Efficacy, effect of hypoglycemia, assessment of QOL to use FreeStyle Libre Flash Glucose Monitoring System in type 1 diabetis
Not Applicable
- Conditions
- Type1 diabetes using insulin
- Registration Number
- JPRN-UMIN000029837
- Lead Sponsor
- Medical Corporation H.E.C Science Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
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 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 unsuitable to participate due to any other cause/reason.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline in HbA1c and bodyweight at 3 months
- Secondary Outcome Measures
Name Time Method Change for 2 weeks between at baseline and at 3months, for the following measures With the date from snapshot through FreeStyle Libre softwear, average sensor glucose, time in range (setting sensor glucose70-180mg/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 Bolas insulin dose and basal insulin dose 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.