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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043563
Receipt No. R000049748
Scientific Title Efficacy of isCGM on HbA1c improvement and behavior in Japanese type 2 diabetic patient - multicenter randomized prospective study -
Date of disclosure of the study information 2021/03/10
Last modified on 2021/06/28

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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