An observational study in Type 1 Diabetes (T1D) and Surgery, Day, sponsored by Hospital Universitario San Ignacio. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by Hospital Universitario San Ignacio · Observational
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.
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:
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 15 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Hospital Universitario San Ignacio is the lead sponsor of 25 studies on the registry; 8 are open to participants now.
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Patients with type 1 diabetes users of AHCL undergoing elective and urgent surgery during the study period.
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.
AHCL users (Minimed 780G) undergoing elective and emergent surgical procedures during the study period.
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.
Time in range
Time spent in the range of 100 - 180 mg/dl during the surgery
Time frame: Duration fo the surgery
Time below range
To determine safety by the percentage of mean time below the 70 mg/dl range (TBR) in the perioperative period of surgical procedures.
Time frame: Duration fo the surgery
THRH
To investigate the association between 70-100mg/dl (time at high risk of hypoglycaemia, THRH) and TBR \<54mg/dl.
Time frame: Duration fo the surgery
Plan to share: Undecided — The availability of information is for academic purposes. It is at the discretion of the principal investigator.
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Hospital Universitario San Ignacio