Flash glucose monitoring: objective, not self-referential, outcomes are needed. Reply to Warren RE [letter].
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ABSTRACT:
SUBMITTER: Bolinder J
PROVIDER: S-EPMC6061142 | biostudies-literature | 2018 Aug
REPOSITORIES: biostudies-literature
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Flash glucose monitoring: objective, not self-referential, outcomes are needed. Reply to Warren RE [letter].
Bolinder Jan J Oskarsson Per P Antuna Ramiro R Geelhoed-Duijvestijn Petronella P Krӧger Jens J Weitgasser Raimund R
Diabetologia 20180602 8
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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.
| S-EPMC8280849 | biostudies-literature
Project description:Background and aimsTo compare the effects of real-time and retrospective flash glucose monitoring (FGM) on daily glycemic control and lifestyle in patients with type 2 diabetes on premix insulin therapy.Methods and resultsA total of 172 patients using premix insulin, with HbA1c ≥ 7.0% (56 mmol/mol), or the time below the target (TBR) ≥ 4%, or the coefficient of variation (CV) ≥36% during the screening period, were randomly assigned to retrospective FGM (n = 89) or real-time FGM group (n = 83). Another two retrospective or real-time 14-day FGMs were performed respectively, 1 month apart. Both groups received educations and medication adjustment after each FGM. Time in range (3.9~10.0 mmol/l, TIR) increased significantly after 3 months in the real-time FGM group (6.5%) compared with the retrospective FGM group (-1.1%) (p = 0.014). HbA1c decreased in both groups (both p < 0.01). Real-time FGMs increased daily exercise time compared with the retrospective group (p = 0.002).ConclusionsReal-time FGM with visible blood glucose improves daily glycemic control and diabetes self-care behaviors better than retrospective FGM in patients with type 2 diabetes on premix insulin therapy.Clinical trial registrationhttps://clinicaltrials.gov/NCT04847219.
| S-EPMC8867069 | biostudies-literature
Project description:BackgroundThis real-world data study analyzed glucose metrics from FreeStyle Libre® flash glucose monitoring in relation to scanning frequency, time in range (TIR) and estimated A1c (eA1c) in Saudi Arabia.MethodsAnonymized reader data were analyzed according to scanning frequency quartiles, eA1c categories (<7%,≥7%‒≤9% or>9%) and TIR categories (<50%,≥50%‒≤70% or>70%). Sensors, grouped by reader, were required to have≥120 h of operation. Differences in scanning frequency, eA1c, TIR, time in hypoglycemia and hyperglycemia, and glucose variability (standard deviation [SD] and coefficient of variation [CV]) were analyzed between groups.Results6097 readers, 35,747 sensors, and 40 million automatic glucose measurements were analyzed. Patients in the highest scanning frequency quartile (Q4, mean 32.0 scans/day) had lower eA1c (8.47%), greater TIR (46.4%) and lower glucose variation (SD 75.0 mg/dL, CV 38.2%) compared to the lowest quartile (Q1, mean 5.2 scans/day; eA1c 9.77%, TIR 32.8%, SD 94.9 mg/dL, CV 41.3%). Lower eA1c and higher TIR were associated with greater scanning frequency, lower glucose variability and less time in hyperglycemia.ConclusionsHigher scanning frequency in flash glucose users from Saudi Arabia is associated with lower eA1c, higher TIR, lower glucose variability and less time in hypoglycemia or hyperglycemia.
| S-EPMC9063302 | biostudies-literature
Project description:IntroductionThe purpose of the study was to evaluate the performance and usability of the FreeStyle(®) Libre™ Flash glucose monitoring system (Abbott Diabetes Care, Alameda, CA) for interstitial glucose results compared with capillary blood glucose results.Materials and methodsSeventy-two study participants with type 1 or type 2 diabetes were enrolled by four U.S. clinical sites. A sensor was inserted on the back of each upper arm for up to 14 days. Three factory-only calibrated sensor lots were used in the study. Sensor glucose measurements were compared with capillary blood glucose (BG) results (approximately eight per day) obtained using the BG meter built into the reader (BG reference) and with the YSI analyzer (Yellow Springs Instrument, Yellow Springs, OH) reference tests at three clinic visits (32 samples per visit). Sensor readings were masked to the participants.ResultsThe accuracy of the results was demonstrated against capillary BG reference values, with 86.7% of sensor results within Consensus Error Grid Zone A. The percentage of readings within Consensus Error Grid Zone A on Days 2, 7, and 14 was 88.4%, 89.2%, and 85.2%, respectively. The overall mean absolute relative difference was 11.4%. The mean lag time between sensor and YSI reference values was 4.5±4.8 min. Sensor accuracy was not affected by factors such as body mass index, age, type of diabetes, clinical site, insulin administration, or hemoglobin A1c.ConclusionsInterstitial glucose measurements with the FreeStyle Libre system were found to be accurate compared with capillary BG reference values, with accuracy remaining stable over 14 days of wear and unaffected by patient characteristics.
| S-EPMC4649725 | biostudies-literature
Project description:AimsGestational diabetes mellitus (GDM) is the most common type of hyperglycaemia in pregnancy. GDM is a risk factor of adverse perinatal outcomes, with the incidence rate increasing proportionally to the level of maternal dysglycaemia. Therefore, glycaemic control plays an important role in management of GDM. The aim of this study was to assess the efficacy of flash glucose monitoring (FGM) in GDM.Materials and methodsThis was a non-blinded, randomised controlled trial, that recruited 100 pregnant women diagnosed with GDM between 24 and 28 weeks of gestation at the 1st Department of Obstetrics and Gynaecology, Medical University of Warsaw. After meeting the inclusion criteria patients were randomly allocated to the study group (FGM, n = 50) or control group (self-monitoring of blood glucose-SMBG, n = 50). Clinical and laboratory results were assessed at four follow-up visits. The primary outcome was mean fasting and postprandial glycaemia. The secondary outcomes were perinatal outcomes.ResultsThere was no significant difference in mean glycaemia between the groups (p = 0.437) Compared to the control group, the study group significantly reduced their fasting (p = 0.027) and postprandial glycaemia (p = 0.034) during the first 4 weeks following GDM diagnosis, with no significant difference in progression to insulin therapy (OR 1.09, 95% CI 0.47-2.57). Incidence of fetal macrosomia was significantly higher in SMBG as compared to FGM group (OR 5.63, 95% CI 1.16-27.22).ConclusionsStudy results indicate that FGM has an impact on glycaemic control, dietary habits and incidence of fetal macrosomia in patients with GDM. Trial registration clinicaltrials.gov ID: NCT04422821.
| S-EPMC10359198 | biostudies-literature
Project description:Our aim was to assess the potential of flash glucose monitoring (FGM) for diagnostic workup of suspected post-bariatric hypoglycaemia (PBH). Patients (N = 13) with suspected PBH underwent a food and symptoms diary (FSD) record along with FGM over 14 days. Targeted data analysis confirmed the occurrence of low glucose events in parallel to meal-triggered symptoms. Glycaemic variability, as assessed by Mean Absolute Glucose change (MAG change), was increased, while a higher risk of glycaemic excursions towards both hyper and hypoglycaemia (ADRRFGMGT) was observed in those with more frequent and severe hypoglycaemia. The herein described hypoglycaemia risk index (LBGIFGMGT) with a cut-off value of 4.6 showed to have 100% sensitivity and 100% specificity for PBH. This pilot proof-of-concept study highlighted that FSD coupled with FGM followed by targeted data analysis, provides relevant insights towards PBH diagnosis and grading in a user-friendly and easy to implement study protocol. Furthermore, LBGIFGMGT demonstrated to be an excellent index for PBH diagnosis. The unexpected improvement of glucose profile noticed along the monitoring time also unravels a possible application for PBH management.
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Project description:AimsGlucose and insulin metabolism are altered in hemodialysis patients, and diabetes management is difficult in these patients. We aimed to validate flash glucose monitoring (FGM) in hemodialysis patients with and without diabetes mellitus as an attractive option for glucose monitoring not requiring regular self-punctures.MethodsWe measured interstitial glucose using a FreeStyle Libre device in eight hemodialysis patients with and seven without diabetes mellitus over 14 days and compared the results to simultaneously performed self-monitoring of capillary blood glucose (SMBG).ResultsIn 720 paired measurements, mean flash glucose values were significantly lower than self-measured capillary values (6.17±2.52 vs. 7.15±2.41 mmol/L, p=1.3 E-86). Overall, the mean absolute relative difference was 17.4%, and the mean absolute difference was 1.20 mmol/L. The systematic error was significantly larger in patients without vs. with diabetes (- 1.17 vs. - 0.82 mmol/L) and on dialysis vs. interdialytic days (-1.09 vs. -0.90 mmol/L). Compared to venous blood glucose (72 paired measurements), the systematic error of FGM was even larger (5.89±2.44 mmol/L vs. 7.78±7.25 mmol/L, p=3.74E-22). Several strategies to reduce the systematic error were evaluated, including the addition of +1.0 mmol/L as a correction term to all FGM values, which significantly improved accuracy.ConclusionsFGM systematically underestimates blood glucose in hemodialysis patients but, taking this systematic error into account, the system may be useful for glucose monitoring in hemodialysis patients with or without diabetes.
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