UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050992 |
|---|---|
| Receipt number | R000058126 |
| Scientific Title | Setting of carbohydrate ratios at the time of hybrid closed loop (HCL) introduction in cases with carbocount acquisition difficulties. |
| Date of disclosure of the study information | 2023/05/05 |
| Last modified on | 2024/05/10 18:02:20 |
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Basic information
Public title
Setting of carbohydrate ratios at the time of hybrid closed loop (HCL) introduction in cases with carbocount acquisition difficulties.
Acronym
Setting of carbohydrate ratios at the time of hybrid closed loop (HCL) introduction in cases with carbocount acquisition difficulties.
Scientific Title
Setting of carbohydrate ratios at the time of hybrid closed loop (HCL) introduction in cases with carbocount acquisition difficulties.
Scientific Title:Acronym
Setting of carbohydrate ratios at the time of hybrid closed loop (HCL) introduction in cases with carbocount acquisition difficulties.
Region
| Japan |
Condition
Condition
type 1 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the effectiveness of hybrid closed loop (HCL) introduction in cases of carbocount acquisition difficulties.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c and AGP data before and 1 month, 3 months, 6 months, and 1 year after introduction of hybrid closed loop
Key secondary outcomes
Changes in treatment, number of severe hypoglycemia, other side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Example of CarboCount Non-Introduction
Interventions/Control_2
Example of CarboCount Introduction
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
Type 1 diabetes with hybrid closed loop (HCL)
Key exclusion criteria
Type 1 diabetes mellitus after discontinuation of hybrid closed loop (HCL)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishibashi |
Organization
Kimitsu Chuo Hospital
Division name
Department of Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
292-8535
Address
1010 Sakurai, Kisarazu-city, Chiba
TEL
0438361071
ishibashi-cib@umin.net
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishibashi |
Organization
Kimitsu Chuo Hospital
Division name
Department of Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
292-8535
Address
1010 Sakurai, Kisarazu-city, Chiba
TEL
0438361071
Homepage URL
ishibashi-cib@umin.net
Sponsor or person
Institute
Kimitsu Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kimitsu Chuo Hospital
Address
1010 Sakurai, Kisarazu-city, Chiba
Tel
0438361071
soumu@kc-hosp.or.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 05 | 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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 05 | Day |
Last modified on
| 2024 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058126
