UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of continuous glucose monitoring system useing at the diabetes mellitus outpatient clinic
Title of the study (Brief title)	The effect of CGM at the diabetes mellitus outpatient clinic
Region	Japan

Condition
Condition	Diabetes Mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of useing CGM(iPro2)at the diabetes mellitus outpatient clinic
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of HbA1c Improvement of glucose movement Decrease of hypoglycemia
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment Behavior,custom
Interventions/Control_1	With the data of CGM, more suitable medication and life habit are suggested to the patient for better treatment.
Interventions/Control_2	Without the data of CGM, more suitable medication and life habit are suggested to the patient for better treatment.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patient whose HbA1c is 6.9-11% for three months. 2.Patients doing nutrition and exercise therapy. 3.Patients doing insulin therapy excluding BOT.
Key exclusion criteria	1.Patients with serious liver,renal,heart,pancreatic insufficiency. 2.Patients with cancer 3.Patients with anemia or plastocytopenia 4.Patients with serious diabetic complications 5.Patients with serious infection 6.Patients before and after the operation 7.Patients of heavy alcoholic drinker 8.Pregnant women 9.Patients with hepatic viruses
Target sample size	34

Research contact person
Name of lead principal investigator	Sato Junko
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Metabolism and Endocrinology
Address	2-1-1Hongo,Bunkyoku,Tokyo
TEL	03-3813-3111
Email	jsato@juntendo.ac.jp

Public contact
Name of contact person	Sato, Junko
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Metabolism and Endocrinology
Address	2-1-1Hongo,Bunkyoku,Tokyo
TEL	03-3813-3111
Homepage URL
Email	jsato@juntendo.ac.jp

Sponsor
Institute	Juntendo University Graduate School of Medicine, Department of Metabolism and Endocrinology
Institute
Department

Funding Source
Organization	Juntendo University Graduate School of Medicine, Department of Metabolism and Endocrinology
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	YES
Study ID_1	12-86
Org. issuing International ID_1	Juntendo University Hospital
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 10 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 25 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 15 Day
Last modified on	2016 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014066