UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of risk of glucose fluctuation during nighttime by Average Daily Risk Range (ADRR) in type 1 diabetes
Title of the study (Brief title)	Evaluation of risk of glucose fluctuation during nighttime by ADRR 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 investigate the relations between ADRR and glucose fluctuation at nighttime evaluated by continuous glucose monitoring
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlations between frequencies of hypoglycemia (below 70mg/dl), hyperglycemia (200mg/dl and over) and mean blood glucose during nighttime (0:00-5:59) and ADRR
Key secondary outcomes	Correlations between frequencies of hypoglycemia (below 70mg/dl), hyperglycemia (200mg/dl and over) and mean blood glucose during daytime (6:00-23:59) and ADRR

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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Age 20 and ove, below 80 at consent 2) Type 1 diabetes 3) Patients who can do SMBG three times a day 4) Provided written informed consent
Key exclusion criteria	1) Patients with liver cirrhosis and renal failure (hemodialysis and serum creatinine 2.0mg/dl and over) 2) Pregnant patients 3) Malignancy 4) Considered inadequate by the investigator
Target sample size	30

Research contact person
Name of lead principal investigator	Akio Kanazawa
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Metabolism & Endocrinology
Address	Hongo 2-1-1, Bunkyo-ku
TEL	03-3813-3111
Email	akana@juntendo.ac.jp

Public contact
Name of contact person	Akio Kanazawa
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Metabolism & Endocrinology
Address	Hongo 2-1-1, Bunkyo-ku
TEL	03-3813-3111
Homepage URL
Email	akana@juntendo.ac.jp

Sponsor
Institute	Juntendo University Graduate 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	2016 Year 02 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 24 Day
Anticipated trial start date	2016 Year 03 Month 04 Day
Last follow-up date	2017 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	Recruitment period: 2016.3.4-2017.8.31 Study design: Participants: type 1 diabetes with intensive insulin therapy. At the next visit after informed consent, CGM has been performed for 6 days. At the same time, SMBG has also been performed three times daily for 14 days until the next visit after 4-8 weeks. Then, ADRR is calculated based on the results of SMBG. After that, association between the ADRR and CGM data is investigated. During the study periods, dosage of insulin is not changed in principle. And calculation of ADRR is performed by the method reported previously (Kovatchev et al.2006 Diabetes care).

Management information
Registered date	2016 Year 02 Month 24 Day
Last modified on	2017 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024384