UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050550 |
|---|---|
| Receipt number | R000057433 |
| Scientific Title | Development of Feedback Sheet for Type 1 Diabetes Care - Derivation Study |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/01/26 00:14:58 |
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Basic information
Public title
Development of Feedback Sheet for Type 1 Diabetes Care - Derivation Study
Acronym
T1DM FBS
Scientific Title
Development of Feedback Sheet for Type 1 Diabetes Care - Derivation Study
Scientific Title:Acronym
T1DM FBS
Region
| Japan |
Condition
Condition
Type 1 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Creation of a tool (feedback sheet) to continuously encourage patients with type 1 diabetes and their families to think and act on their own initiative to control their blood glucose.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c change before and after feedback sheet use
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Use of feedback sheets
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
| 1 | months-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons diagnosed with type 1 diabetes and on insulin therapy
Children or young adults under 40 years old
Patients who visit the hospital more than once in three month for treatment of type 1 diabetes mellitus
Persons who have been fully informed about the study and who have given their or their surrogate's free and voluntary consent based on a thorough understanding of the study
Key exclusion criteria
Persons deemed unsuitable as subjects by the investigators
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Akahoshi |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of Endocrinology and Metabolism
Zip code
183-8561
Address
2-8-29 Musashidai, Fuchu, Tokyo
TEL
042-300-5111
shiyougo_akahoshi@tmhp.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Nagata |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Clinical Research Support Center
Zip code
183-8561
Address
2-8-29 Musashidai, Fuchu, Tokyo
TEL
042-300-5111
Homepage URL
tomohiro_nagata@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Children's Medical Center Research Ethics Review Committee
Address
2-8-29 Musashidai, Fuchu, Tokyo
Tel
042-300-5111
sn_crsc03@tmhp.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 | 04 | Month | 01 | 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
| 2023 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 03 | 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 | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057433
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
