- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05251506
The Evaluation of Laser Lancing Devices in Adult Type 2 Diabetes Patients
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Min Jeong Park
- Telefonnummer: +82-10-7271-3805
- E-mail: minjeong87@gmail.com
Undersøgelse Kontakt Backup
- Navn: Hye Jin Yoo
- Telefonnummer: +82-10-8951-9451
- E-mail: deisy21@naver.com
Studiesteder
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Seoul, Korea, Republikken, 08308
- Rekruttering
- Korea University Medical Center
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Kontakt:
- Min Jeong Park, M.D.
- Telefonnummer: +82-10-7271-3805
- E-mail: minjeong87@gmail.com
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Kontakt:
- Hye Jin Yoo, M.D. Ph.D
- Telefonnummer: +82-10-8951-9451
- E-mail: deisy21@naver.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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Subjects measure blood glucose level using laser lancing device (LMT-1000) and lancet for 2 months each.
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Aktiv komparator: 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.
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Subjects measure blood glucose level using laser lancing device (LMT-1000) and lancet for 2 months each.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
average number of checking blood glucose per week
Tidsramme: two months after using the device
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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)
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two months after using the device
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glycated hemoglobin level
Tidsramme: two months after using the device
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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 (%).
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two months after using the device
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
average satisfaction score
Tidsramme: two months after using the device
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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)
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two months after using the device
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average pain scale
Tidsramme: two months after using the device
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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)
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two months after using the device
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Diabetes Distress Scale
Tidsramme: two months after using the device
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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)
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two months after using the device
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Diabetes Fear of Self-injecting
Tidsramme: two months after using the device
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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)
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two months after using the device
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success rate of measurement of blood glucose by laser lancing device
Tidsramme: two months after using the device
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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)
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two months after using the device
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- K2021-1520-002
Plan for individuelle deltagerdata (IPD)
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