Phase
Condition
Diabetes Mellitus, Type 2
Treatment
Glucose monitoring using FreeStyle Libre 2
Glucose monitoring using FreeStyle Libre pro iQ
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males and females living with type 2 diabetes mellitus (T2DM) who are aged ≥ 18 and ≤ 75 years
On one or more non-insulin glucose lowering agent(s)
HbA1c ≥ 69 mmol/mol
Able to provide written informed consent
Exclusion
Exclusion Criteria:
Participants with a life expectancy of less than 1 year
Participants with cognitive dysfunction or neurological disorder, which willinterfere with regular, flash glucose monitoring
Participants with chronic kidney disease (CKD) with eGFR < 45ml/min/1.73m2 ordecompensated liver disease or decompensated congestive cardiac failure
Myocardial infarction in the preceding 3 months or if percutaneous coronaryintervention planned in the next 6 months
Participants on supra-physiological doses of steroids, for example, Prednisolone forthe treatment of Rheumatoid arthritis
Participants on active dialysis or planned for dialysis treatment during the study
Currently participating in another device or drug study that could affect glucosemeasurements or management
Women who are pregnant, breastfeeding or planning to become pregnant. Women shoulduse a reliable form of contraception throughout the study
Participants who are already using continuous glucose monitoring (CGM)
Participants who have pacemakers, implanted cardioverter defibrillator devices orneurostimulators
Participants with an allergy to medical grade adhesive
A blood transfusion in the preceding 3 months or a planned blood transfusion duringthe course of the study
Study Design
Study Description
Connect with a study center
Hull University Teaching Hospitals NHS Trust, Academic diabetes, Endocrinology and metabolism
Hull, HU32RW
United KingdomSite Not Available

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