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

NCT ID: NCT04879693

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2021-12-31

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.

Conditions

Patients Needing Glucose Control

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Hospitalized Patients

To assess performance of CGM compared to comparator measurement.

Group Type: EXPERIMENTAL

Continuous Glucose Monitoring System

Intervention Type: DEVICE

Continuous Glucose Monitoring System

Interventions

Continuous Glucose Monitoring System

Continuous Glucose Monitoring System

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DexCom, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Stayce Beck, PhD, MPH

Role: CONTACT

PTL904283@dexcom.com

858-203-6454

Kathleen Hurst

Role: CONTACT

PTL904283@dexcom.com

Other Identifiers

PTL-904283

Identifier Type: -

Identifier Source: org_study_id