Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Keywords
lancing device, lancet, fingerprick, capillary blood, self-monitoring of blood glucose
Brief summary
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.
Interventions
DEVICEDroplet lancing device (HTL-Strefa S.A.)
DEVICEMicrolet 2 lancing device (Bayer)
DEVICEOneTouch Delicia lancing device (LifeScan)
DEVICEReliOn lancing device (ReliOn)
DEVICEAccu-Chek Softclix lancing device (Roche)
DEVICEBGStar lancing device (Sanofi Aventis)
DEVICEUltra-Fine 33G lancets (BD)
DEVICEDroplet 33G lancets (HTL-Strefa S.A.)
DEVICEOneTouch Delicia Extra Fine 33G lancets (LifeScan)
DEVICEHaemoFine 33G lancets (HTL-Strefa S.A.)
DEVICESoftclix 28 G lancets (Roche)
DEVICEReliOn Ultra-Thin Plus 33G lancets (ReliOn)
DEVICEGlucoJect Dual S lancing device (Menarini)
DEVICEMicrolet 28G lancets (Bayer)
DEVICEBGStar Ultra-Thin 33G lancets (Sanofi Aventis)
Sponsors
HTL-Strefa S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume (uL) of blood in the capillary tube | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The intensity of pain perceived by the patient assessed with the use of the VAS (Visual Analog Scale). | 3 minutes (+/- 1 minute) after lancing | 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). |
Outcome results
None listed