CompletedNCT03479619Updated Feb 5, 2020

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

An interventional study of Lancing device A and Lancing device B in Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by HTL-Strefa S.A.. Completed at 1 site in Poland. Open to participants aged 18 Years to 50 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: 90
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study 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.

Conditions studied

Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2

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Keywords

lancing device
lancet

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 90 participants (actual)

Study arms

Experimental
A/28/1
Lancing device A with personal lancet of size 28 G and minimum puncture depth.
Device: Lancing device A · Device: 28 G lancet · Other: Lancing 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 · Device: 28 G lancet · Other: Lancing 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 · Device: 30 G lancet · Other: Lancing depth setting (1)
Experimental
A/30/5
Lancing device A with personal lancet of size 30 G and maximum puncture depth.
Device: Lancing device A · Device: 30 G lancet · Other: Lancing depth setting (5)
Experimental
A/33/1
Lancing device A with personal lancet of size 33 G and minimum puncture depth.
Device: Lancing device A · Device: 33 G lancet · Other: Lancing depth setting (1)
Experimental
A/33/5
Lancing device A with personal lancet of size 33 G and maximum puncture depth.
Device: Lancing device A · Device: 33 G lancet · Other: Lancing depth setting (5)
Experimental
B/28/1
Lancing device B with personal lancet of size 28 G and minimum puncture depth.
Device: Lancing device B · Device: 28 G lancet · Other: Lancing depth setting (1)
Experimental
B/28/5
Lancing device B with personal lancet of size 28 G and maximum puncture depth.
Device: Lancing device B · Device: 28 G lancet · Other: Lancing depth setting (5)
Experimental
B/30/1
Lancing device B with personal lancet of size 30 G and minimum puncture depth.
Device: Lancing device B · Device: 30 G lancet · Other: Lancing depth setting (1)
Experimental
B/30/5
Lancing device B with personal lancet of size 30 G and maximum puncture depth.
Device: Lancing device B · Device: 30 G lancet · Other: Lancing depth setting (5)
Experimental
B/33/1
Lancing device B with personal lancet of size 33 G and minimum puncture depth.
Device: Lancing device B · Device: 33 G lancet · Other: Lancing depth setting (1)
Experimental
B/33/5
Lancing device B with personal lancet of size 33 G and maximum puncture depth.
Device: Lancing device B · Device: 33 G lancet · Other: Lancing depth setting (5)
Experimental
C/28/1
Lancing device C with personal lancet of size 28 G and minimum puncture depth.
Device: Lancing device C · Device: 28 G lancet · Other: Lancing depth setting (1)
Experimental
C/28/5
Lancing device C with personal lancet of size 28 G and maximum puncture depth.
Device: Lancing device C · Device: 28 G lancet · Other: Lancing depth setting (5)
Experimental
C/30/1
Lancing device C with personal lancet of size 30 G and minimum puncture depth.
Device: Lancing device C · Device: 30 G lancet · Other: Lancing depth setting (1)
Experimental
C/30/5
Lancing device C with personal lancet of size 30 G and maximum puncture depth.
Device: Lancing device C · Device: 30 G lancet · Other: Lancing depth setting (5)
Experimental
C/33/1
Lancing device C with personal lancet of size 33 G and minimum puncture depth.
Device: Lancing device C · Device: 33 G lancet · Other: Lancing depth setting (1)
Experimental
C/33/5
Lancing device C with personal lancet of size 33 G and maximum puncture depth.
Device: Lancing device C · Device: 33 G lancet · Other: Lancing depth setting (5)

Interventions

DeviceLancing device A
Glucoject Dual Plus lancing device
DeviceLancing device B
Droplet lancing device
DeviceLancing device C
Commercially available lancing device
Device28 G lancet
Droplet 28 G
Device30 G lancet
Droplet personal lancet 30 G
Device33 G lancet
Droplet personal lancet 33 G
OtherLancing depth setting (1)
The lowest depth setting (1)
OtherLancing depth setting (5)
The highest depth setting (5)

What researchers measure

Primary outcomes

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.
Time frame: 1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min

Secondary outcomes

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).
Time frame: 1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min

Study locations

1 site

Nzoz Magmed
Lodz, 91-738, Poland

References and documents

Publications

Mianowska B, Mlynarski W, Szadkowska I, Szadkowska A. Evaluation of Three Lancing Devices: What Do Blood Volume and Lancing Pain Depend On? J Diabetes Sci Technol. 2021 Sep;15(5):1076-1083. doi: 10.1177/1932296820949930. Epub 2020 Aug 17. PubMed 32856497 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03479619
Lead sponsor: HTL-Strefa S.A.
Collaborators: Medical University of Lodz
Responsible party: Sponsor
First posted: Mar 27, 2018
Start date: Mar 6, 2018
Primary completion: May 14, 2018
Completion: Sep 27, 2018
Last update: Feb 5, 2020

Study contacts

Agnieszka Szadkowska, PhD,Md

principal investigator · Medical University of Lodz

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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