A trial to evaluate the efficacy of continuous glucose monitoring as add on therapy in people with newly diagnosed type 2 diabetes
- Project No.: 101095426
- Project funding agreement with LMT No.: S-ERA4Health-26-1
- Project acronym: ATTENTION-T2D
- Principal investigator (LSMU): Rasa Verkauskienė
- Project coordinator: Medical University of Graz (MUG), Interdisciplinary Metabolic Medicine Trials Unit (Austria)
- Project duration: from 2026-04-01 to 2030-03-31
- Total project value: 2 860 652,00 Euro
- Part of the project value allocated to the LSMU: 499 850,00 Euro
- Funding programme: This study received funding from Research Council of Lithuania LMTLT under the umbrella of the Partnership Fostering a European Research Area for Health (ERA4Health)
The ATTENTION-T2D project launches an innovative research endeavour to evaluate continuous glucose monitoring (CGM) technology in newly diagnosed type 2 diabetes (T2Dnew) to modify the natural course of the disease and prevent life-altering complications. Recently, CGM technology has revolutionised type 2 diabetes (T2D) management but is largely limited to those on intensive insulin regimens. Given the rising burden of T2Dand growing evidence supporting CGM potential in improving health outcomes, this project investigates CGM assisted lifestyle management in real-world settings among a diverse group of T2Dnew patients from Austria, Latvia, Lithuania, Poland, and the Czech Republic. This pragmatic three-arm comparative effectiveness randomised controlled trial will include 246 treatment-naïve T2Dnew patients. Participants will be equally randomised to either initial (3-months) CGM, permanent (12-months) CGM, or standard care alone. The primary outcome is the difference in HbA1c levels from baseline to week 52.
Secondary outcomes are changes in body weight, triglyceride levels, CGM-derived metrics, patient-reported outcomes, physical activity, and pharmacotherapy initiation. Both primary and secondary outcomes will be analysed on Intention-to-treat population using estimand-based approach. Safety and health economic evaluations will also be performed The transnational design promotes knowledge and expertise exchange, strengthening the research community and harmonising scientific and healthcare practices across Europe. It will comply with ethical standards, data protection regulations, and Responsible Research and Innovation principles.ATTENTION-T2D aims to provide an evidence-based, practical approach for patients, healthcare professionals, and public health stakeholders to address the alarming rise in T2D burden. The goal is to assess its potential totransform healthcare practices and improve patients’ health and quality of life in a cost-effective manner.
We believe that CGM-supported lifestyle management and awareness of blood glucose changes with diet and physical activity can motivate and empower patients to adopt a healthier lifestyle. This approach is believed to support effective early management of T2D and improve overall diabetes control. We will share our findings with patients and health experts to support more personalised early T2D care.
This study received funding from Research Council of Lithuania LMTLT (grant number S-ERA4Health-26-1) under the umbrella of the Partnership Fostering a European Research Area for Health (ERA4Health) (GA N° 101095426 of the EU Horizon Europe Research and Innovation Programme).
PROJECT PARTNERS
- Medical University of Innsbruck (MUI)
- Latvian University Hospital (LU)
- Medical University of Warsaw (MUW)
- Institute for Clinical and Experimental Medicine(IKEM)