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Perioperative Continuous Glucose Monitoring

NCT ID: NCT05937373

Last Updated: 2025-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-04

Study Completion Date

2024-05-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Keywords

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A1c blood glucose changes hyperglycemic and hypoglycemic events

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continuous Glucose Monitor

CGM placed preoperative to monitor blood glucose and insulin correction to achieve perioperative glucose management

Group Type EXPERIMENTAL

Continuous Glucose monitor

Intervention Type DEVICE

Perioperative glucose management beginning preoperative through postoperative monitoring

Standard of Care

no study intervention-conventional glucose management per subjects medical providers as standard of care

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

no study intervention. participant follows current medical providers recommendations for glucose management

Interventions

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Continuous Glucose monitor

Perioperative glucose management beginning preoperative through postoperative monitoring

Intervention Type DEVICE

Standard of Care

no study intervention. participant follows current medical providers recommendations for glucose management

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Vishneski, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00097714

Identifier Type: -

Identifier Source: org_study_id