ECG data from the Movesense device of all 48 patients included to the PROVIDE project till 28.02.2025
Device used: Movesense Flash Sensor
Legend for file names: ICZMP001-ICZMP048 - subsequent patient codes
.zip file contain one or more .csv files recorded by the Movesense device in given patient
---
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.