The Characteristics of Different Personal Lancets on Blood Volume and Perceived Pain in Patients With Diabetes Mellitus
NCT ID: NCT04253431
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
60 participants
INTERVENTIONAL
2013-08-31
2013-08-31
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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L01
Finger pricking using lancing device with personal lancets
Droplet lancing device (HTL-Strefa S.A.)
Ultra-Fine 33G lancets (BD)
L02
Finger pricking using lancing device with personal lancets
Microlet 2 lancing device (Bayer)
Droplet 33G lancets (HTL-Strefa S.A.)
L03
Finger pricking using lancing device with personal lancets
OneTouch Delicia lancing device (LifeScan)
OneTouch Delicia Extra Fine 33G lancets (LifeScan)
L04
Finger pricking using lancing device with personal lancets
Droplet lancing device (HTL-Strefa S.A.)
HaemoFine 33G lancets (HTL-Strefa S.A.)
L05
Finger pricking using lancing device with personal lancets
ReliOn lancing device (ReliOn)
ReliOn Ultra-Thin Plus 33G lancets (ReliOn)
L06
Finger pricking using lancing device with personal lancets
Accu-Chek Softclix lancing device (Roche)
Softclix 28 G lancets (Roche)
L07
Finger pricking using lancing device with personal lancets
Microlet 2 lancing device (Bayer)
Microlet 28G lancets (Bayer)
L08
Finger pricking using lancing device with personal lancets
Droplet lancing device (HTL-Strefa S.A.)
Droplet 33G lancets (HTL-Strefa S.A.)
L09
Finger pricking using lancing device with personal lancets
BGStar lancing device (Sanofi Aventis)
BGStar Ultra-Thin 33G lancets (Sanofi Aventis)
L10
Finger pricking using lancing device with personal lancets
HaemoFine 33G lancets (HTL-Strefa S.A.)
GlucoJect Dual S lancing device (Menarini)
Interventions
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Droplet lancing device (HTL-Strefa S.A.)
Microlet 2 lancing device (Bayer)
OneTouch Delicia lancing device (LifeScan)
ReliOn lancing device (ReliOn)
Accu-Chek Softclix lancing device (Roche)
BGStar lancing device (Sanofi Aventis)
Ultra-Fine 33G lancets (BD)
Droplet 33G lancets (HTL-Strefa S.A.)
OneTouch Delicia Extra Fine 33G lancets (LifeScan)
HaemoFine 33G lancets (HTL-Strefa S.A.)
Softclix 28 G lancets (Roche)
ReliOn Ultra-Thin Plus 33G lancets (ReliOn)
GlucoJect Dual S lancing device (Menarini)
Microlet 28G lancets (Bayer)
BGStar Ultra-Thin 33G lancets (Sanofi Aventis)
Eligibility Criteria
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Inclusion Criteria
* Must currently be diagnosed with either Type I or Type II diabetes mellitus.
* Otherwise in good physical and mental health.
* Must currently be performing self-monitoring of blood glucose (self reported).
* Must be between 18-75 years of age (inclusive).
* Ability to read and follow study instructions.
Exclusion Criteria
* Severe poor blood circulation in the fingers.
* Any skin condition on his or her fingers that prevents blood sampling.
* History of a bleeding disorder.
* Neuropathy or other condition affecting sensation in the hands.
* Self-reported blood borne infection (e.g., HIV, hepatitis B or C, syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, T lymphotropic virus Type 1, Creutzfeldt-Jakob disease).
* Currently participating in another study.
* History of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse.
* Donation or loss of 400 mL or more of blood within 4 weeks prior to the start of the study.
* Any prescription or OTC medication within two days of starting the study which might affect pain perception (for example, ibuprofen or paracetamol).
* Alcohol 48 hours before study start.
18 Years
75 Years
ALL
No
Sponsors
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HTL-Strefa S.A.
INDUSTRY
Responsible Party
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Other Identifiers
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mp08.13
Identifier Type: -
Identifier Source: org_study_id
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