UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018649
Receipt number 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 10:30:00

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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 or person

Institute

the University of Tokyo

Institute

Department

Personal name



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

Value
https://center6.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