JRCT ID: jRCTs032240198
Registered date:28/06/2024
Online Diabetes Care Using FreeStyle Libre2 CGM in Japan
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Type 2 diabetes without insulin treatment |
Date of first enrollment | 28/06/2024 |
Target sample size | 420 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Treatment of Type 2 Diabetes Using FreeStyle Libre 2 CGM with Telemedicine |
Outcome(s)
Primary Outcome | Decrease in HbA1c in 52 weeks of intervention |
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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 |
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Age maximum | <= 80age old |
Gender | Both |
Include criteria | 1) 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 criteria | 1) 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
Primary Sponsor | Ono Hiraku |
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Secondary Sponsor | |
Source(s) of Monetary Support | Abbott Diabetes Care |
Secondary ID(s) |
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 |
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 |
hono@chiba-u.jp | |
Affiliation | Chiba University Hospital |