Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity.

January 30, 2020 updated by: HTL-Strefa S.A.
A randomized single-blind study with the use of three lancing devices equipped with personal lancets. Every device will be studied for three lancet sizes: 28G, 30G, and 33G with the minimum and maximum puncture depth setting.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lodz, Poland, 91-738
        • Nzoz Magmed

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with diagnosed diabetes type 1 or 2 ,
  • aged 18 - 50,
  • period of suffering from diabetes >2 years,
  • performing on average 3-8 daily measurements of glycaemia,
  • glycaemia at the moment of the beginning of the study between 70 and 200 mg/dl.

Exclusion Criteria:

  • glycaemia below 70 mg/dl or glycaemia above 200 mg/dl at the moment of the beginning of the study,
  • previously diagnosed hemorrhagic diathesis or heavy bleedings in the past (also those without a medical diagnosis),
  • anticoagulant (thrombolytic medication) therapy within 3 weeks prior to the study or on the day of the study,
  • non steroidal anti-inflammatory drugs (NSAID) treatment 1 week prior to the study or on the day of the study,
  • patients with signs of dehydration,
  • patients who are currently participating in another clinical study,
  • currently diagnosed or reported by the patient skin diseases, nervous system diseases, psychiatric diseases, etc., which, in the opinion of the person conducting the study, disqualify the patient from the participation in the study, in care for the patient's well-being.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A/28/1
Lancing device A with personal lancet of size 28 G and minimum puncture depth.
Device: Lancing device A
Glucoject Dual Plus lancing device
Device: 28 G lancet
Droplet 28 G
Other: Lancing depth setting (1)
The lowest depth setting (1)
Experimental: A/28/5
Lancing device A with personal lancet of size 28 G and maximum puncture depth.
Device: Lancing device A
Glucoject Dual Plus lancing device
Device: 28 G lancet
Droplet 28 G
Other: Lancing depth setting (5)
The highest depth setting (5)
Experimental: A/30/1
Lancing device A with personal lancet of size 30 G and minimum puncture depth.
Device: Lancing device A
Glucoject Dual Plus lancing device
Other: Lancing depth setting (1)
The lowest depth setting (1)
Device: 30 G lancet
Droplet personal lancet 30 G
Experimental: A/30/5
Lancing device A with personal lancet of size 30 G and maximum puncture depth.
Device: Lancing device A
Glucoject Dual Plus lancing device
Other: Lancing depth setting (5)
The highest depth setting (5)
Device: 30 G lancet
Droplet personal lancet 30 G
Experimental: A/33/1
Lancing device A with personal lancet of size 33 G and minimum puncture depth.
Device: Lancing device A
Glucoject Dual Plus lancing device
Other: Lancing depth setting (1)
The lowest depth setting (1)
Device: 33 G lancet
Droplet personal lancet 33 G
Experimental: A/33/5
Lancing device A with personal lancet of size 33 G and maximum puncture depth.
Device: Lancing device A
Glucoject Dual Plus lancing device
Other: Lancing depth setting (5)
The highest depth setting (5)
Device: 33 G lancet
Droplet personal lancet 33 G
Experimental: B/28/1
Lancing device B with personal lancet of size 28 G and minimum puncture depth.
Device: 28 G lancet
Droplet 28 G
Other: Lancing depth setting (1)
The lowest depth setting (1)
Device: Lancing device B
Droplet lancing device
Experimental: B/28/5
Lancing device B with personal lancet of size 28 G and maximum puncture depth.
Device: 28 G lancet
Droplet 28 G
Other: Lancing depth setting (5)
The highest depth setting (5)
Device: Lancing device B
Droplet lancing device
Experimental: B/30/1
Lancing device B with personal lancet of size 30 G and minimum puncture depth.
Other: Lancing depth setting (1)
The lowest depth setting (1)
Device: 30 G lancet
Droplet personal lancet 30 G
Device: Lancing device B
Droplet lancing device
Experimental: B/30/5
Lancing device B with personal lancet of size 30 G and maximum puncture depth.
Other: Lancing depth setting (5)
The highest depth setting (5)
Device: 30 G lancet
Droplet personal lancet 30 G
Device: Lancing device B
Droplet lancing device
Experimental: B/33/1
Lancing device B with personal lancet of size 33 G and minimum puncture depth.
Other: Lancing depth setting (1)
The lowest depth setting (1)
Device: 33 G lancet
Droplet personal lancet 33 G
Device: Lancing device B
Droplet lancing device
Experimental: B/33/5
Lancing device B with personal lancet of size 33 G and maximum puncture depth.
Other: Lancing depth setting (5)
The highest depth setting (5)
Device: 33 G lancet
Droplet personal lancet 33 G
Device: Lancing device B
Droplet lancing device
Experimental: C/28/1
Lancing device C with personal lancet of size 28 G and minimum puncture depth.
Device: 28 G lancet
Droplet 28 G
Other: Lancing depth setting (1)
The lowest depth setting (1)
Device: Lancing device C
Commercially available lancing device
Experimental: C/28/5
Lancing device C with personal lancet of size 28 G and maximum puncture depth.
Device: 28 G lancet
Droplet 28 G
Other: Lancing depth setting (5)
The highest depth setting (5)
Device: Lancing device C
Commercially available lancing device
Experimental: C/30/1
Lancing device C with personal lancet of size 30 G and minimum puncture depth.
Other: Lancing depth setting (1)
The lowest depth setting (1)
Device: 30 G lancet
Droplet personal lancet 30 G
Device: Lancing device C
Commercially available lancing device
Experimental: C/30/5
Lancing device C with personal lancet of size 30 G and maximum puncture depth.
Other: Lancing depth setting (5)
The highest depth setting (5)
Device: 30 G lancet
Droplet personal lancet 30 G
Device: Lancing device C
Commercially available lancing device
Experimental: C/33/1
Lancing device C with personal lancet of size 33 G and minimum puncture depth.
Other: Lancing depth setting (1)
The lowest depth setting (1)
Device: 33 G lancet
Droplet personal lancet 33 G
Device: Lancing device C
Commercially available lancing device
Experimental: C/33/5
Lancing device C with personal lancet of size 33 G and maximum puncture depth.
Other: Lancing depth setting (5)
The highest depth setting (5)
Device: 33 G lancet
Droplet personal lancet 33 G
Device: Lancing device C
Commercially available lancing device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Volume (uL) of blood in the capillary tube
Time Frame: 1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min

Examination of the volume of blood obtained after puncturing a fingertip with the use of 3 lancing devices set to minimum and maximum puncture depth, with the use of various-sized personal lancets (28G, 30G, and 33G).

The volume of blood sample will be measured with the use of capillary tubes calibrated for the volume of 10 μl and a graduated ruler.
1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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: 1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min
Examination of the intensity of pain perceived when puncturing a fingertip with the use of 3 lancing devices set to minimum and maximum puncture depth, with the use of various-sized personal lancets (28G, 30G, and 33G).
1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HTL-Strefa S.A.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of Lodz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Agnieszka Szadkowska, PhD,Md, Medical University of Lodz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 27, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 010617

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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