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OpenTrials
Completed

NCT Number: NCT04253431

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Device

Primary outcomes

  1. Volume (uL) of blood in the capillary tube

    Time frame: 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 outcomes

  1. The intensity of pain perceived by the patient assessed with the use of the VAS (Visual Analog Scale).

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

HTL-Strefa S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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