UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062325 |
|---|---|
| Receipt number | R000071294 |
| Scientific Title | Multifaceted verification for the practical application of an aggravation prevention program for type 2 diabetes using ICT |
| Date of disclosure of the study information | 2026/07/24 |
| Last modified on | 2026/07/22 14:12:22 |
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Basic information
Public title
Multifaceted verification for the practical application of an aggravation prevention program for type 2 diabetes using ICT
Acronym
Verification of an aggravation prevention program for type 2 diabetes using ICT
Scientific Title
Multifaceted verification for the practical application of an aggravation prevention program for type 2 diabetes using ICT
Scientific Title:Acronym
Multifaceted verification for the practical application of an aggravation prevention program for type 2 diabetes using ICT
Region
| Japan |
Condition
Condition
Type 2 diabetes, Prediabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this clinical study, with the cooperation of health insurance societies, we will conduct a practical program evaluation involving 300 participants, aiming for social implementation. Specifically, the objectives are to evaluate the following:
1) Rationalization of intervention costs while maintaining effectiveness in high-risk subjects.
2) Program composition at an appropriate cost-effectiveness level for medium-risk subjects.
3) Construction of approaches for low-risk individuals and young generations.
4) Reaching the indifferent demographic in collaboration with health insurance societies and occupational physicians.
5) Establishment of a scheme for sending/receiving health checkup/receipt data and extracting target individuals using existing systems.
Through this study, we aim to optimize individualized guidance by risk tier using biological information obtained from FreeStyle Libre 2 and the dietary management app "glucose flight," thereby realizing effective and sustainable glycemic control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycemic variability from baseline (start of study) to the end of the study (12 weeks for the high-risk group, 8 weeks for the medium-risk group, 4 weeks for the low-risk group, and 2 weeks for the youth group). FreeStyle Libre 2 indices (Mean Glucose, Standard Deviation, AC_Var).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Depending on the participant's risk tier (high, medium, low, youth), participants will wear the FreeStyle Libre 2 and record data in the dietary management app "glucose flight" for a period (up to 12 weeks), and receive online nutritional guidance by a registered dietitian (up to 8 times).
Interventions/Control_2
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) Japanese individuals aged 18 or older (regardless of gender).
2) Individuals who underwent a health checkup within the past year and are considered to have type 2 diabetes (HbA1c >= 6.5% or currently undergoing treatment for type 2 diabetes) and fall into albuminuria categories A1 and A2.
3) Individuals who are not diabetic but met the criteria for specific health guidance based on health checkup results within the past year.
4) Individuals who can comply with the necessary procedures according to the research protocol.
5) Individuals from whom informed consent to participate in the study has been obtained.
Key exclusion criteria
1) Participants undergoing dialysis.
2) Participants unable to continuously wear the Libre sensor for the specified period.
3) Other participants deemed inappropriate for participation in this study by the principal investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Oyama |
| Middle name | |
| Last name | Yuta |
Organization
Tokio Marine & Nichido Fire Insurance Co., Ltd.
Division name
NA
Zip code
100-0004
Address
2-6-4, Otemachi, Chiyoda-ku, Tokyo
TEL
03-3212-6211
YUUTA.OOYAMA@tmnf.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Iwasa |
Organization
THE PHAGE, Inc.
Division name
NA
Zip code
150-0002
Address
VEIL SHIBUYA 2F, 2-16-8 Shibuya, Shibuya-ku, Tokyo 150-0002, Japan
TEL
03-4500-1654
Homepage URL
kosuke.iwasa@thephage.life
Sponsor or person
Institute
Tokio Marine & Nichido Fire Insurance Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Tokio Marine & Nichido Fire Insurance Co., Ltd.
New Energy and Industrial Technology Development Organization (NEDO)
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
THE PHAGE, Inc. Ethics Committee
Address
VEIL SHIBUYA 2F, 2-16-8 Shibuya, Shibuya-ku, Tokyo
Tel
070-4813-6517
kotaro.fujino@thephage.life
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 | 07 | Month | 24 | 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
| 2026 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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 | 07 | Month | 24 | Day |
Last modified on
| 2026 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071294
