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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06575842

Enrollment

120

Registered

2024-08-28

Start date

2024-08-21

Completion date

2027-12-01

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Anesthesia, Continuous glucose monitors, Accuracy, Pediatrics

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 26 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTErin Cobry, MD

Erin.Cobry@cuanschutz.edu3037242323

Outcome results