Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063047) titled 'Effectiveness of a Diabetes Self-Management Support App for home-based patients with diabetes' on Sept. 30.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Hamamatsu University School of Medicine
Condition:
Condition - Type 2 diabetic patient
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to determine, through a randomized controlled trial, whether the use of a diabetes self-management support app developed by the applicants influences the self-management behaviors and awareness of patients with diabetes receiving home-based care.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Conventional health guidance and the use of Diabetes Self-Management Support Apps
Interventions/Control_2 - Conventional health counseling only
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - This study is intended for patients who meet all of the following criteria:
1. Patients aged 20 to 80 years
2. Patients with type 2 diabetes attending the University Hospital, Hamamatsu University School of Medicine
3. Patients who have provided informed consent to participate in this study by signing a consent form
4. Patients who use a smartphone on a daily basis
5. Patients who can speak and read Japanese
Key exclusion criteria - Patients who meet any of the following criteria shall be excluded from this study.
1. Patients with an infectious disease
2. Patients with type 1 diabetes
3. Patients with diabetic nephropathy at stage 3 or higher
4. Patients currently undergoing treatment for a malignant tumor
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 11 Day
Date of IRB - 2026 Year 09 Month 17 Day
Anticipated trial start date - 2026 Year 10 Month 23 Day
Last follow-up date - 2028 Year 01 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071088
Disclaimer: Curated by HT Syndication.
