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| Name | Class |
|---|---|
| Medical University of Lodz | OTHER |
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A randomized single-blind study with the use of three lancing devices equipped with personal lancets. Every device will be studied for three lancet sizes: 28G, 30G, and 33G with the minimum and maximum puncture depth setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A/28/1 | Experimental | Lancing device A with personal lancet of size 28 G and minimum puncture depth. |
|
| A/28/5 | Experimental | Lancing device A with personal lancet of size 28 G and maximum puncture depth. |
|
| A/30/1 | Experimental | Lancing device A with personal lancet of size 30 G and minimum puncture depth. |
|
| A/30/5 | Experimental | Lancing device A with personal lancet of size 30 G and maximum puncture depth. |
|
| A/33/1 | Experimental | Lancing device A with personal lancet of size 33 G and minimum puncture depth. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lancing device A | Device | Glucoject Dual Plus lancing device |
|
| 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 3 lancing devices set to minimum and maximum puncture depth, with the use of various-sized personal lancets (28G, 30G, and 33G). The volume of blood sample will be measured with the use of capillary tubes calibrated for the volume of 10 μl and a graduated ruler. | 1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min |
| 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 3 lancing devices set to minimum and maximum puncture depth, with the use of various-sized personal lancets (28G, 30G, and 33G). | 1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agnieszka Szadkowska, PhD,Md | Medical University of Lodz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nzoz Magmed | Lodz | 91-738 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32856497 | Derived | Mianowska B, Mlynarski W, Szadkowska I, Szadkowska A. Evaluation of Three Lancing Devices: What Do Blood Volume and Lancing Pain Depend On? J Diabetes Sci Technol. 2021 Sep;15(5):1076-1083. doi: 10.1177/1932296820949930. Epub 2020 Aug 17. |
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| A/33/5 | Experimental | Lancing device A with personal lancet of size 33 G and maximum puncture depth. |
|
| B/28/1 | Experimental | Lancing device B with personal lancet of size 28 G and minimum puncture depth. |
|
| B/28/5 | Experimental | Lancing device B with personal lancet of size 28 G and maximum puncture depth. |
|
| B/30/1 | Experimental | Lancing device B with personal lancet of size 30 G and minimum puncture depth. |
|
| B/30/5 | Experimental | Lancing device B with personal lancet of size 30 G and maximum puncture depth. |
|
| B/33/1 | Experimental | Lancing device B with personal lancet of size 33 G and minimum puncture depth. |
|
| B/33/5 | Experimental | Lancing device B with personal lancet of size 33 G and maximum puncture depth. |
|
| C/28/1 | Experimental | Lancing device C with personal lancet of size 28 G and minimum puncture depth. |
|
| C/28/5 | Experimental | Lancing device C with personal lancet of size 28 G and maximum puncture depth. |
|
| C/30/1 | Experimental | Lancing device C with personal lancet of size 30 G and minimum puncture depth. |
|
| C/30/5 | Experimental | Lancing device C with personal lancet of size 30 G and maximum puncture depth. |
|
| C/33/1 | Experimental | Lancing device C with personal lancet of size 33 G and minimum puncture depth. |
|
| C/33/5 | Experimental | Lancing device C with personal lancet of size 33 G and maximum puncture depth. |
|
| Lancing device B | Device | Droplet lancing device |
|
| Lancing device C | Device | Commercially available lancing device |
|
| 28 G lancet | Device | Droplet 28 G |
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| 30 G lancet | Device | Droplet personal lancet 30 G |
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| 33 G lancet | Device | Droplet personal lancet 33 G |
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| Lancing depth setting (1) | Other | The lowest depth setting (1) |
|
| Lancing depth setting (5) | Other | The highest depth setting (5) |
|
| 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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