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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018649
Receipt No. R000021596
Scientific Title Evaluation of safety of DialBetics, a smartphone based self-management support system for type 2 diabetes patients with insulin therapy
Date of disclosure of the study information 2015/08/12
Last modified on 2018/02/21

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Basic information
Public title Evaluation of safety of DialBetics, a smartphone based self-management support system for type 2 diabetes patients with insulin therapy
Acronym Safety evaluation of DialBetics for type 2 diabetes patients with insulin therapy
Scientific Title Evaluation of safety of DialBetics, a smartphone based self-management support system for type 2 diabetes patients with insulin therapy
Scientific Title:Acronym Safety evaluation of DialBetics for type 2 diabetes patients with insulin therapy
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety of DialBetics for type 2 diabetes patients with insulin therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Presence or absence of adverse events and hypoglycemia(< 40 mg/dL) after one month intervention
Key secondary outcomes answer of use intention survey / physical data (height, body weight, BMI, blood pressure, visceral fat area) / input data during the study (physical activity, food intake, exercise record) / clinical laboratory results (fasting blood glucose, HDL cholesterol, LDL cholesterol, triglyceride, urinary protein, urinary microalbumin, urinary electrolytes)/ oral medicine / urinary sodium to potassium ratio / data of 24 hour food recall / answer of pre- and post-study interview survey

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
Other
Interventions/Control_1 To support self-management with DialBetics
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
75 years-old >
Gender Male and Female
Key inclusion criteria Type 2 diabetes patients with insulin therapy.
Patients who answered our previous intention survey and expressed to participate in this study.
Patients who can use measuring devices (glucose meter, blood pressure monitor, weight scale, pedometer, urinary Na/K scan) and smartphone, who are considered to be eligible by the doctor.
Patients without retinopathy or with simple retinopathy.
Plasma creatinine level is less than 1.5 mg/dL.
Patients who provided written informed consent.
Key exclusion criteria Patients with mental illness.
Patients with pacemakers.
Patients who are enrolled in other clinical trials.
Patients who have/had moderate to severe (requiring medical care) heart disease.
Patients who have moderate to severe (unstable condition) autoimmune disease, liver disease, digestive disorder, and/or respiratory disease.
Patients who are unable to exercise.
Patients who are under special dietary therapy (e.g. protein restriction, potassium restriction).
Female patients who are breast-feeding or have possibility (hope) of pregnancy.
Patients who are considered ineligible by the doctor.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kayo Waki
Organization the University of Tokyo
Division name Department of Ubiquitous Health Informatics, Graduate school of Medicine
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-5800-9129
Email kwaki-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kayo Waki
Organization the University of Tokyo
Division name Department of Ubisuitous Health Informatics, Graduate School of Medicine
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-5800-9129
Homepage URL
Email kwaki-tky@umin.ac.jp

Sponsor
Institute the University of Tokyo
Institute
Department

Funding Source
Organization NTT DOCOMO, INC. (The division is engaged in a cooperative program between the University of Tokyo and NTT DOCOMO.)
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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)、the University of Tokyo Hospital (Tokyo)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/27460625
Number of participants that the trial has enrolled
Results DialBetics was found safe in data transmission, evaluation, and text communication for patients on insulin injections. Mean HbA1c (-0.26+/-0.27%, p=.014) and BMI (-0.41+/-0.56 kg/m2, p=.035) significantly decreased after one month.
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
2015 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 12 Day
Last modified on
2018 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021596

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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