Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614127
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Continuous Glucose Monitoring A Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Continuous Intraoperative Glucose Monitoring A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None