Loma Linda University Troesch Medical Center
Loma Linda, California, 92354, United States
NCT Number: NCT06614127
The purpose of this study is to evaluate connectivity of the FDA approved DexCom G7® continuous glucose monitor in the operating room. Continuous glucose monitors are applied to the skin and a thin sampling filament is inserted into the skin and measures blood sugar in the interstitial fluid. The DexCom G7® is used regularly outside of the operating room to monitor blood sugar, however the use of the device in the operating room environment has been limited by connectivity issues. This study will assess device connectivity at different monitoring sites.
This study is active but is not currently recruiting participants.
Notify Me18 year–65 year
All sexes
Observational
Loma Linda, California, 92354, United States
This feasibility pilot study will assess connectivity of the DexCom G7® continuous glucose monitoring device (CGM) in the operating room environment at different locations on the body. The investigators believe device connectivity is affected by use of electrocautery. The monitoring sites were selected to limit electromagnetic interference from electrocautery.
One cohort will have the CGM device placed on the deltoid and the electrodispersive pad placed on the thigh and the other cohort will have the CGM device placed on the thigh with the electrodispersive pad on the opposite thigh.
Study personnel will note when electrocautery is used throughout the surgery and observe if the DexCom G7® continues to maintain connectivity with the receiver and provides a glucose reading. Comparing the timing of electrocautery use with connectivity to the DexCom G7® receiver provides important insight to the relationship between electrocautery and device connectivity.
The CGM readings will solely be used for feasibility purposes for this study and not for determining interventions for the subjects.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For the "subjects with Dexcom G7® sensor placed in the upper arm and positioned over the deltoid" cohort, study personnel will place the Dexcom G7® sensor on the subjects' deltoid and the electrodispursive pad on the thigh.
For the "subjects with Dexcom G7® sensor place in anterior thigh" cohort, study personnel will place the Dexcom G7® sensor in the anterior thighs and the electrodispursive pad will be placed on the opposite thigh.
Time frame: Change between baseline at start of procedure and completion of procedure, up to 6 hours.
Connectivity will be recorded continuously from start to finish of the procedure.
The percentage of time the Dexcom G7® device remains connected during the subject's surgical case will be measured. The effect of electrocautery on CGM connectivity will be assessed by comparing the start and stop times in connectivity to the start and stop times of electrocautery. Connectivity time greater than 80% is considered highly effective. Connectivity time between 20% and 80% is considered effective. Connectivity time less than 20% is considered sub-optimal.
Loma Linda University
Other
Continuous Intraoperative Glucose Monitoring: A Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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