Evaluation of Modified Adhesives With Dexcom G6 Sensor

The purpose of the study is to collect and compare information on the performance of CGM adhesives in adults.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: Dexcom Continuous Glucose Monitoring System

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33647
      • Jaeb Center for Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Potential study participants will be identified via diabetes patient website and/or virtual registry.

Description

Inclusion Criteria:

1. Age 18 or older;
2. No previously self-reported adhesive reactions to the any continuous glucose monitor (CGM);

Exclusion Criteria:

1. Extensive skin changes/diseases that preclude wearing the required number of devices (e.g., history of severe reactions from adhesive wear, extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
2. Current or anticipated use of systemic corticosteroids (oral, injectable, or intravenous)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adhesiveness and survivability of the adhesives	Number of adhesives that survive on the body during wear period	10-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin irritation with the adhesives	Proportion of participants who self-report skin irritation during wear period.	10-days
Occurrence of adverse events with the adhesives	Highest Draize scale score for adhesive erythema, and edema during wear period. Recorded medical adhesive-related skin injuries (MARSI) and severity during wear period.	10-days
Assess user preference or acceptance of the adhesives worn during the study	Final day post-study satisfaction questionnaire (for each adhesive) will be given a score by taking the mean response on the scale 1-5. Satisfaction scores will be tabulated by adhesive.	10-days

Collaborators and Investigators

• Sponsor: DexCom, Inc.
• Collaborators: Jaeb Center for Health Research
• Investigators: Principal Investigator: Thomas J Mouse, BS, Jaeb Center for Health Research

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Actual): March 16, 2021
• Study Completion (Actual): March 19, 2021

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes; Continuous Glucose Monitoring Systems
• Other Study ID Numbers: PTL-904288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No