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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000032441
Receipt No. 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

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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
Email 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
Email dialbetics-office@umin.ac.jp

Sponsor
Institute Department of Healthcare Information Management, The University of Tokyo Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036945

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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