Online Diabetes Care Using FreeStyle Libre2 CGM in Japan

Randomized multicentered non-blinded study to evaluate benefits of a CGM with abnormal glucose alarm combined with telemedicine compared to SMBG for treating of type 2 diabetes in Japan

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032240198

Enrollment

420

Registered

2024-06-28

Start date

2024-06-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes without insulin treatment insulin, diabetes, oral hypoglycemic agents, continuous glucose monitoring, telemedicine

Interventions

Treatment of Type 2 Diabetes Using FreeStyle Libre 2 CGM with Telemedicine

CGM, telemedicine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria: 1) Type 2 diabetes patients who are not treated by medicines 2) Patients whose HbA1c 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

Design outcomes

Primary

Measure	Time frame
Decrease in HbA1c in 52 weeks of intervention	—

Secondary

Measure	Time frame
[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	—

Measure

Time frame

[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

—

Contacts

Public ContactHiraku Ono

Chiba University Hospital

hono@chiba-u.jp+81-43-226-2092

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026