NCT04840446

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
Last Updated

April 12, 2021

Status Verified

April 1, 2021

Enrollment Period

1 month

First QC Date

March 30, 2021

Last Update Submit

April 8, 2021

Conditions

Diabetes

Keywords

DiabetesContinuous Glucose Monitoring Systems

Outcome Measures

Primary Outcomes (1)

  • Adhesiveness and survivability of the adhesives

    Number of adhesives that survive on the body during wear period

    10-days

Secondary Outcomes (3)

  • Skin irritation with the adhesives

    10-days

  • Occurrence of adverse events with the adhesives

    10-days

  • Assess user preference or acceptance of the adhesives worn during the study

    10-days

Interventions

Dexcom Continuous Glucose Monitoring SystemDEVICE

Dexcom Sensor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Thomas J Mouse, BS

    Jaeb Center for Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 12, 2021

Study Start

February 8, 2021

Primary Completion

March 16, 2021

Study Completion

March 19, 2021

Last Updated

April 12, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)