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The primary objective of the study examines the success rate of various OneTouch Delica lancet sizes across depth settings of the OneTouch Delica lancing device. The sample size is based on 30 subjects per lancet size for a given depth setting. Each subject is lanced 4 times with two lancet sizes at a single depth setting. There will be 120 paired lancing events for each lancet size within the group.
Null hypothesis (H0): there is a 90% success rate of attaining a minimum blood volume of 1.0μL for the 28g lancet across all depth settings.
Alternate hypothesis (H1): the success rate of attaining a minimum blood volume of 1.0μL for the 28g lancet across all depth settings is less than 90%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delica 28g Depth 3 vs Delica 30g Depth 3 | 30 subjects with diabetes |
| |
| Delica 28g Depth 5 vs Delica 30g Depth 5 | 30 subjects with diabetes |
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| Delica 28g Depth 7 vs Delica 30g Depth 7 | 30 subjects with diabetes |
| |
| Delica 28g Depth 3 vs Delica 33g Depth 3 | 30 subjects with diabetes |
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| Delica 28g Depth 5 vs Delica 33g Depth 5 | 30 subjects with diabetes |
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| Delica 28g Depth 7 vs Delica 33g Depth 7 | 30 subjects with diabetes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delica Device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Volume Measurements | Lancing events were performed on subjects fingers. After each lancing event blood volume was measure with a scale. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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People with diabetes from the surrounding communitu
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| Name | Affiliation | Role |
|---|---|---|
| Barry Ginsberg, MD | Facet Technologies | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facet Technologies | Kennesaw | Georgia | 30144 | United States |
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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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