Efficacy, effect of hypoglycemia, assessment of QOL to use FreeStyle Libre Flash Glucose Monitoring System in type 2 diabetis

Efficacy, effect of hypoglycemia, assessment of QOL to use FreeStyle Libre Flash Glucose Monitoring System in type 2 diabetis - Efficacy, effect of hypoglycemia, assessment of QOL to use FreeStyle Libre Flash Glucose Monitoring System in type 2 diabetis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000029842

Enrollment

Registered

2017-11-06

Start date

2017-11-07

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

Type2 diabetes using insulin

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Out patients(type 2 diabetes) who receive insulin therapy and monitor their blood glucose level with conventional blood glucose meters >=6 months. Patients who give written informed consent to participate in the study In the treatment for diabetes, patients who will be able to receive benefits by using Free Style Libre Flash Glucose Monitoring System and hope to use it patients themselves. In the investigator's opinion, the subject is technically capable of using device. In the investigator's opinion, the subject is proactive and therefore willing to modify their diabetes management.

Exclusion criteria

Exclusion criteria: Currently receiving dialysis treatment or planning to receive dialysis during the trial. A female subject who is pregnant or planning to become pregnant within the trial duration. Has a pacemaker or any other neurostimulators. In the investigator's opinion, the subject is unsuitable to participate due to any other cause/reason.

Design outcomes

Primary

Measure	Time frame
Change from Baseline in HbA1c and bodyweight at 3 months	—

Secondary

Measure	Time frame
Change for 2 weeks between at baseline and at 3 months, for the following measures With the date from snapshot through FreeStyle Libre softwear, average sensor glucose, time in range(setting sensor glucose 70-180mg/dl in target), the percentage above, below, and in target, number and duration of hypoglycemic episodes. QOL questionnaire. Bodyweight and BMI Number of Sensor scans performed. Relationships between the blood glucose and sensor glucose In cases of discontinuation, examination of the reason for discontinuation and the occurrence of adverse events. Comparison of a continued group and a discontinued group.	—

Measure

Time frame

Change for 2 weeks between at baseline and at 3 months, for the following measures With the date from snapshot through FreeStyle Libre softwear, average sensor glucose, time in range(setting sensor glucose 70-180mg/dl in target), the percentage above, below, and in target, number and duration of hypoglycemic episodes. QOL questionnaire. Bodyweight and BMI Number of Sensor scans performed. Relationships between the blood glucose and sensor glucose In cases of discontinuation, examination of the reason for discontinuation and the occurrence of adverse events. Comparison of a continued group and a discontinued group.

—

Countries

Japan

Contacts

Public ContactTakashi Makuuchi

Medical Corporation H.E.C Science Clinic Clinical Trial Secretariat

hec@asahi-net.email.ne.jp045-831-0031

Outcome results