iCaReMe Global Registry (iCaReMe)

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ClinicalTrials.gov Identifier: NCT03549754

Recruitment Status : Recruiting

First Posted : June 8, 2018

Last Update Posted : January 11, 2023

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Tracking Information

First Submitted Date

May 15, 2018

First Posted Date

June 8, 2018

Last Update Posted Date

January 11, 2023

Actual Study Start Date

February 17, 2018

Estimated Primary Completion Date

December 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

1. Provide real world data on patient characteristics [ Time Frame: Average of 3 years through study completion ]
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
2. Provide real world data on disease management [ Time Frame: Average of 3 years through study completion ]
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
3. Provide real world data on healthcare utilization [ Time Frame: Average of 3 years through study completion ]
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
4. Provide real world data on quality of care indicators [ Time Frame: Average of 3 years through study completion ]
Smoking cessation Eye and foot examinations Dietary counselling
Provide real world data on cardiovascular outcomes in patients with type 2 diabetes; Chronic Kidney Disease and Heart Failure [ Time Frame: Average of 3 years through study completion ]
All-cause and cause-specific deaths and hospitalizations, including recurrent events
6. Provide real world data on renal outcomes and other microvascular complications in patients with type 2 diabetes and Heart Failure [ Time Frame: Average of 3 years through study completion ]
All-cause and cause-specific deaths and hospitalizations, including recurrent events

Original Primary Outcome Measures

Provide real world data on patient characteristics. [ Time Frame: Average of 3 years through study completion ]
Patient demography Patient height & weight, blood pressure Diabetes and general medical history Laboratory test results
Provide real world data on disease management. [ Time Frame: Average of 3 years through study completion ]
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
Provide real world data on healthcare utilization. [ Time Frame: Average of 3 years through study completion ]
Number of diabetes-related visits to a physician not at study site Number of urgent care visits for diabetes Number of diabetes-related hospital emergency department visits and reason(s) for visits Number of hospitalizations, lengths of stay, and reasons for hospitalizations
Provide real world data on quality of care indicators. [ Time Frame: Average of 3 years through study completion ]
Smoking cessation Eye and foot examinations Dietary counselling
Provide real world data on cardiovascular outcomes in patients with type 2 diabetes. [ Time Frame: Average of 3 years through study completion ]
All-cause and cause-specific deaths and hospitalizations, including recurrent events
Provide real world data on renal outcomes and other microvascular complications in patients with type 2 diabetes [ Time Frame: Average of 3 years through study completion ]
All-cause and cause-specific deaths and hospitalizations, including recurrent events

Change History

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

iCaReMe Global Registry

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

Brief 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

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.

Study Type

Observational [Patient Registry]

Study Design

Observational Model: Other
Time Perspective: Prospective

Target Follow-Up Duration

3 Years

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Adults with type 2 diabetes, Hypertension, Heart Failure and/or chronic kidney disease

Condition

Type 2 Diabetes
Hypertension
Chronic Kidney Disease
Heart Failure

Intervention

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Recruiting

Estimated Enrollment

35000

Original Estimated Enrollment

20000

Estimated Study Completion Date

December 31, 2025

Estimated Primary Completion Date

December 31, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts

Contact: AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Listed Location Countries

Costa Rica, Egypt, India, Malaysia, Mexico

Removed Location Countries

Angola, Argentina, Brazil, Canada, China, Ethiopia, Georgia, Ghana, Greece, Guatemala, Hong Kong, Indonesia, Kenya, Korea, Republic of, Lebanon, Oman, Philippines, Qatar, Russian Federation, Saudi Arabia, Thailand, Uganda, Ukraine

Administrative Information

NCT Number

NCT03549754

Other Study ID Numbers

D1690R00044

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Plan to Share IPD:	Yes
Plan Description:	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.
Time Frame:	AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria:	When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL:	https://astrazenecagroup-dt.pharmacm.com/DT/Home

Current Responsible Party

AstraZeneca

Original Responsible Party

Same as current

Current Study Sponsor

AstraZeneca

Original Study Sponsor

Same as current

Collaborators

Not Provided

Investigators

Not Provided

PRS Account

AstraZeneca

Verification Date

December 2022

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