CGM Boosted by Artificial Intelligence for Better Glycaemic Control in T2 Diabetes

NCT ID: NCT07064499

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 440 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2027-07-31

Brief 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

Type 2 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Type 2 diabetes on MDI and starting CGM

Exclusion Criteria

• Dialysis
• Treatment that raises blood sugar levels (corticosteroids, etc.)
• Secondary and type 1 diabetes
• Patient not able to sign the Informed Consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HUB-Hôpital ERASME

Brussels, , Belgium

Countries

Belgium

References

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Other Identifiers

SRB2021470

Identifier Type: -

Identifier Source: org_study_id