Comparison of Diabetes Patients - Care Trajectory Versus Convention

NCT06577584 | Not Yet Recruiting

• 1 other identifier: S69595
• Study Type: observational
• Target: 20,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Glycated haemoglobin A1c

  Yearly for the entire study period (2009 - 2024)

Secondary Outcomes (3)

• Complications of diabetes

  Yearly for the entire study period (2009 - 2024)

• Cholesterol profile

  Yearly for the entire study period (2009 - 2024)

• Insulin requirements

  Yearly for the entire study period (2009 - 2024)

Study Arms (2)

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.

Other: Follow-up in the Diabetes Care Trajectory

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.

Other: Follow-up in the Diabetes Convention

Interventions

Follow-up in the Diabetes Care Trajectory OTHER

Being followed-up in the Diabetes Care Trajectory in Belgium

The Diabetes Care trajectory

Follow-up in the Diabetes Convention OTHER

Being followed-up in the Diabetes Convention in Belgium

The Diabetes Convention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

T2DM patients being followed up in the Diabetes Care Trajectory or in the Diabetes Convention (group B) in Belgium

You may qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Chantal Mathieu, MD,pHD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Astrid Lavens

CONTACT

0032 2 642 57 82; astrid.lavens@kuleuven.be

Lisa Van Ryckeghem, PhD

CONTACT

003216342129; CSM.endocrino@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 29, 2024
• Study Start: February 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 10, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share