scholarly journals Flash Glucose Monitoring Systems in Pediatric Populations With Diabetes

2021 ◽  
Vol 1 (4) ◽  
Author(s):  
Calvin Young ◽  
Aleksandra Grobelna

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.

Author(s):  
Gillian Garden ◽  
David W Hunt ◽  
Karen Mackie ◽  
Beverly Tuthill ◽  
Helen Griffith ◽  
...  

People with type 1 diabetes who met NHS England funding criteria attended an accredited, intensive one-day structured education programme and completed the online FreeStyle Libre Academy training module followed by a 30-minute healthcare professional face-to-face practical training session. HbA1c, Gold hypoglycaemia score and Diabetes Distress Screening score were documented before commencement of the intervention and at 6 months. 213 people with type 1 diabetes (52% men; average age 48 years (range 18–87)) completed the 6-month intervention. Overall mean HbA1c reduced by 6 mmol/mol (0.5%) from 62±14 mmol/mol (7.8%) to 56±12 mmol/mol (7.3%) (p<0.0001). Subgroup analysis of participants with a baseline HbA1c ≥54 mmol/mol (7.1%) revealed a more dramatic reduction of 10 mmol/mol (0.9%) from 69±12 mmol/mol (8.5%) to 59±11 mmol/mol (7.6%). No deterioration was demonstrated for people with HbA1c <54 mmol/mol (7.1%). 143 people (75%) reported a reduction in hypoglycaemia episodes and 162 (85%) reported a reduction in time spent in the hypoglycaemic range. There was significant improvement in the Gold score (p<0.0001) and Diabetes Distress Screening score (p=0.0001). Rates of hospital admissions, paramedic call-outs and third-party assistance were reduced. The combination of a one-day intensive structured education programme alongside flash glucose monitoring initiation provides a pragmatic, cost-effective and easily implemented intervention with positive clinical outcomes at 6 months.


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.


2020 ◽  
Author(s):  
Sara E Boucher ◽  
Andrew R Gray ◽  
Esko J Wiltshire ◽  
Martin I de Bock ◽  
Barbara C Galland ◽  
...  

OBJECTIVE <p>To investigate whether intermittently scanned continuous glucose monitoring (isCGM) significantly improves glycemic control compared with capillary self-monitored blood glucose (SMBG) in youth with type 1 diabetes and high-risk glycemic control.</p> <p>RESEARCH DESIGN AND METHODS</p> <p>This multi-center 6-month randomized, controlled, parallel-arm trial included 64 participants aged 13 to 20 years with established Type 1 diabetes and glycated hemoglobin (HbA1c) ≥9% (≥75mmol/mol). Participants were allocated to 6-month intervention (isCGM, FreeStyle Libre, Abbott; n = 33) or control (SMBG; n = 31) using minimization. The primary outcome was the difference in change in HbA1c from baseline to 6 months. </p> <p>RESULTS</p> <p>There was no evidence of a difference between groups for changes in HbA1c at 6 months (adjusted mean 0.2% greater improvement for isCGM, 95% CI -0.9% to 0.5% [-2.1 mmol/mol, 95% CI -9.6 to 5.4], p = 0.576). However, glucose monitoring frequency was 2.83 (95% CI 1.72 to 4.65, p < 0.001) times higher in the isCGM group compared to that in the SMBG group at 6 months. The change in the Diabetes Treatment Satisfaction Questionnaire mean item score also favored isCGM at 6 months (p=0.048), with no significant differences between groups for fear of hypoglycemia and quality of life (both general and diabetes-specific) all p>0.1.</p> <p>CONCLUSIONS</p> <p>For youth with high-risk glycemic control, isCGM led to improvements in glucose testing frequency and diabetes treatment satisfaction. However, these did not translate to greater improvement in glycemic control over usual care with SMBG at 6 months. </p>


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