The Evaluation of Laser Lancing Devices in Adult Type 2 Diabetes Patients

Type 2 Diabetes Clinical Trial

Official title:

The Evaluation of Laser Lancing Devices in Constructing Self-management Systems for Chronic Diseases in Adult Diabetes Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05251506
• Other study ID #: K2021-1520-002
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2022
• Source: Korea University Guro Hospital
• Contact: Min Jeong Park
• Phone: +82-10-7271-3805
• Email: minjeong87[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University medical center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Guro Hospital	Korea Medical Device Development Fund

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	two months after using the device
Primary	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 (%).	two months after using the device
Secondary	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)	two months after using the device
Secondary	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)	two months after using the device
Secondary	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)	two months after using the device
Secondary	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)	two months after using the device
Secondary	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)	two months after using the device