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

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

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.

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.