AnesthesiaNCT06614127
Continuous Glucose Monitoring: A Pilot Study
An observational study of Anesthesia, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Dexcom G7® sensor placed in upper arm and positioned over deltoid and Dexcom G7® sensor placed in lateral thigh
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2024to 30 Oct 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult abdominal and general surgical patients.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Troesch Medical Center
Loma Linda, California, 92354
About this study
Official title: Continuous Intraoperative Glucose Monitoring: A Pilot Study
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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Dexcom G7® sensor placed in upper arm and positioned over deltoid, Dexcom G7® sensor placed in lateral thigh
- Keywords
- Continuous Glucose Monitoring, Electrocautery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G7® sensor placed in upper arm and positioned over deltoidDevice
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.
Dexcom G7® sensor placed in lateral thighDevice
For the "subjects with Dexcom G7® sensor place in lateral thigh" cohort, study personnel will place the Dexcom G7® sensor in the lateral thigh and the electrodispursive pad will be placed on the opposite thigh.
| Study group | Role | What they receive |
|---|---|---|
| Continuous glucose monitoring site: upper arm | Adult, non-cardiothoracic surgical patients with Dexcom G7® sensor placed in upper arm over the deltoid Receives: Device: Dexcom G7® sensor placed in upper arm and positioned over deltoid | |
| Continuous glucose monitoring site: lateral thigh | Adult, non-cardiothoracic surgical patients with Dexcom G7® sensor placed on the lateral aspect of the thigh Receives: Device: Dexcom G7® sensor placed in lateral thigh |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between baseline at start of procedure and completion of procedure, up to 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start24 Oct 2024
- Primary completion1 Aug 2025
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa McCabe, Loma Linda University
- Investigators
- Richard L Applegate, MD, Study chair, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614127
- Sponsor's protocol ID
- IRB 5230596
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32759361Sweeney 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.
PubMed 35276324Espinoza 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.
PubMed 34802286Avari 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.
PubMed 36444418Renard 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.
PubMed 24128998Dumitrascu 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.
PubMed 36566985Adamska 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.
PubMed 36281192Spanakis 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.
PubMed 35984478Faulds 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.
PubMed 37052790Boeder 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.
PubMed 33315629Jackson 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.
PubMed 33534631Stutzman R, Pineda LS, Reynoso EE, Chou P, Lauer RE, Applegate RL 2nd, McCabe MD. Intraoperative Continuous Glucose Monitor Sensor-Receiver Connectivity Is Maintained With Alternative Sensor Placement: A Pilot Study. Diabetes Obes Metab. 2026 Oct 19. doi: 10.1111/dom.71442. Online ahead of print.
PubMed 42897106
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Intraoperative Glucose Monitoring: A Pilot Study
- ClinicalTrials.gov ID
- NCT06614127
- Acronym / sponsor ID
- IRB 5230596
- Conditions
- Anesthesia
- Keywords
- Continuous Glucose Monitoring, Electrocautery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 26 Sep 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous glucose monitoring site: upper arm | – | Device: Dexcom G7® sensor placed in upper arm and positioned over deltoidAdult, non-cardiothoracic surgical patients with Dexcom G7® sensor placed in upper arm over the deltoid |
| Continuous glucose monitoring site: lateral thigh | – | Device: Dexcom G7® sensor placed in lateral thighAdult, non-cardiothoracic surgical patients with Dexcom G7® sensor placed on the lateral aspect of the thigh |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult abdominal and general surgical patients.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexcom G7® sensor placed in upper arm and positioned over deltoidFor 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. | Device | Continuous glucose monitoring site: upper arm |
| Dexcom G7® sensor placed in lateral thighFor the "subjects with Dexcom G7® sensor place in lateral thigh" cohort, study personnel will place the Dexcom G7® sensor in the lateral thigh and the electrodispursive pad will be placed on the opposite thigh. | Device | Continuous glucose monitoring site: lateral thigh |
Primary outcome
Effect of DexCom G7® sensor position on receiver connectivity during and after electrocautery use.
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.
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 13 Aug 2026.
- Background: PubMed 32759361Singh 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.
- Background: PubMed 35276324Sweeney 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.
- Background: PubMed 34802286Espinoza 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.
- Background: PubMed 36444418Avari 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.
- Background: PubMed 24128998Renard 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.
- Background: PubMed 36566985Dumitrascu 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.
- Background: PubMed 36281192Adamska 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.
- Background: PubMed 35984478Spanakis 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.
- Background: PubMed 37052790Faulds 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.
- Background: PubMed 33315629Boeder 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.
- Background: PubMed 33534631Jackson 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.
- Derived from this study: PubMed 42897106Stutzman R, Pineda LS, Reynoso EE, Chou P, Lauer RE, Applegate RL 2nd, McCabe MD. Intraoperative Continuous Glucose Monitor Sensor-Receiver Connectivity Is Maintained With Alternative Sensor Placement: A Pilot Study. Diabetes Obes Metab. 2026 Oct 19. doi: 10.1111/dom.71442. Online ahead of print.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Richard L Applegate, MD study chair
Loma Linda University
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 Anesthesia, run by Loma Linda University 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 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of DexCom G7® sensor position on receiver connectivity during and after electrocautery use. (time frame: Change between baseline at start of procedure and completion of procedure, up to 6 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06614127, which also lists 12 linked publications.
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 13 Aug 2026.