Clinical trial NCT05251506: The Evaluation of Laser Lancing Devices in Adult Type 2 Diabetes Patients
Official title: The Evaluation of Laser Lancing Devices in Constructing Self-management Systems for Chronic Diseases in Adult Diabetes Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: self monitoring of blood glucose
lancing device
type 2 diabetes
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
Collaborators: name: Korea Medical Device Development Fund
First posted: 2022-02-22
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: average number of checking blood glucose per week
timeFrame: two months after using the device
measure: glycated hemoglobin level
timeFrame: two months after using the device
Secondary outcomes:
measure: average satisfaction score
timeFrame: two months after using the device
measure: average pain scale
timeFrame: two months after using the device
measure: Diabetes Distress Scale
timeFrame: two months after using the device
measure: Diabetes Fear of Self-injecting
timeFrame: two months after using the device
measure: success rate of measurement of blood glucose by laser lancing device
timeFrame: two months after using the device
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University medical center
Study officials:
References: