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

University of Colorado, Denver120 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Type 1 Diabetes

Eligibility

Sex: ALLMin age: 2 YearsMax age: 26 Years

Medical Language ↔ Plain English

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

Locations (1)

Barbara Davis Center

Aurora, Colorado, United States

RECRUITING

Outcomes

Primary Outcomes

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.

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

Central Contacts

Erin Cobry, MD

CONTACT

3037242323 Erin.Cobry@cuanschutz.edu

Data from ClinicalTrials.gov

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