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

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ClinicalTrials.gov Identifier: NCT04253431
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
HTL-Strefa S.A.

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Device: 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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
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
Actual Study Start Date : August 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: L01
Finger pricking using lancing device with personal lancets
Device: Droplet lancing device (HTL-Strefa S.A.)
Device: Ultra-Fine 33G lancets (BD)
Experimental: L02
Finger pricking using lancing device with personal lancets
Device: Microlet 2 lancing device (Bayer)
Device: Droplet 33G lancets (HTL-Strefa S.A.)
Experimental: L03
Finger pricking using lancing device with personal lancets
Device: OneTouch Delicia lancing device (LifeScan)
Device: OneTouch Delicia Extra Fine 33G lancets (LifeScan)
Experimental: L04
Finger pricking using lancing device with personal lancets
Device: Droplet lancing device (HTL-Strefa S.A.)
Device: HaemoFine 33G lancets (HTL-Strefa S.A.)
Experimental: L05
Finger pricking using lancing device with personal lancets
Device: ReliOn lancing device (ReliOn)
Device: ReliOn Ultra-Thin Plus 33G lancets (ReliOn)
Experimental: L06
Finger pricking using lancing device with personal lancets
Device: Accu-Chek Softclix lancing device (Roche)
Device: Softclix 28 G lancets (Roche)
Experimental: L07
Finger pricking using lancing device with personal lancets
Device: Microlet 2 lancing device (Bayer)
Device: Microlet 28G lancets (Bayer)
Experimental: L08
Finger pricking using lancing device with personal lancets
Device: Droplet lancing device (HTL-Strefa S.A.)
Device: Droplet 33G lancets (HTL-Strefa S.A.)
Experimental: L09
Finger pricking using lancing device with personal lancets
Device: BGStar lancing device (Sanofi Aventis)
Device: BGStar Ultra-Thin 33G lancets (Sanofi Aventis)
Experimental: L10
Finger pricking using lancing device with personal lancets
Device: HaemoFine 33G lancets (HTL-Strefa S.A.)
Device: GlucoJect Dual S lancing device (Menarini)



Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: HTL-Strefa S.A.
ClinicalTrials.gov Identifier: NCT04253431    
Other Study ID Numbers: mp08.13
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HTL-Strefa S.A.:
lancing device
lancet
fingerprick
capillary blood
self-monitoring of blood glucose
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases