UMIN-CTR Clinical Trial

Basic information
Public title	Single arm intervention study of the efficacy of the App for improving the lifestyle behavior in patients with Type 2 DM
Acronym	Single arm intervention study of the efficacy of the App for improving the lifestyle behavior in patients with Type 2 DM
Scientific Title	Single arm intervention study of the efficacy of the App for improving the lifestyle behavior in patients with Type 2 DM
Scientific Title:Acronym	Single arm intervention study of the efficacy of the App for improving the lifestyle behavior in patients with Type 2 DM
Region	Japan

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

Objectives
Narrative objectives1	To develop the App that focuses on lifestyle improvement and evaluate its effects on type 2 diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	weight, HbA1c, completion rate, utilization of App, improvement of blood test value
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
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	Behavior,custom
Interventions/Control_1	Lifestyle behavior improvement support by feedback from the App based on input data.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients aged over 20 years or older at the time of informed consent (both genders) 2) Patients with documented consent to participate in the study 3) Patients diagnosed with type 2 diabetes mellitus 4) Patients taking hypoglycemic drugs 5) Patients with HbA1c >= 7.0 6) Patients with a smartphone
Key exclusion criteria	1) A female subject who wishes to become pregnant, is pregnant, or is breastfeeding 2) Patients diagnosed with type 1 diabetes mellitus 3) Patients with a diagnosis of secondary diabetes mellitus 4) Patients with physician-determined advanced complications 5) Patients scheduled for hospitalization or surgery during this study 6) Patients with diseases other than diabetes mellitus who are instructed to restrict exercise 7) Patients who have participated in a clinical study or a post-marketing clinical study of another prescription drug or a medical device within 3 months, who are now participating in such a study, or who plan to participate in such a study during this study 8) Patients who have used a mobile application running on a smartphone terminal for the purpose of managing or assisting diabetes mellitus within the past 3 months 9) Medical institution staff or close relatives involved in this study 10) Other patients judged by the investigator to be inappropriate for inclusion in this study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Osamu Middle name Last name Tomonaga
Organization	Tomonaga Clinic
Division name	Internal medicine
Zip code	160-0022
Address	4-2-23 Shinjuku, Shinjuku-ku, Tokyo
TEL	03-3351-0032
Email	info@tomonaga-clinic.com

Public contact
Name of contact person	1st name Koji Middle name Last name Tokutomi
Organization	Mitsubishi Tanabe Pharma Corporation
Division name	Digital Transformation Department
Zip code	103-8405
Address	17-10, Nihonbashi-Koamicho Chuo-ku, Tokyo
TEL	03-6748-7637
Homepage URL
Email	tokutomi.koji@mr.mt-pharma.co.jp

Sponsor
Institute	Mitsubishi Tanabe Pharma Corporation
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Tomonaga Clinic
Address	4-2-23 Shinjuku, Shinjuku-ku, Tokyo
Tel	03-3351-0032
Email	info@tomonaga-clinic.com

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	医療法人社団ライフスタイル　ともながクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 05 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	2021 Year 03 Month 11 Day
Date of IRB	2021 Year 03 Month 11 Day
Anticipated trial start date	2021 Year 03 Month 29 Day
Last follow-up date	2022 Year 02 Month 28 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 04 Month 02 Day
Last modified on	2021 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050004

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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