Type 2 Diabetes
Conditions
Keywords
Evolution of Type 2 Diabetes Following CGM Introduction, Progression of Type 2 Diabetes Across Endotypes Following CGM Initiation
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.
Interventions
None listed
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evolution of TIR (glucose 70-180 mg/dl) over a 12-month period after initiation of CGM in patients with T2D treated with MDI regimens. | From registration to end of 1-year follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Evolution of Hba1c over a 12-month period after initiation of CGM | From registration to end of 1-year follow-up |
Other
| Measure | Time frame |
|---|---|
| Evolution of TIR according to T2D endotypes as defined by Ahlqvist et al. | From registration to end of 1-year follow-up |
Countries
Belgium