臨床研究等提出・公開システム

Japanese

Date of registration	June. 28, 2024
Last modified on	Oct. 21, 2024
Trial ID	jRCTs032240198

Scientific Title	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
Public Title	Online Diabetes Care Using FreeStyle Libre2 CGM in Japan

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

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 28, 2024
Actual date of first enrollment
Target sample size		420
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion 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	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
	Age Minimum	18age old over
	Age Maximum	80age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Type 2 diabetes without insulin treatment
Intervention(s)		Treatment of Type 2 Diabetes Using FreeStyle Libre 2 CGM with Telemedicine
Health Condition(s) Keyword		insulin, diabetes, oral hypoglycemic agents, continuous glucose monitoring, telemedicine
Intervention(s) Keyword		CGM, telemedicine
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Decrease in HbA1c in 52 weeks of intervention
Secondary Outcome(s)		[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

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Abbott Diabetes Care
Secondary Sponsor	Not applicable

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval	Mar. 18, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Oct. 21, 2024	(this page)	Changes
1	June. 28, 2024	Detail

List of change history