Diabetes Mellitus, Type 1NCT03479619
Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity.
A study testing Lancing device A, Lancing device B and Lancing device C in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by HTL-Strefa S.A. at 1 site in Poland.
Trial summary
A randomized single-blind study with the use of three lancing devices equipped with personal lancets. Every device will be studied for three lancet sizes: 28G, 30G, and 33G with the minimum and maximum puncture depth setting. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- Lancing device A, Lancing device B and Lancing device C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 6 Mar 2018to 27 Sep 2018
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with diagnosed diabetes type 1 or 2 ,
- aged 18 - 50,
- period of suffering from diabetes >2 years,
- performing on average 3-8 daily measurements of glycaemia,
- glycaemia at the moment of the beginning of the study between 70 and 200 mg/dl.
Who cannot join
- glycaemia below 70 mg/dl or glycaemia above 200 mg/dl at the moment of the beginning of the study,
- previously diagnosed hemorrhagic diathesis or heavy bleedings in the past (also those without a medical diagnosis),
- anticoagulant (thrombolytic medication) therapy within 3 weeks prior to the study or on the day of the study,
- non steroidal anti-inflammatory drugs (NSAID) treatment 1 week prior to the study or on the day of the study,
- patients with signs of dehydration,
- patients who are currently participating in another clinical study,
- currently diagnosed or reported by the patient skin diseases, nervous system diseases, psychiatric diseases, etc., which, in the opinion of the person conducting the study, disqualify the patient from the participation in the study, in care for the patient's well-being.
Trial locations and contacts
1 site in 1 country.
About this study
A randomized single-blind study with the use of three lancing devices equipped with personal lancets. Every device will be studied for three lancet sizes: 28G, 30G, and 33G with the minimum and maximum puncture depth setting.
- Being tested
- Lancing device A, Lancing device B, Lancing device C, 28 G lancet, 30 G lancet
- Keywords
- lancing device, lancet
- 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.
Lancing device ADevice
Glucoject Dual Plus lancing device
Lancing device BDevice
Droplet lancing device
Lancing device CDevice
Commercially available lancing device
28 G lancetDevice
Droplet 28 G
30 G lancetDevice
Droplet personal lancet 30 G
33 G lancetDevice
Droplet personal lancet 33 G
Lancing depth setting (1)Other
The lowest depth setting (1)
Lancing depth setting (5)Other
The highest depth setting (5)
| Study group | Role | What they receive |
|---|---|---|
| A/28/1 | Experimental | Lancing device A with personal lancet of size 28 G and minimum puncture depth. Receives: Device: Lancing device A; Device: 28 G lancet; Other: Lancing depth setting (1) |
| A/28/5 | Experimental | Lancing device A with personal lancet of size 28 G and maximum puncture depth. Receives: Device: Lancing device A; Device: 28 G lancet; Other: Lancing depth setting (5) |
| A/30/1 | Experimental | Lancing device A with personal lancet of size 30 G and minimum puncture depth. Receives: Device: Lancing device A; Device: 30 G lancet; Other: Lancing depth setting (1) |
| A/30/5 | Experimental | Lancing device A with personal lancet of size 30 G and maximum puncture depth. Receives: Device: Lancing device A; Device: 30 G lancet; Other: Lancing depth setting (5) |
| A/33/1 | Experimental | Lancing device A with personal lancet of size 33 G and minimum puncture depth. Receives: Device: Lancing device A; Device: 33 G lancet; Other: Lancing depth setting (1) |
| A/33/5 | Experimental | Lancing device A with personal lancet of size 33 G and maximum puncture depth. Receives: Device: Lancing device A; Device: 33 G lancet; Other: Lancing depth setting (5) |
| B/28/1 | Experimental | Lancing device B with personal lancet of size 28 G and minimum puncture depth. Receives: Device: Lancing device B; Device: 28 G lancet; Other: Lancing depth setting (1) |
| B/28/5 | Experimental | Lancing device B with personal lancet of size 28 G and maximum puncture depth. Receives: Device: Lancing device B; Device: 28 G lancet; Other: Lancing depth setting (5) |
| B/30/1 | Experimental | Lancing device B with personal lancet of size 30 G and minimum puncture depth. Receives: Device: Lancing device B; Device: 30 G lancet; Other: Lancing depth setting (1) |
| B/30/5 | Experimental | Lancing device B with personal lancet of size 30 G and maximum puncture depth. Receives: Device: Lancing device B; Device: 30 G lancet; Other: Lancing depth setting (5) |
| B/33/1 | Experimental | Lancing device B with personal lancet of size 33 G and minimum puncture depth. Receives: Device: Lancing device B; Device: 33 G lancet; Other: Lancing depth setting (1) |
| B/33/5 | Experimental | Lancing device B with personal lancet of size 33 G and maximum puncture depth. Receives: Device: Lancing device B; Device: 33 G lancet; Other: Lancing depth setting (5) |
| C/28/1 | Experimental | Lancing device C with personal lancet of size 28 G and minimum puncture depth. Receives: Device: Lancing device C; Device: 28 G lancet; Other: Lancing depth setting (1) |
| C/28/5 | Experimental | Lancing device C with personal lancet of size 28 G and maximum puncture depth. Receives: Device: Lancing device C; Device: 28 G lancet; Other: Lancing depth setting (5) |
| C/30/1 | Experimental | Lancing device C with personal lancet of size 30 G and minimum puncture depth. Receives: Device: Lancing device C; Device: 30 G lancet; Other: Lancing depth setting (1) |
| C/30/5 | Experimental | Lancing device C with personal lancet of size 30 G and maximum puncture depth. Receives: Device: Lancing device C; Device: 30 G lancet; Other: Lancing depth setting (5) |
| C/33/1 | Experimental | Lancing device C with personal lancet of size 33 G and minimum puncture depth. Receives: Device: Lancing device C; Device: 33 G lancet; Other: Lancing depth setting (1) |
| C/33/5 | Experimental | Lancing device C with personal lancet of size 33 G and maximum puncture depth. Receives: Device: Lancing device C; Device: 33 G lancet; Other: Lancing depth setting (5) |
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 3 lancing devices set to minimum and maximum puncture depth, with the use of various-sized personal lancets (28G, 30G, and 33G).
The volume of blood sample will be measured with the use of capillary tubes calibrated for the volume of 10 μl and a graduated ruler.
Measured: 1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min
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 3 lancing devices set to minimum and maximum puncture depth, with the use of various-sized personal lancets (28G, 30G, and 33G).
Measured: 1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start6 Mar 2018
- Primary completion14 May 2018
- Study completion27 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- HTL-Strefa S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Lodz
- Responsible party
- Sponsor
- Investigators
- Agnieszka Szadkowska, PhD,Md, Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479619
- Sponsor's protocol ID
- 010617
- Status last verified
- Nov 2018
- First submitted
- 20 Mar 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mianowska B, Mlynarski W, Szadkowska I, Szadkowska A. Evaluation of Three Lancing Devices: What Do Blood Volume and Lancing Pain Depend On? J Diabetes Sci Technol. 2021 Sep;15(5):1076-1083. doi: 10.1177/1932296820949930. Epub 2020 Aug 17.
PubMed 32856497
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
- Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity.
- ClinicalTrials.gov ID
- NCT03479619
- Acronym / sponsor ID
- 010617
- Keywords
- lancing device, lancet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- HTL-Strefa S.A.Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Lodz
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 14 May 2018 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 27 Mar 2018 (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 three lancing devices equipped with personal lancets. Every device will be studied for three lancet sizes: 28G, 30G, and 33G with the minimum and maximum puncture depth setting.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| A/28/1 | Experimental | Device: Lancing device A, Device: 28 G lancet, Other: Lancing depth setting (1)Lancing device A with personal lancet of size 28 G and minimum puncture depth. |
| A/28/5 | Experimental | Device: Lancing device A, Device: 28 G lancet, Other: Lancing depth setting (5)Lancing device A with personal lancet of size 28 G and maximum puncture depth. |
| A/30/1 | Experimental | Device: Lancing device A, Device: 30 G lancet, Other: Lancing depth setting (1)Lancing device A with personal lancet of size 30 G and minimum puncture depth. |
| A/30/5 | Experimental | Device: Lancing device A, Device: 30 G lancet, Other: Lancing depth setting (5)Lancing device A with personal lancet of size 30 G and maximum puncture depth. |
| A/33/1 | Experimental | Device: Lancing device A, Device: 33 G lancet, Other: Lancing depth setting (1)Lancing device A with personal lancet of size 33 G and minimum puncture depth. |
| A/33/5 | Experimental | Device: Lancing device A, Device: 33 G lancet, Other: Lancing depth setting (5)Lancing device A with personal lancet of size 33 G and maximum puncture depth. |
| B/28/1 | Experimental | Device: Lancing device B, Device: 28 G lancet, Other: Lancing depth setting (1)Lancing device B with personal lancet of size 28 G and minimum puncture depth. |
| B/28/5 | Experimental | Device: Lancing device B, Device: 28 G lancet, Other: Lancing depth setting (5)Lancing device B with personal lancet of size 28 G and maximum puncture depth. |
| B/30/1 | Experimental | Device: Lancing device B, Device: 30 G lancet, Other: Lancing depth setting (1)Lancing device B with personal lancet of size 30 G and minimum puncture depth. |
| B/30/5 | Experimental | Device: Lancing device B, Device: 30 G lancet, Other: Lancing depth setting (5)Lancing device B with personal lancet of size 30 G and maximum puncture depth. |
| B/33/1 | Experimental | Device: Lancing device B, Device: 33 G lancet, Other: Lancing depth setting (1)Lancing device B with personal lancet of size 33 G and minimum puncture depth. |
| B/33/5 | Experimental | Device: Lancing device B, Device: 33 G lancet, Other: Lancing depth setting (5)Lancing device B with personal lancet of size 33 G and maximum puncture depth. |
| C/28/1 | Experimental | Device: Lancing device C, Device: 28 G lancet, Other: Lancing depth setting (1)Lancing device C with personal lancet of size 28 G and minimum puncture depth. |
| C/28/5 | Experimental | Device: Lancing device C, Device: 28 G lancet, Other: Lancing depth setting (5)Lancing device C with personal lancet of size 28 G and maximum puncture depth. |
| C/30/1 | Experimental | Device: Lancing device C, Device: 30 G lancet, Other: Lancing depth setting (1)Lancing device C with personal lancet of size 30 G and minimum puncture depth. |
| C/30/5 | Experimental | Device: Lancing device C, Device: 30 G lancet, Other: Lancing depth setting (5)Lancing device C with personal lancet of size 30 G and maximum puncture depth. |
| C/33/1 | Experimental | Device: Lancing device C, Device: 33 G lancet, Other: Lancing depth setting (1)Lancing device C with personal lancet of size 33 G and minimum puncture depth. |
| C/33/5 | Experimental | Device: Lancing device C, Device: 33 G lancet, Other: Lancing depth setting (5)Lancing device C with personal lancet of size 33 G and maximum puncture depth. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- patients with diagnosed diabetes type 1 or 2 ,
- aged 18 - 50,
- period of suffering from diabetes >2 years,
- performing on average 3-8 daily measurements of glycaemia,
- glycaemia at the moment of the beginning of the study between 70 and 200 mg/dl.
Key exclusion criteria (7 listed)
- glycaemia below 70 mg/dl or glycaemia above 200 mg/dl at the moment of the beginning of the study,
- previously diagnosed hemorrhagic diathesis or heavy bleedings in the past (also those without a medical diagnosis),
- anticoagulant (thrombolytic medication) therapy within 3 weeks prior to the study or on the day of the study,
- non steroidal anti-inflammatory drugs (NSAID) treatment 1 week prior to the study or on the day of the study,
- patients with signs of dehydration,
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 |
|---|---|---|
| Lancing device AGlucoject Dual Plus lancing device | Device | A/28/1, A/28/5, A/30/1, A/30/5, A/33/1, A/33/5 |
| Lancing device BDroplet lancing device | Device | B/28/1, B/28/5, B/30/1, B/30/5, B/33/1, B/33/5 |
| Lancing device CCommercially available lancing device | Device | C/28/1, C/28/5, C/30/1, C/30/5, C/33/1, C/33/5 |
| 28 G lancetDroplet 28 G | Device | A/28/1, A/28/5, B/28/1, B/28/5, C/28/1, C/28/5 |
| 30 G lancetDroplet personal lancet 30 G | Device | A/30/1, A/30/5, B/30/1, B/30/5, C/30/1, C/30/5 |
| 33 G lancetDroplet personal lancet 33 G | Device | A/33/1, A/33/5, B/33/1, B/33/5, C/33/1, C/33/5 |
| Lancing depth setting (1)The lowest depth setting (1) | Other | A/28/1, A/30/1, A/33/1, B/28/1, B/30/1, B/33/1, C/28/1, C/30/1, C/33/1 |
| Lancing depth setting (5)The highest depth setting (5) | Other | A/28/5, A/30/5, A/33/5, B/28/5, B/30/5, B/33/5, C/28/5, C/30/5, C/33/5 |
Primary outcome
Volume (uL) of blood in the capillary tube
Time frame: 1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min
Examination of the volume of blood obtained after puncturing a fingertip with the use of 3 lancing devices set to minimum and maximum puncture depth, with the use of various-sized personal lancets (28G, 30G, and 33G). The volume of blood sample will be measured with the use of capillary tubes calibrated for the volume of 10 μl and a graduated ruler.
1 secondary outcome
The intensity of pain perceived by the patient assessed with the use of the VAS (Visual Analog Scale).
Time frame: 1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min
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.
- Derived from this study: PubMed 32856497Mianowska B, Mlynarski W, Szadkowska I, Szadkowska A. Evaluation of Three Lancing Devices: What Do Blood Volume and Lancing Pain Depend On? J Diabetes Sci Technol. 2021 Sep;15(5):1076-1083. doi: 10.1177/1932296820949930. Epub 2020 Aug 17.
- Individual participant dataSharing planned: No
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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.
Agnieszka Szadkowska, PhD,Md principal investigator
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lancing device A, Lancing device B and Lancing device C in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by HTL-Strefa S.A. at 1 site in Poland.
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 5 inclusion and 7 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.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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: 1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03479619, which also lists 1 linked publication.
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.