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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032231
Receipt No. R000034806
Scientific Title The Effect of Nutrition Education Using Artificial Intelligence on patients with Diabetes Mellitus.: A Randomized controlled trial
Date of disclosure of the study information 2018/04/13
Last modified on 2019/04/14

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Basic information
Public title The Effect of Nutrition Education Using Artificial Intelligence on patients with Diabetes Mellitus.: A Randomized controlled trial
Acronym Nutrition Education Using AI on patients with Diabetes Mellitus
Scientific Title The Effect of Nutrition Education Using Artificial Intelligence on patients with Diabetes Mellitus.: A Randomized controlled trial
Scientific Title:Acronym Nutrition Education Using AI on patients with Diabetes Mellitus
Region
Japan

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

Objectives
Narrative objectives1 To compare the efficacy between the nutrition education using an Internet Website Dish-Based Dietary Record besides comments from AI and conventional face-to-face nutrition education in outpatient department.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Blood HbA1c level in the end
Key secondary outcomes 1.fasting blood glucose
2.expenditure
3.body mass index
4.blood pressure
5.lipid metabolism (TCHO,TG,LDL-C,HDL-C)
6.urinary albumin
7.diabetic complication state
8.medication changing during the trial
9.frequency of application use

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 application use+, nutrition education in outpatient department-
1.Dish-Based Dietary Record per 1 week and reception a message everyday
2.conventional hospital visit (medical examination)

application use-->nutrition education in outpatient department-->application use(each:1year, total:3year)
Interventions/Control_2 application use-, nutrition education in outpatient department+
1.Having nutrition education at least per 3 months
2.conventional hospital visit (medical examination)

nutrition education in outpatient department-->application use-->nutrition education in outpatient department(each:1year, total:3year)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Diabetes Mellitus
2. HbA1c level is within a range of 5.2-7.5%
3. Written informed consent
4. Ability of using smartphone or getting assist to use it
Key exclusion criteria 1. Malignant hypertension or secondary hypertension
2. Necessity of treatment by insulin
3. Pregnancy or potentialities pregnancy
4. Severe renal dysfunction (eGFR<45ml/min/1.73^2)
5. Severe hepatic dysfunction
6. Under the treatment or within 3 months outbreak of
myocardial infarction or cerebrovascular disease
7. Sever allergy or taking steroid
8. chronic pancreatitis
9. Under the treatment of malignancy
10. Patients ineligible for the study determined by doctors
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Mitsuhiro
Middle name
Last name Kometani
Organization Kanazawa University Hospital
Division name Internal medicine of Endocrinology and Metabolism
Zip code 920-8641
Address Ishikawa Kanazawa-city takaramachi 13-1
TEL 076-265-2252
Email mkome@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Mitsuhiro
Middle name
Last name Kometani
Organization Kanazawa University Hospital
Division name Internal medicine of Endocrinology and Metabolism
Zip code 920-8641
Address Ishikawa Kanazawa-city takaramachi 13-1
TEL 076-265-2252
Homepage URL
Email mkome@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Hospital
Internal medicine
Institute
Department

Funding Source
Organization Kanazawa University Hospital
Internal medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor WIT Co.Ltd.
Houju Memorial Hospital
Hokuriku Central Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kanazawa University, Medical department, Ethics Committee
Address Ishikawa Kanazawa-city takaramachi 13-1
Tel 076-265-2110
Email t-isomu@adm.kanazawa-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 2623-1
Org. issuing International ID_1 Kanazawa University medical ethics committee
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 04 Month 13 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 20 Day
Date of IRB
2017 Year 12 Month 27 Day
Anticipated trial start date
2018 Year 04 Month 13 Day
Last follow-up date
2023 Year 04 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2023 Year 04 Month 13 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 13 Day
Last modified on
2019 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034806

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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