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

Not yet recruiting

• Conditions: Heart Failure; Arrhythmias; Diabetes; Atrial Fibrillation

• Registration Number: NCT05994755
• Lead Sponsor: Antonio Rapacciuolo

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-16
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21
• Study Start: 2023-10-30
• Primary Completion: 2025-04-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
association between hypoglycemia, glycemic variability and cardiac arrhythmias	6 months	Incidence of cardiac arrhythmias (atrial fibrillation, atrial flutter, PVC...) detected through remote monitoring and correlation with hypoglycemic episodes.

Secondary Outcome Measures

Name	Time	Method
association between hypoglycemia, glycemic variability and heart failure	6 months	The relationship between cardiovascular disease (heart failure and ischemic heart disease) at baseline and clinically relevant cardiovascular disease in relation to TBR and TAR.

Trial Locations

Locations (1)

Federico II University; 🇮🇹 Naples, Italy