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

NCT04879693 | Unknown FDA Device

• 1 other identifier: PTL-904283
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Patients Needing Glucose Control

Outcome Measures

Primary Outcomes (1)

• System Performance

  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.

  Up to 10 days

Study Arms (1)

Hospitalized Patients

EXPERIMENTAL

To assess performance of CGM compared to comparator measurement.

Device: Continuous Glucose Monitoring System

Interventions

Continuous Glucose Monitoring System DEVICE

Continuous Glucose Monitoring System

Hospitalized Patients

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• DexCom, Inc.: lead

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Central Study Contacts

Stayce Beck, PhD, MPH

CONTACT

858-203-6454; PTL904283@dexcom.com

Kathleen Hurst

CONTACT

PTL904283@dexcom.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All systems worn will be blinded. All sensor insertions will be performed at the clinic by subjects and/or caregivers.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 10, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share