CClinicalTrials.gg
Sign In
CompletedNCT04253431Updated Feb 5, 2020

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

An interventional study of Droplet lancing device (HTL-Strefa S.A.) and Microlet 2 lancing device (Bayer) in Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by HTL-Strefa S.A.. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by HTL-Strefa S.A. · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • lancing device
  • lancet
  • fingerprick
  • capillary blood
  • self-monitoring of blood glucose
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • 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)

Interventions

  • DeviceDroplet lancing device (HTL-Strefa S.A.)
  • DeviceMicrolet 2 lancing device (Bayer)
  • DeviceOneTouch Delicia lancing device (LifeScan)
  • DeviceReliOn lancing device (ReliOn)
  • DeviceAccu-Chek Softclix lancing device (Roche)
  • DeviceBGStar lancing device (Sanofi Aventis)
  • DeviceUltra-Fine 33G lancets (BD)
  • DeviceDroplet 33G lancets (HTL-Strefa S.A.)
  • DeviceOneTouch Delicia Extra Fine 33G lancets (LifeScan)
  • DeviceHaemoFine 33G lancets (HTL-Strefa S.A.)
  • DeviceSoftclix 28 G lancets (Roche)
  • DeviceReliOn Ultra-Thin Plus 33G lancets (ReliOn)
  • DeviceGlucoJect Dual S lancing device (Menarini)
  • DeviceMicrolet 28G lancets (Bayer)
  • DeviceBGStar Ultra-Thin 33G lancets (Sanofi Aventis)
05

What researchers measure

Primary outcomes

  1. 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).

    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

Secondary outcomes

  1. 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).

    Time frame: 3 minutes (+/- 1 minute) after lancing

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT04253431
Lead sponsor
HTL-Strefa S.A.
Responsible party
Sponsor
First posted
Feb 5, 2020
Start date
Aug 2013
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Feb 5, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus→

Other studies from this sponsor

HTL-Strefa S.A.

Start the discussion