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NCT Number: NCT06577584

Comparison of Diabetes Patients - Care Trajectory Versus Convention

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow-up in the Diabetes Care Trajectory

Other

Being followed-up in the Diabetes Care Trajectory in Belgium

Follow-up in the Diabetes Convention

Other

Being followed-up in the Diabetes Convention in Belgium

Primary outcomes

  1. HbA1c

    Time frame: Yearly for the entire study period (2009 - 2024)

    Glycated haemoglobin A1c

Secondary outcomes

  1. Complications of diabetes

    Time frame: Yearly for the entire study period (2009 - 2024)

    Number of diabetes-associated complications such as retinopathy, nephropathy and macroangiopathy.

  2. Cholesterol profile

    Time frame: Yearly for the entire study period (2009 - 2024)

    Total levels of cholesterol

  3. Insulin requirements

    Time frame: Yearly for the entire study period (2009 - 2024)

    The need for insulin (units) on a daily basis

Study contacts

Contact information is provided by the study sponsor or research team.

Astrid Lavens

CONTACT

[email protected]

0032 2 642 57 82

Lisa Van Ryckeghem, PhD

CONTACT

[email protected]

003216342129

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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