UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060828 |
|---|---|
| Receipt number | R000069606 |
| Scientific Title | A prospective observational study evaluating the effectiveness of a digital peer-support app-based program to prevent diabetes complications |
| Date of disclosure of the study information | 2026/03/05 |
| Last modified on | 2026/03/05 10:12:56 |
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Basic information
Public title
Effectiveness of a digital peer supported app based program to prevent diabetes complications: a prospective observational study
Acronym
DPSA-DM
Scientific Title
A prospective observational study evaluating the effectiveness of a digital peer-support app-based program to prevent diabetes complications
Scientific Title:Acronym
DPSA-DM
Region
| Japan |
Condition
Condition
Diabetes mellitus and prediabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of a digital peer supported app based program for preventing the progression of diabetes severity and related complications through online mutual support.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in lifestyle behaviors (diet, physical activity, smoking, alcohol consumption, and sleep) and medication status/adherence assessed at baseline (program start), 3 months (midpoint), and 6 months (program end).
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- Age 20 to 64 years.
- Having undergone a specific health checkup or comprehensive medical checkup, or having visited a medical institution within the past year, with available clinical laboratory results.
-Lifestyle-related diabetes or prediabetes, defined as follows:
- For individuals who have visited a medical institution: HbA1c 6.0 to 8.9, or blood glucose < 250 mg/dL regardless of fasting/random status.
- For individuals who have not visited a medical institution: HbA1c 6.0 to 6.9, or fasting plasma glucose 110 to <140 mg/dL, or random plasma glucose 140 to 199 mg/dL.
Key exclusion criteria
-Non-lifestyle-related diabetes/prediabetes (e.g., pancreatic disease, endocrine/hormonal disorders, drug-induced).
-Type 1 diabetes or receiving insulin therapy.
-Diabetic kidney disease, chronic renal failure, or undergoing dialysis.
-Cardiovascular disease (e.g., angina, myocardial infarction, heart failure) or stroke.
-Prohibited from exercise by a physician, or history of severe hypoglycemia that cannot be adequately self-managed.
-Pregnancy.
-Grade 2 hypertension or higher.
-Dyslipidemia (LDL-C >= 180 mg/dL or triglycerides >= 500 mg/dL). Note: Lipid-based exclusion applies only to individuals who have not visited a medical institution.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Yoshihara |
Organization
Kitasato University Graduate School
Division name
Medical Sciences
Zip code
252-0373
Address
1-15-1 Kitazato, Minami-ku, Sagamihara, Kanagawa 252-0373, Japan
TEL
042-778-9305
yoshihara.shota@st.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Yoshihara |
Organization
Kitasato University
Division name
Medical Sciences
Zip code
252-0373
Address
1-15-1 Kitazato, Minami-ku, Sagamihara, Kanagawa 252-0373, Japan
TEL
042-778-9305
Homepage URL
yoshihara.shota@st.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Conflicts of interest were reviewed by the Kitasato University Conflict of Interest Committee and are appropriately managed.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Kitasato University School of Allied Health Sciences
Address
1-15-1 Kitazato, Minami-ku, Sagamihara, Kanagawa 252-0373, Japan
Tel
0427789602
a-soumu@kitasato-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 | 03 | 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 | 11 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a single-arm prospective observational study.
Participants will take part in a 6-month diabetes complications prevention program using a digital peer-support app. Assessments will be conducted at baseline (program start), 3 months, and 6 months and will include questionnaires on lifestyle behaviors and medication status.
The primary outcomes are longitudinal changes in lifestyle behaviors and medication status.
Management information
Registered date
| 2026 | Year | 03 | Month | 05 | Day |
Last modified on
| 2026 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069606
