Tokyo, March 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060912) titled 'Investigation of the effect of interaction with a chatbot on postprandial blood glucose levels' on March 12.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Ritsumeikan University
Condition:
Condition - diabetes mellitus
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We will clarify whether the interaction with the chatbot can suppress the increase in postprandial blood glucose level and improve health.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intervention 1: ingest glucose, talk to chatbot
Interventions/Control_2 - Intervention 2: ingest glucose, talk to new person
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male
Key inclusion criteria - Twelve healthy male students of the University, aged between 18 and 30 years old
Key exclusion criteria - The following subjects should be excluded from the oral glucose tolerance test because of the risk of causing an exacerbation of metabolic abnormalities (worsening of symptoms such as thirst, frequent urination, and easy fatigue due to hyperglycemia) when the test is performed.
- Subjects with type 1 diabetes
- Subjects with type 2 diabetes
- Subjects with diabetic ketoacidosis
- Subjects with symptoms of fasting hyperglycemia
- Subjects with symptoms of infection
The following subjects are excluded because of the use of glucose monitoring system.
- Subjects who are using any kind of glucose monitoring device (because there is a possibility of incorrect measurement)
- Subjects who are using an implantable medical device such as a pacemaker (because there is a possibility of malfunction)
- Subjects who are allergic to alcohol or have sensitive skin (because alcohol disinfection is performed when the device is worn)
The following subjects are excluded from the study because of the possibility of affecting autonomic nervous system activity:
- Subjects who have not had enough sleep the night before the experiment
Target Size - 12
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 08 Month 26 Day
Date of IRB - 2025 Year 08 Month 26 Day
Anticipated trial start date - 2025 Year 08 Month 26 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067078
Disclaimer: Curated by HT Syndication.