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 | 2025/04/23 15:31:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
Completed
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
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034806
