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A randomized single-blind study with the use of different lancing devices equipped with personal lancets to determine and to compare the amount of capillary blood volume and perceived pain after a single lancing of the fingertip.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L01 | Experimental | Finger pricking using lancing device with personal lancets |
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| L02 | Experimental | Finger pricking using lancing device with personal lancets |
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| L03 | Experimental | Finger pricking using lancing device with personal lancets |
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| L04 | Experimental | Finger pricking using lancing device with personal lancets |
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| L05 | Experimental | Finger pricking using lancing device with personal lancets |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Droplet lancing device (HTL-Strefa S.A.) | Device |
| ||
| Microlet 2 lancing device (Bayer) |
| Measure | Description | Time Frame |
|---|---|---|
| Volume (uL) of blood in the capillary tube | Examination of the volume of blood obtained after puncturing a fingertip with the use of different lancing devices set to maximum puncture depth, with the use of various-sized personal lancets (28G and 33G). | The blood from the puncture site was collected to the capillaries for 30 seconds, and afterwards amount of the blood was measured using a calibrated ruler |
| Measure | Description | Time Frame |
|---|---|---|
| The intensity of pain perceived by the patient assessed with the use of the VAS (Visual Analog Scale). | Examination of the intensity of pain perceived when puncturing a fingertip with the use of different lancing devices set to maximum puncture depth, with the use of various-sized personal lancets (28G and 33G). | 3 minutes (+/- 1 minute) after lancing |
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Inclusion Criteria:
Exclusion Criteria:
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| L06 | Experimental | Finger pricking using lancing device with personal lancets |
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| L07 | Experimental | Finger pricking using lancing device with personal lancets |
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| L08 | Experimental | Finger pricking using lancing device with personal lancets |
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| L09 | Experimental | Finger pricking using lancing device with personal lancets |
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| L10 | Experimental | Finger pricking using lancing device with personal lancets |
|
| Device |
|
| OneTouch Delicia lancing device (LifeScan) | Device |
|
| ReliOn lancing device (ReliOn) | Device |
|
| Accu-Chek Softclix lancing device (Roche) | Device |
|
| BGStar lancing device (Sanofi Aventis) | Device |
|
| Ultra-Fine 33G lancets (BD) | Device |
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| Droplet 33G lancets (HTL-Strefa S.A.) | Device |
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| OneTouch Delicia Extra Fine 33G lancets (LifeScan) | Device |
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| HaemoFine 33G lancets (HTL-Strefa S.A.) | Device |
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| Softclix 28 G lancets (Roche) | Device |
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| ReliOn Ultra-Thin Plus 33G lancets (ReliOn) | Device |
|
| GlucoJect Dual S lancing device (Menarini) | Device |
|
| Microlet 28G lancets (Bayer) | Device |
|
| BGStar Ultra-Thin 33G lancets (Sanofi Aventis) | Device |
|
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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