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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-26
SponsorUniversity of Colorado, Denver

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy.

Currently using hydroxyurea.

A condition that the investigator determines would prevent the patient from participation.

Trial population

All participants will have a clinical diagnosis of type 1 diabetes and be wearing a continuous glucose monitor as part of routine care.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 1 trial group
Group A: Pediatric patients undergoing anesthesia

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

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