UMIN-CTR Clinical Trial

Basic information
Public title	Study on effects of "online education and life improvement program for diabetic patients" on behavior change, biochemical parameter, and related factors.
Acronym	Study on effects of "online education and life improvement program for diabetic patients" on behavior change, biochemical parameter, and related factors.
Scientific Title	Study on effects of "online education and life improvement program for diabetic patients" on behavior change, biochemical parameter, and related factors.
Scientific Title:Acronym	Study on effects of "online education and life improvement program for diabetic patients" on behavior change, biochemical parameter, and related factors.
Region	Japan

Condition
Condition	Diabetes
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to build a program that brings change to one's behavior. The program will refer to in-hospital diabetes educational program, and designed to be safe (not to worsen the patient's condition) under the direction of a doctor.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c weight BMI
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	expanded access
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food Behavior,custom
Interventions/Control_1	Provide online educational program for a week, and observe their change for 4 weeks after the program.
Interventions/Control_2
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Diabetic patients of the University of Tsukuba Hospital 2) Patients whose HbA1c is more than 7.0 % and less than 7.9 % 3) Males and females aged between 20 and 65 at the start of this clinical trial 4) Patients who are not taking sulfonylureas or injecting insulin at the start of this clinical trial 5) Patients who can walk about 6,000 steps a day 6) Patients who have difficulty in normal education hospitalization 7) Patients whose doctor permits the entry of this stud
Key exclusion criteria	1) Patients with severe infections, before or after operations or having serious external injuries at the time of agreement acquisition 2) Patients with exercise restrictions 3) Pregnant women, lactating women, or women who have possibility of pregnancy 4) Patients who are judged to be inappropriate by the research managers
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Naoya Middle name Last name Yahagi
Organization	University of Tsukuba
Division name	Faculty of Medicine
Zip code	305-8575
Address	1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL	029-853-3053
Email	nyahagi-tky@umin.ac.jp

Public contact
Name of contact person	1st name Noya Middle name Last name Yahagi
Organization	University of Tsukuba
Division name	Faculty of Medicine
Zip code	305-8575
Address	1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL	029-853-3053
Homepage URL
Email	nyahagi-tky@umin.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	JMDC Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Habitus Care Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of Tsukuba
Address	1-1-1 Tennoundai, Tsukuba, Ibaraki
Tel	029-853-3053
Email	nyahagi-tky@umin.ac.jp

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	2021 Year 01 Month 04 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	Preinitiation
Date of protocol fixation	2020 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 04 Day
Last modified on	2021 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048967

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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