NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032240198

Registered date:28/06/2024

Online Diabetes Care Using FreeStyle Libre2 CGM in Japan

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedType 2 diabetes without insulin treatment
Date of first enrollment28/06/2024
Target sample size420
Countries of recruitment
Study typeInterventional
Intervention(s)Treatment of Type 2 Diabetes Using FreeStyle Libre 2 CGM with Telemedicine

Outcome(s)

Primary OutcomeDecrease in HbA1c in 52 weeks of intervention
Secondary Outcome[Secondary Outcomes for the Effectiveness] Patient satisfaction for the treatment evaluated with DSTQ and DQoL Body weight and BMI Change in medicine use including insulin and GLP-1 receptor agonists (kinds/classes of newly begun, stopped, increased and decreased medicine at the end of the study compared to the ones at the start of the study) Change in laboratory data from the blood and urine samples other than HbA1c Frequency of hypoglycemia (< 70mg/dL, self-awared and mesurement by the devices) [Secondary Outcomes for the Safety] Allergic reactions and other unconfortable symptoms Pain due to the finger pricking for SMBG

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 80age old
GenderBoth
Include criteria1) 18-80 years old at the agreement 2) patients diagonosed as type 2 diabetes by diagnostic criteria defined by Japan Diabetes Society 3) patients whose HbA1c between 7.0% and 9.0% (NGSP) in the screening period 4) patients who are treated with oral hypoglycemic agent or GLP-1 receptor agonist 5) patients who understand and agreed to attend the study
Exclude criteria1) Type 2 diabetes patients who are not treated by medicines 2) Patients whose HbA1c < 7.0 % or > 9.0 % 3) Patients who are treated by insulin therapy within 3 months from the enrollment 4) Patients who have type 1 diabetes or suspected as having it 5) Patients who are not suitable for online meeting with doctors 6) Patients who cannot use either smartphone or Libre2 reader to read their subcutaneous glucose concentrations 7) Patients who are recognized by physicians as not able to safely conduct the present study by any reasons

Related Information

Contact

Public contact
Name Hiraku Ono
Address Inohana 1-8-1, Chuo-Ku, Chiba City, Chiba Chiba Japan 260-8670
Telephone +81-43-226-2092
E-mail hono@chiba-u.jp
Affiliation Chiba University Hospital
Scientific contact
Name Hiraku Ono
Address Inohana 1-8-1, Chuo-Ku, Chiba City, Chiba Chiba Japan 260-8670
Telephone +81-43-226-2092
E-mail hono@chiba-u.jp
Affiliation Chiba University Hospital