UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062479 |
|---|---|
| Receipt number | R000071509 |
| Scientific Title | Stratified randomized controlled trial |
| Date of disclosure of the study information | 2026/08/05 |
| Last modified on | 2026/08/05 16:06:05 |
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Basic information
Public title
Effectiveness of an ICT-Based Regional Collaboration System Combined with an AI-Enabled Personal Health Record for Glycemic Management in Individuals with Impaired Glucose Tolerance
Acronym
Evaluation of the Effectiveness of an AI-Enabled Personal Health Record-Based Support Intervention for Glycemic Management
Scientific Title
Stratified randomized controlled trial
Scientific Title:Acronym
RCT
Region
| Japan |
Condition
Condition
People with type 2 diabetes mellitus or impaired glucose tolerance (Excluding non-obese individuals)
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effectiveness of AI-based remote nutritional support compared with conventional face-to-face support using a Personal Health Record (PHR) system in diabetes care. Furthermore, we aim to identify factors associated with improvements in clinical outcomes to develop more effective and personalized support strategies. In addition, we will investigate whether automated feedback and reminder functions provided by AI can contribute to reducing the burden on healthcare professionals and establish a framework for continuous support under limited medical resources.
Basic objectives2
Others
Basic objectives -Others
Between-group difference in the change in HbA1c from baseline to 6 months after the intervention.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Between-group difference in the change in HbA1c from baseline to 6 months after the intervention.
Key secondary outcomes
Between-group differences in changes in body weight and CGM-derived parameters at baseline, 2, 4, and 6 months.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Only participants in the intervention group will receive AI messages. The AI message intervention will start 2 weeks after the index date and continue for 6 months.
Interventions/Control_2
Participants in the control group will not receive AI message-based intervention and will receive usual care.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who have been using the Health2Sync application for at least 6 months at the time of enrollment.
2.Patients who are 18 years of age or older at the time of informed consent.
3.No restriction on sex.
4.Patients with a body weight change of less than 5% during the 6 months before enrollment.
5.Patients with an HbA1c change of less than 0.5% during the 6 months before enrollment.
6.Patients who have received sufficient information about the study, fully understood the study, and provided written informed consent voluntarily.
Key exclusion criteria
1.Patients who had an addition or change in antidiabetic medications during the study period
2.Patients who were judged by the attending physician to be inappropriate for participation in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Isaki |
| Middle name | |
| Last name | Hanamura |
Organization
University of Nagasaki
Division name
Department of Nutrition Science, Faculty of Nursing and Nutrition
Zip code
851-2195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan
TEL
0958135493
hanamura02@sun.ac.jp
Public contact
Name of contact person
| 1st name | Isaki |
| Middle name | |
| Last name | Hanamura |
Organization
University of Nagasaki
Division name
Department of Nutrition Science, Faculty of Nursing and Nutrition
Zip code
851-2195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan
TEL
0958135493
Homepage URL
hanamura02@sun.ac.jp
Sponsor or person
Institute
University of Nagasaki
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Nagasaki
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan
Tel
095-813-5500
hanamura02@sun.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 05 | Day |
Last modified on
| 2026 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071509
