scholarly journals Flash glucose monitoring with the FreeStyle Libre 2 compared with self-monitoring of blood glucose in suboptimally controlled type 1 diabetes: the FLASH-UK randomised controlled trial protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e050713
Author(s):  
Emma G Wilmot ◽  
Mark Evans ◽  
Katharine Barnard-Kelly ◽  
M Burns ◽  
Iain Cranston ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Blood Glucose ◽  
Glycaemic Control ◽  
Health Service ◽  
Glucose Monitoring ◽  
Self Monitoring ◽  
Flash Glucose Monitoring ◽  
Freestyle Libre ◽  
Randomised Controlled

IntroductionOptimising glycaemic control in type 1 diabetes (T1D) remains challenging. Flash glucose monitoring with FreeStyle Libre 2 (FSL2) is a novel alternative to the current standard of care self-monitoring of blood glucose (SMBG). No randomised controlled trials to date have explored the potential benefits of FSL2 in T1D. We aim to assess the impact of FSL2 in people with suboptimal glycaemic control T1D in comparison with SMBG.MethodsThis 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%. Eligible participants will be randomised to 24 weeks of FSL2 (intervention) or SMBG (control) periods, after 2-week of blinded sensor wear. Participants will be assessed virtually or in-person owing to the COVID-19 pandemic. HbA1c will be measured at baseline, 12 and 24 weeks (primary outcome). Participants will be contacted at 4 and 12 weeks for glucose optimisation. Control participants will wear a blinded sensor during the last 2 weeks. Psychosocial outcomes will be measured at baseline and 24 weeks. Secondary outcomes include sensor-based metrics, insulin doses, adverse events and self-report psychosocial measures. Utility, acceptability, expectations and experience of using FSL2 will be explored. Data on health service resource utilisation will be collected.AnalysisEfficacy analyses will follow intention-to-treat principle. Outcomes will be analysed using analysis of covariance, adjusted for the baseline value of the corresponding outcome, minimisation factors and other known prognostic factors. Both within-trial and life-time economic evaluations, informed by modelling from the perspective of the National Health Service setting, will be performed.EthicsThe study was approved by Greater Manchester West Research Ethics Committee (reference 19/NW/0081). Informed consent will be sought from all participants.Trial registration numberNCT03815006.Protocol version4.0 dated 29 June 2020.

scholarly journals A comparison of FreeStyle Libre 2 to self-monitoring of blood glucose in children with type 1 diabetes and sub-optimal glycaemic control: a 12-week randomised controlled trial protocol

2021 ◽  
Author(s):  
Sara Styles ◽  
Ben Wheeler ◽  
Alisa Boucsein ◽  
Hamish Crocket ◽  
Michel de Lange ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Blood Glucose ◽  
Glycaemic Control ◽  
Second Generation ◽  
Controlled Trial ◽  
Glucose Monitoring ◽  
Self Monitoring ◽  
Freestyle Libre ◽  
Randomised Controlled

Abstract Purpose Frequent glucose monitoring is necessary for optimal glycaemic control. Second-generation intermittently scanned glucose monitoring (isCGM) systems inform users of out-of-target glucose levels and may reduce monitoring burden. We aim to compare FreeStyle Libre 2 (Abbott Diabetes Care, Witney, U.K.) to self-monitoring of blood glucose in children with type 1 diabetes and sub-optimal glycaemic control. Methods This open-label randomised controlled trial will enrol 100 children (4–13 years inclusive, diagnosis of type 1 diabetes ≥ 6 months, HbA1c 58–110 mmol/mol [7.5–12.2%]), from 5 New Zealand diabetes centres. Following 2 weeks of blinded sensor wear, children will be randomised 1:1 to control or intervention arms. The intervention (duration 12 weeks) includes second-generation isCGM (FreeStyle Libre 2) and education on using interstitial glucose data to manage diabetes. The control group will continue self-monitoring blood glucose. The primary outcome is the difference in glycaemic control (measured as HbA1c) between groups at 12 weeks. Pre-specified secondary outcomes include change in glucose monitoring frequency, glycaemic control metrics and psychosocial outcomes at 12 weeks as well as isCGM acceptability. Discussion This research will investigate the effectiveness of the second-generation isCGM to promote recommended glycaemic control. The results of this trial may have important implications for including this new technology in the management of children with type 1 diabetes. Trial registration This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 19 February 2020 (ACTRN12620000190909p) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1237-0090).

scholarly journals Flash glucose monitoring in type 1 diabetes: A comparison with self‐monitoring blood glucose

2020 ◽  
Vol 11 (5) ◽  
pp. 1222-1229 ◽  
Author(s):  
Naru Babaya ◽  
Shinsuke Noso ◽  
Yoshihisa Hiromine ◽  
Yasunori Taketomo ◽  
Fumimaru Niwano ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Blood Glucose ◽  
Glucose Monitoring ◽  
Self Monitoring ◽  
Flash Glucose Monitoring

scholarly journals Flash Glucose Monitoring Systems in Pediatric Populations With Diabetes

2021 ◽  
Vol 1 (4) ◽  
Author(s):  
Calvin Young ◽  
Aleksandra Grobelna
Keyword(s):  
Type 1 Diabetes ◽  
Blood Glucose ◽  
Glucose Monitoring ◽  
Diabetes Distress ◽  
Signal Loss ◽  
Flash Glucose Monitoring ◽  
Glucose Testing ◽  
Freestyle Libre ◽  
Pediatric Populations

Flash glucose monitoring (FGM) is a method of glucose testing where a sensor inserted into the skin continuously measures interstitial glucose levels. It can be used by people with diabetes to inform treatment decisions, such as insulin dosing, as an alternative or complement to blood glucose testing. Evidence of variable quality from 2 randomized controlled trials and 8 non-randomized studies, including those summarized within systematic reviews, suggests that FGM may improve quality of life, patient satisfaction, diabetes distress, self-efficacy, and frequency of glucose monitoring compared to self-monitoring blood glucose techniques in pediatric populations with type 1 diabetes. Findings related to other outcomes, such as hemoglobin A1C, glucose time in range metrics, and adverse events were mixed or inconclusive (i.e., in some studies the use of FGM was associated with improved outcomes, while in other studies it was not). While the results summarized in this report generally suggest that the use of FGM is associated with improved clinical outcomes in pediatric populations with type 1 diabetes, the limitations of the included literature should be considered when interpreting these findings. No studies were identified that compared the clinical effectiveness of FGM systems with hypoglycemic, hyperglycemia, or signal loss alarms (e.g., FreeStyle Libre 2) to FGM systems without these features (e.g., FreeStyle Libre) in people of any age with diabetes requiring insulin therapy.

scholarly journals Effects of novel flash glucose monitoring system on glycaemic control in adult patients with type 1 diabetes mellitus: protocol of a multicentre randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e039400
Author(s):  
Yongwen Zhou ◽  
Hongrong Deng ◽  
Hongxia Liu ◽  
Daizhi Yang ◽  
Wen Xu ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 1 Diabetes ◽  
Blood Glucose ◽  
Glycaemic Control ◽  
Type 1 Diabetes Mellitus ◽  
Glucose Monitoring ◽  
Adult Patients ◽  
Flash Glucose Monitoring ◽  
Distress Scale

IntroductionOptimal glycaemic control is beneficial to prevent and delay microvascular complications in patients with type 1 diabetes mellitus (T1DM). The benefits of flash glucose monitoring (FGM) have been proved among well-controlled adults with T1DM, but evidence for FGM in adults with T1DM who have suboptimal glycaemic control is limited. This study aims to evaluate the effect of FGM in suboptimally controlled adult patients with T1DM .Methods and analysisThis open-label, multicentre, randomised trial will be conducted at eight tertiary hospitals and recruit 104 adult participants (≥18 years old) with T1DM diagnosed for at least 1 year and with suboptimal glycaemic control (glycated haemoglobin (HbA1c) ranging from 7.0% to 10.0%). After a run-in period (baseline, 0–2 weeks), eligible participants will be randomised 1:1 to either use FGM or self-monitoring of blood glucose alone consequently for the next 24 weeks. At baseline, 12–14 weeks and 24–26 weeks, retrospective continuous glucose monitoring (CGM) systems will be used in both groups for device-related data collection. Biological metrics, including HbA1c, blood routine, lipid profiles, liver enzymes, questionnaires and adverse events, will be assessed at baseline, week 14 and week 26. All analyses will be conducted on the intent-to-treat population. Efficacy endpoint analyses will also be repeated on the per-protocol population. The primary outcome is the change of HbA1c from baseline to week 26. The secondary outcomes are the changes of CGM metrics, including time spent in range, time spent in target, time spent below range, time spent above range, SD, coefficient of variation, mean amplitude of glucose excursions, high or low blood glucose index, mean of daily differences, percentage of HbA1c in target (<7%), frequency of FGM use, total daily insulin dose and the scores of questionnaires including Diabetes Distress Scale, Hypoglycemia Fear Scale and European Quality of Life Scale.Ethics and disseminationThis study was approved by the Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University in January 2017. Ethical approval has been obtained at all centres. All participants will be provided with oral and written information about the trial. The study will be disseminated by peer-review publications and conference presentations.Trial registration numberNCT03522870.

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