UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027845 |
|---|---|
| Receipt number | R000031883 |
| Scientific Title | Safety of Flash Sensor-based Glucose Monitoring in Allogeneic Hematopoietic Stem Cell Transplantation Recipients |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2020/06/22 14:39:07 |
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Basic information
Public title
Safety of Flash Sensor-based Glucose Monitoring in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Acronym
FGM-SCT P1 Study
Scientific Title
Safety of Flash Sensor-based Glucose Monitoring in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Scientific Title:Acronym
FGM-SCT P1 Study
Region
| Japan |
Condition
Condition
Hematological disorder
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of "FreeStyle LibrePro" (Flash sensor-based Glucose Monitoring) in hematopoietic stem cell transplantation recipients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Severe bleeding of the sensor site
Requirement of antibiotics due to the infection of the sensor site
Key secondary outcomes
Insertion site symptoms
Correlation with the value of blood glucose and interstitial fluid glucose
The times of the sensor exchanges
Overall survival and progression free survival at days 100
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Flash Sensor-based monitoring for 28 days
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who will undergo allogeneic hematopoietic stem cell transplantation
Patients who sign a written informed consent
Patients who have never used FreeStyle LibrePro
Key exclusion criteria
Patients who will undergo HLA haplo-identical stem cell transplantation
Patients who need to perform X-ray or CT scan more than once a week
Patients who have infection on their upper arms for sensor sites
Patients with contact dermatitis
Patients who cannot use alcohol and chlorhexidine gluconate for sterilization
Patients who have implanted medical devices
Patients judged inappropriate participants for this study by their attending doctors
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironobu Minami |
Organization
Kobe University Hospital
Division name
Division of Medical Oncology and Hematology
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
+81-78-382-5820
hminami@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimikazu Yakushijin |
Organization
Kobe University Hospital
Division name
Division of Medical Oncology and Hematology
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
+81-78-382-5111
Homepage URL
kyakushi@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
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
Address
Tel
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
| 2017 | Year | 08 | 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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 20 | Day |
Last modified on
| 2020 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031883
