UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043563 |
|---|---|
| Receipt number | 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 14:22:00 |
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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
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
info@shido.co.jp
Sponsor or person
Institute
Tokyo Teishin Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049748
