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Accuracy of Flash Glucose Monitoring During Postprandial Rest and Different Walking Conditions in Overweight or Obese Young Adults

ABSTRACT: Aims: To investigate the accuracy of FreeStyle LibreTM flash glucose monitoring (FGM) relevant to plasma glucose (PG) measurements during postprandial rest and different walking conditions in overweight/obese young adults. Methods: Data of 40 overweight/obese participants from two randomized crossover studies were pooled into four trials: (1) sitting (SIT, n = 40); (2) walking continuously for 30 min initiated 20 min before individual postprandial glucose peak (PPGP) (20iP + CONT, n = 40); (3) walking continuously for 30 min initiated at PPGP (iP + CONT, n = 20); and (4) accumulated walking for 30 min initiated 20 min before PPGP (20iP + ACCU, n = 20). Paired FGM and PG were measured 4 h following breakfast. Results: The overall mean absolute relative difference (MARD) between PG and FGM readings was 16.4 ± 8.6% for SIT, 16.2 ± 4.7% for 20iP + CONT, 16.7 ± 12.2% for iP + CONT, and 19.1 ± 6.8% for 20iP + ACCU. The Bland–Altman analysis showed a bias of −1.03 mmol⋅L–1 in SIT, −0.89 mmol⋅L–1 in 20iP + CONT, −0.82 mmol⋅L–1 in iP + CONT, and −1.23 mmol⋅L–1 in 20iP + ACCU. The Clarke error grid analysis showed that 99.6–100% of the values in all trials fell within zones A and B. Conclusion: Although FGM readings underestimated PG, the FGM accuracy was overall clinically acceptable during postprandial rest and walking in overweight/obese young adults.

SUBMITTER: Zhang X

PROVIDER: S-EPMC8555657 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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.

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Accuracy of Flash Glucose Monitoring During Postprandial Rest and Different Walking Conditions in Overweight or Obese Young Adults

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