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

NCT ID: NCT06575842

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-21

Study Completion Date

2025-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Type 1 Diabetes

Keywords

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Anesthesia Continuous glucose monitors Accuracy Pediatrics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Barbara Davis Center

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erin Cobry, MD

Role: CONTACT

Phone: 3037242323

Email: [email protected]

Facility Contacts

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Erin Cobry, MD

Role: primary

Other Identifiers

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24-0717

Identifier Type: -

Identifier Source: org_study_id