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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04253431
• Other study ID #: mp08.13
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2018
• Source: HTL-Strefa S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

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

• Microlet 2 lancing device (Bayer)

• OneTouch Delicia lancing device (LifeScan)

• ReliOn lancing device (ReliOn)

• Accu-Chek Softclix lancing device (Roche)

• BGStar lancing device (Sanofi Aventis)

• Ultra-Fine 33G lancets (BD)

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

• OneTouch Delicia Extra Fine 33G lancets (LifeScan)

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

• Softclix 28 G lancets (Roche)

• ReliOn Ultra-Thin Plus 33G lancets (ReliOn)

• GlucoJect Dual S lancing device (Menarini)

• Microlet 28G lancets (Bayer)

• BGStar Ultra-Thin 33G lancets (Sanofi Aventis)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HTL-Strefa S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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