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NCT05937373 | RECRUITING | Diabetes Mellitus


Perioperative Continuous Glucose Monitoring
Sponsor:

Wake Forest University Health Sciences

Brief Summary:

To evaluate use of continuous glucose monitoring (CGM) technology in the preoperative setting: evaluate feasibility of placement of CGM during preoperative clinic visit with intent to utilize CGM throughout perioperative period.

Condition or disease

Diabetes Mellitus

Intervention/treatment

Continuous Glucose monitor

Standard of Care

Phase

NA

Detailed Description:

To further study potential barriers related to loss of continuous glucose monitoring (CGM) data as it relates to use of electrocautery and grounding devices utilized in the perioperative setting. To assess how CGM technology could improve glycemic management in the perioperative setting, specifically in predicting and preventing hypoglycemic episodes as well as utilization for treating hyperglycemia with resultant improvement in patient morbidity, mortality, length of stay, and overall quality of life. CGM technology aids tremendously in data collection with recognition of glycemic patterns, as well as evaluating prediction of blood glucose changes including both hyperglycemic and hypoglycemic events. The availability of such a large volume of glycemic data has been shown to make a tremendous impact in patient care, resulting in statistically significant reductions in hemoglobin A1c, a decrease in hypoglycemia, a decrease in hospital admissions for diabetes complications, and improved overall quality of life and fear of hypoglycemia in patients using CGM technology.

Study Type : INTERVENTIONAL
Estimated Enrollment : 220 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Pilot Trial of Continuous Glucose Monitoring (CGM) Technology in Preoperative Assessment Clinic
Actual Study Start Date : 2023-08-04
Estimated Primary Completion Date : 2025-02
Estimated Study Completion Date : 2025-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Participants that are 18 years of age or older with hyperglycemia and/or diabetes mellitus who will be undergoing surgery at Atrium Health Wake Forest Baptist
  • * smartphone compatible with Libre 2 phone application
Exclusion Criteria
  • * Pregnant women will not be excluded from this study
  • * Participants undergoing surgery that would limit the placement of Continuous Glucose Monitoring (CGM) to the posterior aspect of the upper extremity will be excluded from this study
  • * neurosurgical type of surgery

Perioperative Continuous Glucose Monitoring

Location Details

NCT05937373


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Locations


RECRUITING

United States, North Carolina

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States, 27157

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