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Completed

NCT Number: NCT03479619

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nzoz Magmed

Lodz, 91-738, Poland

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Lancing device A

Device

Glucoject Dual Plus lancing device

Lancing device B

Device

Droplet lancing device

Lancing device C

Device

Commercially available lancing device

28 G lancet

Device

Droplet 28 G

30 G lancet

Device

Droplet personal lancet 30 G

33 G lancet

Device

Droplet personal lancet 33 G

Lancing depth setting (1)

Other

The lowest depth setting (1)

Lancing depth setting (5)

Other

The highest depth setting (5)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

HTL-Strefa S.A.

Industry

Collaborators

  • Medical University of Lodz

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2018
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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