UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of isCGM on HbA1c improvement and behavior in Japanese type 2 diabetic patient
Acronym	HANABI STUDY
Scientific Title	Efficacy of isCGM on HbA1c improvement and behavior in Japanese type 2 diabetic patient - multicenter randomized prospective study -
Scientific Title:Acronym	HANABI STUDY
Region	Japan

Condition
Condition	Type 2 Diabetes Mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of isCGM on HbA1c improvement and behavior in Japanese type 2 diabetic patient
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Group differences in HbA1c change after 6 months of study
Key secondary outcomes	1)TIR: time in range 2)TBR: time below range 3)TAR: time above range 4)HbA1c (except after 6 months), fasting blood glucose, C-peptide, body weight 5) Within-group changes in TIR goal achievement rates and between-group comparisons 6) HbA1c goal achievement rates and between-group comparisons 7) Within-group changes in the composite endpoint of 5) and 6) and between-group comparisons 8) Changes in psychological and behavioral indicators (DTSQ)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	isCGM (Freestyle Libre)
Interventions/Control_2	6 months
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)SMBG user of type 2 diabetic patients treated with self-injection therapy (over 6 months treatment) 2)Adaptation for type 2 diabates on the attached document of Freestyle Libre 3)Patients for whom written consent can be obtained (those with capacity to consent)
Key exclusion criteria	1)Contraindication of Freestyle Libre on the attachment document 2)Patients with an HbA1c level of less than 7.0% (20 to 65 years old) and patients with an HbA1c level of less than 7.5% (65 to 75 years old) 3)Mentally handicapped patient unsuitable for study evaluation 4)Pregnant women 5)Poor prognostic patient with malignancy 6)Patient with progressive diabetic retinopathy 7)Less than eGFR 30 ml/min/1.73m2 8)Hemoglobinopathy 9)Exercise restricted patient 10)Patient in treatment with drugs affect blood glucose levels including steroids, anti-cancer drugs, interferon et al 11)Dementia 12)Patients with therapeutic contraindications to the use of Freestyle Libre 13)Patients deemed unsuitable for this study by the researcher in this study
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Hidenori Middle name Last name Katsuta
Organization	Tokyo Teishin Hospital
Division name	Department of Internal Medicine, Division of Endocrinology and Metabolism
Zip code	102-8798
Address	2-14-23 Fujimi Chiyoda, Tokyo
TEL	03-5214-7111
Email	hkatsuta@tth-japanpost.jp

Public contact
Name of contact person	1st name Keishi Middle name Last name Mori
Organization	Shido Inc.
Division name	Research Office
Zip code	140-0001
Address	1-9-7 Kitashinagawa Shinagawa-ku Tokyo
TEL	03-4500-5075
Homepage URL
Email	info@shido.co.jp

Sponsor
Institute	Tokyo Teishin Hospital
Institute
Department

Funding Source
Organization	Diabetes and Lifestyle Study Society
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tomonaga Clinic Japan Community Health care Organization Tokyo Shinjuku Medical Center Tokyo Yamate Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Teishin hospital medical ethics committee
Address	1-14-23 Fujimi Chiyoda-ku Tokyo
Tel	03-5214-7111
Email	ykonno@tth-japanpost.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	東京逓信病院（東京） ともながクリニック（東京） JCHO東京新宿メディカルセンター（東京） 東京山手メディカルセンター（東京）

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 10 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
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	Preinitiation
Date of protocol fixation	2021 Year 03 Month 05 Day
Date of IRB	2021 Year 03 Month 05 Day
Anticipated trial start date	2021 Year 03 Month 10 Day
Last follow-up date	2021 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 09 Day
Last modified on	2021 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049748