FGM in Allogeneic Hematopoietic Stem Cell Transplantation Recipients

JRCT ID: jRCTs052180059

Registered date:14/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients who will receive hematopoietic stem cell transplantation
• Date of first enrollment: 30/11/2017
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Flash Sensor-based monitoring for 28days

Outcome(s)

Primary Outcome

(1)Severe bleeding of the sensor site
(2)Requirement of antibiotics due to the infection of the sensor site

Secondary Outcome

(1)Correlation with the value of blood glucose and interstitial fluid glucose
(2)The times of the sensor exchanges
(3)Insertion site symptoms
(4)Relationship between bleeding (onset and degree) and patients characteristics

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 69age old
• Gender: Both

Include criteria

(1)Patients who are at least 20 and under 70 years of age
(2)Patients who will undergo allogeneic hematopoietic stem cell transplantation
(3)Patients who sign a written informed consent
(4)Patients who have never used FreeStyle LibrePro

Exclude criteria

(1)Patients who will undergo HLA haplo-identical stem cell transplantation
(2)Patients who need to perform X-ray or CT scan more than once a week
(3)Patients who have infection on their upper arms for sensor sites
(4)Patients who contact dermatitis
(5)Patients who cannot use alcohol and chlorhexidine gluconate for sterilization
(6)Patients who have implanted medical devices
(7)Patients judged inappropriate perticipants for this study by their attending doctors

Related Information

• Primary Sponsor: MINAMI Hironobu
• Secondary ID(s): 000027845