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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039879
Receipt No. R000045475
Scientific Title The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with a combination of oral antihyperglycemic drugs and basal insulin
Date of disclosure of the study information 2020/09/11
Last modified on 2020/09/11

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Basic information
Public title The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with a combination of oral antihyperglycemic drugs and basal insulin
Acronym The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with a combination of oral antihyperglycemic drugs and basal insulin
Scientific Title The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with a combination of oral antihyperglycemic drugs and basal insulin
Scientific Title:Acronym The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with a combination of oral antihyperglycemic drugs and basal insulin
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the association between hypoglycemia and glycemic control among patients treated with a combination of oral anti-hyperglycemic drugs and basal insulin using FreeStyle Libre Pro.
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association between time of hypoglycemic range(min/day) and levels of HbA1c
Key secondary outcomes Association between hypoglycemic symptons, MEAN, SD/MAGE/CV, time of hyperglycemic range, AUC, TIR, TBR, TAR, and levels of HbA1c

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Type 2 diabetic patients treated with combination of oral antihyperglycemic drugs or GLP-1 receptor agonist and basal insulin
2)HbA1c < 12%
3)Patients whose antihyperglycemic drugs and basal insulin have not changed for three monthes
4)Outpatient
5)With regard to participation in this study, patients who gained document consent by their own voluntary intentio
Key exclusion criteria 1)Patients participating in other clinical trials
2)Patients with severe skin disease on the upper arm
3)Patients using other implantable medical devices such as pacemakers
4)Patients taking steroid
5)Cancer patients
6)Patients taking sulfonylureas or glinide
7)Patients trated with bolus insulin
8)Patients using FreeStyle Libre
9)In addition, patients judged inappropriate by the doctor in charge of this study
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Wataru
Middle name
Last name Ogawa
Organization Kobe University Graduate School of Medicine
Division name Department of Internal Medicine, Division of Diabetes and Endocrinology
Zip code 650-0017
Address 7-5-1 Kusunoki-Cho, Kobe 650-0017, Japan
TEL 078-382-5860
Email hirota@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Yushi
Middle name
Last name Hirota
Organization Kobe University Hospital
Division name Department of Internal Medicine, Division of Diabetes and Endocrinology
Zip code 650-0017
Address 7-5-1 Kusunoki-Cho, Kobe 650-0017, Japan
TEL 078-382-5860
Homepage URL
Email akane.agbd.3284@gmail.com

Sponsor
Institute kobe University Graduate School of Medicine Diabetes / Endocrine Internal Science
Institute
Department

Funding Source
Organization Abbott Diabetes Care Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Yokota Medical Clinic, Kakogawa central city hospital, kita-harima medical center, Kobe City Medical Center West Hospital,Ippanzadanhoujin Kohnankai Kohnanbyouin,National Hospital Organization Kobe Medical Center,National Hospital Organization Hyogo Chuo Hospital, ShinkoHospital, Akashi Medical Center, Takatsuki General Hospital, Chibune General Hospital, STEEL MEMORIAL HIROHATA HOSPITAL, TAKABE CLINIC, Nishiwaki Municipal Hospital, Hyogo Prefectural AWAJI Medical Center, Hyogo Prefectural Kakogawa Medical Center, Hyogo Brain And Heart Center At Himeji, Yodogawa Christian Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kobe University Clinical Research Review Committee Secretariat
Address 7-5-2 Kusunokimachi, Chuo-ku, Kobe-shi Hyogo ken
Tel 078-382-6669
Email cerb@med.kobe-u.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 神戸大学医学部附属病院
医療法人社団よこた内科クリニック
加古川中央市民病院
北播磨総合医療センター
神戸市民病院機構神戸市立医療センター 西市民病院
甲南医療センター
国立病院機構神戸医療センター
国立病院機構兵庫中央病院
神鋼記念病院
社会医療法人 愛仁会明石医療センター
社会医療法人 愛仁会高槻病院
社会医療法人 愛仁会千船病院
製鉄記念広畑病院
糖尿病内科たかべクリニック
西脇市立西脇病院
兵庫県立淡路医療センター
兵庫県立加古川医療センター
兵庫県立姫路循環器病センター
淀川キリスト教病院

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 11 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 Enrolling by invitation
Date of protocol fixation
2020 Year 04 Month 20 Day
Date of IRB
2020 Year 04 Month 20 Day
Anticipated trial start date
2020 Year 08 Month 12 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Preinitiation

Management information
Registered date
2020 Year 03 Month 19 Day
Last modified on
2020 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045475

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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