Evaluation of Modified Adhesives With Dexcom G6 Sensor

Diabetes Clinical Trial

Official title:

Evaluation of Modified Adhesives With Dexcom G6 Sensor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04840446
• Other study ID #: PTL-904288
• Status: Completed
• Start date: February 8, 2021
• Est. completion date: March 19, 2021

Study information

• Verified date: April 2021
• Source: DexCom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 19, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Dexcom Continuous Glucose Monitoring System
Dexcom Sensor

Locations

Country	Name	City	State
United States	Jaeb Center for Health Research	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
DexCom, Inc.	Jaeb Center for Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adhesiveness and survivability of the adhesives	Number of adhesives that survive on the body during wear period	10-days
Secondary	Skin irritation with the adhesives	Proportion of participants who self-report skin irritation during wear period.	10-days
Secondary	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
Secondary	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