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NCT05597293
FreeStyle Libre Monitoring in T2DM
Conditions: Type2diabetes
Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 40
Sponsor: University of Hull
Location: United Kingdom
Summary
The goal of this clinical trial is to learn if blood sugar monitoring using a FreeStyle Libre device can improve overall Diabetes control in people with Type 2 Diabetes.The main questions it aims to answer are:What is the effect of monitoring using the FreeStyle Libre device for a period of 12 weeks on the blood sugar control of people with Type 2 Diabetes?Can monitoring using the FreeStyle Libre device improve the quality of life of people with Type 2 diabetes?Participants will be asked to wear one of two brands of FreeStyle Libre devices.
In one group, participants will have 3 visits, while those in the second group, they will have 4 visits.Researchers will compare the improvement in the sugar control for the individuals but also compare between the 2 groups.
Eligibility Criteria
Inclusion Criteria:Males and females living with type 2 diabetes mellitus (T2DM) who are aged ≥ 18 and ≤ 75 yearsOn one or more non-insulin glucose lowering agent(s)HbA1c ≥ 69 mmol/molAble to provide written informed consentExclusion Criteria:Participants with a life expectancy of less than 1 yearParticipants with cognitive dysfunction or neurological disorder, which will interfere with regular, flash glucose monitoringParticipants with chronic kidney disease (CKD) with eGFR < 45ml/min/1.73m2 or decompensated liver disease or decompensated congestive cardiac failureMyocardial infarction in the preceding 3 months or if percutaneous coronary intervention planned in the next 6 monthsParticipants on supra-physiological doses of steroids, for example, Prednisolone for the treatment of Rheumatoid arthritisParticipants on active dialysis or planned for dialysis treatment during the studyCurrently participating in another device or drug study that could affect glucose measurements or managementWomen who are pregnant, breastfeeding or planning to become pregnant.
Women should use a reliable form of contraception throughout the studyParticipants who are already using continuous glucose monitoring (CGM)Participants who have pacemakers, implanted cardioverter defibrillator devices or neurostimulatorsParticipants with an allergy to medical grade adhesiveA blood transfusion in the preceding 3 months or a planned blood transfusion during the course of the study
Source: ClinicalTrials.gov (NCT05597293). StuddyBuddy aggregates publicly available trial information.