Effectiveness And Safety Of The Dexcom G6 Continuous Glucose Monitoring System In Non-Critically Ill Patients In The Inpatient Setting

Overview

About this study

The purpose of this study is to assess the effectiveness and safety of the Dexcom G6 Continuous Glucose Monitoring System when used in non-critically ill hospitalized patients on glucose control. Participants will wear up to three (3) Dexcom sensor configurations, on the arm and on the abdomen.

Hospitalized patients with a stay for a minimum of 2 days in which they are on treatment to manage glucose will participate in the study. There will be no purposeful glucose manipulation since the CGM will be used in blinded mode. Data to determine the accuracy of the CGM in comparison with YSI will be collected through day 5 of CGM wear. Subjects will continue to wear the CGM until their discharge from the hospital up to 10 days of wear. The trial is designed to have at least two blood collection sessions to measure blood glucose on the YSI instrument per patient on different days and times of the day. Blood draws will be performed for periods of 6 hours each at 30-minute intervals on separate days for each participating patient. Day of YSI sessions should be on different sensor wear days. Every attempt will be made to obtain equal numbers of YSI sessions on each day (days 1-5). However, it is anticipated that fewer subjects will remain hospitalized for the full 5 days, so there will likely be more YSI sessions on days 1-3.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 18 years of age and older.
  • Admitted to the hospital in a non-ICU bed or once transferred out of ICU.
  • Hospital units from which patients will be recruited:
    • Post critical care unit (step down units);
    • Surgical units: these include units which provide pre- and post-surgical care and/or specialized in certain types of surgery (for example orthopedic surgery, programmed surgeries if the patient will remain in the hospital for at least 48 hours: example complicated hernia);
    • Medical units which provide care for conditions such as stroke, heart conditions, infections (also call general unit or med surg unit).
  • Patients admitted to ICU with the following diagnoses will be acceptable to enroll:
    • Neurologic or stroke ICU (NNICU): Patients admitted with ischemic strokes without other critical neurological conditions;
    • Hyperosmolar Hyperglycemic Nonketotic Syndrome (HHNS or HHS) as the primary condition for ICU admission without other critical conditions that warrant ICU admission, or any conditions described in the exclusion criteria;
    • Diabetes Ketoacidosis (DKA) as the primary condition for ICU admission without other critical conditions that warrant ICU admission, or any conditions described in the exclusion criteria.
  • Anticipate at least 48 hours of hospital stay.
  • On treatment for glucose control.
  • Willingness to complete the study.
  • Willingness to wear up to 3 CGM systems simultaneously. Two in the abdomen and one on the back of the arm or one on each arm and one on the abdomen.
  • Subject and/or caretaker are able to speak, read, and write English.

Exclusion Criteria:

  • Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
  • Currently in an intensive care unit (ICU) of the following (does not apply to participants placed in an ICU bed due to space issues in the non-ICU areas).
  • Different ICUs admissions will be excluded as follow:
    • Psychiatric Intensive Care Unit (PICU);
    • Coronary Intensive Care Unit (CCU);
    • Cardiothoracic Intensive Care Unit (CTU);
    • Severe burn Care Unit;
    • Burn units that are not in severe unit ICU will be accepted.;
    • Adult Medical Intensive Care Unit (MICU), also call regular ICU in some places;
    • Neurosurgical Intensive Care Unit (except patients with diagnoses of ischemic strokes treated with insulin drips);
    • Respiratory Intensive Care Unit;
    • Surgical Intensive Care Unit (SICU);
    • Trauma Intensive Care Unit;
    • Long Term Care ICU (LTC-ICU).
  • Patients admitted to ICU with the following diagnoses will be acceptable to enroll per inclusion criteria described above:
    • Neurologic or stroke ICU (NNICU): Patients admitted with ischemic strokes;
    • Hyperosmolar Hyperglycemic Nonketotic Syndrome (HHNS or HHS);
    • Diabetes Ketoacidosis (DKA).

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yogish Kudva, M.B.B.S.

Open for enrollment

Contact information:

Shelly McCrady-Spitzer

5072937122

mccradyspitzer.shelly@mayo.edu

More information

Publications

Publications are currently not available