UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032231
Receipt number 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 2023/10/23 13:04:44

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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 or person

Institute

Kanazawa University Hospital
Internal medicine

Institute

Department

Personal name



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
KKR Hokuriku 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

金沢大学附属病院(石川県)


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

17

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

No longer 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

2027 Year 04 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2027 Year 04 Month 13 Day


Other

Other related information



Management information

Registered date

2018 Year 04 Month 13 Day

Last modified on

2023 Year 10 Month 23 Day



Link to view the page

Value
https://center6.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