Comparison of Diabetes Patients - Care Trajectory Versus Convention

Universitaire Ziekenhuizen KU Leuven

Status: Not yet enrolling

Conditions: Type 2 Diabetes

Treatments: Other: Follow-up in the Diabetes Care Trajectory; Other: Follow-up in the Diabetes Convention

Study type: Observational

Funder types: Other

Identifiers

NCT06577584

S69595

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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
• Followed in the Diabetes Care Trajectory or in the Diabetes Convention (group B) in Belgium Exclusion Criteria: no specific exclusion criteria

Trial design

20,000 participants in 2 patient groups

The Diabetes Care trajectory

Description:

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.

Treatment:

Other: Follow-up in the Diabetes Care Trajectory

The Diabetes Convention

Description:

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.

Treatment:

Other: Follow-up in the Diabetes Convention