Clinical trial NCT06947031: Efficacy and Safety of the Minimed 780G® Advanced Hybrid Closed Loop System (AHCL) in Patients With Type 1 Diabetes Undergoing Surgery
Official title: Efficacy and Safety of the Minimed 780G® Advanced Hybrid Closed Loop System (AHCL) in Patients With Type 1 Diabetes Undergoing Surgery
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Type 1 Diabetes (T1D)
Surgery, Day
Keywords: Type 1 diabetes
Advanced Hybrid Closed Loop system
Time in range
surgery
Lead sponsor: Hospital Universitario San Ignacio
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Javeriana
First posted: 2025-04-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 1 diabetes users of AHCL undergoing elective and urgent surgery during the study period.

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.

Detailed description: Patients using the Minimed 780G device who completed training and clinical follow-up in the Endocrinology Unit of San Ignacio University Hospital. Through the clinical follow-up established by the unit, patients must inform their physicians if they will be undergoing elective surgery or contact the medical team if they require emergency surgery during the recruitment period.

Data Collection Prior to the Surgical Procedure Once enrolled in the study, information about the surgical procedure will be collected, including the type of procedure and approximate duration. Patients will then be asked to upload their data for viewing on the Medtronic Carelink platform https://carelink.minimed.com/app/login. Glucose monitoring data from the 14 days prior to the surgical procedure will be downloaded from this platform for subsequent analysis.

Prior to the Surgical Procedure The downloaded data will be analyzed prior to the surgical procedure. According to 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 to reduce the risk of perioperative hypoglycemia.

Data Collection After the Surgical Procedure Once the surgical procedure is complete, data on glycemic control will be downloaded again during the surgical period and the following 14 days. The data will be analyzed according to the Consensus for CGM Metrics in Inpatient Clinical Trials published in 2023 in the Journal of Diabetes Science and Technology, presented later in the text. This consensus aims to identify the most important metrics to measure in CGM studies in patients in the hospital setting and recommend target values for these metrics (32).

Once the patient is discharged, they will be contacted to confirm information about the surgical procedure, such as type of anesthesia, duration of surgery, and postoperative complications, whether related to infectious processes or poor glycemic control.

Data Analysis

The specific metrics mentioned in the Consensus for Continuous Glucose Monitoring Metrics in Inpatient Clinical Trials (22) are described below:

Eligibility criteria: Inclusion Criteria:Patients older than 18 years AHCL (Minimed 780G) users undergoing elective and urgent surgery during the study period.

Exclusion Criteria:

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

Primary outcomes:
measure: Time in range
timeFrame: Duration fo the surgery
Secondary outcomes:
measure: Time below range
timeFrame: Duration fo the surgery
measure: THRH
timeFrame: Duration fo the surgery
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio
state: Cundinamarca
Study officials:
affiliation: Hospital Universitario San Ignacio
name: Ana M Gómez Medina, Endocrinologyst
role: PRINCIPAL_INVESTIGATOR
References: