Type 1 DiabetesNCT06575842
Accuracy of Continuous Glucose Monitors During the Perioperative Period in Youth With Type 1 Diabetes
An observational study of Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study is assessing the accuracy of continuous glucose monitors during surgical procedures requiring anesthesia. Read more about this study
- Who is it for?
- Ages 2 to 26 years
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2024to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All participants will have a clinical diagnosis of type 1 diabetes and be wearing a continuous glucose monitor as part of routine care.
Who may be able to join
- 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.
Who cannot join
- Pregnancy.
- Currently using hydroxyurea.
- A condition that the investigator determines would prevent the patient from participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Barbara Davis Center
Aurora, Colorado, 80045
Erin Cobry, MD, 303-724-2323, erin.cobry@cuanschutz.edu
Erin Cobry, MD
About this study
This study is assessing the accuracy of continuous glucose monitors during surgical procedures requiring anesthesia.
Read the 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.
- Conditions
- Type 1 Diabetes
- Keywords
- Anesthesia, Continuous glucose monitors, Accuracy, Pediatrics
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperatively (length of time will vary based on the operative procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start21 Aug 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575842
- Sponsor's protocol ID
- 24-0717
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Continuous Glucose Monitors During the Perioperative Period in Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06575842
- Acronym / sponsor ID
- 24-0717
- Conditions
- Type 1 Diabetes
- Keywords
- Anesthesia, Continuous glucose monitors, Accuracy, Pediatrics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All participants will have a clinical diagnosis of type 1 diabetes and be wearing a continuous glucose monitor as part of routine care.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnancy.
- Currently using hydroxyurea.
- A condition that the investigator determines would prevent the patient from participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Cobry, MD (3037242323, Erin.Cobry@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.