JPRN-UMIN000023593Completed未知
se of FreeStyle Libre Flash Glucose Monitoring System and the Effect on Hypoglycaemia in People with Type 2 Diabetes in Japan - SHIFT - Study of Hypoglycaemia using FreeStyle Libre
Abbott Diabetes Care Ltd0 sites95 target enrollmentStarted: December 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 95
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Insulin regimen consists entirely of basal or bi-phasic insulin. Subject is currently prescribed animal insulin. Subject is currently prescribed oral, intra-articular, intramuscular or intravenous steroid therapy for any acute or chronic condition or requires it during the study period. Known (or suspected) allergy to medical grade adhesives. Currently participating in another device trial or drug study that could affect glucose measurements or glucose management. Currently using a Continuous Glucose Monitoring (CGM) device or FreeStyle Libre or has used one within the previous 4 months. Is planning to use a CGM device at any time during the trial. Total daily dose (TDD) of insulin >1.75 iu/kg at enrolment. Currently receiving dialysis treatment or planning to receive dialysis during the trial. Has experienced an acute myocardial infarction within previous 6 months. Has a concomitant disease or condition that may compromise patient safety, including and not limited to; unstable coronary heart disease, cystic fibrosis, severe mental illness, known or suspected eating disorder or any other uncontrolled long term medical condition. Has a pacemaker or any other neurostimulators. A female subject who is pregnant or planning to become pregnant within the trial duration. In the investigator's opinion, the subject is unsuitable to participate due to any other cause/reason.
Investigators
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