Back to resultsThe Characteristics of Different Personal Lancets on Blood Volume and Perceived Pain in Patients With Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
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)
Sponsored by
About this trial
This is an interventional other trial for Diabetes Mellitus, Type 1 focused on measuring lancing device, lancet, fingerprick, capillary blood, self-monitoring of blood glucose
Eligibility Criteria
Inclusion Criteria:
- Willing to sign the informed consent.
- 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:
- Pregnancy (self reported).
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
L01
L02
L03
L04
L05
L06
L07
L08
L09
L10
Arm Description
Finger pricking using lancing device with personal lancets
Finger pricking using lancing device with personal lancets
Finger pricking using lancing device with personal lancets
Finger pricking using lancing device with personal lancets
Finger pricking using lancing device with personal lancets
Finger pricking using lancing device with personal lancets
Finger pricking using lancing device with personal lancets
Finger pricking using lancing device with personal lancets
Finger pricking using lancing device with personal lancets
Finger pricking using lancing device with personal lancets
Outcomes
Primary Outcome Measures
Volume (uL) of blood in the capillary tube
Examination of the volume of blood obtained after puncturing a fingertip with the use of different lancing devices set to maximum puncture depth, with the use of various-sized personal lancets (28G and 33G).
Secondary Outcome Measures
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 different lancing devices set to maximum puncture depth, with the use of various-sized personal lancets (28G and 33G).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04253431
Brief Title
The Characteristics of Different Personal Lancets on Blood Volume and Perceived Pain in Patients With Diabetes Mellitus
Official Title
A Single-blind, Randomized, Single-centre Study to Investigate the Characteristics of Different Personal Lancets on Blood Volume and Perceived Pain in Patients With Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HTL-Strefa S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized single-blind study with the use of different lancing devices equipped with personal lancets to determine and to compare the amount of capillary blood volume and perceived pain after a single lancing of the fingertip.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Keywords
lancing device, lancet, fingerprick, capillary blood, self-monitoring of blood glucose
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L01
Arm Type
Experimental
Arm Description
Finger pricking using lancing device with personal lancets
Arm Title
L02
Arm Type
Experimental
Arm Description
Finger pricking using lancing device with personal lancets
Arm Title
L03
Arm Type
Experimental
Arm Description
Finger pricking using lancing device with personal lancets
Arm Title
L04
Arm Type
Experimental
Arm Description
Finger pricking using lancing device with personal lancets
Arm Title
L05
Arm Type
Experimental
Arm Description
Finger pricking using lancing device with personal lancets
Arm Title
L06
Arm Type
Experimental
Arm Description
Finger pricking using lancing device with personal lancets
Arm Title
L07
Arm Type
Experimental
Arm Description
Finger pricking using lancing device with personal lancets
Arm Title
L08
Arm Type
Experimental
Arm Description
Finger pricking using lancing device with personal lancets
Arm Title
L09
Arm Type
Experimental
Arm Description
Finger pricking using lancing device with personal lancets
Arm Title
L10
Arm Type
Experimental
Arm Description
Finger pricking using lancing device with personal lancets
Intervention Type
Device
Intervention Name(s)
Droplet lancing device (HTL-Strefa S.A.)
Intervention Type
Device
Intervention Name(s)
Microlet 2 lancing device (Bayer)
Intervention Type
Device
Intervention Name(s)
OneTouch Delicia lancing device (LifeScan)
Intervention Type
Device
Intervention Name(s)
ReliOn lancing device (ReliOn)
Intervention Type
Device
Intervention Name(s)
Accu-Chek Softclix lancing device (Roche)
Intervention Type
Device
Intervention Name(s)
BGStar lancing device (Sanofi Aventis)
Intervention Type
Device
Intervention Name(s)
Ultra-Fine 33G lancets (BD)
Intervention Type
Device
Intervention Name(s)
Droplet 33G lancets (HTL-Strefa S.A.)
Intervention Type
Device
Intervention Name(s)
OneTouch Delicia Extra Fine 33G lancets (LifeScan)
Intervention Type
Device
Intervention Name(s)
HaemoFine 33G lancets (HTL-Strefa S.A.)
Intervention Type
Device
Intervention Name(s)
Softclix 28 G lancets (Roche)
Intervention Type
Device
Intervention Name(s)
ReliOn Ultra-Thin Plus 33G lancets (ReliOn)
Intervention Type
Device
Intervention Name(s)
GlucoJect Dual S lancing device (Menarini)
Intervention Type
Device
Intervention Name(s)
Microlet 28G lancets (Bayer)
Intervention Type
Device
Intervention Name(s)
BGStar Ultra-Thin 33G lancets (Sanofi Aventis)
Primary Outcome Measure Information:
Title
Volume (uL) of blood in the capillary tube
Description
Examination of the volume of blood obtained after puncturing a fingertip with the use of different lancing devices set to maximum puncture depth, with the use of various-sized personal lancets (28G and 33G).
Time Frame
The blood from the puncture site was collected to the capillaries for 30 seconds, and afterwards amount of the blood was measured using a calibrated ruler
Secondary Outcome Measure Information:
Title
The intensity of pain perceived by the patient assessed with the use of the VAS (Visual Analog Scale).
Description
Examination of the intensity of pain perceived when puncturing a fingertip with the use of different lancing devices set to maximum puncture depth, with the use of various-sized personal lancets (28G and 33G).
Time Frame
3 minutes (+/- 1 minute) after lancing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing to sign the informed consent.
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:
Pregnancy (self reported).
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.
12. IPD Sharing Statement
Learn more about this trial
The Characteristics of Different Personal Lancets on Blood Volume and Perceived Pain in Patients With Diabetes Mellitus
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