UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relationship between HbA1c values and the occurrence of hypoglycemia as assessed by continuous glucose monitoring in patients with type 1 diabetes
Title of the study (Brief title)	Type 1 diabetes CGM study
Region	Japan

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

Objectives
Narrative objectives1	We aimed to examine the relationship between the occurrence of hypo-/ hyperglycemia and HbA1c values, as assessed by continuous glucose monitoring (CGM) in patients with type 1 diabetes.
Basic objectives2	Others
Basic objectives -Others	understanding the disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	24-hour mean glucose values and their standard deviations (SDs), time in hypoglycemia, time in nocturnal hypoglycemia, and time in hyperglycemia.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Type 1 diabetes being treated with basal-bolus insulin therapy at our hospital
Key exclusion criteria	continuous subcutaneous insulin infusion (CSII)
Target sample size	200

Research contact person
Name of lead principal investigator	Daisuke Tsujino
Organization	Jikei University School of Medicine
Division name	Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Address	3-15-8 Nishishinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Email	dtsujino7777@gmail.com

Public contact
Name of contact person	Daisuke Tsujino
Organization	Jikei University School of Medicine
Division name	Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Address	3-15-8 Nishishinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Homepage URL
Email	dtsujino7777@gmail.com

Sponsor
Institute	Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine
Institute
Department

Funding Source
Organization	None
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	2015 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 10 Month 01 Day
Anticipated trial start date	2010 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	The inclusion criteria of the study subjects is type 1 diabetic patients on basal-bolus insulin therapy who were put on CGM from October, 2010.

Management information
Registered date	2015 Year 10 Month 01 Day
Last modified on	2016 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022167