Comparison of Diabetes Patients - Care Trajectory Versus Convention

NCT ID: NCT06577584

Last Updated: 2025-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-12-31

Brief Summary

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In Belgium, various structures and reimbursement programs are in place for managing Type 2 Diabetes Mellitus (T2DM). The Diabetes Care Trajectory is primarily utilized for patients who require a maximum of two insulin injections per day. In contrast, patients needing multiple daily insulin injections are managed under a diabetes convention program.

The Diabetes Care Trajectory has been operational since 2009. However, unlike patients in the diabetes convention program, where the profile and quality of care are regularly audited, there is limited information available regarding the profile and outcomes of patients within the Care Trajectory. This retrospective study aims to compare the profiles, including complications and quality of care, of T2DM patients across both groups.

Detailed Description

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This retrospective study will collect data from T2DM patients enrolled in either the Diabetes Care Trajectory or the diabetes convention program. The data gathered will encompass quality of care, clinical status, complications, and metabolic state.

The profiles of these patient populations will be compared cross-sectionally for each year within the study period (2009-2024). Additionally, a longitudinal analysis will be conducted to examine the evolution of these profiles over the entire study period. Data will be extracted from electronic case records maintained at participating sites across Belgium.

Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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The Diabetes Care trajectory

The care trajectory is designed for individuals with T2DM who are treated with Glucagon-like peptide-1 (GLP-1) analogs (injectable or oral) or require 1 to 2 insulin injections per day. It can also be initiated when blood sugar-lowering medication (pills) is no longer sufficient and the use of a GLP-1 analog or insulin is being considered. The follow-up and management is mainly being taken care of by general practioners, with minor follow-up in specialised diabetes centers.

Follow-up in the Diabetes Care Trajectory

Intervention Type OTHER

Being followed-up in the Diabetes Care Trajectory in Belgium

The Diabetes Convention

The Diabetes Convention is intended for individuals with T2DM who require specialized care due to the complexity of their insulin treatment (multiple daily insulin injections). Specialised diabetes centers in (university) hospitals are responsible for providing comprehensive follow-up and management of these patients.

Follow-up in the Diabetes Convention

Intervention Type OTHER

Being followed-up in the Diabetes Convention in Belgium

Interventions

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Follow-up in the Diabetes Care Trajectory

Being followed-up in the Diabetes Care Trajectory in Belgium

Intervention Type OTHER

Follow-up in the Diabetes Convention

Being followed-up in the Diabetes Convention in Belgium

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Followed in one of the NexusHealth hospitals in Belgium: https://www.nexuzhealth.com/en/why-nexuzhealth/patients/affiliated-healthcare-institutions
* Having being diagnosed with type 2 diabetes mellitus
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chantal Mathieu, MD,pHD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Central Contacts

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Astrid Lavens

Role: CONTACT

0032 2 642 57 82

Lisa Van Ryckeghem, PhD

Role: CONTACT

003216342129

Other Identifiers

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S69595

Identifier Type: -

Identifier Source: org_study_id

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