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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031446
Receipt No. R000035900
Scientific Title A Pragmatic Study Modifying Behaviors by Nutritionists to Diabetes Patients through IoT-based Self Monitoring System
Date of disclosure of the study information 2018/02/24
Last modified on 2018/02/23

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Basic information
Public title A Pragmatic Study Modifying Behaviors by Nutritionists to Diabetes Patients through IoT-based Self Monitoring System
Acronym AMEND-IT
Scientific Title A Pragmatic Study Modifying Behaviors by Nutritionists to Diabetes Patients through IoT-based Self Monitoring System
Scientific Title:Acronym 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
1st name
Middle name
Last name Mitsuru Ohsugi, MD
Organization National Center for Global Health and Medicine
Division name Diabetes and Metabolism Information Center
Zip code
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
1st name
Middle name
Last name Mitsuru Ohsugi, MD
Organization National Center for Global Health and Medicine
Division name Diabetes and Metabolism Information Center
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Enrolling by invitation
Date of protocol fixation
2017 Year 12 Month 25 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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