Trials / Active Not Recruiting
Active Not RecruitingNCT07064499
CGM Boosted by Artificial Intelligence for Better Glycaemic Control in T2 Diabetes
CGM Boosted by Artificial Intelligence for Better Glycaemic Control in T2 Diabetes: a Real-life Multicentre Observational Study in Belgium.
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 440 (estimated)
- Sponsor
- Erasme University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Title: CGM Boosted by Artificial Intelligence for better glycaemic control in T2 Diabetes : a real-life multicenter observational study in Belgium - MAGIC-T2D Background: In Belgium, since May 2023, reimbursement for continuous glucose monitoring systems has been extended to people with type 2 diabetes taking multiple injections of insulin. Despite the results of previous studies, the impact of this technology in terms of glycaemic control and patient-reported outcomes (PROMs) in real life for patients with type 2 diabetes is still unclear. Objective: To evaluate the impact of the CGMs on glycemic control and PROMs in people living with type 2 diabetes under real-life conditions. Methods and analysis: In a multicenter real-world observational study, more than 440 people with type 2 diabetes under multiple daily injection therapy who start to be monitored by a CGM in one of the 13 participating Belgian centers, will be followed for a period of 24 months. Outcomes: The primary and secondary endpoint are respectively the evolution of time spent in range (defined as a sensor glucose value between 70 and 180 mg/dL) and HbA1c from before start to 12 months after start of the CGM. Exploratory objectives will be studied using artificial intelligence (AI) to study glucose profiles to characterize the heterogeneity of type 2 diabetes.
Conditions
Timeline
- Start date
- 2023-12-15
- Primary completion
- 2026-07-31
- Completion
- 2027-07-31
- First posted
- 2025-07-14
- Last updated
- 2025-08-11
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT07064499. Inclusion in this directory is not an endorsement.