UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035077
Receipt number R000039882
Scientific Title Study on a program for prevention of aggravation of diabetes: effectiveness of behavior modification model using Internet of Things including interventions by multiple types of professionals
Date of disclosure of the study information 2018/12/03
Last modified on 2019/12/19 16:09:46

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Basic information

Public title

Study on a program for prevention of aggravation of diabetes: effectiveness of behavior modification model using Internet of Things including interventions by multiple types of professionals

Acronym

Effectiveness of a program using IoT for prevention of aggravation of diabetes

Scientific Title

Study on a program for prevention of aggravation of diabetes: effectiveness of behavior modification model using Internet of Things including interventions by multiple types of professionals

Scientific Title:Acronym

Effectiveness of a program using IoT for prevention of aggravation of diabetes

Region

Japan


Condition

Condition

Diabetes/pre-diabetes

Classification by specialty

Medicine in general Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effectiveness of a program for prevention of aggravation of diabetes for patients with diabetes or pre-diabetes.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Change in hemoglobin (Hb) A1c at 12 and 24 weeks from baseline

Key secondary outcomes

1. Change in body weight (body mass index) at 12 and 24 weeks from baseline
2. Change in abdominal girth at 12 and 24 weeks from baseline
3. Change in blood pressure at 12 and 24 weeks from baseline
4. Change in blood test values (fasting blood glucose, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol) at 12 and 24 weeks from baseline
5. Change in lifestyle behavior and depression status based on questionnaires at 24 weeks from baseline
6. Monthly change in exercise behavior based on recorded number of steps


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment Behavior,custom

Interventions/Control_1

Use of the smartwatch, use of the mobile application for self-monitoring health data, and advice by doctors (video call at 1 month and 3 months from start), pharmacists (weekly chatting for patients with medication) and nutrition managers (chatting three times a week, monthly video call) for 6 months

Interventions/Control_2

No intervention

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

1. With HbA1c 7.0% or more and 8.0% or less
2. Aged 25 years or more and less than 75 (male and female)
3. Daily smartphone user
4. Wishing to participate to the program

Key exclusion criteria

1. Having comorbidity of severe hepatic dysfunction (3 times or more of upper limit of reference value for AST or ALT), hemodialysis, or comorbidity of cancer
2. Receiving treatment with insulin
3. In pregnancy or planning to get pregnant
4. Being restricted exercise
5. Having cognitive dysfunction
6. Having serious cardiovascular diseases (myocardial infarct, angina, serious arrhythmia, hypertension with a systolic blood pressure 180 mmHg or more or with a diastolic blood pressure 110 mmHg or more)
7. Being deemed inappropriate to participate to this study by his/her primary physician

Target sample size

105


Research contact person

Name of lead principal investigator

1st name Mizunobu
Middle name
Last name Kinoshita

Organization

Medical Corporation Syojinkai

Division name

Nagoya Station Clinic

Zip code

450-0002

Address

Nagoya Building 8F, 4 Chome 6-17, Meieki, Nakamura-ku, Nagoya, Aichi, Japan

TEL

052-551-6663

Email

m-kinoshita@station-clinic.com


Public contact

Name of contact person

1st name Kohei
Middle name
Last name Sasaki

Organization

Sugi Pharmacy Co., Ltd.

Division name

Corporate Planning division

Zip code

474-0011

Address

62-1, Shin'e, Yokone-machi, Obu, Aichi, Japan

TEL

0562-45-2700

Homepage URL


Email

ko-sasaki@drug-sugi.co.jp


Sponsor or person

Institute

Nagoya Station Clinic

Institute

Department

Personal name



Funding Source

Organization

Sugi Pharmacy Co., Ltd., M-aid Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Milliman Inc.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Non-Profit Organization MINS Institutional Review Board

Address

5-20-9-401 Mita, Minato-ku, Tokyo, Japan

Tel

03-6416-1868

Email

npo-mins@j-irb.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



Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 03 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

Terminated

Date of protocol fixation

2018 Year 11 Month 01 Day

Date of IRB

2018 Year 11 Month 21 Day

Anticipated trial start date

2018 Year 12 Month 10 Day

Last follow-up date

2019 Year 12 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

2018 Year 11 Month 30 Day

Last modified on

2019 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039882


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name