Status:
UNKNOWN
A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)
Lead Sponsor:
LifeScan Scotland Ltd
Collaborating Sponsors:
Institut für Diabetes-Technologie ( IfDT)
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
12+ years
Phase:
NA
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 V...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 19 2019
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT03851549
Start Date
March 12 2019
End Date
April 19 2019
Last Update
March 8 2019
Active Locations (4)
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1
Institut für Diabetes-Technologie
Ulm, Germany, D-89081
2
Royal Infirmary of Edinburgh
Edinburgh, Lothian, United Kingdom, EH16 4SA
3
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
4
Centre for Health Science
Inverness, United Kingdom, IV2 3JH