UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031883