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

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 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

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

Value
https://center6.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