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

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 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


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

Value
https://center6.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