UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between glucose fluctuation and hypoglycemia in type 1 diabetes
Title of the study (Brief title)	Relationship between glucose fluctuation and hypoglycemia in type 1 diabetes
Region	Japan

Condition
Condition	Type 1 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether Continuous Glucose Monitoring(CGM) improves glucose fluctuation and time in hypoglycemia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Time in Hypoglycemia HbA1c Glucose fluctuation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Flash Glucose Monitoring
Interventions/Control_2
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	Type 1 diabetes(insulin dependent)
Key exclusion criteria	Patients were excluded if: they were pregnant, thought likely to be pregnant or were planning to become pregnant during the study they were receiving dialysis they had complications or conditions that could affect their metabolic control or which were judged by the investigator to be likely to pose a threat to their safety they were judged by the investigator to be ineligible for study participation.
Target sample size	15

Research contact person
Name of lead principal investigator	Rimei Nishimura
Organization	The Jikei University School of Medicine
Division name	Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine
Address	3-25-8 Nishishimbashi, Minato-ku, Tokyo 105-8461 Japan
TEL	03-3433-1111
Email	rimei@jikei.ac.jp

Public contact
Name of contact person	Rimei Nishimura
Organization	The Jikei University School of Medicine
Division name	Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine
Address	3-25-8 Nishishimbashi, Minato-ku, Tokyo 105-8461 Japan
TEL	03-3433-1111
Homepage URL
Email	rimei@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare in Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	none
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	東京慈恵会医科大学附属病院/ Jikei University Hospital

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 24 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 06 Month 19 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2018 Year 12 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	2018 Year 04 Month 24 Day
Last modified on	2018 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036896