UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052495 |
|---|---|
| Receipt number | R000059789 |
| Scientific Title | Co-design development of a decision guide on continuous glucose monitoring for people with diabetes and diabetes professionals |
| Date of disclosure of the study information | 2023/10/13 |
| Last modified on | 2024/01/29 16:40:56 |
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Basic information
Public title
Co-design development of a decision guide on continuous glucose monitoring for people with diabetes and diabetes professionals
Acronym
Co-design development of a decision guide on continuous glucose monitoring for people with diabetes and diabetes professionals
Scientific Title
Co-design development of a decision guide on continuous glucose monitoring for people with diabetes and diabetes professionals
Scientific Title:Acronym
CGM-decision guide study
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a Shared Decision-Making (SDM) tool for the selection of CGM and to compare changes in healthcare providers' confidence in providing guidance on CGM.
Basic objectives2
Others
Basic objectives -Others
Knowledge Score on CGM,Attitude Score towards CGM Adoption,Usability of SDM Tool for CGM Selection (Shared Decision-Making Scale 8),Recommendation Level
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Confidence Score in Diabetes Management Guidance Using CGM
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
The healthcare providers in the intervention group will participate in an approximately 2-hour online training session. This session will include a mini-lecture on blood glucose management using CGM, instruction and demonstration of how to use the SDM tool, and case studies, among other topics. Confidence levels (the primary outcome measure) and knowledge and attitudes regarding CGM will be measured before the intervention, at 4 weeks, and at 12 weeks after the intervention.
Interventions/Control_2
The waitlist control group will have their confidence levels (the primary outcome measure) and knowledge and attitudes regarding CGM measured before the intervention, at 4 weeks, and at 12 weeks after the intervention. After the follow-up assessment, they will have the opportunity to participate in the online training session.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthcare provider
Providing diabetes management guidance to individuals with diabetes at a healthcare facility
Key exclusion criteria
Unable to complete self-administered questionnaire.
Unable to participate in online training sessions.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yaeko |
| Middle name | |
| Last name | Kawaguchi |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Preventive Medicine, Clinical Research Institute,
Zip code
612-8555
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan.
TEL
075-641-9161
404-j-doit1@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Yaeko |
| Middle name | |
| Last name | Kawaguchi |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Preventive Medicine, Clinical Research Institute,
Zip code
612-8555
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan.
TEL
075-641-9161
Homepage URL
404-j-doit1@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
NO
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
National Hospital Organization Kyoto Medical Center
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan.
Tel
075-641-9161
404-j-doit1@mail.hosp.go.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 | 10 | Month | 13 | 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
| 2023 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2024 | 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 | 10 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059789
| 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 |
