CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Clinical Effectiveness of Continuous Blood Glucose Monitoring In Patients With Type 2 Diabetes Undergoing Orthopaedic Hip or Knee Replacement Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05666479
• Other study ID #: IRB2021-00351
• Status: Active, not recruiting
• Start date: September 9, 2022
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to analyze the efficacy and accuracy of real-time continuous glucose monitoring devices (rtCGM) in patients with Type 2 diabetes undergoing inpatient elective hip or knee surgery in the pre-, peri-, and post-operative setting at Stony Brook University Hospital (SBUH).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: September 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Greater than or equal to 18 years of age

• Scheduled for elective inpatient hip or knee replacement surgery at Stony Brook University Hospital (SBUH)

• Clinically diagnosed Type 2 Diabetes at least 6 months prior to surgery

• Literate and able to provide written informed consent

• Negative pregnancy test by serum or urine HCG at screening [as documented in subject's medical record) for women of childbearing potential (WCBP)]

Exclusion Criteria:

• Less than 18 years of age

• Not scheduled for elective inpatient hip or knee replacement surgery at SBUH

• No clinical diagnosis of Type 2 diabetes at least 6 months prior to surgery

• Not literate or unable to provide written informed consent

• Documented diagnosis of organ failure

• Documented diagnosis of chronic infection

• Documented diagnosis of any active malignancy

• Documented diagnosis of hepatic (liver) dysfunction or cirrhosis

• Pregnant by serum or urine HCG at screening [as documented in subject's medical record) for women of childbearing potential (WCBP)]

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Arthroplasty, Replacement, Knee
• Diabetes Mellitus, Type 2

Intervention

Device:
• Dexcom G6 Pro Continuous Glucose Monitor (CGM)
A DexCom G6 CGM will be implanted on the subject's abdomen contralateral to the surgical site (i.e. left abdomen for right knee or right hip replacements) no less than 30 cm from the surgical site. This CGM shall be termed "primary" for study purposes. Subjects will wear the primary DexCom G6 CGM for the entirety of the following 10-day timeline: 3/4-days pre-operative, day of hip or knee replacement surgery, and 5/6-day postoperative recovery. A second CGM will be implanted in subjects postoperatively while in the Post Anesthesia Care Unit (PACU). This CGM, termed "secondary" for study purposes, will be implanted immediately adjacent to the primary CGM. Subjects will wear the secondary DexCom CGM for the 7 days: day of hip or knee replacement surgery (postoperatively) and 5/6-day postoperative recovery.

Locations

Country	Name	City	State
United States	Stony Brook University	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Real-Time Continuous Glucose Monitoring	Analyze data from real-time continuous glucose monitoring and point-of-care glucose monitoring (POC-BG). rtCGM data will be matched and compared to POC-BG collected for standard clinical care in the pre-op and post-op settings (i.e. mealtimes, bedtime, and every 6 hours).	10 days
Secondary	Interference of Intraoperative Electrocautery on Real-Time Continuous Glucose Monitoring	Analyze intraoperative rtCGM. Electrocautery, a common surgical technique using electrical current to mitigate bleeding by thermal damage of tissue, may emit electrical pulses which adversely interfere with the measurement and/or data transmission of the rtCGM device. All data points collected during the 60-90-minute operative window will be analyzed for interference, aberrant, or missing values.	60-90 minutes
Secondary	Assess Irreversible Damage/Interference of Real-Time Continuous Glucose Monitoring Devices Caused by Electrocautery	Assess irreversible damage/interference of rtCGMs caused by electrocautery. In the postoperative setting, a second rtCGM will be implanted on patients. Data sets between the two rtCGMs will be analyzed for statistically significant mean absolute relative difference (MARD).	6-7 days