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A Study to Evaluate Continuous Glucose Monitor in Hospitalized, Post-operative Patients With Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04845685
Recruitment Status : Not yet recruiting
First Posted : April 15, 2021
Last Update Posted : October 22, 2021
Sponsor:
Information provided by (Responsible Party):
Adrian G. Dumitrascu, Mayo Clinic

Study Description
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Brief Summary:
The purposes of this study is to study if CGMs worn in the postoperative ICU or non-ICU hospital setting have adequate accuracy for blood glucose monitoring when compared to point-of-care (POC) capillary glucometers.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Continuous Glucose Monitor (CGM) Not Applicable

Detailed Description:
Eligible patients will be approached by research staff either preoperatively or on the first 5 days post-surgery and offered to be enrolled. If agreed to participate, they will be fitted with a blinded CGM monitor (Dexcom G6 PRO) as soon as they are awake and alert after the surgery. They will continue to have their blood glucose check as usual in the ICU and on surgical floors with POC glucometers. On discharge, or at the end of the first CGM sensor life, the sensor will be removed and sensor data will be analyzed. CGM data will be compared with Point-of-Care blood glucose monitoring obtained in the hospital.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Hospital Use of CGM (Continuous Glucose Monitor) in Post-operative Patients With Diabetes Mellitus at High Risk for Hypo and Hyperglycemia
Estimated Study Start Date : April 2022
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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Arm Intervention/treatment
Experimental: CGM Patients
Subjects with diabetes mellitus or medication induced diabetes that have been admitted to the hospital after a surgery for organ transplantation or scheduled for organ transplant surgery will be fitted with a CGM monitor to monitor glucose levels during hospitalization
 Device: Continuous Glucose Monitor (CGM)
A device that measures blood sugar levels every 1-5 minutes
Other Name: Dexcom G6 PRO


Outcome Measures
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Primary Outcome Measures :
  1. CGM accuracy [ Time Frame: From date of enrollment and until discharge from the hospital up to 30 days. ]
    Measured by the mean absolute relative difference (MARD), calculated between matched pairs of POC (point of care) glucose monitors and the closest CGM reading. MARD will be summarized as mean (standard deviation) or median (range) for glucose readings <70g/dl, >180g/dl, >250g/dl respectively.


Secondary Outcome Measures :
  1. CGM recorded hypoglycemia episodes [ Time Frame: From date of enrollment and until discharge from the hospital up to 30 days. ]
    The incidence and duration of hypoglycemic episodes

  2. CGM recorded hyperglycemia episodes [ Time Frame: From date of enrollment and until discharge from the hospital up to 30 days. ]
    The incidence of hyperglycemic episodes


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Type 1 or 2 Diabetes Mellitus.
  • Patients 18 years of age or older.
  • Admitted for deceased donor renal transplant surgery, pancreas transplant surgery, heart transplant surgery, liver transplant surgery and lung transplant surgery.
  • Anticipated minimum of 72h hospital stay.
  • Patients on insulin therapy (IV, SQ) post-surgery.

Exclusion Criteria:

  • Active COVID-19 infection.
  • Pregnant or lactating female.
  • Altered Mental Status at the time of sensor placement (sensor will be placed once mental status will improve).
  • Inability to provide informed consent.
  • Patients taking more than 4 g of acetaminophen in 24 hours or more than 1 gm every 6 hours.

Patients with skin lesions at the application site that may interfere with placement of the sensor.

Patients with known allergy to medical grade adhesive.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04845685


Contacts
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Contact: Michelle Perry, RN 904-956-0056 perry.michelle@mayo.edu

Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Adrian Dumitrascu, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Adrian G. Dumitrascu, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04845685    
Other Study ID Numbers: 20-010924
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases