UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Home Telemonitoring System for Diabetic Patients: a randomised controlled crossover study.
Title of the study (Brief title)	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	Takashi Yoneda
Organization	Kanazawa University
Division name	Kanazawa University Hospital
Address	Takaramachi13-1, Kanazawa, Japan, 9208640
TEL	+81762652252
Email	endocrin@med.kanazawa-u.ac.jp

Public contact
Name of contact person	Takashi Yoneda
Organization	Kanazawa University
Division name	Kanazawa University Hospital
Address	Takaramachi13-1, Kanazawa, Japan, 9208640
TEL	+81762652252
Homepage URL
Email	endocrin@med.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University Hospital,Department of Endocrinology and Metabolism
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 03 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013147