NCT Number: NCT04253431
The Characteristics of Different Personal Lancets on Blood Volume and Perceived Pain in Patients With Diabetes Mellitus
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.
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Microlet 2 lancing device (Bayer)
DeviceOneTouch Delicia lancing device (LifeScan)
DeviceReliOn lancing device (ReliOn)
DeviceAccu-Chek Softclix lancing device (Roche)
DeviceBGStar lancing device (Sanofi Aventis)
DeviceUltra-Fine 33G lancets (BD)
DeviceDroplet 33G lancets (HTL-Strefa S.A.)
DeviceOneTouch Delicia Extra Fine 33G lancets (LifeScan)
DeviceHaemoFine 33G lancets (HTL-Strefa S.A.)
DeviceSoftclix 28 G lancets (Roche)
DeviceReliOn Ultra-Thin Plus 33G lancets (ReliOn)
DeviceGlucoJect Dual S lancing device (Menarini)
DeviceMicrolet 28G lancets (Bayer)
DeviceBGStar Ultra-Thin 33G lancets (Sanofi Aventis)
DevicePrimary outcomes
-
Volume (uL) of blood in the capillary tube
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
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 outcomes
-
The intensity of pain perceived by the patient assessed with the use of the VAS (Visual Analog Scale).
Time frame: 3 minutes (+/- 1 minute) after lancing
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).
Sponsors and collaborators
Lead sponsor
HTL-Strefa S.A.
Industry
Registry information
Official study 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
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Feb 5, 2020
- Registry last updated
- Feb 5, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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