FSL use was associated with improvement in a range of glucose-related outcomes: a 38% reduction in time spent in hypoglycaemia (<3.9 mmol/L).
#FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM CLASS IIB TRIAL#
The IMPACT randomised controlled multicentre European trial was the largest study to evaluate the FSL 8 in 328 participants with well-controlled (HbA1c ≤7.5%, 59 mmol/mol) T1D, one-third of whom used continuous subcutaneous insulin infusion (CSII) therapy. The arm-worn sensor is scanned using a reader or mobile phone app and provides information on current and previous glucose levels and trends. The sensor utilises wired enzyme technology 7 to continuously measure interstitial glucose levels. In 2014, the FreeStyle Libre Flash Glucose Monitoring System (FSL) (Abbott Diabetes Care, Oxon, UK) became available as a potential alternative to SMBG. 5 6 However, due to pain, inconvenience and the limited information a moment-in-time glucose value provides, finger-stick glucose monitoring remains a key barrier in achieving near normal glucose levels. 4 Studies have shown a strong relationship between the frequency of SMBG and HbA1c, with the National Institute of Clinical Excellence recommending 4–10 checks per day. 3 In England, less than one-third of people with T1D achieve a glycated haemoglobin (HbA1c) level <7.5%. 1 Despite the availability of therapeutic options such as self-monitoring of blood glucose (SMBG), structured education, rapid-acting insulin analogues and insulin pump therapy, glycaemic control in the majority of people with T1D remains suboptimal 2 and they therefore remain prone to complications associated with high glucose levels, such as kidney failure and blindness. It is estimated that approximately 415 million adults (5%–15% T1D) and 520 thousand children (95% T1D) worldwide suffer from diabetes. Type 1 diabetes mellitus (T1D) is one of the most common endocrine conditions. Data on health service resource utilisation will be collected. Utility, acceptability, expectations and experience of using FSL2 will be explored. Secondary outcomes include sensor-based metrics, insulin doses, adverse events and self-report psychosocial measures. Psychosocial outcomes will be measured at baseline and 24 weeks. Control participants will wear a blinded sensor during the last 2 weeks. Participants will be contacted at 4 and 12 weeks for glucose optimisation. HbA1c will be measured at baseline, 12 and 24 weeks (primary outcome). Participants will be assessed virtually or in-person owing to the COVID-19 pandemic. Eligible participants will be randomised to 24 weeks of FSL2 (intervention) or SMBG (control) periods, after 2-week of blinded sensor wear. This open-label, multicentre, randomised (via stochastic minimisation), parallel design study conducted at eight UK secondary and primary care centres will aim to recruit 180 people age ≥16 years with T1D for >1 year and glycated haemoglobin (HbA1c) 7.5%–11%.
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