Accuracy of Continuous Glucose Monitors During the Perioperative Period in Youth With Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes. Basic parameters: 2 years — 26 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Barbara Davis Center — Aurora
Identifiers
NCT: NCT06575842 · 24-0717