UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Pragmatic Study Modifying Behaviors by Nutritionists to Diabetes Patients through IoT-based Self Monitoring System
Title of the study (Brief title)	AMEND-IT
Region	Japan

Condition
Condition	Diabetes Mellitus
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Exploring whether remote diabetes self-management support by certified dieticians via smartphones is effective for improving glycemic control and weight management.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in HbA1c after 52-week self-management support.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Providing diabetes self-management support once a week by dieticians over continuous 52 weeks.
Interventions/Control_2	Providing diabetes self-management support 3 times a week for 9 weeks by dieticians intermittently, from the beginning of the intervention to the end of 9th week and from 26th week to the end of 35the week.
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. HbA1c equals to or greater than 6.0% and eqauls to or less than 8.0% 2. No change in medications for diabetes during 8 weeks prior to the randomization. 3. Those able to sign a written consent form.
Key exclusion criteria	1. Those with serious liver, renal, malignant neoplasms or infections. 2. Those treated with 3 or more oral antihyperglycemic agents. 3. Those treated with insulin or GLP-1 receptor agonists. 4. Those with active proliferative diabetic retinopathy. 5. Those with recent cardiovascular events for the past 6 months. 6. Those with decompensated congestive heart failure. 7. Pregnancy. 8. Those with history of hypoglycemia requiring assistance from others. 9. Those judged to be disqualified for the study by investigators.
Target sample size	150

Research contact person
Name of lead principal investigator	Mitsuru Ohsugi, MD
Organization	National Center for Global Health and Medicine
Division name	Diabetes and Metabolism Information Center
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL	03-3202-7181
Email	moosugi@hosp.ncgm.go.jp

Public contact
Name of contact person	Mitsuru Ohsugi, MD
Organization	National Center for Global Health and Medicine
Division name	Diabetes and Metabolism Information Center
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL	03-3202-7181
Homepage URL
Email	moosugi@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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 02 Month 24 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 12 Month 25 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 23 Day
Last modified on	2018 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035900