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Recruiting

NCT Number: NCT06575842

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

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

Recruiting

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Key information

Age range

2 year–26 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Erin Cobry, MD

CONTACT

[email protected]

303-724-2323

Erin Cobry, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Cobry, MD

CONTACT

[email protected]

3037242323

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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