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

Recruiting

• Conditions: Type 1 Diabetes

• Registration Number: NCT06575842
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

Detailed Description

This study is an observational study design that includes collection of continuous glucose data and venous blood glucose data (from either an IV or fingerstick) from a blood glucose meter. All subjects will be undergoing a surgical procedure that requires anesthesia. The primary outcome of this study is to evaluate the accuracy of the CGM glucose values in comparison to the reference glucometer glucose value during anesthesia. There is currently limited data on accuracy of CGMs during these events and therefore it is not know whether CGM glucose data is reliable to be used as the sole source of glucose monitoring during surgery.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-08-21
• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-26
• Study First Posted: 2024-08-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Participants will be 2 to 26 years of age at the time of enrollment.
2. Participants will have a diagnosis of type 1 diabetes on insulin therapy and requiring close glucose monitoring during the hospitalization and the perioperative period.
3. 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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of CGM compared to blood glucose using standard statistical methods including mean absolute relative difference (MARD).	Perioperatively (length of time will vary based on the operative procedure)	Accuracy assessment will be completed comparing CGM glucose values to blood glucose values using standard statistical assessments.

Trial Locations

Locations (1)

Barbara Davis Center; 🇺🇸 Aurora, Colorado, United States