Status:
UNKNOWN
Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting
Lead Sponsor:
DexCom, Inc.
Conditions:
Patients Needing Glucose Control
Eligibility:
All Genders
18-120 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04879693
Start Date
June 1 2021
End Date
December 1 2021
Last Update
May 10 2021
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