Artificial intelligence to predict cardiovascular risk recurrence in people with type 2 diabetes

CARDIO-DIABETES AI: Multimodal machine learning-based risk stratification of cardiovascular recurrence in patients with type 2 diabetes

Registry ID
ISRCTN15690435
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
Navarre Health Research Institute Foundation (IDISNA)
Enrollment
250
Start date
2026-04-01
Completion date
2029-12-31
Last update
2026-08-17

Conditions

Summary

Type 2 diabetes mellitus and cardiovascular disease (secondary prevention of cardiovascular events)

Detailed description

Observational study with no intervention. Data collection only, including clinical, biological and wearable-derived variables. A total of 250 patients aged 40–70 years will be recruited from hospital and primary care settings in Navarra, Spain. Clinical, biological and wearable data will be collected.

Interventions

Inclusion criteria

1. Adults aged 40–70 years 2. Confirmed type 2 diabetes mellitus 3. History of a major cardiovascular event within the previous 12 months (including acute coronary syndrome, atherothrombotic stroke or arterial revascularisation) 4. Able to provide written informed consent and willing and able to use wearable monitoring devices

Exclusion criteria

1. Advanced heart failure requiring palliative care or transplant evaluation 2. Chronic dialysis 3. Active malignancy or life expectancy less than 3 years 4. Severe haematological or infectious diseases 5. Uncontrolled psychiatric disorders 6. Significant cognitive impairment 7. Inability to ensure follow-up or comply with wearable device use 8. Participation in other studies that may interfere with the study outcomes

Locations

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