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

Not Applicable

• Conditions: Patients Needing Glucose Control
• Interventions: Device: Continuous Glucose Monitoring System

• Registration Number: NCT04879693
• Lead Sponsor: DexCom, Inc.

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.

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-07
• Last Update Submitted: 2021-05-07
• Study First Posted: 2021-05-10
• Last Update Posted: 2021-05-10
• Study Start: 2021-06
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hospitalized Patients	Continuous Glucose Monitoring System	To assess performance of CGM compared to comparator measurement.

Primary Outcome Measures

Name	Time	Method
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.