UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043815
Receipt number R000050004
Scientific Title Single arm intervention study of the efficacy of the App for improving the lifestyle behavior in patients with Type 2 DM
Date of disclosure of the study information 2021/04/05
Last modified on 2023/04/07 08:09:34

* 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

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 >= 6.5
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 or person

Institute

Mitsubishi Tanabe Pharma Corporation

Institute

Department

Personal name



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

58

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

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 10 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 04 Month 02 Day

Last modified on

2023 Year 04 Month 07 Day



Link to view the page

Value
https://center6.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