Diabetes Mellitus, Type 2NCT05666479
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
An observational study of Diabetes Mellitus, Type 2 and Arthroplasty, Replacement, Hip, run by Stony Brook University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- What is being tested?
- Dexcom G6 Pro Continuous Glucose Monitor (CGM)
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2022to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes undergoing orthopaedic hip or knee replacement surgery.
Who may be able to join
- 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)]
Who cannot join
- 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
Show all 9Show fewer
- 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)]
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effectiveness of Continuous Blood Glucose Monitoring In Patients With Type 2 Diabetes Undergoing Orthopaedic Hip or Knee Replacement Surgery
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).
- Conditions
- Diabetes Mellitus, Type 2, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- Being tested
- Dexcom G6 Pro Continuous Glucose Monitor (CGM)
- Keywords
- Type 2 Diabetes, Orthopaedic Hip Replacement, Orthopaedic Knee Replacement, Continuous Blood Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G6 Pro Continuous Glucose Monitor (CGM)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Type 2 Diabetes Undergoing Orthopaedic Hip or Knee Replacement Surgery | Not described Receives: Device: Dexcom G6 Pro Continuous Glucose Monitor (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 days
Secondary outcomes (2)
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.
Measured: 60-90 minutes
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).
Measured: 6-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start9 Sep 2022
- Primary completion30 Apr 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Igor Kravets, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666479
- Sponsor's protocol ID
- IRB2021-00351
- Status last verified
- Apr 2024
- First submitted
- 17 Dec 2022
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Continuous Blood Glucose Monitoring In Patients With Type 2 Diabetes Undergoing Orthopaedic Hip or Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT05666479
- Acronym / sponsor ID
- IRB2021-00351
- Conditions
- Diabetes Mellitus, Type 2, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- Keywords
- Type 2 Diabetes, Orthopaedic Hip Replacement, Orthopaedic Knee Replacement, Continuous Blood Glucose Monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 27 Dec 2022 (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 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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Type 2 Diabetes Undergoing Orthopaedic Hip or Knee Replacement Surgery | – | Device: Dexcom G6 Pro Continuous Glucose Monitor (CGM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes undergoing orthopaedic hip or knee replacement surgery.
Key inclusion criteria (5 listed)
- 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)]
Key exclusion criteria (9 listed)
- 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
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 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. | Device | Patients with Type 2 Diabetes Undergoing Orthopaedic Hip or Knee Replacement Surgery |
Primary outcome
Accuracy of Real-Time Continuous Glucose Monitoring
Time frame: 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).
2 secondary outcomes
Interference of Intraoperative Electrocautery on Real-Time Continuous Glucose Monitoring
Time frame: 60-90 minutes
Assess Irreversible Damage/Interference of Real-Time Continuous Glucose Monitoring Devices Caused by Electrocautery
Time frame: 6-7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetes Mellitus, Type 2 and Arthroplasty, Replacement, Hip, run by Stony Brook 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. 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?
Results are not available in the source record.
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?
Accuracy of Real-Time Continuous Glucose Monitoring (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024.