UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011219 |
|---|---|
| Receipt number | R000013147 |
| Scientific Title | Home Telemonitoring System for Diabetic Patients: a randomised controlled crossover study. |
| Date of disclosure of the study information | 2013/07/18 |
| Last modified on | 2017/11/04 22:42:33 |
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Basic information
Public title
Home Telemonitoring System for Diabetic Patients: a randomised controlled crossover study.
Acronym
Home Telemonitoring System for Diabeteic Patients
Scientific Title
Home Telemonitoring System for Diabetic Patients: a randomised controlled crossover study.
Scientific Title:Acronym
Home Telemonitoring System for Diabeteic Patients
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of home telemonitoring system using multi-functional mobile phone for diabetic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Following items at every 3 months
1 changes in plasma glucose level and HbA1C
2 Changes in urine alubumin excretion
3 Changes in lipid levels
4 Changes in blood pressure
5 Changes in body weight and body mass index(BMI)
6 Occurrence of diabetic complication
7 Newly required medicine for diabetes, blood pressure, or dyslipidemia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention period to non-intervention period,
1)Intervention period(one year):
Home telemonitoring system using multi-functional mobile phone for a year
1)Every day:records of meals(photos), body weight, amount of exercise(number of steps, blood pressure)
Above data are sent from home to Aoki Health Network by the mobile phone.
Based on the data, the guidance of diet and exercise are performed by e-mails using mobile phone.
2)non-intervention period(one year):
Guidance for diet, exercise, and medication are conducted at every 3 months during the non-intervention period.
3)Every 3 months during both intevention and non intevention periods of 2 years, blood and urine samples are taken.
Period of the study: from the day of approval to October 31, 2014
Interventions/Control_2
non intervention period to Intervention period,
1)Intervention period(one year)::
Home telemonitoring system using multi-functional mobile phone for a year
1)Every day:records of meals(photos), body weight, amount of exercise(number of steps, blood pressure)
Above data are sent from home to Aoki Health Network by the mobile phone.
Based on the data, the guidance of diet and exercise are performed by e-mails using mobile phone.
2)non-intervention period(one year):
Guidance for diet, exercise, and medication are conducted at every 3 months during the non-intervention period.
3)Every 3 months during both intevention and non intevention periods of 2 years, blood and urine samples are taken.
Period of the study: from the day of approval to October 31, 2014
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
| 19 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with diabetes or impaired glucose tolerance
2) HbA1C 5.2~7.0% (JDS)
3)Patients whose content is obtained in written form
Key exclusion criteria
1) Patients with malignant hypertension or secondary hypertension
2) Diabetic patients requiring insulin therapy
3) Pregnant and probably pregnant patients
4) patients with abnormal serum creatinin value
5) Patients with severe hepatic dysfunction
6) Patients who had myocardial infarction or apoplexy within 3 months before the satrt of the study or who are treated.
7) Patients with severe allergy or with steroid therapy
8) Patients with pancreatitis or pasthistory of pancreatitis
9) Patients with malignacy
10) Other patients judged as being inappropriate for the subjects of the study by investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Yoneda |
Organization
Kanazawa University
Division name
Kanazawa University Hospital
Zip code
Address
Takaramachi13-1, Kanazawa, Japan, 9208640
TEL
+81762652252
endocrin@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Yoneda |
Organization
Kanazawa University
Division name
Kanazawa University Hospital
Zip code
Address
Takaramachi13-1, Kanazawa, Japan, 9208640
TEL
+81762652252
Homepage URL
endocrin@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital,Department of Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 07 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2014 | Year | 10 | 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
| 2013 | Year | 07 | Month | 18 | Day |
Last modified on
| 2017 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013147
