Evaluating continuous glucose monitors during surgery in youth with type 1 diabetes
Accuracy of Continuous Glucose Monitors During the Perioperative Period in Youth With Type 1 Diabetes
This study is testing how well continuous glucose monitors work for young people with type 1 diabetes during surgery to see if they can safely replace traditional blood tests while under anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 2 Years to 26 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06575842 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the accuracy of continuous glucose monitors (CGMs) in youth with type 1 diabetes during surgical procedures that require anesthesia. Participants aged 2 to 26 will have their CGM data compared to venous blood glucose measurements to determine the reliability of CGMs in this critical setting. The study aims to fill the knowledge gap regarding the effectiveness of CGMs as a sole glucose monitoring source during anesthesia. By collecting data from participants undergoing surgery, the study seeks to provide insights into the safety and accuracy of CGMs in perioperative care.
Who should consider this trial
Good fit: Ideal candidates are youth aged 2 to 26 with type 1 diabetes who are on insulin therapy and currently using a continuous glucose monitor.
Not a fit: Patients who are pregnant, using hydroxyurea, or have conditions preventing participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and management of glucose levels in youth with type 1 diabetes during surgical procedures.
How similar studies have performed: There is limited data on the accuracy of continuous glucose monitors during anesthesia, making this study a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aurora, Colorado
- Barbara Davis Center — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Erin Cobry, MD
- Email: Erin.Cobry@cuanschutz.edu
- Phone: 3037242323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.