Diabetes Mellitus, Type 1NCT04253431
The Characteristics of Different Personal Lancets on Blood Volume and Perceived Pain in Patients With Diabetes Mellitus
A study testing Droplet lancing device (HTL-Strefa S.A.), Microlet 2 lancing device (Bayer) and OneTouch Delicia lancing device (LifeScan) in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by HTL-Strefa S.A..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- Droplet lancing device (HTL-Strefa S.A.), Microlet 2 lancing device (Bayer) and OneTouch Delicia lancing device (LifeScan)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
About this study
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
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.
- Being tested
- 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)
- Keywords
- lancing device, lancet, fingerprick, capillary blood, self-monitoring of blood glucose
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Droplet lancing device (HTL-Strefa S.A.)Device
Microlet 2 lancing device (Bayer)Device
OneTouch Delicia lancing device (LifeScan)Device
ReliOn lancing device (ReliOn)Device
Accu-Chek Softclix lancing device (Roche)Device
BGStar lancing device (Sanofi Aventis)Device
Ultra-Fine 33G lancets (BD)Device
Droplet 33G lancets (HTL-Strefa S.A.)Device
OneTouch Delicia Extra Fine 33G lancets (LifeScan)Device
HaemoFine 33G lancets (HTL-Strefa S.A.)Device
Softclix 28 G lancets (Roche)Device
ReliOn Ultra-Thin Plus 33G lancets (ReliOn)Device
GlucoJect Dual S lancing device (Menarini)Device
Microlet 28G lancets (Bayer)Device
BGStar Ultra-Thin 33G lancets (Sanofi Aventis)Device
| Study group | Role | What they receive |
|---|---|---|
| L01 | Experimental | Finger pricking using lancing device with personal lancets Receives: Device: Droplet lancing device (HTL-Strefa S.A.); Device: Ultra-Fine 33G lancets (BD) |
| L02 | Experimental | Finger pricking using lancing device with personal lancets Receives: Device: Microlet 2 lancing device (Bayer); Device: Droplet 33G lancets (HTL-Strefa S.A.) |
| L03 | Experimental | Finger pricking using lancing device with personal lancets Receives: Device: OneTouch Delicia lancing device (LifeScan); Device: OneTouch Delicia Extra Fine 33G lancets (LifeScan) |
| L04 | Experimental | Finger pricking using lancing device with personal lancets Receives: Device: Droplet lancing device (HTL-Strefa S.A.); Device: HaemoFine 33G lancets (HTL-Strefa S.A.) |
| L05 | Experimental | Finger pricking using lancing device with personal lancets Receives: Device: ReliOn lancing device (ReliOn); Device: ReliOn Ultra-Thin Plus 33G lancets (ReliOn) |
| L06 | Experimental | Finger pricking using lancing device with personal lancets Receives: Device: Accu-Chek Softclix lancing device (Roche); Device: Softclix 28 G lancets (Roche) |
| L07 | Experimental | Finger pricking using lancing device with personal lancets Receives: Device: Microlet 2 lancing device (Bayer); Device: Microlet 28G lancets (Bayer) |
| L08 | Experimental | Finger pricking using lancing device with personal lancets Receives: Device: Droplet lancing device (HTL-Strefa S.A.); Device: Droplet 33G lancets (HTL-Strefa S.A.) |
| L09 | Experimental | Finger pricking using lancing device with personal lancets Receives: Device: BGStar lancing device (Sanofi Aventis); Device: BGStar Ultra-Thin 33G lancets (Sanofi Aventis) |
| L10 | Experimental | Finger pricking using lancing device with personal lancets Receives: Device: HaemoFine 33G lancets (HTL-Strefa S.A.); Device: GlucoJect Dual S lancing device (Menarini) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 outcomes (1)
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).
Measured: 3 minutes (+/- 1 minute) after lancing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startAug 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- HTL-Strefa S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253431
- Sponsor's protocol ID
- mp08.13
- Status last verified
- Aug 2018
- First submitted
- 31 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04253431
- Acronym / sponsor ID
- mp08.13
- Keywords
- lancing device, lancet, fingerprick, capillary blood, self-monitoring of blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- HTL-Strefa S.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2013 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| L01 | Experimental | Device: Droplet lancing device (HTL-Strefa S.A.), Device: Ultra-Fine 33G lancets (BD)Finger pricking using lancing device with personal lancets |
| L02 | Experimental | Device: Microlet 2 lancing device (Bayer), Device: Droplet 33G lancets (HTL-Strefa S.A.)Finger pricking using lancing device with personal lancets |
| L03 | Experimental | Device: OneTouch Delicia lancing device (LifeScan), Device: OneTouch Delicia Extra Fine 33G lancets (LifeScan)Finger pricking using lancing device with personal lancets |
| L04 | Experimental | Device: Droplet lancing device (HTL-Strefa S.A.), Device: HaemoFine 33G lancets (HTL-Strefa S.A.)Finger pricking using lancing device with personal lancets |
| L05 | Experimental | Device: ReliOn lancing device (ReliOn), Device: ReliOn Ultra-Thin Plus 33G lancets (ReliOn)Finger pricking using lancing device with personal lancets |
| L06 | Experimental | Device: Accu-Chek Softclix lancing device (Roche), Device: Softclix 28 G lancets (Roche)Finger pricking using lancing device with personal lancets |
| L07 | Experimental | Device: Microlet 2 lancing device (Bayer), Device: Microlet 28G lancets (Bayer)Finger pricking using lancing device with personal lancets |
| L08 | Experimental | Device: Droplet lancing device (HTL-Strefa S.A.), Device: Droplet 33G lancets (HTL-Strefa S.A.)Finger pricking using lancing device with personal lancets |
| L09 | Experimental | Device: BGStar lancing device (Sanofi Aventis), Device: BGStar Ultra-Thin 33G lancets (Sanofi Aventis)Finger pricking using lancing device with personal lancets |
| L10 | Experimental | Device: HaemoFine 33G lancets (HTL-Strefa S.A.), Device: GlucoJect Dual S lancing device (Menarini)Finger pricking using lancing device with personal lancets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Droplet lancing device (HTL-Strefa S.A.) | Device | L01, L04, L08 |
| Microlet 2 lancing device (Bayer) | Device | L02, L07 |
| OneTouch Delicia lancing device (LifeScan) | Device | L03 |
| ReliOn lancing device (ReliOn) | Device | L05 |
| Accu-Chek Softclix lancing device (Roche) | Device | L06 |
| BGStar lancing device (Sanofi Aventis) | Device | L09 |
| Ultra-Fine 33G lancets (BD) | Device | L01 |
| Droplet 33G lancets (HTL-Strefa S.A.) | Device | L02, L08 |
| OneTouch Delicia Extra Fine 33G lancets (LifeScan) | Device | L03 |
| HaemoFine 33G lancets (HTL-Strefa S.A.) | Device | L04, L10 |
| Softclix 28 G lancets (Roche) | Device | L06 |
| ReliOn Ultra-Thin Plus 33G lancets (ReliOn) | Device | L05 |
| GlucoJect Dual S lancing device (Menarini) | Device | L10 |
| Microlet 28G lancets (Bayer) | Device | L07 |
| BGStar Ultra-Thin 33G lancets (Sanofi Aventis) | Device | L09 |
Primary outcome
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Droplet lancing device (HTL-Strefa S.A.), Microlet 2 lancing device (Bayer) and OneTouch Delicia lancing device (LifeScan) in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by HTL-Strefa S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.