Accuracy of Continuous Glucose Monitors During the Perioperative Period in Youth With Type 1 Diabetes

NCT06575842 | Recruiting

• 1 other identifier: 24-0717
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study is assessing the accuracy of continuous glucose monitors during surgical procedures requiring anesthesia.

Conditions

Type 1 Diabetes

Keywords

Anesthesia; Continuous glucose monitors; Accuracy; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Accuracy of CGM compared to blood glucose using standard statistical methods including mean absolute relative difference (MARD).

  Accuracy assessment will be completed comparing CGM glucose values to blood glucose values using standard statistical assessments.

  Perioperatively (length of time will vary based on the operative procedure)

Study Arms (1)

Pediatric patients undergoing anesthesia

Pediatric patients who are undergoing a surgical procedure with anesthesia. Patients will have type 1 diabetes and be wearing a continuous glucose monitor as part of routine care.

Eligibility Criteria

• Age: 2 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All participants will have a clinical diagnosis of type 1 diabetes and be wearing a continuous glucose monitor as part of routine care.

You may qualify if:

• Participants will be 2 to 26 years of age at the time of enrollment.
• Participants will have a diagnosis of type 1 diabetes on insulin therapy and requiring close glucose monitoring during the hospitalization and the perioperative period.
• Participant currently wearing a continuous glucose monitor (for example: Dexcom G6 or G7; Freestyle Libre 2, 2 Plus, or 3; Medtronic Guardian 3 or 4; or future sensors as they become available) for home diabetes management and willing to share personal CGM data with the BDC clinical CGM account.

You may not qualify if:

• Pregnancy.
• Currently using hydroxyurea.
• A condition that the investigator determines would prevent the patient from participation.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Barbara Davis Center

Aurora, Colorado, 80045, United States

RECRUITING

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

Central Study Contacts

Erin Cobry, MD

CONTACT

3037242323; Erin.Cobry@cuanschutz.edu

Study Design

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

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 28, 2024
• Study Start: August 21, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

US (1)