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

NCT06947031 | Completed DMC FDA Device

• 1 other identifier: FM-CIE-0085-25
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Type 1 diabetes; Advanced Hybrid Closed Loop system; Time in range; surgery

Outcome Measures

Primary Outcomes (1)

• Time in range

  Time spent in the range of 100 - 180 mg/dl during the surgery

  Duration fo the surgery

Secondary Outcomes (2)

• Time below range

  Duration fo the surgery

• THRH

  Duration fo the surgery

Study Arms (1)

AHCL

AHCL users (Minimed 780G) undergoing elective and emergent surgical procedures during the study period.

Device: AHCL

Interventions

AHCL DEVICE

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.

AHCL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with type 1 diabetes users of AHCL undergoing elective and urgent surgery during the study period.

You may not qualify if:

• Patients whose pump use was discontinued during the perioperative period. Pregnant patients. Patients without sensor data in the 2 weeks before and after surgery.

Sponsors & Collaborators

• Hospital Universitario San Ignacio: lead
• Pontificia Universidad Javeriana: collaborator

Study Sites (1)

Hospital Universitario San Ignacio

Bogota, Cundinamarca, 860.015.536-1, Colombia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ana M Gómez Medina, Endocrinologyst

  Hospital Universitario San Ignacio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 27, 2025
• Study Start: August 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: April 30, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

CO (1)