ECG data from the Movesense device - next 60 patients included to the PROVIDE project
Device used: Movesense Flash Sensor
Legend for file names: ICZMP071-ICZMP130 - subsequent patient codes
.zip file contain one or more .csv files recorded by the Movesense device in given patient.
Please note that due to their large size, the .csv files may not open properly in Microsoft Excel.
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Full project name: Prediction and pReventiOn of cardiovascular disease In DiabEtes (PROVIDE)
Participating Centers: AGH University of Krakow (AGH), Poland; Campus Bio Medico University of Rome (UCBM), Italy; Polish Mother's Memorial Hospital Research Institute (PMMHRI), Poland; Sapienza University of Rome (UNIROMA1), Italy; IRCCS San Raffaele Roma SRL (HSR), Italy; Andalusian Health Service Costa del Sol Hospital (SAS HUCS), Spain; Medical Services Institute (MSI), France; Polish Diabetes Association (PDA), Poland.
Grant: EU4Health Programme Project: 101128983 — PROVIDE.
Study Type: Multicenter, prospective observational study lasting 36 months.
Background: The primary goal of the study is to identify a model for early prediction and personalized prevention of cardiovascular diseases (CVD) in patients with type 2 diabetes mellitus (DM). This approach aims to detect CVD early in preclinical stages using cost-effective methods.
Participants: The planned total sample size is 600 participants, consisting of 400 individuals with type 2 diabetes and 200 non-diabetic individuals as a reference (control) group.
Inclusion criteria: Subjects aged 18+ with diabetes/prediabetes according to current guidelines (ADA 2024)
Exclusion criteria: recent (3 months) acute CV or cerebral event, end-stage renal disease (GFR< 15ml/min), advanced liver diseases, pregnancy, treatment with beta-blockers or other antiarrhythmic drugs.
Shortened Protocol: All patients undergo a 24-hour ECG using the wearable Movesense device during daily activities and sleep. The protocol also includes a standard 12-lead ECG for signal quality comparison. Clinical procedures involve blood collection for metabolic and diabetic kidney disease markers, and echocardiography.