UMIN-CTR Clinical Trial

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
Email	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
Email	a-muramoto@grp.ahv.pref.aichi.jp

Sponsor
Institute	Aichi Health Promotion Public Interest Foundation
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025890