Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity.
NCT ID: NCT03479619
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2018-03-06
2018-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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A/28/1
Lancing device A with personal lancet of size 28 G and minimum puncture depth.
Lancing device A
Glucoject Dual Plus lancing device
28 G lancet
Droplet 28 G
Lancing depth setting (1)
The lowest depth setting (1)
A/28/5
Lancing device A with personal lancet of size 28 G and maximum puncture depth.
Lancing device A
Glucoject Dual Plus lancing device
28 G lancet
Droplet 28 G
Lancing depth setting (5)
The highest depth setting (5)
A/30/1
Lancing device A with personal lancet of size 30 G and minimum puncture depth.
Lancing device A
Glucoject Dual Plus lancing device
30 G lancet
Droplet personal lancet 30 G
Lancing depth setting (1)
The lowest depth setting (1)
A/30/5
Lancing device A with personal lancet of size 30 G and maximum puncture depth.
Lancing device A
Glucoject Dual Plus lancing device
30 G lancet
Droplet personal lancet 30 G
Lancing depth setting (5)
The highest depth setting (5)
A/33/1
Lancing device A with personal lancet of size 33 G and minimum puncture depth.
Lancing device A
Glucoject Dual Plus lancing device
33 G lancet
Droplet personal lancet 33 G
Lancing depth setting (1)
The lowest depth setting (1)
A/33/5
Lancing device A with personal lancet of size 33 G and maximum puncture depth.
Lancing device A
Glucoject Dual Plus lancing device
33 G lancet
Droplet personal lancet 33 G
Lancing depth setting (5)
The highest depth setting (5)
B/28/1
Lancing device B with personal lancet of size 28 G and minimum puncture depth.
Lancing device B
Droplet lancing device
28 G lancet
Droplet 28 G
Lancing depth setting (1)
The lowest depth setting (1)
B/28/5
Lancing device B with personal lancet of size 28 G and maximum puncture depth.
Lancing device B
Droplet lancing device
28 G lancet
Droplet 28 G
Lancing depth setting (5)
The highest depth setting (5)
B/30/1
Lancing device B with personal lancet of size 30 G and minimum puncture depth.
Lancing device B
Droplet lancing device
30 G lancet
Droplet personal lancet 30 G
Lancing depth setting (1)
The lowest depth setting (1)
B/30/5
Lancing device B with personal lancet of size 30 G and maximum puncture depth.
Lancing device B
Droplet lancing device
30 G lancet
Droplet personal lancet 30 G
Lancing depth setting (5)
The highest depth setting (5)
B/33/1
Lancing device B with personal lancet of size 33 G and minimum puncture depth.
Lancing device B
Droplet lancing device
33 G lancet
Droplet personal lancet 33 G
Lancing depth setting (1)
The lowest depth setting (1)
B/33/5
Lancing device B with personal lancet of size 33 G and maximum puncture depth.
Lancing device B
Droplet lancing device
33 G lancet
Droplet personal lancet 33 G
Lancing depth setting (5)
The highest depth setting (5)
C/28/1
Lancing device C with personal lancet of size 28 G and minimum puncture depth.
Lancing device C
Commercially available lancing device
28 G lancet
Droplet 28 G
Lancing depth setting (1)
The lowest depth setting (1)
C/28/5
Lancing device C with personal lancet of size 28 G and maximum puncture depth.
Lancing device C
Commercially available lancing device
28 G lancet
Droplet 28 G
Lancing depth setting (5)
The highest depth setting (5)
C/30/1
Lancing device C with personal lancet of size 30 G and minimum puncture depth.
Lancing device C
Commercially available lancing device
30 G lancet
Droplet personal lancet 30 G
Lancing depth setting (1)
The lowest depth setting (1)
C/30/5
Lancing device C with personal lancet of size 30 G and maximum puncture depth.
Lancing device C
Commercially available lancing device
30 G lancet
Droplet personal lancet 30 G
Lancing depth setting (5)
The highest depth setting (5)
C/33/1
Lancing device C with personal lancet of size 33 G and minimum puncture depth.
Lancing device C
Commercially available lancing device
33 G lancet
Droplet personal lancet 33 G
Lancing depth setting (1)
The lowest depth setting (1)
C/33/5
Lancing device C with personal lancet of size 33 G and maximum puncture depth.
Lancing device C
Commercially available lancing device
33 G lancet
Droplet personal lancet 33 G
Lancing depth setting (5)
The highest depth setting (5)
Interventions
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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
Lancing depth setting (1)
The lowest depth setting (1)
Lancing depth setting (5)
The highest depth setting (5)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
No
Sponsors
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Medical University of Lodz
OTHER
HTL-Strefa S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Agnieszka Szadkowska, PhD,Md
Role: PRINCIPAL_INVESTIGATOR
Medical University of Lodz
Locations
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Nzoz Magmed
Lodz, , Poland
Countries
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References
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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.
Other Identifiers
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010617
Identifier Type: -
Identifier Source: org_study_id
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