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RecruitingNCT06275971Updated Feb 23, 2024

Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients

An interventional study of Dexcom G6 and SMBG or venous/arterial blood glucose in Cardiac Disease, PreDiabetes and Diabetes Mellitus, sponsored by Kangbuk Samsung Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-23.

Sponsored by Kangbuk Samsung Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to assess the level of glycemic control and the incidence of surgery-related complications in cardiac patients post-surgery when Continuous Glucose Monitoring (CGM) is utilized, as compared to traditional methods of arterial/venous blood sampling and Point-of-Care Testing (POCT) for glucose monitoring.

02

Conditions studied

  • Cardiac Disease
  • PreDiabetes
  • Diabetes Mellitus

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Keywords

  • continuous glucose monitoring
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects waiting for Elective Cardiac Surgery (CABG, Cardiac Valve Operation, Congenital heart anomaly surgery, aortic surgery, etc.)
  • Subjects over the age of 18
  • Patients with type 2 diabetes
  • Patients with prediabetes

    1. HbA1c 5.7% or more
    2. fasting blood glucose 100 mg/dL or more
    3. 2 hours 75g-OGTT 140 mg/dL or more

Exclusion criteria

Exclusion Criteria:

  • Emergency surgery patients
  • Patients performing co-operation other than cardiac surgery
  • Patients with type 1 diabetes
  • Total Pancreatectomy patients
  • Patients with high surgical severity (STS score of 8 or more or EURO score of 5 or more)
  • Patients who do not consent to the study
  • Severe patients who are deemed difficult to continue research during surgery (excluded at the researcher's discretion)

    1. Cases where severe weight gain and severe edema occur after surgery
    2. Cases where the surgery time is significantly longer than average
    3. Cases where cardiopulmonary bypass is used more than once during surgery
  • Others who are deemed unsuitable for research progression at the researcher's discretion
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    CGM arm

    Glycemic control was monitored using CGM data for seven days following cardiac surgery

    Device: Dexcom G6

  • Active comparator
    SMBG or venous/arterial glucose arm

    Glycemic control was monitored using SMBG or venous/arterial glucose data for seven days following cardiac surgery

    Device: SMBG or venous/arterial blood glucose

Interventions

  • DeviceDexcom G6

    Glycemic control was monitored using CGM data for seven days following cardiac surgery

  • DeviceSMBG or venous/arterial blood glucose

    Glycemic control was monitored using SMBG or venous/arterial blood glucose data for seven days following cardiac surgery

05

What researchers measure

Primary outcomes

  1. Time within the target range of 100-180 mg/dL

    Time within the target range of 100-180 mg/dL as assessed by CGM for 7 days after surgery

    Time frame: 1-7 days after surgery

Secondary outcomes

  1. Time within the target range of 100-140 mg/dL

    Time within the target range of 100-140 mg/dL as assessed by CGM for 7 days after surgery

    Time frame: 1-7 days after surgery

  2. Time within the target range of 70-180 mg/dL

    Time within the target range of 70-180 mg/dL as assessed by CGM for 7 days after surgery

    Time frame: 1-7 days after surgery

  3. Time to reach <70 mg/dL

    Time to reach \<70 mg/dL as assessed by CGM for 7 days after surgery

    Time frame: 1-7 days after surgery

  4. Time to reach <54 mg/dL

    Time to reach \<54 mg/dL as assessed by CGM for 7 days after surgery

    Time frame: 1-7 days after surgery

  5. Time to reach >180 mg/dL

    Time to reach \>180 mg/dL as assessed by CGM for 7 days after surgery

    Time frame: 1-7 days after surgery

  6. Time to reach >250 mg/dL

    Time to reach \>250 mg/dL as assessed by CGM for 7 days after surgery

    Time frame: 1-7 days after surgery

  7. Standard Deviation (SD)

    SD value evaluated by CGM for 7 days after surgery

    Time frame: 1-7 days after surgery

  8. Coefficient of variation (CV)

    CV value evaluated by CGM for 7 days after surgery

    Time frame: 1-7 days after surgery

  9. Mean glucose

    Mean glucose value evaluated by CGM for 7 days after surgery

    Time frame: 1-7 days after surgery

  10. Glucose management indicator (GMI)

    GMI value evaluated by CGM for 7 days after surgery

    Time frame: 1-7 days after surgery

  11. Number of days of ICU hospitalization

    Number of days of ICU hospitalization

    Time frame: From 1 day after surgery until the date of ICU discharge or date of death from any cause, whichever came first, asessed up to 30 days

  12. Number of days hospitalized after surgery

    Number of days hospitalized after surgery

    Time frame: From 1 day after surgery until the date of hospital discharge or date of death from any cause, whichever came first, asessed up to 30 days

  13. Number of participants with pneumonia occurrence after surgery

    Number of participants with pneumonia occurrence within 1 week after surgery

    Time frame: 1-7 days after surgery

  14. Number of participants with wound infection occurrence after surgery

    Number of participants with wound infection occurrence within 1 week after surgery

    Time frame: 1-7 days after surgery

  15. Number of participants who underwent CRRT implementation after surgery

    Number of participants who underwent CRRT implementation within 1 week after surgery

    Time frame: 1-7 days after surgery

  16. Number of participants with Atrial fibrillation occurrence after surgery

    Number of participants with Atrial fibrillation occurrence within 1 week after surgery

    Time frame: 1-7 days after surgery

  17. Number of participants with symptomatic CVA (ischemic and hemorrhagic) occurrence after surgery

    Number of participants with symptomatic CVA (ischemic and hemorrhagic) occurrence within 1 week after surgery

    Time frame: 1-7 days after surgery

  18. Changes in concentration of serum CRP level after surgery

    Changes in concentration of serum CRP level after surgery (between baseline and peak value within 1 week after surgery)

    Time frame: 1-7 days after surgery

  19. Mortality within 30 days of surgery

    Mortality within 30 days of surgery

    Time frame: 1-30 days after surgery

06

Study locations

1 of 1 sites recruiting
  • Kangbuk Samsung Hospital
    Seoul, 03181, Korea, Republic of
    • Sun Joon Moon, MD · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06275971
Lead sponsor
Kangbuk Samsung Hospital
Collaborators
DexCom, Inc.
Responsible party
Cheol-Young Park (Professor, MD. PhD, Kangbuk Samsung Hospital, Sungkyunkwan University) — Principal investigator
First posted
Feb 23, 2024
Start date
Nov 24, 2022
Primary completion
Jun 30, 2024 (estimated)
Completion
Aug 31, 2024 (estimated)
Last update
Feb 23, 2024

Study contacts

Cheol-Young Park, MD, PhD
Contact
cydoctor68@gmail.com
+82220011550
Sun Joon Moon, MD
Contact
ipleat.m@gmail.com
+82220011550
Sun Joon Moon, MD
study director · Kangbuk Samsung Hospital, Sungkyunkwan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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