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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05994755

Acronym

ARRHYTHMIAFREE

Enrollment

Registered

2023-08-16

Start date

2023-10-30

Completion date

2025-07-01

Last updated

2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias, Atrial Fibrillation, Diabetes, Heart Failure

Keywords

diabetes type II, cardiac arrhythmias

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Italy

Contacts

Primary ContactAntonio Rapacciuolo, Prof.

antonio.rapacciuolo@unina.it081 1962 2964

Outcome results