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

January 31, 2020 updated by: HTL-Strefa S.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 minutes (+/- 1 minute) after lancing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HTL-Strefa S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

January 31, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 31, 2020

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mp08.13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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