UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060579 |
|---|---|
| Receipt number | R000069291 |
| Scientific Title | Efficacy of a Diabetes Onset Prevention App System Utilizing Continuous Glucose Monitoring and Artificial Intelligence in Individuals at High Risk for Type 2 Diabetes |
| Date of disclosure of the study information | 2026/02/13 |
| Last modified on | 2026/02/04 14:53:13 |
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Basic information
Public title
Efficacy of a Diabetes Onset Prevention App System Utilizing Continuous Glucose Monitoring and Artificial Intelligence in Individuals at High Risk for Type 2 Diabetes
Acronym
Evaluation of an AI and Continuous Glucose Monitoring Based App to Support the Prevention of Type 2 Diabetes
Scientific Title
Efficacy of a Diabetes Onset Prevention App System Utilizing Continuous Glucose Monitoring and Artificial Intelligence in Individuals at High Risk for Type 2 Diabetes
Scientific Title:Acronym
Evaluation of an A- and Continuous Glucose Monitoring Based App to Support the Prevention of Type 2 Diabetes
Region
| Japan |
Condition
Condition
Prediabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As existing evidence is limited to improvements in surrogate markers, this study will conduct a 1-year randomized controlled trial using an improved system, with diabetes incidence as the primary endpoint, to establish empirical evidence for the prevention of type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of diabetes mellitus before and after the intervention will be compared between the intervention group and the control group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention using a continuous glucose monitoring function + AI-powered disease prevention application system
Interventions/Control_2
Standard diabetes prevention guidance
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals with HbA1c < 6.5 percent and fasting blood glucose < 126 mg/dL and random blood glucose < 200 mg/dL
2. Individuals meeting condition 1 HbA1c >= 6.0 percent and fasting blood glucose >= 103 mg/dL or condition 2 HbA1c >= 6.2 percent or condition 3 fasting blood glucose >= 112 mg/dL
3. Individuals aged 20 years or older and 70 years or younger at the time of consent acquisition
4. Individuals with a BMI >= 25 kg/m2 and < 40 kg/m2
5.Individuals capable of using the smartphone application employed in the research
6. Individuals who have received an explanation of the research content and have provided consent to participate in the study
Key exclusion criteria
1.Individuals currently receiving treatment for diabetes
2.Individuals deemed inappropriate for participation by the attending physician
Target sample size
660
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Kitazawa |
Organization
Graduate School of Medical and Dental Sciences, Niigata University
Division name
Department of Haematology, Endocrinology and Metabolism
Zip code
9518510
Address
754 Asahimachidori Ichibancho, Chuo-ku, Niigata City, Niigata, Japan
TEL
0253689026
m-kitazawa.med@niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Kitazawa |
Organization
Graduate School of Medical and Dental Sciences, Niigata University
Division name
Department of Haematology, Endocrinology and Metabolism
Zip code
9518510
Address
754 Asahimachidori Ichibancho, Chuo-ku, Niigata City, Niigata, Japan
TEL
0253689026
Homepage URL
m-kitazawa.med@niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
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
Niigata University Research Ethics Committee for Studies Involving Human Subjects
Address
754 Asahimachidori Ichibancho, Chuo-ku, Niigata City, Niigata, Japan
Tel
025-227-2625
ethics@adm.niigata-u.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 | 02 | Month | 13 | 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 | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2028 | Year | 02 | Month | 28 | 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 | 02 | Month | 04 | Day |
Last modified on
| 2026 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069291
