UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012034
Receipt number R000014066
Scientific Title The effect of continuous glucose monitoring system useing at the diabetes mellitus outpatient clinic
Date of disclosure of the study information 2013/10/15
Last modified on 2016/10/18 19:43:10

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Basic information

Public title

The effect of continuous glucose monitoring system useing at the diabetes mellitus outpatient clinic

Acronym

The effect of CGM at the diabetes mellitus outpatient clinic

Scientific Title

The effect of continuous glucose monitoring system useing at the diabetes mellitus outpatient clinic

Scientific Title:Acronym

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

1st name
Middle name
Last name Sato Junko

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Metabolism and Endocrinology

Zip code


Address

2-1-1Hongo,Bunkyoku,Tokyo

TEL

03-3813-3111

Email

jsato@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sato, Junko

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Metabolism and Endocrinology

Zip code


Address

2-1-1Hongo,Bunkyoku,Tokyo

TEL

03-3813-3111

Homepage URL


Email

jsato@juntendo.ac.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2012 Year 09 Month 25 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014066


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name