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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Follow-up in the Diabetes Care Trajectory; Other: Follow-up in the Diabetes Convention

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.

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Astrid Lavens; Phone Number: 0032 2 642 57 82; Email: astrid.lavens@kuleuven.be
• Study Contact Backup: Name: Lisa Van Ryckeghem, PhD; Phone Number: 003216342129; Email: CSM.endocrino@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Being followed-up in the Diabetes Care Trajectory in Belgium
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; Being followed-up in the Diabetes Convention in Belgium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Glycated haemoglobin A1c	Yearly for the entire study period (2009 - 2024)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications of diabetes	Number of diabetes-associated complications such as retinopathy, nephropathy and macroangiopathy.	Yearly for the entire study period (2009 - 2024)
Cholesterol profile	Total levels of cholesterol	Yearly for the entire study period (2009 - 2024)
Insulin requirements	The need for insulin (units) on a daily basis	Yearly for the entire study period (2009 - 2024)

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Chantal Mathieu, MD,pHD, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus
• Other Study ID Numbers: S69595

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No