The Characteristics of Different Personal Lancets on Blood Volume and Perceived Pain in Patients With Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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A Single-blind, Randomized, Single-centre Study to Investigate the Characteristics of Different Personal Lancets on Blood Volume and Perceived Pain in Patients With Diabetes Mellitus

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

Intervention / Treatment
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* Device: Droplet lancing device (HTL-Strefa S.A.)
* Device: Microlet 2 lancing device (Bayer)
* 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: Droplet 33G lancets (HTL-Strefa S.A.)
* Device: OneTouch Delicia Extra Fine 33G lancets (LifeScan)
* Device: HaemoFine 33G lancets (HTL-Strefa S.A.)
* Device: Softclix 28 G lancets (Roche)
* Device: 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)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to sign the informed consent. Must currently be diagnosed with either Type I or Type II diabetes mellitus. Otherwise in good physical and mental health. Must currently be performing self-monitoring of blood glucose (self reported). Must be between 18-75 years of age (inclusive). Ability to read and follow study instructions. Exclusion Criteria: Pregnancy (self reported). Severe poor blood circulation in the fingers. Any skin condition on his or her fingers that prevents blood sampling. History of a bleeding disorder. Neuropathy or other condition affecting sensation in the hands. Self-reported blood borne infection (e.g., HIV, hepatitis B or C, syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, T lymphotropic virus Type 1, Creutzfeldt-Jakob disease). Currently participating in another study. History of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse. Donation or loss of 400 mL or more of blood within 4 weeks prior to the start of the study. Any prescription or OTC medication within two days of starting the study which might affect pain perception (for example, ibuprofen or paracetamol). Alcohol 48 hours before study start.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: L01<br>Finger pricking using lancing device with personal lancets | Device: Droplet lancing device (HTL-Strefa S.A.)<br> <br> Device: Ultra-Fine 33G lancets (BD)<br> <br> |
| Experimental: L02<br>Finger pricking using lancing device with personal lancets | Device: Microlet 2 lancing device (Bayer)<br> <br> Device: Droplet 33G lancets (HTL-Strefa S.A.)<br> <br> |
| Experimental: L03<br>Finger pricking using lancing device with personal lancets | Device: OneTouch Delicia lancing device (LifeScan)<br> <br> Device: OneTouch Delicia Extra Fine 33G lancets (LifeScan)<br> <br> |
| Experimental: L04<br>Finger pricking using lancing device with personal lancets | Device: Droplet lancing device (HTL-Strefa S.A.)<br> <br> Device: HaemoFine 33G lancets (HTL-Strefa S.A.)<br> <br> |
| Experimental: L05<br>Finger pricking using lancing device with personal lancets | Device: ReliOn lancing device (ReliOn)<br> <br> Device: ReliOn Ultra-Thin Plus 33G lancets (ReliOn)<br> <br> |
| Experimental: L06<br>Finger pricking using lancing device with personal lancets | Device: Accu-Chek Softclix lancing device (Roche)<br> <br> Device: Softclix 28 G lancets (Roche)<br> <br> |
| Experimental: L07<br>Finger pricking using lancing device with personal lancets | Device: Microlet 2 lancing device (Bayer)<br> <br> Device: Microlet 28G lancets (Bayer)<br> <br> |
| Experimental: L08<br>Finger pricking using lancing device with personal lancets | Device: Droplet lancing device (HTL-Strefa S.A.)<br> <br> Device: Droplet 33G lancets (HTL-Strefa S.A.)<br> <br> |
| Experimental: L09<br>Finger pricking using lancing device with personal lancets | Device: BGStar lancing device (Sanofi Aventis)<br> <br> Device: BGStar Ultra-Thin 33G lancets (Sanofi Aventis)<br> <br> |
| Experimental: L10<br>Finger pricking using lancing device with personal lancets | Device: HaemoFine 33G lancets (HTL-Strefa S.A.)<br> <br> Device: GlucoJect Dual S lancing device (Menarini)<br> <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 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 | 

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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lancing device, lancet, fingerprick, capillary blood, self-monitoring of blood glucose