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

NCT07064499 | Active Not Recruiting

• 1 other identifier: SRB2021470
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

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

Keywords

Evolution of Type 2 Diabetes Following CGM Introduction; Progression of Type 2 Diabetes Across Endotypes Following CGM Initiation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evolution of Hba1c over a 12-month period after initiation of CGM

  From registration to end of 1-year follow-up

Other Outcomes (1)

• Evolution of TIR according to T2D endotypes as defined by Ahlqvist et al.

  From registration to end of 1-year follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with type 2 diabetes on multiple insulin injections, monitored in the endocrinology-diabetology departments of participating hospitals.

You may qualify if:

• Type 2 diabetes on MDI and starting CGM

You may not qualify if:

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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

HUB-Hôpital ERASME

Brussels, 7850, Belgium

Location

Related Publications (7)

• Zaccardi F, Khunti K. Glucose dysregulation phenotypes - time to improve outcomes. Nat Rev Endocrinol. 2018 Nov;14(11):632-633. doi: 10.1038/s41574-018-0092-3. No abstract available.

  PMID: 30202117 BACKGROUND

• Hall H, Perelman D, Breschi A, Limcaoco P, Kellogg R, McLaughlin T, Snyder M. Glucotypes reveal new patterns of glucose dysregulation. PLoS Biol. 2018 Jul 24;16(7):e2005143. doi: 10.1371/journal.pbio.2005143. eCollection 2018 Jul.

  PMID: 30040822 BACKGROUND

• Slieker RC, Donnelly LA, Fitipaldi H, Bouland GA, Giordano GN, Akerlund M, Gerl MJ, Ahlqvist E, Ali A, Dragan I, Festa A, Hansen MK, Mansour Aly D, Kim M, Kuznetsov D, Mehl F, Klose C, Simons K, Pavo I, Pullen TJ, Suvitaival T, Wretlind A, Rossing P, Lyssenko V, Legido-Quigley C, Groop L, Thorens B, Franks PW, Ibberson M, Rutter GA, Beulens JWJ, 't Hart LM, Pearson ER. Replication and cross-validation of type 2 diabetes subtypes based on clinical variables: an IMI-RHAPSODY study. Diabetologia. 2021 Sep;64(9):1982-1989. doi: 10.1007/s00125-021-05490-8. Epub 2021 Jun 10.

  PMID: 34110439 BACKGROUND

• Ahlqvist E, Storm P, Karajamaki A, Martinell M, Dorkhan M, Carlsson A, Vikman P, Prasad RB, Aly DM, Almgren P, Wessman Y, Shaat N, Spegel P, Mulder H, Lindholm E, Melander O, Hansson O, Malmqvist U, Lernmark A, Lahti K, Forsen T, Tuomi T, Rosengren AH, Groop L. Novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables. Lancet Diabetes Endocrinol. 2018 May;6(5):361-369. doi: 10.1016/S2213-8587(18)30051-2. Epub 2018 Mar 5.

  PMID: 29503172 BACKGROUND

• Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther. 2017 Feb;8(1):55-73. doi: 10.1007/s13300-016-0223-6. Epub 2016 Dec 20.

  PMID: 28000140 BACKGROUND

• McGill JB, Ahmann A. Continuous Glucose Monitoring with Multiple Daily Insulin Treatment: Outcome Studies. Diabetes Technol Ther. 2017 Jun;19(S3):S3-S12. doi: 10.1089/dia.2017.0090.

  PMID: 28585875 BACKGROUND

• Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.

  PMID: 31177185 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 14, 2025
• Study Start: December 15, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-06

Locations

BE (1)