Type 2 DiabetesNCT06577584
Comparison of Diabetes Patients - Care Trajectory Versus Convention
An observational study of Type 2 Diabetes, run by Universitaire Ziekenhuizen KU Leuven.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Follow-up in the Diabetes Care Trajectory and Follow-up in the Diabetes Convention
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 20,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: T2DM patients being followed up in the Diabetes Care Trajectory or in the Diabetes Convention (group B) in Belgium
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Follow-up in the Diabetes Care Trajectory, Follow-up in the Diabetes Convention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up in the Diabetes Care TrajectoryOther
Being followed-up in the Diabetes Care Trajectory in Belgium
Follow-up in the Diabetes ConventionOther
Being followed-up in the Diabetes Convention in Belgium
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Follow-up in the Diabetes Convention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Glycated haemoglobin A1c
Measured: Yearly for the entire study period (2009 - 2024)
Secondary outcomes (3)
Complications of diabetes
Number of diabetes-associated complications such as retinopathy, nephropathy and macroangiopathy.
Measured: Yearly for the entire study period (2009 - 2024)
Cholesterol profile
Total levels of cholesterol
Measured: Yearly for the entire study period (2009 - 2024)
Insulin requirements
The need for insulin (units) on a daily basis
Measured: Yearly for the entire study period (2009 - 2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Feb 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chantal Mathieu, MD,pHD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577584
- Sponsor's protocol ID
- S69595
- Status last verified
- Sep 2024
- First submitted
- 19 Aug 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Profile of People with Diabetes Followed Up in the Context of the Care Trajectory Versus the Diabetes Convention
- ClinicalTrials.gov ID
- NCT06577584
- Acronym / sponsor ID
- S69595
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Diabetes Care trajectory | – | Other: Follow-up in the Diabetes Care TrajectoryThe 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. |
| The Diabetes Convention | – | Other: Follow-up in the Diabetes ConventionThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- T2DM patients being followed up in the Diabetes Care Trajectory or in the Diabetes Convention (group B) in Belgium
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-up in the Diabetes Care TrajectoryBeing followed-up in the Diabetes Care Trajectory in Belgium | Other | The Diabetes Care trajectory |
| Follow-up in the Diabetes ConventionBeing followed-up in the Diabetes Convention in Belgium | Other | The Diabetes Convention |
Primary outcome
HbA1c
Time frame: Yearly for the entire study period (2009 - 2024)
Glycated haemoglobin A1c
3 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chantal Mathieu, MD,pHD principal investigator
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Astrid Lavens (0032 2 642 57 82, astrid.lavens@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Yearly for the entire study period (2009 - 2024)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.