Clinical Performance of Flash Glucose Monitoring System in Patients with Liver Cirrhosis and Diabetes Mellitus.
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SUBMITTER: Costa D
PROVIDER: S-EPMC7198519 | biostudies-literature | 2020 May
REPOSITORIES: biostudies-literature
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Clinical Performance of Flash Glucose Monitoring System in Patients with Liver Cirrhosis and Diabetes Mellitus.
Costa Dalila D Lourenço Joana J Monteiro Ana Margarida AM Castro Beatriz B Oliveira Patricia P Tinoco Maria Carmo MC Fernandes Vera V Marques Olinda O Gonçalves Raquel R Rolanda Carla C
Scientific reports 20200504 1
Flash glucose monitoring system (FGMS) is an improved subset of continuous glucose monitoring with a recognized effectiveness on glycemic control, though validation in patients with Liver Cirrhosis (LC) is lacking. To evaluate the accuracy of FGMS in patients with Type 2 Diabetes Mellitus (DM) and LC, a prospective, case-control study was performed in 61 ambulatory patients with LC and DM (LC group, n = 31) or DM (Control group, n = 30). During 14 days, patients performed 4 assessments per day o ...[more]
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Project description:A flash glucose monitoring system (FGMS) has been validated for use in diabetic dogs. However, it is unknown whether skin thickness affects FGMS measurements. The aim of this study was to evaluate whether FGMS accuracy is affected by skin thickness. Fourteen client-owned diabetic dogs on insulin treatment were prospectively enrolled in the study. The dogs were divided into two groups according to their ultrasound-measured skin thickness: dogs with skin thickness < 5 mm (Group 1) and dogs with skin thickness > 5 mm (Group 2). On days 1, 7 and 14, glucose curves were obtained simultaneously using the FGMS and a validated portable blood glucose meter. Paired measurements were used to calculate the mean bias and to determine accuracy according to ISO 15197:2013 criteria. The mean bias was significantly inversely correlated (p = 0.02; r = -0.6) with the mean skin thickness. Clinical accuracy was observed only in Group 2, with 99% of the results in zone A + B of the Parkes consensus error grid analysis. In conclusion, skin thickness seems to affect FGMS measurements, and the device is accurate in dogs with thicker skin (>5 mm); in dogs with thin skin (<5 mm), the clinical accuracy is low, and the results should be interpreted with caution.
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Project description:ObjectivesHome blood glucose monitoring using a portable blood glucose meter is important in the management of feline diabetes mellitus, but taking blood samples may be stressful for owners and cats. A flash glucose monitoring system measuring interstitial glucose, such as the FreeStyle Libre, overcomes some of these drawbacks. The aim of this study was to evaluate the practical use and analytical and clinical accuracy of the FreeStyle Libre in 41 client-owned diabetic cats.MethodsIn this prospective study, interstitial glucose concentrations were measured with the FreeStyle Libre and compared with blood glucose concentrations measured with a portable blood glucose meter (AlphaTRAK) on days 1, 7 or 8 and 14 after application of the device. Cat behaviour during application, location, skin reaction at the attachment site and owner satisfaction were assessed. Accuracy was determined by fulfilment of ISO 15197:2013 criteria, including Bland-Altman plotting and error grid analysis.ResultsPlacing the device was easy, with 70% of cats showing no reaction. Most sensors were placed on the thoracic wall. Skin reactions at the attachment site were not present or mild in almost all cats. Owners were very satisfied with the use of the FreeStyle Libre. Median functional life of the sensor was 10 days (range 1-14). Good correlation was found between interstitial and blood glucose measurements (rho[r] = 0.88, P <0.0001). Fifty-three percent of interstitial glucose concentrations were within a maximum deviation of 15% from blood glucose concentrations and 92.7% were within the safe risk zones 0 and 1 of the surveillance error grid.Conclusions and relevanceThe flash glucose monitoring system was easy to use and owners of diabetic cats were satisfied with its use. Although the device did not completely fulfil ISO requirements, it is sufficiently accurate for glucose monitoring in diabetic cats.
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Project description:INTRODUCTION:The 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 METHODS:Seventy-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. RESULTS:The 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. CONCLUSIONS:Interstitial 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
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Project description:Introduction: Optimal 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 analysis: This 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 dissemination: This 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 number: NCT03522870.
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Project description:Purpose: To determine the effect of Voglibose add-on therapy on daily glycemic excursions (using FreeStyle® Libre Pro™, a Flash glucose monitoring system) in Indian patients with type 2 diabetes mellitus (T2DM) receiving a stable dose of metformin (Met) or metformin+sulfonylurea (Met+SU). Patients and Methods: T2DM patients with glycosylated hemoglobin (HbA1c) ≥7.0% and at least two postprandial excursions ≥140 mg/dL (within 2 h of meal) during the screening phase (visit 1/day -14 ± 2) were enrolled in this prospective, multicenter interventional study. The patients were randomized at visit 2 (day 0 ± 2) to receive Voglibose 0.2 or 0.3 mg tablets (BID/TID) as add-on therapy to Met and Met+SU. All the patients were followed at day 14 ± 2 (visit 3), month 3 ± 14 days (visit 4), 14 weeks (i.e., visit 4 + 14 days) ±2 days (visit 5), and month 6 ± 14 days (visit 6). Continuous glucose monitoring was performed to study glycemic excursions at visits 2, 3, and 5. The study outcomes were: change in average number of glycemic excursions per day, percent time spent in glucose fluctuations, mean Postprandial glucose (PPG), Fasting plasma glucose (FPG), day and night time mean glucose levels from baseline to day 14 and week 14; change in mean amplitude of glycemic excursion (MAGE) from baseline to 14 weeks; and mean HbA1c level at 3 and 6 months. Results: Out of 110 patients enrolled, 101 patients (91.8%) (Met+SU+Voglibose: 73 and Met+Voglibose: 28) completed the study. There was a significant decrease in average number of glycemic excursions per day from baseline to day 14 in the Met+Sul+Voglibose group and to week 14 in the Met+Voglibose group. There was also a significant reduction in percent time spent above target glucose range from baseline to day 14 in both treatment groups and to week 14 in the Met+SU+Voglibose group. A significant reduction in mean PPG area under the curve, day and night time mean glucose levels, and mean FPG levels from baseline to day 14 was reported in both treatment groups. A significant reduction in night time glucose, and average MAGE and HbA1c levels was reported from baseline to week 14 in the Met+Voglibose group and the Met+SU+Voglibose group, respectively. At 6 months, body weight, glucose levels, cholesterol, low-density lipoprotein-cholesterol, and HbA1c were significantly lower, especially in the Met+SU+Voglibose arm. Conclusion: Voglibose was useful in reducing glycemic variability and improving glycemic control in Asian Indian adults with T2DM. (CTRI/2018/04/013074).
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| S-EPMC7757524 | biostudies-literature
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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Project description:BackgroundThis study aimed to investigate the characteristics and extent of glycometabolism impairment in patients with adrenal diseases, including Cushing syndrome, primary aldosteronism, pheochromocytoma, and nonfunctional adrenal incidentaloma.MethodsThis study enrolled thirty-two patients with adrenal diseases as adrenal disease groups and eight healthy individuals as healthy controls. Blood glucose levels were indicated by glucose concentration in interstitial fluid, which was documented using flash glucose monitoring system. According to flash glucose monitoring system data, parameters representing general blood glucose alterations, within-day and day-to-day glucose variability, and glucose-target-rate were calculated. Furthermore, blood glucose levels at nocturnal, fasting, and postprandial periods were analyzed. Besides, islet β-cell function and insulin resistance were assessed.ResultsAnalysis of flash glucose monitoring system-related parameters indicated impaired glycometabolism in patients with adrenal diseases compared with that of healthy controls at general blood glucose, within-day and day-to-day glucose variability, and glucose-target-rate levels. Furthermore, the dynamic glucose monitoring data revealed that significantly affected blood glucose levels compared with that of healthy controls were observed at postprandial periods in the Cushing syndrome and primary aldosteronism groups; at nocturnal, fasting and postprandial periods in the pheochromocytoma group. Significant insulin resistance and abnormal β-cell function were observed in the Cushing syndrome group compared with that in healthy controls.ConclusionAdrenal diseases can negatively affect glucose metabolism. Patients diagnosed with adrenal diseases should receive timely and appropriate treatment to avoid adverse cardiovascular events linked to hyperglycemia and insulin resistance.
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Project description:Liver cirrhosis (LC) is largely associated with diabetes mellitus (DM). More than 80% of patients with LC manifest glucose intolerance and about 30% have type 2 DM. A particular and yet unrecognized entity is hepatogenous diabetes (HD), defined as impaired glucose regulation caused by altered liver function following LC. Numerous studies have shown that DM could negatively influence liver-related outcomes. We aimed to investigate whether patients with LC and DM are at higher risk for hepatic encephalopathy (HE), variceal hemorrhage (VH), infections and hepatocellular carcinoma (HCC). The impact of DM on liver transplant (LT) outcomes was also addressed. Literature search was performed in PubMed, Ovid, and Elsevier databases. Population-based observational studies reporting liver outcomes in patients with LC were included. Diabetics are at higher risk for HE, including post-transjugular intrahepatic portosystemic shunt HE. DM also increases the risk of VH and contributes to elevated portal pressure and variceal re-bleeding, while uncontrolled DM is associated with increased risk of bacterial infections. DM also increases the risk of HCC and contributes to adverse LT outcomes. Patients with DM and LC may benefit from close follow-up in order to reduce readmissions and mortality. Due to the heterogeneity of available research, prospective multicenter clinical trials are needed to further validate these findings.
| S-EPMC7827383 | biostudies-literature