Evaluation of Modified Adhesives With Dexcom G6 Sensor

NCT ID: NCT04840446

Last Updated: 2021-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-08

Study Completion Date

2021-03-19

Brief Summary

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

Detailed Description

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Conditions

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Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Dexcom Continuous Glucose Monitoring System

Dexcom Sensor

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jaeb Center for Health Research

OTHER

Sponsor Role collaborator

DexCom, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas J Mouse, BS

Role: PRINCIPAL_INVESTIGATOR

Jaeb Center for Health Research

Locations

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Jaeb Center for Health Research

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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PTL-904288

Identifier Type: -

Identifier Source: org_study_id

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