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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035077
Receipt No. R000039882
Official scientific title of the study 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 2018/11/30

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Basic information
Official scientific title of the study 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
Title of the study (Brief title) 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 Mizunobu Kinoshita
Organization Medical Corporation Syojinkai
Division name Nagoya Station Clinic
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 Kohei Sasaki
Organization Sugi Pharmacy Co., Ltd.
Division name Corporate Planning division
Address 62-1, Shin'e, Yokone-machi, Obu, Aichi, Japan
TEL 0562-45-2700
Homepage URL
Email ko-sasaki@drug-sugi.co.jp

Sponsor
Institute Nagoya Station Clinic
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 01 Day
Anticipated trial start date
2018 Year 12 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 30 Day
Last modified on
2018 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.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


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