as counts, percentages of participants, and rate per 100 person-years.
Measured: Average of 3 years
22. Incidence of All-Cause Mortality
All-cause mortality reported as counts, percentages of participants, and rate per 100 person-years.
Measured: Average of 3 years
23. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Incidence of Hypoglycemic Events
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and incidence of hypoglycemic events.
Measured: Average of 3 years
24. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Uncontrolled T2DM
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and uncontrolled T2DM (HbA1c ≥7%).
Measured: Average of 3 years
26. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Uncontrolled HTN
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and uncontrolled HTN (BP ≥140/90 mmHg).
Measured: Average of 3 years
27. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Heart Failure Worsening
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and heart failure worsening.
Measured: Average of 3 years
28. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and CKD Progression/RRT Initiation/ESRD Progression
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and CKD Progression/RRT Initiation/ESRD Progression
Measured: Average of 3 years
29. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and All-cause mortality
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and All-cause mortality
Measured: Average of 3 years
30. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and and Myocardial Infarction/Stroke/PAD
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and Myocardial Infarction/Stroke/PAD
Measured: Average of 3 years
31. Correlation Between Patient Characteristics and Treatment Choices for T2DM
Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for T2DM (line of treatment and drug class: metformin, SGLT2i, GLP-1RA, DPP-4i, sulfonylureas, insulin).
Measured: Average of 3 years
32. Correlation Between Patient Characteristics and Treatment Choices for HTN
Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for HTN (line of treatment and drug class: ACEi, ARBs, CCBs, beta-blockers, diuretics).
Measured: Average of 3 years
33. Correlation Between Patient Characteristics and Treatment Choices for HF
Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for HF (line of treatment and drug class: ACEi, ARBs, ARNI, beta-blockers, MRAs, SGLT2i).
Measured: Average of 3 years
34. Correlation Between Patient Characteristics and Treatment Choices for CKD
Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for CKD (line of treatment and drug class: ACEi, ARBs, SGLT2i).
Measured: Average of 3 years
35. Percentage of Participants with Dyslipidemia by Category
Distribution of participants with dyslipidemia by category reported as counts and percentages.
Measured: Average of 3 years
36. Percentage of Participants with Obesity by Category
Distribution of participants with obesity by BMI category reported as counts and percentages.
Measured: Average of 3 years
37. Percentage of Participants Achieving LDL-C Target <100 mg/dL
Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) target of <100 mg/dL reported as counts and percentages.
Measured: Average of 3 years
38. Percentage of Participants Achieving LDL-C Target <70 mg/dL
Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) target of <70 mg/dL reported as counts and percentages.
Measured: Average of 3 years
40. Percentage of Participants Achieving Weight Loss ≥5%
Percentage of participants achieving weight loss of 5% or more from baseline reported as counts and percentages.
Measured: Average of 3 years
41. Percentage of Participants Achieving Weight Loss ≥10%
Percentage of participants achieving weight loss of 10% or more from baseline reported as counts and percentages.
Measured: Average of 3 years
42. Percentage of Participants Achieving Weight Loss ≥15%
Percentage of participants achieving weight loss of 15% or more from baseline reported as counts and percentages.
Measured: Average of 3 years
43. Percentage of Participants Developing Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Percentage of participants developing metabolic dysfunction-associated steatotic liver disease (MASLD) as an obesity complication reported as counts and percentages.
Measured: Average of 3 years
44. Percentage of Participants Developing T2DM as an Obesity Complication
Percentage of participants developing new-onset type 2 diabetes mellitus (T2DM) as an obesity complication reported as counts and percentages.
Measured: Average of 3 years
45. Incidence of Myocardial Infarction/Stroke in Participants with Dyslipidemia/Obesity
Incidence of myocardial infarction (MI)/stroke in participants with dyslipidemia and/or obesity reported as counts and percentages.
Measured: Average of 3 years
46. Lipid levels in Participants with Dyslipidemia/Obesity
Total cholesterol, LDL-C, HDL-C, Triglyceride in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL.
Measured: Average of 3 years
47. Body Weight in Participants with Dyslipidemia/Obesity
Body weight in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kilograms (kg).
Measured: Average of 3 years
48. BMI in Participants with Dyslipidemia/Obesity
Body mass index (BMI) in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kg/m².
Measured: Average of 3 years
49. Waist Circumference in Participants with Dyslipidemia/Obesity
Waist circumference in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in centimeters (cm).
Measured: Average of 3 years
50. Waist-to-Hip Ratio in Participants with Dyslipidemia/Obesity
Waist-to-hip ratio in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
Measured: Average of 3 years through
51. Frequency of Lipid Profile Monitoring in Participants with Dyslipidemia/Obesity
Frequency of lipid profile testing in participants with dyslipidemia and/or obesity reported as counts and percentages of participants monitored per clinical guidelines.
Measured: Average of 3 years
52. Frequency of Weight and BMI Monitoring in Participants with Dyslipidemia/Obesity
Frequency of weight and BMI measurements in participants with dyslipidemia and/or obesity reported as counts and percentages of participants monitored per clinical guidelines.
Measured: Average of 3 years
53. Frequency of Obesity Complication Assessments
Frequency of obesity complication assessments (screening for MASLD, T2DM, cardiovascular risk) reported as counts and percentages of participants assessed per clinical guidelines.
Measured: Average of 3 years
54. Percentage of Participants Receiving Lifestyle Modifications for Dyslipidemia/Obesity
Percentage of participants receiving lifestyle modification interventions (dietary, exercise, behavioral) for dyslipidemia and/or obesity management reported as counts and percentages.
Measured: Average of 3 years
55. Percentage of Participants Receiving Statins/Ezetimibe/PCSK9 Inhibitors/Fibrates/Omega-3 Farry Acids/GLP-1 Receptor Agonists for Obesity/ other Anti-Obesity Medications
Counts and Percentage of Participants Receiving Statins/Ezetimibe/PCSK9 Inhibitors/Fibrates/Omega-3 Farry Acids/GLP-1 Receptor Agonists for Obesity/ other Anti-Obesity Medications
Measured: Average of 3 years
56. Percentage of Participants Undergoing Bariatric Surgery
Percentage of participants undergoing bariatric surgery for obesity management reported as counts and percentages.
Measured: Average of 3 years
57. Mean Number of Visits for Dyslipidemia/Obesity
Number of visits for dyslipidemia and/or obesity management reported as counts and percentages of participants with at least one visit. Visits for dyslipidemia and/or obesity management reported as mean ± standard deviation (SD) and total visits.
Measured: Average of 3 years
58. Percentage of Participants Hospitalized for Dyslipidemia/Obesity
Percentage of participants with at least one hospitalization related to dyslipidemia and/or obesity reported as counts and percentages. Hospitalizations for dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and total hospitalizations.
Measured: Average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start17 Feb 2018
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 35,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hardik Vasnawala, MD, Study director, AstraZenecaIsidro Villanueva, MD, Study director, AstraZenecaAhmed Hadaoui, PharmD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549754
- Sponsor's protocol ID
- D1690R00044
- Acronym
- iCaReMe
- Status last verified
- Aug 2026
- First submitted
- 15 May 2018
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Khunti K, Arici M, Pollock C, Huang CN, Silva-Tinoco R, Sayed AAE, Coto E, Salama K, Vasnawala H, Hadaoui A. Uncontrolled Hypertension in Cardio-Renal-Metabolic Diseases: Real-World Insights on Patient Profiles and Management Patterns From iCaReMe Global Registry. Int J Hypertens. 2026 Sep 3;2026:9668123. doi: 10.1155/ijhy/9668123. eCollection 2026.
PubMed 42694927