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

NCT05251506 | Unknown

• 1 other identifier: K2021-1520-002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

self monitoring of blood glucose; lancing device; type 2 diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• average satisfaction score

  two months after using the device

• average pain scale

  two months after using the device

• Diabetes Distress Scale

  two months after using the device

• Diabetes Fear of Self-injecting

  two months after using the device

• success rate of measurement of blood glucose by laser lancing device

  two months after using the device

Study Arms (2)

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.

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.

Device: laser lancing device or lancet for blood glucose level measurement

Interventions

laser lancing device or lancet for blood glucose level measurement DEVICE

Subjects measure blood glucose level using laser lancing device (LMT-1000) and lancet for 2 months each.

lancet first user; laser lancing device (LMT-1000) first user

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• Korea Medical Device Development Fund: collaborator

Study Sites (1)

Korea University medical center

Seoul, 08308, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Min Jeong Park

CONTACT

+82-10-7271-3805; minjeong87@gmail.com

Hye Jin Yoo

CONTACT

+82-10-8951-9451; deisy21@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: February 22, 2022
• Study Start: August 10, 2021
• Primary Completion: March 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)