Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity.

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity.

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Lancing device A
* Device: Lancing device B
* Device: Lancing device C
* Device: 28 G lancet
* Device: 30 G lancet
* Device: 33 G lancet
* Other: Lancing depth setting (1)
* Other: Lancing depth setting (5)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with diagnosed diabetes type 1 or 2 , aged 18 - 50, period of suffering from diabetes >2 years, performing on average 3-8 daily measurements of glycaemia, glycaemia at the moment of the beginning of the study between 70 and 200 mg/dl. Exclusion Criteria: glycaemia below 70 mg/dl or glycaemia above 200 mg/dl at the moment of the beginning of the study, previously diagnosed hemorrhagic diathesis or heavy bleedings in the past (also those without a medical diagnosis), anticoagulant (thrombolytic medication) therapy within 3 weeks prior to the study or on the day of the study, non steroidal anti-inflammatory drugs (NSAID) treatment 1 week prior to the study or on the day of the study, patients with signs of dehydration, patients who are currently participating in another clinical study, currently diagnosed or reported by the patient skin diseases, nervous system diseases, psychiatric diseases, etc., which, in the opinion of the person conducting the study, disqualify the patient from the participation in the study, in care for the patient's well-being.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A/28/1<br>Lancing device A with personal lancet of size 28 G and minimum puncture depth. | Device: Lancing device A<br>* Glucoject Dual Plus lancing device<br>Device: 28 G lancet<br>* Droplet 28 G<br>Other: Lancing depth setting (1)<br>* The lowest depth setting (1)<br>|
| Experimental: A/28/5<br>Lancing device A with personal lancet of size 28 G and maximum puncture depth. | Device: Lancing device A<br>* Glucoject Dual Plus lancing device<br>Device: 28 G lancet<br>* Droplet 28 G<br>Other: Lancing depth setting (5)<br>* The highest depth setting (5)<br>|
| Experimental: A/30/1<br>Lancing device A with personal lancet of size 30 G and minimum puncture depth. | Device: Lancing device A<br>* Glucoject Dual Plus lancing device<br>Device: 30 G lancet<br>* Droplet personal lancet 30 G<br>Other: Lancing depth setting (1)<br>* The lowest depth setting (1)<br>|
| Experimental: A/30/5<br>Lancing device A with personal lancet of size 30 G and maximum puncture depth. | Device: Lancing device A<br>* Glucoject Dual Plus lancing device<br>Device: 30 G lancet<br>* Droplet personal lancet 30 G<br>Other: Lancing depth setting (5)<br>* The highest depth setting (5)<br>|
| Experimental: A/33/1<br>Lancing device A with personal lancet of size 33 G and minimum puncture depth. | Device: Lancing device A<br>* Glucoject Dual Plus lancing device<br>Device: 33 G lancet<br>* Droplet personal lancet 33 G<br>Other: Lancing depth setting (1)<br>* The lowest depth setting (1)<br>|
| Experimental: A/33/5<br>Lancing device A with personal lancet of size 33 G and maximum puncture depth. | Device: Lancing device A<br>* Glucoject Dual Plus lancing device<br>Device: 33 G lancet<br>* Droplet personal lancet 33 G<br>Other: Lancing depth setting (5)<br>* The highest depth setting (5)<br>|
| Experimental: B/28/1<br>Lancing device B with personal lancet of size 28 G and minimum puncture depth. | Device: Lancing device B<br>* Droplet lancing device<br>Device: 28 G lancet<br>* Droplet 28 G<br>Other: Lancing depth setting (1)<br>* The lowest depth setting (1)<br>|
| Experimental: B/28/5<br>Lancing device B with personal lancet of size 28 G and maximum puncture depth. | Device: Lancing device B<br>* Droplet lancing device<br>Device: 28 G lancet<br>* Droplet 28 G<br>Other: Lancing depth setting (5)<br>* The highest depth setting (5)<br>|
| Experimental: B/30/1<br>Lancing device B with personal lancet of size 30 G and minimum puncture depth. | Device: Lancing device B<br>* Droplet lancing device<br>Device: 30 G lancet<br>* Droplet personal lancet 30 G<br>Other: Lancing depth setting (1)<br>* The lowest depth setting (1)<br>|
| Experimental: B/30/5<br>Lancing device B with personal lancet of size 30 G and maximum puncture depth. | Device: Lancing device B<br>* Droplet lancing device<br>Device: 30 G lancet<br>* Droplet personal lancet 30 G<br>Other: Lancing depth setting (5)<br>* The highest depth setting (5)<br>|
| Experimental: B/33/1<br>Lancing device B with personal lancet of size 33 G and minimum puncture depth. | Device: Lancing device B<br>* Droplet lancing device<br>Device: 33 G lancet<br>* Droplet personal lancet 33 G<br>Other: Lancing depth setting (1)<br>* The lowest depth setting (1)<br>|
| Experimental: B/33/5<br>Lancing device B with personal lancet of size 33 G and maximum puncture depth. | Device: Lancing device B<br>* Droplet lancing device<br>Device: 33 G lancet<br>* Droplet personal lancet 33 G<br>Other: Lancing depth setting (5)<br>* The highest depth setting (5)<br>|
| Experimental: C/28/1<br>Lancing device C with personal lancet of size 28 G and minimum puncture depth. | Device: Lancing device C<br>* Commercially available lancing device<br>Device: 28 G lancet<br>* Droplet 28 G<br>Other: Lancing depth setting (1)<br>* The lowest depth setting (1)<br>|
| Experimental: C/28/5<br>Lancing device C with personal lancet of size 28 G and maximum puncture depth. | Device: Lancing device C<br>* Commercially available lancing device<br>Device: 28 G lancet<br>* Droplet 28 G<br>Other: Lancing depth setting (5)<br>* The highest depth setting (5)<br>|
| Experimental: C/30/1<br>Lancing device C with personal lancet of size 30 G and minimum puncture depth. | Device: Lancing device C<br>* Commercially available lancing device<br>Device: 30 G lancet<br>* Droplet personal lancet 30 G<br>Other: Lancing depth setting (1)<br>* The lowest depth setting (1)<br>|
| Experimental: C/30/5<br>Lancing device C with personal lancet of size 30 G and maximum puncture depth. | Device: Lancing device C<br>* Commercially available lancing device<br>Device: 30 G lancet<br>* Droplet personal lancet 30 G<br>Other: Lancing depth setting (5)<br>* The highest depth setting (5)<br>|
| Experimental: C/33/1<br>Lancing device C with personal lancet of size 33 G and minimum puncture depth. | Device: Lancing device C<br>* Commercially available lancing device<br>Device: 33 G lancet<br>* Droplet personal lancet 33 G<br>Other: Lancing depth setting (1)<br>* The lowest depth setting (1)<br>|
| Experimental: C/33/5<br>Lancing device C with personal lancet of size 33 G and maximum puncture depth. | Device: Lancing device C<br>* Commercially available lancing device<br>Device: 33 G lancet<br>* Droplet personal lancet 33 G<br>Other: Lancing depth setting (5)<br>* The highest depth setting (5)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lancing device, lancet