N/A
N=10
Continuous Glucose Monitoring During and After Surgery
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02572856 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Safety and Feasibility Evaluation - Number of Unanticipated Safety Issues — 0 Number of unanticipated safety events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous Glucose Monitor (CGM) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Feasibility Evaluation - Number of Unanticipated Safety Issues |
— | — |
| PRIMARY Mean Absolute Relative Difference for CGM and POC Glucose Measurements |
9.4 | — |
| PRIMARY Feasibility of Instrument: Count of CGM Instrument Issues |
— | — |
Summary
During surgery and after surgery elevated blood glucose levels can lead to poor outcome such as wound infections. Current technology does not allow close monitoring of glucose levels often resulting in poor management of glucose levels. In this study, the investigators will evaluate the feasibility of using a continuous glucose monitor (Dexcom Gen 6 Professional) during and after surgery. Such a monitor has the potential of monitoring glucose levels continuously and in real-time, thus allowing better glucose management
Eligibility Criteria
Inclusion Criteria
- Adult (≥ 18 years) diabetic (both Type 1 & 2) patients who are self-monitoring glucose levels (via finger stick measurements) two to three times daily.
- Scheduled to have elective general surgery at UW Medical Center. Preferably target Surgery A- Orthopedic/GYN surgery/Bariatric patients.
- Proposed case duration > 2 hour case.
Exclusion Criteria
- Pregnant and lactating females
- MRI, CT & Diathermy procedure
Data sourced from ClinicalTrials.gov (NCT02572856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.