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Clinical Trials/NCT04879693
NCT04879693UnknownNot Applicable

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

DexCom, Inc.0 sites250 target enrollmentStarted: June 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
250
Primary Endpoint
System Performance
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
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 Criteria

Ages
18 Years to 120 Years (Adult, Older Adult)
Sex
All
Accepts 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)

Outcomes

Primary Outcomes

System Performance

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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Effectiveness and Safety of the Dexcom G6... | Clinical Trial