Type 2 DiabetesNCT05251506
The Evaluation of Laser Lancing Devices in Adult Type 2 Diabetes Patients
A study testing laser lancing device or lancet for blood glucose level measurement in people with Type 2 Diabetes, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
Self monitoring of blood glucose level is crucial in diabetes management, but currently available methods, lancet, have shown low compliance of self monitoring of blood glucose because of pain, keratinization of finger tip, secondary infection. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- laser lancing device or lancet for blood glucose level measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Aug 2021to 31 Dec 2022
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients who visit Korea University medical center, Guro hospital, Ansan hospital
- Patients with Hba1c more than 6.5% and less than 8.5%
- Adults who are able to measure blood glucose level by themselves
- Adults who are able to lance their same finger from both hands
- Adults who comprehend risk of participating in the clinical research, who are able to communicate each other, who are able to follow rules of clinical research
- Subjects who decide to participate in the clinical research voluntarily and sign in the consent format after being informed purposes, methods, expectations of the clinical research
Who cannot join
- Subject whose age is younger than 19 or older than 80
- students of research institutes
- Pregnant and lactating women
- Subjects who are not able to make decision
- Subjects who are in emergency or being hospitalized
- Subjects who cannot lance sane finger from both hands
Show all 9Show fewer
- Subjects who are infected by HIV in hospital records
- Subjects who have thrombocytopenia, coagulation disorder or haemophilia
- Subjects who are incompatible for clinical research as researcher evaluated
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University medical center
Seoul, 08308
Min Jeong Park, M.D., +82-10-7271-3805, minjeong87@gmail.com
Hye Jin Yoo, M.D. Ph.D, +82-10-8951-9451, deisy21@naver.com
About this study
Official title: The Evaluation of Laser Lancing Devices in Constructing Self-management Systems for Chronic Diseases in Adult Diabetes Patients
Self monitoring of blood glucose level is crucial in diabetes management, but currently available methods, lancet, have shown low compliance of self monitoring of blood glucose because of pain, keratinization of finger tip, secondary infection. The purpose of this study is evaluating laser lancing device which cause much less pain than lancet to increase compliance of blood sugar checking, and to establish self monitoring system for patients of chronic diseases.
The investigators recruit total of 80 type 2 diabetes patients who visit Korea University Medical center Guro and Ansan hospital. HbA1c level of subject is more than 6.5% and less than 8.5%, and their age is above 20 years and under 80 years. Subjects are randomly distributed in group A or B. Group A subjects use laser device to check blood glucose for 2 months, then take a month for wash out period. After wash out period, participants use lancet for following 2 months. Group B perform the process vice versa. The investigators evaluate the number of blood glucose measurement, HbA1c, diabetes distress scale, average pain score, average satisfaction score from each group.
Read the detailed description
Self monitoring of blood glucose level is crucial in diabetes management, so it is important to increase compliance of blood glucose checking. Lancet which is currently available methods have shown low compliance of self monitoring of blood glucose, since it causes pain, keratinization of finger tip, secondary infection. The purpose of this study is evaluating laser lancing device which cause much less pain than lancet to increase compliance of blood sugar checking, and to establish self monitoring system for patients of chronic diseases.
The investigators recruit total of 80 subjects who visit Korea University Medical center Guro and Ansan hospital. Study subject are type 2 diabetes whose glycated hemoglobin level is more than 6.5% and less than 8.5%, and whose age is more than 20 years and under 80 years. Subjects are randomly distributed in group A or B. Group A subjects use laser device to check blood glucose for 2 months, then take a month for wash out period. After wash out period, participants use lancet for following 2 months. Group B subjects use lancet first, then have a month for wash out period, after then, switch to laser device afterwards. During washout period, participants use usual glucose checking method which subjects had used. The investigators evaluate the number of blood glucose measurement, glycated hemoglobin, diabetes distress scale, average pain score, average satisfaction score from each group. Also the investigators compare blood glucose, liver function test, lipid level between values from one hand measured by lancet, and values from the other hand measured by laser lancing device.
- Conditions
- Type 2 Diabetes
- Being tested
- laser lancing device or lancet for blood glucose level measurement
- Keywords
- self monitoring of blood glucose, lancing device, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser lancing device or lancet for blood glucose level measurementDevice
Subjects measure blood glucose level using laser lancing device (LMT-1000) and lancet for 2 months each.
| Study group | Role | What they receive |
|---|---|---|
| laser lancing device (LMT-1000) first user | Experimental | Subjects measure blood glucose using laser lancing device (LMT-1000) for first 2 months, then take a month for wash out period, after that do using lancet for following 2 months. Receives: Device: laser lancing device or lancet for blood glucose level measurement |
| lancet first user | Active comparator | Subjects measure blood glucose using lancet for first 2 months, , then take a month for wash out period, after that do using laser lancing device (LMT-1000) for following 2 months. Receives: Device: laser lancing device or lancet for blood glucose level measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
average number of checking blood glucose per week
Study subject is going to be surveyed about 'average number of checking blood glucose per week' at 2 month after using lancet device, and 2 month after using laser lancing device (LMT-1000)
Measured: two months after using the device
glycated hemoglobin level
Study subject is going to be checked glycated hemoglobin level at 2 month after using lancet device, and 2 month after using laser lancing device (LMT-1000). Data will be shown in percent (%).
Measured: two months after using the device
Secondary outcomes (5)
average satisfaction score
Study subject is going to be surveyed about 'average satisfaction score' at 2 month after using lancet device, and 2 month after using laser lancing device (LMT-1000)
Measured: two months after using the device
average pain scale
Study subject is going to be surveyed about 'average pain scale' at 2 month after using lancet device, and 2 month after using laser lancing device (LMT-1000)
Measured: two months after using the device
Diabetes Distress Scale
Study subject is going to be surveyed about 'Diabetes Distress Scale' at 2 month after using lancet device, and 2 month after using laser lancing device (LMT-1000)
Measured: two months after using the device
Diabetes Fear of Self-injecting
Study subject is going to be surveyed about 'Diabetes Fear of Self injecting' at 2 month after using lancet device, and 2 month after using laser lancing device (LMT-1000)
Measured: two months after using the device
success rate of measurement of blood glucose by laser lancing device
Study subject is going to be surveyed about 'success rate of measurement of blood glucose by laser lancing device' at 2 month after using lancet device, and 2 month after using laser lancing device (LMT-1000)
Measured: two months after using the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start10 Aug 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each group use lancet (or laser) for first 2 months, take wash out period for 1month, then use laser (or lancet) for another 2 months.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Medical Device Development Fund
- Responsible party
- Principal investigator, Hye Jin Yoo, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251506
- Sponsor's protocol ID
- K2021-1520-002
- Status last verified
- Feb 2022
- First submitted
- 2 Sep 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Laser Lancing Devices in Constructing Self-management Systems for Chronic Diseases in Adult Diabetes Patients
- ClinicalTrials.gov ID
- NCT05251506
- Acronym / sponsor ID
- K2021-1520-002
- Conditions
- Type 2 Diabetes
- Keywords
- self monitoring of blood glucose, lancing device, type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Korea Medical Device Development Fund
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Feb 2022 (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.
Self monitoring of blood glucose level is crucial in diabetes management, but currently available methods, lancet, have shown low compliance of self monitoring of blood glucose because of pain, keratinization of finger tip, secondary infection. The purpose of this study is evaluating laser lancing device which cause much less pain than lancet to increase compliance of blood sugar checking, and to establish self monitoring system for patients of chronic diseases.
The investigators recruit total of 80 type 2 diabetes patients who visit Korea University Medical center Guro and Ansan hospital. HbA1c level of subject is more than 6.5% and less than 8.5%, and their age is above 20 years and under 80 years. Subjects are randomly distributed in group A or B. Group A subjects use laser device to check blood glucose for 2 months, then take a month for wash out period. After wash out period, participants use lancet for following 2 months. Group B perform the process vice versa. The investigators evaluate the number of blood glucose measurement, HbA1c, diabetes distress scale, average pain score, average satisfaction score from each group.
Detailed description
Self monitoring of blood glucose level is crucial in diabetes management, so it is important to increase compliance of blood glucose checking. Lancet which is currently available methods have shown low compliance of self monitoring of blood glucose, since it causes pain, keratinization of finger tip, secondary infection. The purpose of this study is evaluating laser lancing device which cause much less pain than lancet to increase compliance of blood sugar checking, and to establish self monitoring system for patients of chronic diseases.
The investigators recruit total of 80 subjects who visit Korea University Medical center Guro and Ansan hospital. Study subject are type 2 diabetes whose glycated hemoglobin level is more than 6.5% and less than 8.5%, and whose age is more than 20 years and under 80 years. Subjects are randomly distributed in group A or B. Group A subjects use laser device to check blood glucose for 2 months, then take a month for wash out period. After wash out period, participants use lancet for following 2 months. Group B subjects use lancet first, then have a month for wash out period, after then, switch to laser device afterwards. During washout period, participants use usual glucose checking method which subjects had used. The investigators evaluate the number of blood glucose measurement, glycated hemoglobin, diabetes distress scale, average pain score, average satisfaction score from each group. Also the investigators compare blood glucose, liver function test, lipid level between values from one hand measured by lancet, and values from the other hand measured by laser lancing device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Each group use lancet (or laser) for first 2 months, take wash out period for 1month, then use laser (or lancet) for another 2 months.
| Arm | Type | Receives |
|---|---|---|
| laser lancing device (LMT-1000) first user | Experimental | Device: laser lancing device or lancet for blood glucose level measurementSubjects measure blood glucose using laser lancing device (LMT-1000) for first 2 months, then take a month for wash out period, after that do using lancet for following 2 months. |
| lancet first user | Active comparator | Device: laser lancing device or lancet for blood glucose level measurementSubjects measure blood glucose using lancet for first 2 months, , then take a month for wash out period, after that do using laser lancing device (LMT-1000) for following 2 months. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes patients who visit Korea University medical center, Guro hospital, Ansan hospital
- Patients with Hba1c more than 6.5% and less than 8.5%
- Adults who are able to measure blood glucose level by themselves
- Adults who are able to lance their same finger from both hands
- Adults who comprehend risk of participating in the clinical research, who are able to communicate each other, who are able to follow rules of clinical research
Key exclusion criteria (9 listed)
- Subject whose age is younger than 19 or older than 80
- students of research institutes
- Pregnant and lactating women
- Subjects who are not able to make decision
- Subjects who are in emergency or being hospitalized
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 |
|---|---|---|
| laser lancing device or lancet for blood glucose level measurementSubjects measure blood glucose level using laser lancing device (LMT-1000) and lancet for 2 months each. | Device | lancet first user, laser lancing device (LMT-1000) first user |
Primary outcome
average number of checking blood glucose per week
Time frame: two months after using the device
Study subject is going to be surveyed about 'average number of checking blood glucose per week' at 2 month after using lancet device, and 2 month after using laser lancing device (LMT-1000)
glycated hemoglobin level
Time frame: two months after using the device
Study subject is going to be checked glycated hemoglobin level at 2 month after using lancet device, and 2 month after using laser lancing device (LMT-1000). Data will be shown in percent (%).
5 secondary outcomes
average satisfaction score
Time frame: two months after using the device
average pain scale
Time frame: two months after using the device
Diabetes Distress Scale
Time frame: two months after using the device
Diabetes Fear of Self-injecting
Time frame: two months after using the device
success rate of measurement of blood glucose by laser lancing device
Time frame: two months after using the device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser lancing device or lancet for blood glucose level measurement in people with Type 2 Diabetes, run by Korea University Guro Hospital at 1 site in South Korea.
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 9 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: status not confirmed, as of the sponsor's last update on 22 Feb 2022. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Jeong Park (+82-10-7271-3805, minjeong87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average number of checking blood glucose per week (time frame: two months after using the device). The study lists 2 primary outcomes in all. 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 22 Feb 2022.