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Comparison of Diabetes Patients - Care Trajectory Versus Convention

The Profile of People with Diabetes Followed Up in the Context of the Care Trajectory Versus the Diabetes Convention

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06577584
Enrollment
20000
Registered
2024-08-29
Start date
2025-02-01
Completion date
2025-12-31
Last updated
2025-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

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

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.

Interventions

OTHERFollow-up in the Diabetes Care Trajectory

Being followed-up in the Diabetes Care Trajectory in Belgium

OTHERFollow-up in the Diabetes Convention

Being followed-up in the Diabetes Convention in Belgium

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HbA1cYearly for the entire study period (2009 - 2024)Glycated haemoglobin A1c

Secondary

MeasureTime frameDescription
Complications of diabetesYearly for the entire study period (2009 - 2024)Number of diabetes-associated complications such as retinopathy, nephropathy and macroangiopathy.
Cholesterol profileYearly for the entire study period (2009 - 2024)Total levels of cholesterol
Insulin requirementsYearly for the entire study period (2009 - 2024)The need for insulin (units) on a daily basis

Contacts

Primary ContactAstrid Lavens
astrid.lavens@kuleuven.be0032 2 642 57 82
Backup ContactLisa Van Ryckeghem, PhD
CSM.endocrino@uzleuven.be003216342129

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026