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OpenTrials
Completed

NCT Number: NCT04840446

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;
  • Current or anticipated use of systemic corticosteroids (oral, injectable, or intravenous)

Treatment and study plan

Dexcom Continuous Glucose Monitoring System

Device

Dexcom Sensor

Primary outcomes

  1. Adhesiveness and survivability of the adhesives

    Time frame: 10-days

    Number of adhesives that survive on the body during wear period

Secondary outcomes

  1. Skin irritation with the adhesives

    Time frame: 10-days

    Proportion of participants who self-report skin irritation during wear period.

  2. Occurrence of adverse events with the adhesives

    Time frame: 10-days

    Highest Draize scale score for adhesive erythema, and edema during wear period. Recorded medical adhesive-related skin injuries (MARSI) and severity during wear period.

  3. Assess user preference or acceptance of the adhesives worn during the study

    Time frame: 10-days

    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.

Sponsors and collaborators

Lead sponsor

DexCom, Inc.

Industry

Collaborators

  • Jaeb Center for Health Research

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 12, 2021
Registry last updated
Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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