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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.