At a glance
ClinicalIndex Comparison RecordN/ACompleted· 102 enrolled
Drug / intervention
Contour TS Blood Glucose Monitoring Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Performance Evaluation of the Contour TS BGMS Using ISO/DIS 15197:2011 Section 8 Study Design and Performance Criteria
In Brief
A clinical study evaluating Contour TS Blood Glucose Monitoring System for Diabetes. Completed, enrolled 102 participants across 1 site.
Detailed Summary
The purpose of this study is to determine if untrained subjects who have diabetes can operate the Blood Glucose Monitoring System (BGMS) and obtain acceptable glucose results.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
Primary CompletionApr 2012
First PostedApr 2012
TodayJul 2026
First PostedApr 11, 2012
Enrollment StartApr 1, 2012
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 14.2 years ago
Interventions
Contour TS Blood Glucose Monitoring Systemdevice
Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm and forearm using the Contour TS Blood Glucose Monitoring System. All BG results are compared to a reference laboratory glucose method.