Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 Diabetes, Orthopaedic Hip Replacement, Orthopaedic Knee Replacement, Continuous Blood Glucose Monitoring
Brief 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).
Interventions
DEVICEDexcom 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.
Sponsors
DexCom, Inc.
Stony Brook University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \[as documented in subject's medical record) for women of childbearing potential (WCBP)\]
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Real-Time Continuous Glucose Monitoring | 10 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interference of Intraoperative Electrocautery on Real-Time Continuous Glucose Monitoring | 60-90 minutes | 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. |
| Assess Irreversible Damage/Interference of Real-Time Continuous Glucose Monitoring Devices Caused by Electrocautery | 6-7 days | 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). |
Countries
United States
Outcome results
None listed