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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-30

Study Completion Date

2025-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hypoglycaemia and Cardiac Arrhythmias in Type 1 Diabetes

NCT04011683

Hypoglycemia (Diabetic) Hyperglycaemia (Diabetic) Arrythmia, Cardiac +2 more

COMPLETED

Predicting Hypoglycaemia and Arrhythmias in the Vulnerable Patient With Diabetes and Chronic Kidney Disease

NCT02315300

Electrocardiography

COMPLETED NA

To Evaluate if Wide Blood Sugar Fluctuations Lead to Injury of Heart Function and Heart Nerves

NCT01170832

Type 1 Diabetes Mellitus

COMPLETED

Electrocardiographic Modifications and Spontaneous Hypoglycemic Episodes in Type 1 Diabetes

NCT03682250

Type 1 Diabetes Mellitus

TERMINATED

Hypoglycemia and Cardiac Arrhythmias in Type 1 Diabetes

NCT03956173

Diabetes type1 Hypoglycemia Arrhythmias, Cardiac

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Arrhythmias Atrial Fibrillation Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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