Association Between Cardiac ARRHYTHMIAs and Glycemic Variability in Patient With Type 2 Diabetes Monitored Through FREEstyle Libre and Bluetooth Technology. (ARRHYTHMIAFREE)

Antonio Rapacciuolo

Status: Not yet enrolling

Conditions: Atrial Fibrillation; Diabetes; Arrhythmias; Heart Failure

Study type: Observational

Funder types: Other

Identifiers

NCT05994755

v1.0 22042023

Details and patient eligibility

About

The aim of this study is to investigate the association between hypoglycemia, glycemic variability and cardiac arrhythmias in patients with diabetes Type II (T2D) already implanted with implantable cardiac defibrillator (ICD) and monitored remotely through Bluetooth technology and CGM (continuous glucose monitoring).

Full description

Studies have shown that, when diabetes is present, there is a 35% to 60% greater risk of developing atrial fibrillation (AF). Diabetic patients with AF had a 61% increase in total mortality, a 77% increase in cardiovascular death and a 68% increase in heart failure. The greatest risk with the combination of AF and Type 2 Diabetes Mellitus (T2D) is a 79% increase in thromboembolic risk, particularly stroke.Hypoglycemia, frequently asymptomatic, may lead to cardiac arrythmias and induce an increased risk of cardiovascular morbidity and mortality in patients with T2D.

However, these conclusions need to be tempered by the limitations of all studies available to date, making it difficult to determine the onset and burden of AF, especially when it is not a monitored end-point.Since prospective randomized trials would be unethical, future research should focus on establishing whether such a link exists by employing an observational design and taking advantage of modern tools for long-term, real-life monitoring.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient already wearing CIEDs (Implantable Cardiac Electronic Device) with Bluetooth technology
2. Diabetes Type II, no insulin-treated
3. Over 18 years of age
4. Patient in Sinus Rhythm at the time of the enrollment
5. Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations

Exclusion criteria

1. Subject who is, or is expected to be inaccessible for follow-up
2. pregnancy
3. Patients with persistent and longstanding persistent AF