MedTrace Logo

Efficacy and Safety of the Minimed 780G® Advanced Hybrid Closed Loop System (AHCL) in Patients With Type 1 Diabetes Undergoing Surgery

NCT06947031 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2025-09-23

No results posted yet for this study

Summary

An analytical observational study based on a cohort of patients who received training at San Ignacio University Hospital. Glycemic control metrics were compared between the perioperative and postoperative periods and the preoperative period using a paired t test. Glycemic control metrics were compared between the preoperative, intraoperative, and postoperative periods using a paired t test. Finally, a subgroup analysis was performed based on the type of procedure, percentage of sensor use, and duration of diabetes.

Conditions

  • Type 1 Diabetes (T1D)
  • Surgery, Day

Interventions

DEVICE

AHCL

The downloaded data will be analyzed prior to the surgical procedure. In accordance with standard clinical practice, a TBR time-under-range % (\<54 mg/dL) or TBR time-under-range % (\<70 mg/dL) greater than 4% will be identified, and the target glucose will be increased by 10 mg/dL relative to the previously established value. This is intended to reduce the risk of perioperative hypoglycemia.

Sponsors & Collaborators

  • Pontificia Universidad Javeriana

    collaborator OTHER

  • Hospital Universitario San Ignacio

    lead OTHER

Principal Investigators

  • Ana M Gómez Medina, Endocrinologyst · Hospital Universitario San Ignacio

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-01-31
Completion
2025-04-30
FDA Device
Yes

Countries

  • Colombia

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06947031 on ClinicalTrials.gov