UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of SGLT2 inhibitors on blood glucose variability in patients with type 1 diabetes
Acronym	SGLT2i and glucose variability in T1DM
Scientific Title	The Effect of SGLT2 inhibitors on blood glucose variability in patients with type 1 diabetes
Scientific Title:Acronym	SGLT2i and glucose variability in T1DM
Region	Japan

Condition
Condition	type 1 diabetes mellitus
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of SGLT2 inhibitors in patients with type 1 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in day-to-day and daily blood glucose variability
Key secondary outcomes	1 Blood and urine test (HbA1c, UACR, etc) 2 Body weight, Body mass index 3 Blood pressure 4 insulin dose 5 Adverse events

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with type 1 diabetes who are treated in Hokkaido University Hospital or collaborate hospitals from December 2018 to June 2020. 2) Patients with type 1 diabetes who have been treated with SGLT2 inhibitors for more than 12 weeks.
Key exclusion criteria	Patients who were thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hideaki Middle name Last name Miyoshi
Organization	Hokkaido University Faculty of Medicine and Graduate School of Medicine
Division name	Division of Diabetes and Obesity
Zip code	060-8638
Address	Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	001-716-1161
Email	hmiyoshi@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Hideaki Middle name Last name Miyoshi
Organization	Hokkaido University Faculty of Medicine and Graduate School of Medicine
Division name	Division of Diabetes and Obesity
Zip code	060-8638
Address	Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-8192
Homepage URL
Email	hmiyoshi@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hokkaido University Hospital Divison of Clinical Research Administration
Address	Nishi 5, Kita 14, Kita-Ku, Sapporo, Hokkaido, Japan
Tel	011-706-7636
Email	crjimu@med.hokudai.ac.jp

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	栗原内科クリニック(北海道)、青木内科クリニック(北海道)

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	30
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	2018 Year 11 Month 25 Day
Date of IRB	2019 Year 12 Month 11 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 02 Month 02 Day
Last modified on	2020 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044887