Continuous Glucose Monitoring: A Pilot Study

NCT06614127 | Active Not Recruiting FDA Device

• 1 other identifier: IRB 5230596
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

Continuous Glucose Monitoring; Electrocautery

Outcome Measures

Primary Outcomes (1)

• Effect of DexCom G7® sensor position on receiver connectivity during and after electrocautery use.

  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.

  Change between baseline at start of procedure and completion of procedure, up to 6 hours.

Study Arms (2)

Continuous glucose monitoring site: upper arm

Adult, non-cardiothoracic surgical patients with Dexcom G7® sensor placed in upper arm over the deltoid

Device: Dexcom G7® sensor placed in upper arm and positioned over deltoid

Continuous glucose monitoring site: anterior thigh

Adult, non-cardiothoracic surgical patients with Dexcom G7® sensor placed on the anterior aspect of the thigh

Device: Dexcom G7® sensor placed in anterior thigh

Interventions

Dexcom G7® sensor placed in upper arm and positioned over deltoid DEVICE

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.

Continuous glucose monitoring site: upper arm

Dexcom G7® sensor placed in anterior thigh DEVICE

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.

Continuous glucose monitoring site: anterior thigh

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult non-cardiothoracic surgical patients.

You may qualify if:

• Adults age 18 and above able to consent for themselves
• Willingness and ability to participate in study procedures
• Surgery length estimated 3 hours or longer

You may not qualify if:

• Cardiothoracic surgical patients
• Plan for intraoperative radiologic imaging
• Patients on IV infusion of insulin prior to surgery
• Anemia with hemoglobin less than 7
• Patients on hydroxyurea
• Patients with known adhesive allergies
• Pregnant women

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Troesch Medical Center

Loma Linda, California, 92354, United States

Location

Related Publications (11)

• Singh LG, Satyarengga M, Marcano I, Scott WH, Pinault LF, Feng Z, Sorkin JD, Umpierrez GE, Spanakis EK. Reducing Inpatient Hypoglycemia in the General Wards Using Real-time Continuous Glucose Monitoring: The Glucose Telemetry System, a Randomized Clinical Trial. Diabetes Care. 2020 Nov;43(11):2736-2743. doi: 10.2337/dc20-0840. Epub 2020 Aug 5.

  PMID: 32759361 BACKGROUND

• Sweeney AT, Pena S, Sandeep J, Hernandez B, Chen Y, Breeze JL, Bulut A, Feghali K, Abdelrehim M, Abdelazeem M, Srivoleti P, Salvucci L, Cann SB, Norman C. Use of a Continuous Glucose Monitoring System in High-Risk Hospitalized Noncritically Ill Patients With Diabetes After Cardiac Surgery and During Their Transition of Care From the Intensive Care Unit During COVID-19: A Pilot Study. Endocr Pract. 2022 Jun;28(6):615-621. doi: 10.1016/j.eprac.2022.03.001. Epub 2022 Mar 8.

  PMID: 35276324 BACKGROUND

• Espinoza J, Xu NY, Nguyen KT, Klonoff DC. The Need for Data Standards and Implementation Policies to Integrate CGM Data into the Electronic Health Record. J Diabetes Sci Technol. 2023 Mar;17(2):495-502. doi: 10.1177/19322968211058148. Epub 2021 Nov 20.

  PMID: 34802286 BACKGROUND

• Avari P, Lumb A, Flanagan D, Rayman G, Misra S, Dhatariya K, Choudhary P. Continuous Glucose Monitoring Within Hospital: A Scoping Review and Summary of Guidelines From the Joint British Diabetes Societies for Inpatient Care. J Diabetes Sci Technol. 2023 May;17(3):611-624. doi: 10.1177/19322968221137338. Epub 2022 Nov 28.

  PMID: 36444418 BACKGROUND

• Renard E, Cobelli C, Kovatchev BP. Closed loop developments to improve glucose control at home. Diabetes Res Clin Pract. 2013 Nov;102(2):79-85. doi: 10.1016/j.diabres.2013.09.009. Epub 2013 Sep 28.

  PMID: 24128998 BACKGROUND

• Dumitrascu AG, Perry MF, Boone RJ, Guzman MP, Chirila RM, McNally AW, Colibaseanu DT, Meek SE, Ball CT, White LJ, Chindris AM. Continuous Glucose Monitoring for Patients with COVID-19 Pneumonia: Initial Experience at a Tertiary Care Center. Endocr Pract. 2023 Mar;29(3):155-161. doi: 10.1016/j.eprac.2022.12.012. Epub 2022 Dec 22.

  PMID: 36566985 BACKGROUND

• Adamska O, Mamcarz A, Lapinski M, Radzimowski K, Stepinski P, Szymczak J, Swiercz M, Zarnovsky K, Maciag BM, Stolarczyk A. Continuous glycemia monitoring in perioperative period in patients undergoing total knee or hip arthroplasty: A protocol for a prospective observational study. Medicine (Baltimore). 2022 Oct 21;101(42):e31107. doi: 10.1097/MD.0000000000031193.

  PMID: 36281192 BACKGROUND

• Spanakis EK, Urrutia A, Galindo RJ, Vellanki P, Migdal AL, Davis G, Fayfman M, Idrees T, Pasquel FJ, Coronado WZ, Albury B, Moreno E, Singh LG, Marcano I, Lizama S, Gothong C, Munir K, Chesney C, Maguire R, Scott WH, Perez-Guzman MC, Cardona S, Peng L, Umpierrez GE. Continuous Glucose Monitoring-Guided Insulin Administration in Hospitalized Patients With Diabetes: A Randomized Clinical Trial. Diabetes Care. 2022 Oct 1;45(10):2369-2375. doi: 10.2337/dc22-0716.

  PMID: 35984478 BACKGROUND

• Faulds ER, Dungan KM, McNett M. Implementation of Continuous Glucose Monitoring in Critical Care: A Scoping Review. Curr Diab Rep. 2023 Jun;23(6):69-87. doi: 10.1007/s11892-023-01503-5. Epub 2023 Apr 13.

  PMID: 37052790 BACKGROUND

• Boeder S, Kulasa K. Hospital care: improving outcomes in type 1 diabetes. Curr Opin Endocrinol Diabetes Obes. 2021 Feb 1;28(1):14-20. doi: 10.1097/MED.0000000000000601.

  PMID: 33315629 BACKGROUND

• Jackson MA, Ahmann A, Shah VN. Type 2 Diabetes and the Use of Real-Time Continuous Glucose Monitoring. Diabetes Technol Ther. 2021 Mar;23(S1):S27-S34. doi: 10.1089/dia.2021.0007.

  PMID: 33534631 BACKGROUND

Study Officials

• Richard L Applegate, MD

  Loma Linda University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Anesthesiology

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 26, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)