UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022465 |
|---|---|
| Receipt number | R000025890 |
| Scientific Title | Development of lifestyle intervention program for diabetes using IoT(Internet of Things) |
| Date of disclosure of the study information | 2016/05/26 |
| Last modified on | 2021/02/01 21:22:03 |
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Basic information
Public title
Development of lifestyle intervention program for diabetes using IoT(Internet of Things)
Acronym
IoT DM program
Scientific Title
Development of lifestyle intervention program for diabetes using IoT(Internet of Things)
Scientific Title:Acronym
IoT DM program
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of lifestyle intervention program for diabetes using IoT, and to explore the effects of the programs
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
Completion rate, utilization of IoT
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Encourage to improve life style by using IoT
Interventions/Control_2
Encourage to improve life style by usual care
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
Diabetes Mellitus, Impaired Glucose tolerance
Key exclusion criteria
Diabetic nephropathy phase 4(eGFR<30ml/min/1.73m2)
Receiving insulin therapy
Proliferative diabetic retinopathy or preproliferative retinopathy, and prohibited from participating the program by ophthalmologist
Under treatment of dementia
Under treatment of cancer
Under treatment of myocardial infarction and apoplexy
Subjects prohibited from participating the program by medical doctors
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuyo |
| Middle name | |
| Last name | Tsushita |
Organization
Aichi Health Promotion Public Interest Foundation
Division name
Comprehensive Health Science Center
Zip code
470-2101
Address
Gengoyama1-1, Morioka, Higashiura-cho, Chita-gun, Aichi, Japan
TEL
0562-82-0211
k-tsushita@grp.ahv.pref.aichi.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Muramoto |
Organization
Aichi Health Promotion Public Interest Foundation
Division name
Comprehensive Health Science Center
Zip code
470-2101
Address
Gengoyama1-1, Morioka, Higashiura-cho, Chita-gun, Aichi, Japan
TEL
0562-82-0211
Homepage URL
a-muramoto@grp.ahv.pref.aichi.jp
Sponsor or person
Institute
Aichi Health Promotion Public Interest Foundation
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Research Institute
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Health Promotion Public Interest Foundation IRB
Address
Gengoyama1-1, Morioka, Higashiura-cho, Chita-gun, Aichi, Japan
Tel
0562-82-0205
so-jinji@grp.ahv.pref.aichi.jp
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
| 2016 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6610601/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6610601/
Number of participants that the trial has enrolled
181
Results
In the health guidance model, both the IoT and control groups showed a significant HbA1c reduction at 3 months as compared with the baseline, while only the IoT group maintained a significant reduction at 6 months along with BMI decreases. In the hospitalization model, both the IoT and the control groups showed significant HbA1c reductions at 3 and 6 months as compared with the baseline, while there were no differences in the values between groups.
Results date posted
| 2021 | Year | 02 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In the health guidance model, there were no significant differences between the groups in gender, HbA1c, fasting blood glucose, and BP. However, there were significant differences in the case of two factors: age (51.5 years versus 55.6 years, and P < 0.05) and body mass index (BMI) (26.6 versus 24.2 kg/m2, and P < 0.05).
In the hospitalization model, there were no significant differences between the groups in age, HbA1c, fasting blood glucose, BMI, and BP; however, there were significant differences for one factor: gender (M/F 33/9 versus 20/19, and P < 0.05) .
Participant flow
We developed a novel IoT system that collected data from health measuring devices transferred them to the cloud system and generated a summary for the patients and their PCPs. This IoT system also automatically generated supportive messages and provided them to patients via a newly developed smartphone application 'Shichifukujin-app'. Following randomization, the participants in the IoT group were provided with Bluetooth-enabled measurement devices to use the IoT system. They were advised to measure lifelogging data every day and to send them to the smartphone for 6 months. The control group was provided the same measurement devices (without an IoT system).
Adverse events
None
Outcome measures
The primary endpoint was changes in HbA1c levels. The secondary endpoints were changes in body weight, BP, fasting blood glucose, and medication.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 26 | Day |
Last modified on
| 2021 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025890
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