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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
