UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

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

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

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

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

Email

uekik@ri.ncgm.go.jp

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/

Email

rybouchi@hosp.ncgm.go.jp

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

National Center for Global Health and Medicine Institutional Review Board

Address

1-21-1 Toyama, Shinjuku-ku, Tokyo

Tel

+81-3-3202-7181

Email

rinrijm@hosp.ncgm.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2018

Year

01

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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