UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039879 |
|---|---|
| Receipt number | 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 | 2024/03/13 11:26:22 |
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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
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
akane.agbd.3284@gmail.com
Sponsor or person
Institute
kobe University Graduate School of Medicine Diabetes / Endocrine Internal Science
Institute
Department
Personal name
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
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
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
医療法人新須磨病院
神戸元町県庁前クリニック
公立宍粟総合病院
坂本医院
糖尿病内科かいせいクリニック
糖尿病内科・内分泌・漢方内科 新神戸おかだクリニック
ふせの内科・循環器科
大久保病院
寺西医院
三木山陽病院
みやけ内科クリニック
医療法人社団 あおぞら会 にしかげ内科クリニック
糖尿病・代謝内科 宮田クリニック
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
No longer recruiting
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
| 2025 | 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
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045475
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