An interventional study of Droplet lancing device (HTL-Strefa S.A.) and Microlet 2 lancing device (Bayer) in Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by HTL-Strefa S.A.. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by HTL-Strefa S.A. · Not applicable, Interventional, and Other
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's enrollment of 60 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →HTL-Strefa S.A. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Finger pricking using lancing device with personal lancets
Device: Droplet lancing device (HTL-Strefa S.A.) · Device: Ultra-Fine 33G lancets (BD)
Finger pricking using lancing device with personal lancets
Device: Microlet 2 lancing device (Bayer) · Device: Droplet 33G lancets (HTL-Strefa S.A.)
Finger pricking using lancing device with personal lancets
Device: OneTouch Delicia lancing device (LifeScan) · Device: OneTouch Delicia Extra Fine 33G lancets (LifeScan)
Finger pricking using lancing device with personal lancets
Device: Droplet lancing device (HTL-Strefa S.A.) · Device: HaemoFine 33G lancets (HTL-Strefa S.A.)
Finger pricking using lancing device with personal lancets
Device: ReliOn lancing device (ReliOn) · Device: ReliOn Ultra-Thin Plus 33G lancets (ReliOn)
Finger pricking using lancing device with personal lancets
Device: Accu-Chek Softclix lancing device (Roche) · Device: Softclix 28 G lancets (Roche)
Finger pricking using lancing device with personal lancets
Device: Microlet 2 lancing device (Bayer) · Device: Microlet 28G lancets (Bayer)
Finger pricking using lancing device with personal lancets
Device: Droplet lancing device (HTL-Strefa S.A.) · Device: Droplet 33G lancets (HTL-Strefa S.A.)
Finger pricking using lancing device with personal lancets
Device: BGStar lancing device (Sanofi Aventis) · Device: BGStar Ultra-Thin 33G lancets (Sanofi Aventis)
Finger pricking using lancing device with personal lancets
Device: HaemoFine 33G lancets (HTL-Strefa S.A.) · Device: GlucoJect Dual S lancing device (Menarini)
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).
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
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).
Time frame: 3 minutes (+/- 1 minute) after lancing
No study locations are listed for this record.
Ran from Aug 2013 to primary completion in Aug 2013, 0 months.
Of 105 industry-sponsored interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's 0 months is below that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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HTL-Strefa S.A.