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Not yet recruiting NCT06577584

Comparison of Diabetes Patients - Care Trajectory Versus Convention

Observational Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Follow-up in the Diabetes Care Trajectory, Follow-up in the Diabetes Convention.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other Follow-up in the Diabetes Care Trajectory
    Being followed-up in the Diabetes Care Trajectory in Belgium
  • Other Follow-up in the Diabetes Convention
    Being followed-up in the Diabetes Convention in Belgium

Primary outcome measures

  • HbA1c [Time frame: Yearly for the entire study period (2009 - 2024)]
Secondary outcome measures (3)
  • Complications of diabetes [Time frame: Yearly for the entire study period (2009 - 2024)]
  • Cholesterol profile [Time frame: Yearly for the entire study period (2009 - 2024)]
  • Insulin requirements [Time frame: Yearly for the entire study period (2009 - 2024)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06577584 · S69595

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗