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| Name | Class |
|---|---|
| Institut für Diabetes-Technologie ( IfDT) | UNKNOWN |
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This study is the US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Glucose monitoring System (BGMS) | Experimental | Intervention: Blood Glucose monitoring Systems (BGMS): Results obtained from the new BGMS for UP are compared to a reference instrument (YSI 2300) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New BGMS (US) | Device | New blood glucose monitoring system / In vitro diagnostic device (IVDD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| User Performance ( UP) | User Performance evaluation (referred to as Method Comparison / User Evaluation in FDA Guidance 2016): Lay User accuracy of BGMS by comparison of meter blood glucose results to a laboratory reference instrument. | < 30 minutes |
| System Use Evaluation | System usability: Lay user system use evaluation (as relevant to fingertip self-testing) by study personnel observation and completion of a scoring questionnaire. | < 30 minutes |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorna Stewart | Contact | +44 01463 721000 | LSTEWAR5@its.jnj.com | |
| Laura Ritchie | Contact | +44 01463 721000 | lritchi6@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Kirsty Macleod | LifeScan Scotland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Diabetes-Technologie | Ulm | D-89081 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32059615 | Derived | Katz LB, Stewart L, King D, Cameron H. Meeting the New FDA Standard for Accuracy of Self-Monitoring Blood Glucose Test Systems Intended for Home Use by Lay Users. J Diabetes Sci Technol. 2020 Sep;14(5):912-916. doi: 10.1177/1932296820906184. Epub 2020 Feb 14. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Royal Infirmary of Edinburgh | Edinburgh | Lothian | EH16 4SA | United Kingdom |
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| Birmingham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
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| Centre for Health Science | Inverness | IV2 3JH | United Kingdom |
|