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

HTL-Strefa

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Treatments: Device: OneTouch Delicia Extra Fine 33G lancets (LifeScan); Device: Softclix 28 G lancets (Roche); Device: BGStar lancing device (Sanofi Aventis); Device: Microlet 2 lancing device (Bayer); Device: BGStar Ultra-Thin 33G lancets (Sanofi Aventis); Device: ReliOn lancing device (ReliOn); Device: Droplet lancing device (HTL-Strefa S.A.); Device: GlucoJect Dual S lancing device (Menarini); Device: ReliOn Ultra-Thin Plus 33G lancets (ReliOn); Device: Ultra-Fine 33G lancets (BD); Device: Microlet 28G lancets (Bayer); Device: HaemoFine 33G lancets (HTL-Strefa S.A.); Device: Accu-Chek Softclix lancing device (Roche); Device: Droplet 33G lancets (HTL-Strefa S.A.); Device: OneTouch Delicia lancing device (LifeScan)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04253431

mp08.13

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 10 patient groups

L01

Experimental group

Description:

Finger pricking using lancing device with personal lancets

Treatment:

Device: Droplet lancing device (HTL-Strefa S.A.)

Device: Ultra-Fine 33G lancets (BD)

L02

Experimental group

Description:

Finger pricking using lancing device with personal lancets

Treatment:

Device: Droplet 33G lancets (HTL-Strefa S.A.)

Device: Microlet 2 lancing device (Bayer)

L03

Experimental group

Description:

Finger pricking using lancing device with personal lancets

Treatment:

Device: OneTouch Delicia lancing device (LifeScan)

Device: OneTouch Delicia Extra Fine 33G lancets (LifeScan)

L04

Experimental group

Description:

Finger pricking using lancing device with personal lancets

Treatment:

Device: HaemoFine 33G lancets (HTL-Strefa S.A.)

Device: Droplet lancing device (HTL-Strefa S.A.)

L05

Experimental group

Description:

Finger pricking using lancing device with personal lancets

Treatment:

Device: ReliOn lancing device (ReliOn)

Device: ReliOn Ultra-Thin Plus 33G lancets (ReliOn)

L06

Experimental group

Description:

Finger pricking using lancing device with personal lancets

Treatment:

Device: Softclix 28 G lancets (Roche)

Device: Accu-Chek Softclix lancing device (Roche)

L07

Experimental group

Description:

Finger pricking using lancing device with personal lancets

Treatment:

Device: Microlet 2 lancing device (Bayer)

Device: Microlet 28G lancets (Bayer)

L08

Experimental group

Description:

Finger pricking using lancing device with personal lancets

Treatment:

Device: Droplet 33G lancets (HTL-Strefa S.A.)

Device: Droplet lancing device (HTL-Strefa S.A.)

L09

Experimental group

Description:

Finger pricking using lancing device with personal lancets

Treatment:

Device: BGStar Ultra-Thin 33G lancets (Sanofi Aventis)

Device: BGStar lancing device (Sanofi Aventis)

L10

Experimental group

Description:

Finger pricking using lancing device with personal lancets

Treatment:

Device: HaemoFine 33G lancets (HTL-Strefa S.A.)

Device: GlucoJect Dual S lancing device (Menarini)