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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479619
• Other study ID #: 010617
• Status: Completed
• Phase: N/A
• Start date: March 6, 2018
• Est. completion date: September 27, 2018

Study information

• Verified date: November 2018
• Source: HTL-Strefa S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 27, 2018
• Est. primary completion date: May 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Lancing device A
Glucoject Dual Plus lancing device
• Lancing device B
Droplet lancing device
• Lancing device C
Commercially available lancing device
• 28 G lancet
Droplet 28 G
• 30 G lancet
Droplet personal lancet 30 G
• 33 G lancet
Droplet personal lancet 33 G

Other:
• Lancing depth setting (1)
The lowest depth setting (1)
• Lancing depth setting (5)
The highest depth setting (5)

Locations

Country	Name	City	State
Poland	Nzoz Magmed	Lodz

Sponsors (2)

Lead Sponsor	Collaborator
HTL-Strefa S.A.	Medical University of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume (uL) of blood in the capillary tube	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	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 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