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
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
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
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
