UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031446 |
|---|---|
| Receipt number | 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 14:35:11 |
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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
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
moosugi@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 (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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035900
