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NCT05629221
Organisational Models Supported by Technology for the Management of Diabetic Disease and Its Complications in a Diabetic Clinic Setting. A Randomised Controlled Trial Targeting Type 2 Diabetes Individuals With Non-ideal Glycemic Values
Conditions: Diabetes type2
Sex: All
Ages: 18 Years – 85 Years
Phase: NA
Enrollment: 120
Sponsor: Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento
Location: Italy
Summary
The goal of this randomised trial is to evaluate the impact of using a digital platform called "TreC Diabete" embedded into a novel organizational asset for poorly controlled type 2 diabetes individuals in the Autonomous Province of Trento (PAT).
The main question aims to answer whether individuals using the "TreC Diabete" platform will improve their haemoglobin glycated level (Hb1Ac) at 12-month post-randomisation.
Participants will be asked to perform some tasks and to share their data with the healthcare staff members through the platform.
Control group will receive standard care.
Eligibility Criteria
Inclusion Criteria:being diagnosed with T2DM;aged ≥ 18 and ≤ 85 years old;having an HbA1c level >7% (53 mmol/mol) and <11% (108 mmol/mol);being able to walk without walking aids;having provided written informed consent;having a smartphone or a tablet and being able to download the App that will be used to insert the required data.Exclusion Criteria:having a BMI <18 Kg/m² and >45 Kg/m²;having a sBP <100 or >200 mmHg and/or dBP <50 or >120 mmHg;being diagnosed with a stage 5 CKD*being diagnosed with a NYHA stage IV;poor collaboration (ie unwilling to modify the actual plan of control and therapy, even if not ideal) for which adherence to the study is unlikelyhaving no possibility of using a smartphone or a tablethaving medical conditions affecting the study participation (i.e.
life expectancy < 1 year)
Source: ClinicalTrials.gov (NCT05629221). StuddyBuddy aggregates publicly available trial information.