Patients Needing Glucose Control
Conditions
Brief summary
Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting
Detailed 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.
Interventions
DEVICEContinuous Glucose Monitoring System
Continuous Glucose Monitoring System
Sponsors
DexCom, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
All systems worn will be blinded. All sensor insertions will be performed at the clinic by subjects and/or caregivers.
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Performance | Up to 10 days | 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. |
Contacts
Primary ContactStayce Beck, PhD, MPH
Backup ContactKathleen Hurst
Outcome results
None listed