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

Heart Failure Clinical Trial

— ARRHYTHMIAFREE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05994755
• Other study ID #: v1.0 22042023
• Status: Not yet recruiting
• Start date: October 30, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: September 2023
• Source: Federico II University
• Contact: Antonio Rapacciuolo, Prof.
• Phone: 081 1962 2964
• Email: antonio.rapacciuolo[@]unina.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: July 1, 2025
• Est. primary completion date: April 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias
• Arrhythmias, Cardiac
• Atrial Fibrillation
• Diabetes
• Diabetes Mellitus
• Heart Failure

Locations

Country	Name	City	State
Italy	Federico II University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Antonio Rapacciuolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	association between hypoglycemia, glycemic variability and cardiac arrhythmias	Incidence of cardiac arrhythmias (atrial fibrillation, atrial flutter, PVC...) detected through remote monitoring and correlation with hypoglycemic episodes.	6 months
Secondary	association between hypoglycemia, glycemic variability and heart failure	The relationship between cardiovascular disease (heart failure and ischemic heart disease) at baseline and clinically relevant cardiovascular disease in relation to TBR and TAR.	6 months