UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032441 |
|---|---|
| Receipt number | R000036945 |
| Scientific Title | To study the association between vital data at home and lifestyle using GlucoNote, a smartphone based self-management support application for type 2 diabetes patients and prediabetes people. |
| Date of disclosure of the study information | 2018/05/02 |
| Last modified on | 2020/05/02 21:11:16 |
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Basic information
Public title
To study the association between vital data at home and lifestyle using GlucoNote, a smartphone based self-management support application for type 2 diabetes patients and prediabetes people.
Acronym
To study the association between vital data at home and lifestyle using GlucoNote.
Scientific Title
To study the association between vital data at home and lifestyle using GlucoNote, a smartphone based self-management support application for type 2 diabetes patients and prediabetes people.
Scientific Title:Acronym
To study the association between vital data at home and lifestyle using GlucoNote.
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus, impaired glucose tolerance
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the efficacy of self-management and medication adherence management using GlucoNotePlus (link system integrating GlucoNote and Okusuritecho Plus) supported by pharmacists for type 2 diabetes patients.
Basic objectives2
Others
Basic objectives -Others
The pharmacist provides medication consultation and lifestyle guidance based on the records of patients' input data with GlucoNotePlus. We study the effects of these interventions on patient`s blood control (HbA1c) and medication adherence.
*GlucoNote: an iOS application based on ResearchKit to support self-management
*Okusuritecho Plus: electronic medicine notebook developed by Nihon Chouzai Co., Ltd.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Compare HbA1c levels between at the start and the end of the study (after 3 months)
Key secondary outcomes
Compare medication adherence rate (MMAS-8), BMI, weight, steps, blood glucose, blood pressure and dietary contents between at the start and the end of the study (after 3 months)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Medication adherence consultation and lifestyle guidance by pharmacists with three-month self-management using application (GlucoNotePlus)
The consultation will be provided onece to twice per each patient.
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) Type 2 diabetes patients
2) more than 20 years old
3) patients who prescripts internal medicine for diabetes
4) Patients who can use iPhone (iOS 9.0 later)
5) Patients who can use GlucoNotePlus and Okusuritecho Plus
6) Patients who can visit same pharmacy (Nihon Chouzai Co., Ltd.)
7) Patients who provided written informed consent.
Key exclusion criteria
1) patients with insulin therapy
2) patients with diabetic nephropathy
3) Patients with mental illness.
4) Patients with pacemakers.
5) Patients who are enrolled in other clinical trials.
6) Patients who have/had moderate to severe (requiring medical care) heart disease.
7) Patients who have moderate to severe (unstable condition) autoimmune disease, liver disease, digestive disorder, and/or respiratory disease.
8) Patients who are unable to exercise.
9) Patients who are under special dietary therapy (e.g. protein restriction, potassium restriction).
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kayo |
| Middle name | |
| Last name | Waki |
Organization
the University of Tokyo
Division name
Department of Healthcare Information Management, The University of Tokyo Hospital
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-9129
kwaki-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kayo |
| Middle name | |
| Last name | Waki |
Organization
the University of Tokyo
Division name
Department of Healthcare Information Management, The University of Tokyo Hospital
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-9129
Homepage URL
dialbetics-office@umin.ac.jp
Sponsor or person
Institute
Department of Healthcare Information Management, The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
1. NTT DOCOMO, INC. (The division is engaged in a cooperative program between the University of Tokyo and NTT DOCOMO, until August 31, 2019)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nihon Chouzai Co., Ltd.
Name of secondary funder(s)
2. Nihon Chouzai Co., Ltd. (Research assistance by employees (pharmacists))
3. NTT Resonant Incorporated (until March 15, 2019)
IRB Contact (For public release)
Organization
The Office for Human Research Studies (OHRS), Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学医学部附属病院（東京都）
日本調剤株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 02 | 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
Suspended
Date of protocol fixation
| 2018 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 01 | Day |
Last modified on
| 2020 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036945
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