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ClinicalTrials.gov ID

NCT03851549

Lead Sponsor

LifeScan Scotland LtdINDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

360Estimated

Last Update Posted

Mar 8, 2019Actual

Start Date

Mar 12, 2019Estimated

Primary Completion Date

Apr 19, 2019Estimated

Completion Date

Apr 19, 2019Estimated

Official Title

US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a New Blood Glucose Monitoring System.

Brief Summary

This study is the US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).

Detailed Description

User Performance - Assess Lay User fingertip test results obtained on the new BGMS compared to a validated method (YSI 2300 STAT PLUS glucose analyzer results) according to FDA Guidance 2016 section VI.C.

Assess System Use of the new BGMS, as relevant to self-testing technique, with reference to the Owner's Booklet.

• Diabetes Mellitus

• New BGMS (US)

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Summary of inclusion criteria:

Subject is at least 12 years old. Informed Consent. Subject has a current diagnosis of type 1 or type 2 diabetes mellitus. Subject reads and understands English. Subject is currently performing unassisted self-monitoring of blood glucose (SMBG) OR naive to SMBG for a 10% sub-group.

Summary of exclusion criteria:

Conflict of interest. Technical expertise.

Primary Purpose

Other

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

LifeScan Scotland LtdINDUSTRY

Collaborators

Institut für Diabetes-Technologie ( IfDT)UNKNOWN

dking38@its.jnj.com