UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048893 |
|---|---|
| Receipt number | R000055276 |
| Scientific Title | Development and evaluation of an educational program using FreeStyle Libre for type 2 diabetes in community pharmacies |
| Date of disclosure of the study information | 2022/09/09 |
| Last modified on | 2022/09/09 10:58:53 |
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Basic information
Public title
Development and evaluation of an educational program using FreeStyle Libre for type 2 diabetes in community pharmacies
Acronym
COMPASS-Libre study
Scientific Title
Development and evaluation of an educational program using FreeStyle Libre for type 2 diabetes in community pharmacies
Scientific Title:Acronym
COMPASS-Libre study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a short, pharmacy-based type 2 diabetes educational program using intermittently scanned continuous glucose monitoring (isCGM) and test its impact on diabetes self-management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in time in range (TIR) [12weeks]
Key secondary outcomes
[Patients] CGM metrics, number of scans, diabetes self-management, medication adherence, hypoglycemia, subjective symptoms, diabetes treatment satisfaction, diabetes knowledge, diabetes stress, sleep, cost effectiveness
[Pharmacist] diabetes support in the pharmacy, diabetes support using Libre, knowledge about Libre, useful knowledge about diabetes and medical care guidance, lifestyle
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Short-time structured diabetes support using FreeStyle Libre
Interventions/Control_2
Conventional diabetes support using FreeStyle Libre
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) Age 20 years or older
2) Type 2 diabetes
3) HbA1c level of 7% or higher for more than 3 months
Key exclusion criteria
1) Type 1 diabetes
2) Currently pregnant
3) Dialysis therapy due to renal failure
4) Have a drug prescription for the treatment of dementia, psychotropic drugs, or other psychiatric disorders
5) Have used CGM in the past
6) A person who cannot use FreeStyle Libre due to a skin disease
7) have difficulty participating in the study on an ongoing basis (can participate in the 3-month study period)
8) Any other person deemed unsuitable as a subject by the principal investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | HIROSHI |
| Middle name | |
| Last name | OKADA |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL
075-641-9161
okada.hiroshi.28z@kyoto-u.jp
Public contact
Name of contact person
| 1st name | MASAYUKI |
| Middle name | |
| Last name | DOMICHI |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL
075-641-9161
Homepage URL
aisei@rc4.so-net.ne.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Pharmaceutical Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Graduate School of Medicine & School of Public Health, Kyoto University / Nara Medical University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyoto Medical Center
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
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
| 2022 | Year | 09 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 09 | Day |
Last modified on
| 2022 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055276
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
