UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053247 |
|---|---|
| Receipt number | R000060768 |
| Scientific Title | Hospitalization for glycemic control in people with diabetes mellitus :Prospective observational study |
| Date of disclosure of the study information | 2023/12/28 |
| Last modified on | 2025/01/05 10:28:33 |
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Basic information
Public title
Hospitalization for glycemic control in people with diabetes mellitus :Prospective observational study
Acronym
Hospitalization for glycemic control in people with diabetes mellitus :Prospective observational study
Scientific Title
Hospitalization for glycemic control in people with diabetes mellitus :Prospective observational study
Scientific Title:Acronym
Hospitalization for glycemic control in people with diabetes mellitus :Prospective observational study
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigates the effect of diabetes education hospitalisation on improving blood glucose and changes in other clinical parameters.
Basic objectives2
Others
Basic objectives -Others
Investigating changes in eating behaviour due to hospital admission for the purpose of blood glucose control
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c after 6 months of hospital discharge compared with admission.
Key secondary outcomes
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 1 and type 2 diabetes mellitus and secondary diabetes mellitus who have been hospitalised and treated at this hospital.
Key exclusion criteria
1) Under 18 years of age
2) Those who could not give consent for this study
3) Others whom the principal investigator resecher unsuitable as research subjects.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Suwanai |
Organization
Tokyo Medical University
Division name
Department of Diabetes, Metabolism, and Endocrinology
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
suwanai-h@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Suwanai |
Organization
Tokyo Medical University
Division name
Department of Diabetes, Metabolism, and Endocrinology,
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
suwanai-h@umin.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Institutional Review Board
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
Tel
03-3342-6111
IRB@tokyo-med.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 28 | 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
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Follow up for 6 months.
Management information
Registered date
| 2023 | Year | 12 | Month | 28 | Day |
Last modified on
| 2025 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060768
