UMIN-CTR Clinical Trial

Basic information
Public title	Health guidance by using wearable devices for diabetic patients
Acronym	Health guidance by using wearable devices for diabetic patients
Scientific Title	Health guidance by using wearable devices for diabetic patients
Scientific Title:Acronym	Health guidance by using wearable devices for diabetic patients
Region	Japan

Condition
Condition	diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to prevent the onset and progression of diabetes,we develop a lifestyle improvement program using Internet of Things (activity meter, scales, blood pressure meter) and verify its helpfulness.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c 6 months after initiation of intervention
Key secondary outcomes

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	6 months lifestyle improvement program using Internet of Things (activity meter, scales, blood pressure meter)
Interventions/Control_2	self management
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients suspected of having diabetes or diabetes (HbA1c > 6.5%) Who, written consent for participation in this study was obtained
Key exclusion criteria	Dialysis patients Patients with insulin therapy Patients who have severe diabetic nephropathy(eGFR<30) Patients who can not properly operate the device to be used Patients who the physician determines that it is inappropriate to participate in the study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Arima
Organization	Nagoya University Graduate School of Medicine
Division name	Endocrinology and Diabetes
Zip code	4668550
Address	65 Tsurumai-Cho,Showa-ku,Nagoya,Japan
TEL	052-744-2142
Email	arima105@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Motomitsu Middle name Last name Goto
Organization	Nagoya University Graduate School of Medicine
Division name	Endocrinology and Diabetes
Zip code	4668550
Address	65 Tsurumai-Cho,Showa-ku,Nagoya,Japan
TEL	052-744-2142
Homepage URL
Email	goto@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Ministry of Economy, Trade and Industry
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	the Ethical Committee of the Nagoya University
Address	65 Tsurumai-Cho,Showa-ku,Nagoya,Japan
Tel	0527442423
Email	ethics@med.nagoya-u.ac.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/PMC5577018/
Publication of results	Unpublished

Result
URL related to results and publications	Unpublished
Number of participants that the trial has enrolled	101
Results	Under analysis
Results date posted	2021 Year 01 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	50 in the IoT group and 51 in the non-IoT group, at the two participating outpatient clinics. The baseline characteristics of two groups did not differ, except for triglycerides.
Participant flow	Following randomization, the participants in the IoT group were provided with Bluetooth-enabled measurement devices to use the IoT system. They were advised based on the measured data by their attending physicians. 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	No longer recruiting
Date of protocol fixation	2016 Year 05 Month 26 Day
Date of IRB	2016 Year 08 Month 17 Day
Anticipated trial start date	2016 Year 08 Month 17 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 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025906