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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027845
Receipt No. 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 2018/03/02

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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
Email 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
Email kyakushi@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Hospital
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
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
2018 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031883

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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