Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting

Dexcom

Status

Unknown

Conditions

Patients Needing Glucose Control

Treatments

Device: Continuous Glucose Monitoring System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04879693

PTL-904283

Details and patient eligibility

About

Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting

Full description

To assess the performance of the CGM System in comparison to a blood glucose comparator method in non-critically ill hospitalized patients who need glucose control.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

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)