The Evaluation of Laser Lancing Devices in Adult Type 2 Diabetes Patients
NCT ID: NCT05251506
Last Updated: 2022-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2021-08-10
2022-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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laser lancing device (LMT-1000) first user
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.
laser lancing device or lancet for blood glucose level measurement
Subjects measure blood glucose level using laser lancing device (LMT-1000) and lancet for 2 months each.
lancet first user
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.
laser lancing device or lancet for blood glucose level measurement
Subjects measure blood glucose level using laser lancing device (LMT-1000) and lancet for 2 months each.
Interventions
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laser lancing device or lancet for blood glucose level measurement
Subjects measure blood glucose level using laser lancing device (LMT-1000) and lancet for 2 months each.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
20 Years
79 Years
ALL
No
Sponsors
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Korea Medical Device Development Fund
UNKNOWN
Korea University Guro Hospital
OTHER
Responsible Party
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Hye Jin Yoo
Professor
Locations
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Korea University medical center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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K2021-1520-002
Identifier Type: -
Identifier Source: org_study_id
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