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

- 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 type (does not apply to
participants placed in an ICU bed due to space issues in the non-ICU areas)

- Known allergy to medical-grade adhesives

- Pregnancy, demonstrated by a positive test (for subjects of childbearing potential)

- Women admitted to give birth or any other admission related to pregnancy

- Patients receiving Hydroxyurea

- Bleeding disorder

- Participants that are currently being treated for malignancies, cancer

- Participant that are hospitalized to receive an organ transplant

- Require a Magnetic Resonance Imaging (MRI) scan

- End stage renal disease and currently managed by dialysis or anticipating initiating
dialysis during the study wear period

- Current participation in another investigational study protocol (If a subject has
recently completed participation in another drug study, the subject must have
completed that study at least 7 days prior to being enrolled in this study.)

- Any condition that, in the opinion of the Investigator, would interfere with their
participation in the trial or pose an excessive risk to study staff (e.g., known
history of hepatitis B or C)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/23/23. 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 M.S. (507) 255-5916 McCradySpitzer.Shelly@mayo.edu

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 M.S.

(507) 255-5916

McCradySpitzer.Shelly@mayo.edu

More information

Publications

Publications are currently not available

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