Lay-user Trial of the iGlucose Blood Glucose Monitoring System
A Lay User Study of the iGlucose, a Device for Self-Monitoring of Blood Glucose (SMBG), Marketed by the Smart Meter Corporation
1 other identifier
observational
153
1 country
1
Brief Summary
Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 8, 2016
CompletedFirst Posted
Study publicly available on registry
March 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 21, 2016
June 1, 2016
3 months
March 8, 2016
June 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy of blood glucose measurements as performed by lay users
10 minutes to produce self blood result and to perform lab comparative method
Secondary Outcomes (1)
Assessment by lay users of the ease of use of the iGlucose Blood Glucose Monitoring System
2 -3 hours of going through a self-training session and producing an assessment
Study Arms (1)
Patients with diabetes
Interventions
Eligibility Criteria
Subjects with a diagnosis of diabetes, either type 1 or type 2, of various duration with blood glucose levels covering the entire measurement range. .
You may qualify if:
- Be 12 years of age and older
- Have pre-existing diagnosis of diabetes
- Be able to read and understand English
- Agree to participate in the study
- Be able and willing to provide informed consent
You may not qualify if:
- With Hemophilia or any other bleeding disorder
- With any condition which in the opinion of the Investigator may place the subject or site staff at excessive risk
- With physical condition/limitation preventing the use of SMBG on their own
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nina Peledlead
Study Sites (1)
Diablo Clinical Research
Walnut Creek, California, 94598, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Regulatory Consultant
Study Record Dates
First Submitted
March 8, 2016
First Posted
March 16, 2016
Study Start
March 1, 2016
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 21, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share