scholarly journals Self-monitoring of blood glucose measurements and glycaemic control in a managed care paediatric type 1 diabetes practice

2015 ◽  
Vol 105 (5) ◽  
pp. 405 ◽  
Author(s):  
Beverley Davey ◽  
David Grant Segal
BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e050713
Author(s):  
Emma G Wilmot ◽  
Mark Evans ◽  
Katharine Barnard-Kelly ◽  
M Burns ◽  
Iain Cranston ◽  
...  

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.


Author(s):  
Sara Styles ◽  
Ben Wheeler ◽  
Alisa Boucsein ◽  
Hamish Crocket ◽  
Michel de Lange ◽  
...  

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).


2015 ◽  
Vol 17 (4) ◽  
pp. 275-282 ◽  
Author(s):  
Claudia Boettcher ◽  
Axel Dost ◽  
Stefan A. Wudy ◽  
Marion Flechtner-Mors ◽  
Martin Borkenstein ◽  
...  

2020 ◽  
Author(s):  
Helleputte Simon ◽  
De Backer Tine ◽  
Calders Patrick ◽  
Pauwels Bart ◽  
Shadid Samyah ◽  
...  

OBJECTIVE: In type 1 diabetes mellitus (T1DM) management, CGM-derived parameters can provide additional insights, with the concept of time in range (TIR) and other parameters reflecting glycaemic control and variability (GV) being put forward. This study aimed to examine the added and interpretative value of the CGM-derived indices TIR and coefficient of variation (CV%) in T1DM patients stratified according to their level of glycaemic control by means of HbA1c. METHODS: T1DM patients with a minimum disease duration of 10 years and without known macrovascular disease were enrolled. Patients were equipped with a blinded CGM device (Dexcom G4) for seven days. TIR (70–180 mg/dl), time in hypoglycaemia (total: <70 mg/dl; level 2: <54 mg/dl) and hyperglycaemia (total: >180 mg/dl; level 2: >250 mg/dl) were determined, and CV% (=standard deviation(SD)/mean blood glucose(MBG)) was used as parameter for GV. Pearson and Spearman correlations, and regression analysis was used to examine associations. RESULTS: 95 patients (age: 45±10 years; HbAc1: 7.7±0.8%) were included (MBG: 159±31 mg/dl; TIR 55.8±14.9%; CV%: 43.5±7.8%) and labeled as having good (HbA1c ≤7%; n=20), moderate (7–8%; n=44) or poor (>8%; n=31) glycaemic control. HbA1c was significantly associated with MBG (rs=0.48, p<0.001) and time spent in hyperglycaemia (total: rs=0.52; level 2: r=0.46; p<0.001), but not with time in hypoglycaemia and CV%, even after analysis in HbA1c subgroups. Similarly, TIR was negatively associated with HbA1c (r=−0.53; p<0.001), MBG (rs=−0.81; p<0.001) and time in hyperglycaemia (total: rs=−0.90; level 2: rs=−0.84; p<0.001), but not with time in hypoglycaemia. Subgroup analyses, however, showed that TIR did associate with shorter time in level 2 hypoglycaemia in those patients with good (rs=−0.60; p=0.007) and moderate (rs=−0.25; p=0.047) glycaemic control. In contrast, CV% was strongly positively associated with time in hypoglycaemia (total: rs=0.78; level 2: rs=0.76; p<0.001), but not with TIR or time in hyperglycaemia in the entire cohort, although subgroup analyses showed that TIR was negatively associated with CV% in patients with good glycaemic control (r=−0.81, p<0.001) and positively in patients with poor glycaemic control (r=0.47; p<0.01). CONCLUSION: This study demonstrates that CGM-derived metrics TIR and CV% relate with clinically important situations, TIR being strongly dependent on hyperglycaemia and CV% being reflective of hypoglycaemic risk. However, the interpretation and applicability of TIR and CV%, and their relationship, depends on the level of glycaemic control of the individual patient, with CV% generally adding less clinically relevant information in those with poor control. This illustrates the need for further research and evaluation of composite measures of glycaemic control in T1DM. Abbreviations: T1DM = Type 1 diabetes mellitus; CGM = Continuous glucose monitoring; TIR = Time in range; TAR = Time above range; TBR = Time below range; GV = Glycaemic variability; CV% = Coefficient of variation; MBG = Mean blood glucose.


2020 ◽  
Vol 33 (3) ◽  
pp. 280-289 ◽  
Author(s):  
Jennifer L. Warnick ◽  
Sarah C. Westen ◽  
Anastasia Albanese-O’Neill ◽  
Stephanie L. Filipp ◽  
Desmond Schatz ◽  
...  

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