UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030823 |
|---|---|
| Receipt number | R000035129 |
| Scientific Title | Prevention of Worsening Diabetes through Behavioral Changes by an IoT-based Self-Monitoring System in Japan (PRISM-J): A multicenter, randomized, open-label, parallel group study |
| Date of disclosure of the study information | 2018/01/16 |
| Last modified on | 2023/09/26 16:23:35 |
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Basic information
Public title
Prevention of Worsening Diabetes through Behavioral Changes by an IoT-based Self-Monitoring System in Japan (PRISM-J): A multicenter, randomized, open-label, parallel group study
Acronym
Prevention of Worsening Diabetes through Behavioral Changes by an IoT-based Self-Monitoring System in Japan (PRISM-J)
Scientific Title
Prevention of Worsening Diabetes through Behavioral Changes by an IoT-based Self-Monitoring System in Japan (PRISM-J): A multicenter, randomized, open-label, parallel group study
Scientific Title:Acronym
Prevention of Worsening Diabetes through Behavioral Changes by an IoT-based Self-Monitoring System in Japan (PRISM-J)
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes using smartphone on a daily basis (including a person who newly visits to a clinic/hospital)
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
While collecting the information of the amount of activity, body weight, blood pressure, etc. daily in patients with type 2 diabetes in this study, we will examine the patient's behavioral changes and the improvement of glycemic control by intervening through feedback messages from the application of a smartphone.
In this research, in order to comprehensively collect health data, etc., whose formats differ in each device manufacturer, and to create a standard that enables distribution and utilization of data, we will revise and utilize the Exchange Agreement prepared in "Infrastructure Project for The Creation of New Industry Model to Promote IoT (a behavioral change promotion project utilizing information about individual health and medical treatment owned by corporate insurance companies, etc.)" based on the 2015 fiscal year supplementary budget by the Ministry of Economy Trade and Industry. Furthermore, by taking an advantage of AI, we will aim to find out factors or combinations thereof that can contribute to the prevention and well management of diabetes, and to develop algorithms that can promote personal behavioral changes and the prevention, management, and improvement of diabetes. We will verify that the data collected in the clinical research field and the service model research field can be standardized by the revised "Definition document of exchange agreement for such as health information" (Exchange Agreement), and perform an exploratory research elucidating whether the common database storing the standardized data could be useful as a general-purpose knowledge database.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in HbA1c at week 52 after the start of the study
Key secondary outcomes
Inter-group comparison will be done for the following items at weeks 12, 24, 36, and 52 after the initiation of the study.
1. Glucose metabolism (blood glucose)
2. Lipid metabolism (total cholesterol, HDL cholesterol)
3. Liver function (ALT), renal function (creatinine)
4. Brief-type self-administered Diet History Questionnaire (BDHQ) (baseline and at 52 weeks)
5. Diabetes Therapy-Related-QOL (DTR-QOL)
6. Lifestyle questionnaire
7. Weight, BMI, systolic and diastolic blood pressures
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Download "Omron Connect" and "Shichifukujin" applications to patients' smartphone and input the information required to use "Omron Connect" and "Shichifukujin" applications. The study subjects measure the amount of activity, body weight, and blood pressure on a daily basis using lent measurement apparatuses, connects "Omron Connect" to the measurement apparatuses, and synchronizes them every day as much as possible. Investigators of the study and family doctors will plan the behavioral targets tailored to the subjects in the intervention group as research introduction and introductory education of the study. The subjects in the intervention group will receive messages of support and attention from "Shichifukujin" application as appropriate feedbacks according to the implementation situation (IoT information). At visit at 12, 24, 36, and 52 weeks or during health guidance, share the measurement data of "Omron Connect" and the comment of "Shichifukujin" applications with the investigators of the study and the family doctors. In addition, investigators and family doctors can access the administrators section in the "Shichifukujin" application webpage, check/confirm the summary of the measurement data, graphs and lifestyle habits, and use them appropriately as the assistance data/documents for medical treatment and guidance based on the subject's life records.
Interventions/Control_2
Download of "Shichifukujin" application will not be performed during the observation period until week 52, but from week 53 the same education and guidance as in the intervention group will be done, and input information required for using "Omron Connect" and "Shichifukujin" applications. The subjects in the control group measure the amount of activity, body weight, and blood pressure on a daily basis using lent measurement apparatuses, connects "Omron Connect" to the measurement apparatuses, and synchronizes them every day as much as possible.
The "Shichifukujin" application which will be used from week 53 is to be upgraded from the previous specifications, and it will be possible to use an improved version that will deliver appropriate messages according to changes in the stage of individual behavioral change.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. A patient whose HbA1c value is 6.0% or higher but 8.9% or lower.
2. A patient whose age is 20 years or older but younger than 75 years old.
3. A patient whose dosage and dose regimen of medications regarding diabetes have not been changed for 8 weeks or longer before the allocation.
4. A patient from whom informed consent of the participation in the study is obtained in written form.
Key exclusion criteria
1. A patient with serious hepatic impairment (his/her ALT exceeds 3-fold of the upper limit of the standard value), kidney diseases (his/her eGFR is less than 30 mL/min/1.73 m2), malignancies (patient whose time to recurrence is less than 5 years), or active infectious diseases (including sepsis).
2. A patient receiving 4 or more oral therapeutic agents for diabetes.
3. A patient receiving any insulin or GLP1 receptor agonist.
4. A patient with active proliferative diabetic retinopathy.
5. A patient who had developed cardiovascular disease within 6 months.
6. A patient with an uncompensated cardiac insufficiency.
7. A patient who is pregnant or is planning to become pregnant within 2 years.
8. A patient who requires assistance from another person to treat hypoglycemia.
9. A patient who is instructed to follow the exercise restrictions due to diseases other than diabetes mellitus.
10. A patient for whom the person in charge of the study judges that his/her participation in this study is inappropriate.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kohjiro |
| Middle name | |
| Last name | Ueki |
Organization
National Center for Global Health and Medicine
Division name
Diabetes Research Center
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
+81-3-3202-7181
uekik@ri.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Ryotaro |
| Middle name | |
| Last name | Bouchi |
Organization
National Center for Global Health and Medicine
Division name
Diabetes and Metabolism Information Center
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
+81-3-6228-0492
Homepage URL
http://prism-j.umin.jp/
rybouchi@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
National Center for Global Health and Medicine Institutional Review Board
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
Tel
+81-3-3202-7181
rinrijm@hosp.ncgm.go.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
あいち健康の森健康科学総合センター/Comprehensive Health Science Center, Aichi Health Promotion Foundation
名古屋大学大学院医学系研究科/Departments of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine
兵庫医科大学内科学/Department of Internal Medicine, Division of Diabetes, Endocrinology and Metabolism, Hyogo College of Medicine
東京医科大学病院/Department of Diabetology, Metabolism, and Endocrinology, Tokyo Medical University Hospital
自治医科大学附属さいたま医療センター/ Department of Endocrinology and Metabolism, Saitama Medical Center, Jichi Medical University
独立行政法人国立病院機構京都医療センター/Division of Diabetic Research, Clinical Research Institute, National Hospital Organization Kyoto Medical Center
国立研究開発法人医薬基盤・健康・栄養研究所/Department of Nutritional Sciences, National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition
一般財団法人医療情報システム開発センター/Medical Information System Development Center
九州大学病院メディカル・インフォメーションセンター/ Medical Information Center, Kyushu University Hospital
東京工業大学科学技術創成研究院/ Institute of Innovative Research, Tokyo Institute of Technology
国立研究開発法人産業技術総合研究所/ National Institute of Advanced Industrial Science and Technology
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 16 | 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
1159
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 01 | Month | 15 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035129
