None listed
Conditions
Interventions
None listed
Sponsors
Korea University Anam Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 20 years or older, male or female, scheduled to undergo catheter ablation for atrial fibrillation 2. Patients with prediabetes or type 2 diabetes with glycated hemoglobin (HbA1c) = 6% 3. Able to wear a continuous glucose monitoring (CGM) device and a wearable ECG patch for =15 days, and capable of using a smartphone application
Exclusion criteria
Exclusion criteria: 1. Patients with type 1 diabetes or a history of pancreatic resection 2. Patients unable to attach patches due to severe dermatologic disease or allergy 3. Patients diagnosed with solid or hematologic malignancy and receiving active treatment within the past 5 years 4. Patients requiring continuous systemic corticosteroid use at screening 5. Patients requiring long-term (=6 months) immunosuppressant therapy 6. Patients with renal impairment (eGFR 3× upper limit or liver cirrhosis) 7. Patients with a history of severe psychiatric disorder or currently receiving psychiatric medication 8. Patients deemed unsuitable for study participation at the investigator’s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial fibrillation recurrence within 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between pre-procedural glycemic variability (GV) indices and heart rate variability (HRV) indices;Predictive value of differences in glycemic variability and heart rate variability before and after the procedure for atrial fibrillation recurrence;Evaluation of cardiovascular events according to changes in glycemic variability and heart rate variability before and after the procedure;Evaluation of device-related adverse events, including skin irritation, rash, and infection at the site of continuous glucose monitoring (CGM) sensor or wearable ECG patch application | — |
Countries
Korea, Republic of
Contacts
Public ContactJung A Kim
Korea University Anam Hospital
Outcome results
None listed