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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: laser lancing device or lancet for blood glucose level measurement

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Jeong Park; Phone Number: +82-10-7271-3805; Email: minjeong87@gmail.com
• Study Contact Backup: Name: Hye Jin Yoo; Phone Number: +82-10-8951-9451; Email: deisy21@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08308
    • Recruiting
    • Korea University Medical Center
    • Contact: Min Jeong Park, M.D.; Phone Number: +82-10-7271-3805; Email: minjeong87@gmail.com
    • Contact: Hye Jin Yoo, M.D. Ph.D; Phone Number: +82-10-8951-9451; Email: deisy21@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital
• Collaborators: Korea Medical Device Development Fund

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: February 13, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 13, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: type 2 diabetes; self monitoring of blood glucose; lancing device
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: K2021-1520-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No