UMIN-CTR Clinical Trial

Basic information
Public title	Study on a program for prevention of aggravation of diabetes: effectiveness of behavior modification model using Internet of Things including interventions by multiple types of professionals
Acronym	Effectiveness of a program using IoT for prevention of aggravation of diabetes
Scientific Title	Study on a program for prevention of aggravation of diabetes: effectiveness of behavior modification model using Internet of Things including interventions by multiple types of professionals
Scientific Title:Acronym	Effectiveness of a program using IoT for prevention of aggravation of diabetes
Region	Japan

Condition
Condition	Diabetes/pre-diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effectiveness of a program for prevention of aggravation of diabetes for patients with diabetes or pre-diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in hemoglobin (Hb) A1c at 12 and 24 weeks from baseline
Key secondary outcomes	1. Change in body weight (body mass index) at 12 and 24 weeks from baseline 2. Change in abdominal girth at 12 and 24 weeks from baseline 3. Change in blood pressure at 12 and 24 weeks from baseline 4. Change in blood test values (fasting blood glucose, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol) at 12 and 24 weeks from baseline 5. Change in lifestyle behavior and depression status based on questionnaires at 24 weeks from baseline 6. Monthly change in exercise behavior based on recorded number of steps

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	Use of the smartwatch, use of the mobile application for self-monitoring health data, and advice by doctors (video call at 1 month and 3 months from start), pharmacists (weekly chatting for patients with medication) and nutrition managers (chatting three times a week, monthly video call) for 6 months
Interventions/Control_2	No intervention
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. With HbA1c 7.0% or more and 8.0% or less 2. Aged 25 years or more and less than 75 (male and female) 3. Daily smartphone user 4. Wishing to participate to the program
Key exclusion criteria	1. Having comorbidity of severe hepatic dysfunction (3 times or more of upper limit of reference value for AST or ALT), hemodialysis, or comorbidity of cancer 2. Receiving treatment with insulin 3. In pregnancy or planning to get pregnant 4. Being restricted exercise 5. Having cognitive dysfunction 6. Having serious cardiovascular diseases (myocardial infarct, angina, serious arrhythmia, hypertension with a systolic blood pressure 180 mmHg or more or with a diastolic blood pressure 110 mmHg or more) 7. Being deemed inappropriate to participate to this study by his/her primary physician
Target sample size	105

Research contact person
Name of lead principal investigator	1st name Mizunobu Middle name Last name Kinoshita
Organization	Medical Corporation Syojinkai
Division name	Nagoya Station Clinic
Zip code	450-0002
Address	Nagoya Building 8F, 4 Chome 6-17, Meieki, Nakamura-ku, Nagoya, Aichi, Japan
TEL	052-551-6663
Email	m-kinoshita@station-clinic.com

Public contact
Name of contact person	1st name Kohei Middle name Last name Sasaki
Organization	Sugi Pharmacy Co., Ltd.
Division name	Corporate Planning division
Zip code	474-0011
Address	62-1, Shin'e, Yokone-machi, Obu, Aichi, Japan
TEL	0562-45-2700
Homepage URL
Email	ko-sasaki@drug-sugi.co.jp

Sponsor
Institute	Nagoya Station Clinic
Institute
Department

Funding Source
Organization	Sugi Pharmacy Co., Ltd., M-aid Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Milliman Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Non-Profit Organization MINS Institutional Review Board
Address	5-20-9-401 Mita, Minato-ku, Tokyo, Japan
Tel	03-6416-1868
Email	npo-mins@j-irb.com

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	2018 Year 12 Month 03 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	Terminated
Date of protocol fixation	2018 Year 11 Month 01 Day
Date of IRB	2018 Year 11 Month 21 Day
Anticipated trial start date	2018 Year 12 Month 10 Day
Last follow-up date	2019 Year 12 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 11 Month 30 Day
Last modified on	2019 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039882