UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022480 |
|---|---|
| Receipt number | R000025906 |
| Scientific Title | Health guidance by using wearable devices for diabetic patients |
| Date of disclosure of the study information | 2016/05/26 |
| Last modified on | 2021/01/08 19:00:36 |
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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
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
goto@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025906
