Usefulness of artificial endocrine pancreas with closed-loop glycemic control system in patients undergoing cardiovascular surgery: a prospective randomized controlled trial

Usefulness of artificial endocrine pancreas with closed-loop glycemic control system in patients undergoing cardiovascular surgery: a prospective randomized controlled trial - LEAP study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000044452

Enrollment

Registered

2021-07-01

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Cardiovascular diseases

Interventions

Conventional glycemic control in perioperative period Glycemic control using artificial endocrine pancreas in perioperative period

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients slated for cardiovascular surgery using CPB (2) Patients over 20 years old (3) Elective surgery

Exclusion criteria

Exclusion criteria: (1) Patients on maintenance dialysis (2) Patients with preoperative persistent atrial fibrillation (3) Patients undergoing ventricular assist device (4) Patients undergoing heart transplant (5) Patients who are expected to stay in ICU for less than 2 days (6) Patients with psychiatric disorders or cognitive impairment who are considered difficult to participate in the study

Design outcomes

Primary

Measure	Time frame
Glycemic variability from intraoperative to postoperative day 3	—

Secondary

Measure	Time frame
Incidences of SSI and postoperative atrial fibrillation from postoperative to discharge etc.	—

Countries

Japan

Contacts

Public ContactKonosuke Sasaki

Tohoku University Graduate School of Medicine Department of Oncology Nursing

konosuke.sasaki.b6@tohoku.ac.jp0227177928

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026