Lay-user Trial of the iGlucose Blood Glucose Monitoring System

Diabetes Mellitus Clinical Trial

Official title:

A Lay User Study of the iGlucose, a Device for Self-Monitoring of Blood Glucose (SMBG), Marketed by the Smart Meter Corporation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709707
• Other study ID #: CP00001
• Status: Completed
• Phase: N/A
• First received: March 8, 2016
• Last updated: June 19, 2016
• Start date: March 2016
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Smart Meter Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users

Description:

A non-randomized, prospective study of recruited subjects with diabetes. Subjects will include those with type I or type II diabetes of various duration and those who are naive to self-testing of blood glucose. Subjects will use provided instructions-for-use to undergo self-training on the use of the device and will then self-test their blood glucose level. Results will be compared to those obtained by a lab glucose analyzer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Do not meet Inclusion Criteria

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Blood glucose monitor

Locations

Country	Name	City	State
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Nina Peled

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of blood glucose measurements as performed by lay users		10 minutes to produce self blood result and to perform lab comparative method	No
Secondary	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	No