Online Diabetes Care Using FreeStyle Libre2 CGM in Japan

JRCT ID: jRCTs032240198

Registered date:28/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes without insulin treatment
• Date of first enrollment: 28/06/2024
• Target sample size: 420
• 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

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
• 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
• Source(s) of Monetary Support: Abbott Diabetes Care