Capillary Glucose Measurements Research Articles

Weight gain during pregnancy and the probability of macrosomia in women with gestational diabetes

Objective. To analyze the association between gestational weight gain in women with gestational diabetes and an increased risk of macrosomia. Materials and methods. Cohort study with 139 pregnant women screened by a single-step oral glucose tolerance curve between 24-28 weeks of gestation were confirmed with gestational diabetes and sent to a hospital. Pre-pregnancy body mass index (BMI) was calculated from pre-pregnancy weight. Weight was measured at each prenatal consultation. The reference category was women with normal prenatal BMI who gained appropriate weight during pregnancy. At each visit, medical nutrition therapy (MNT) consisted of nutritional counseling, physical activity plan, and insulin therapy. Compliance with MNT was measured by capillary glucose measurements taken by each participant at home. Results. 74.8% were primiparous, and 28.8% had normal pre-pregnancy BMI. The no linear logistic regression model showed women with normal pre-pregnancy BMI had twice (OR= 2.08, 95%CI: 1.07,4.05) the possibility of macrosomia, compared to mothers with overweight or obesity, adjusting for Capurro index, number of children in the family, and percent of compliance MNT. Macrosomia was the most prevalent childhood complication (12.3%). Conclusion. Women with normal pre-pregnancy BMI who gained more weight during pregnancy were at higher risk of having macrosomic infants.

Noninvasive Real-Time Glucose Monitoring Is in the Near Future.

Objective: Since the introduction of continuous glucose monitoring (CGM) technology, developers have rigorously researched the feasibility of creating a noninvasive glucose monitoring device. In a recent pilot study, investigators reported a strong correlation between glucose values obtained from novel noninvasive monitoring device (GWave) values to venous and capillary glucose measurements. Research Design and Methods: We investigated whether the level of accuracy observed in the pilot study could be reproduced in a larger cohort, using a smaller third-generation manufacturable device (Gen III GWave) containing a standardized sensor chip that can be mass produced for commercial use. The evaluation assessed concordance with capillary blood glucose, reproducibility between two Gen III devices, and accuracy during insulin-induced hypoglycemia. Results: Assessment of samples from 75 subjects (type 2 diabetes, n = 6; type 1 diabetes, n = 28; nondiabetic pregnant subjects, n = 10; and nondiabetic, n = 31) showed that 97% of values were in Zone A with 3% in Zone B of the Clarke Error Grid, with a mean absolute relative difference of 6.7% from reference blood glucose. Comparison between two independent Gen III GWave devices demonstrated reproducibility between the sensors (R2 = 0.95), with 100% of values within Zone A. In the hypoglycemia assessment, measurements from the Gen III sensor tightly followed the capillary glucose measurements down to 42 mg/dL (2.3 mmol/L), whereas the CGM measurements from two different CGM only converged with the GWave and capillary glucose readings after 90 min of decreasing glucose levels. Conclusion: Our results show promise as potentially the first noninvasive technology. Future studies will focus on larger number of people in all glucose ranges. Real-time noninvasive blood glucose monitoring is possible using GWave technology.

Continuous Glucose Monitoring System After Coronary Artery Bypass Graft Surgery: A Feasibility Study.

Blood glucose level variability has been associated with increased risk of complication in the postoperative setting of cardiovascular surgery. Although interesting for optimization of blood glucose management in this context, continuous blood glucose (CBG) devices can have a limited reliability in this context, in particular because of the use of paracetamol. The aim of this study was to evaluate the reliability of Dexcom G6®, a recently developed continuous glucose monitoring device. We performed a prospective, observational, non-randomized, single-centre study comparing Dexcom G6® CBG level monitoring with the standard methods routinely used in this context. The standard blood glucose values were paired to the time corresponding values measured with Dexcom G6®. Agreement between the two methods and potential correlation in case of paracetamol use were calculated. From May 2020 to August 2021, 36 out of 206 patients operated for isolated coronary artery bypass grafting were enrolled; 673 paired blood glucose level were analyzed. Global agreement (ρc) was 0.85 (95% C.I.: 0.84-0.86), intensive care unit agreement was 0.78 (95%C.I.: 0.74-0.82) and ward agreement was 0.91 (95%C.I.: 0.89-0.93). In the diabetic population, it was 0.87 (95%C.I.: 0.85-0.90). When paracetamol was used, the difference was 0.02 mmol/l (95%C.I.: 0.29-0.33). Dexcom G6® provides good blood glucose level accuracy in the postoperative context of cardiac surgery compared to the standard methods of measurements. The results are particularly reliable in the ward where the need for repeated capillary glucose measurements implies patient discomfort and time-consuming manipulations for the nursing staff.

118-LB: Feasibility of a Prototype Dual Function Glucose Sensing Insulin Delivery Cannula in People with Type 1 Diabetes

Background: SynerGTM (Pacific Diabetes Technology, Portland, OR), a prototype subcutaneous cannula combining glucose sensing and insulin infusion could reduce the burden on people with diabetes (PWD) using insulin pump therapy (IPT) and glucose sensors. Aim: To assess and refine SynerGTM sensor accuracy, evaluate insulin infusion site function, and user tolerability. Method: Adults with type 1 diabetes established on IPT participated. Following a 48-hour run-in using a commercially available infusion set with a study pump (Medtronic 780G), a SynerGTM set was inserted subcutaneously in the anterior abdomen and attached to the pump. Participants were blinded to the investigational device readings. A standardised meal was eaten 60 minutes post-insertion. Glucose was measured on arterialised blood by YSI and finger-stick test strips (Roche Accu-Chek Guide) every 10 minutes for 60 minutes before and every 15 minutes for 4 hours after the meal. An insulin bolus was delivered immediately prior to the study meal using SynerGTM. Insulin continued to be delivered using SynerGTM at home and fingerstick readings continued. A second meal test as described above was performed on day 4 before study conclusion. A commercially available (Dexcom G6) continuous glucose monitor (CGM) was inserted prior to the 48 hour run-in preceding day 1 and worn throughout the study. Result: In 15 participants 99% of 679 data pairs of SynerGTM vs. YSI and 1305 data pairs vs. capillary glucose measurement were in zones A and B of the consensus error grid. MARD was 13.5% and 13.5% respectively. No artifact sensor spikes were observed with bolused insulin. SynerGTM was well tolerated and there were no significant differences in CGM time in range or TDD of insulin compared with run-in. Conclusion: This study proves the feasibility of SynerGTM as the first single through-the-skin device providing co-located insulin infusion and glucose sensing for PWD who take insulin. Disclosure J. Lu: None. C. Yuan: None. Y. W. Kong: None. E. Netzer: None. H. Wu: None. T. Seidl: None. D. N. O'neal: None. Funding JDRF (IND-2016-261)

1296-P: Comparison of Fingerstick and Venous Plasma Glucose in the Ugandan Diabetes in Low-Resource Populations Study

As Africa is experiencing the most rapid rise in the world of type 2 diabetes (T2D), identifying feasible, accurate ways to measure glucose is imperative. While venous glucose (ven-glucose) is recommended, cost and lack of access to pre-analytical processing often rules out this option. Fingerstick measurement of capillary glucose (fs-glucose) is a potential alternative. But data on the correlation between fs-glucose and ven-glucose are scant. Hence OGTT were performed in 512 Ugandans (Male: 46% (234/512), age: 43±17y (mean±SD) enrolled in the Diabetes in Low Resource Populations Study with fs-glucose (Contour Plus Glucometer) and ven-glucose (Glucokinase Method, Roche Cobas 6000) obtained at 0h and 2h. To determine correlation, bias and levels of agreement, Pearson’s correlations and Bland Altman analyses were performed. T2D, preT2D and normal glucose tolerance occurred in 2% (9/512), 18% (92/512) and 80% (411/512), resp. At 0h, fs-glucose and ven-glucose were modestly correlated (r= 0.56) (Fig) with a modest bias for lower glucose by fs-glucose 0.28 mmol/L (95% CI: 0.23, -0.34). At 2h, glucose, fs-glucose and ven-glucose were highly correlated (r=0.92) (Fig) with modest bias for higher glucose by fs-glucose 0.60 mmol/L (95% CI: 0.53, 0.66) mmol/L. Overall, fs-glucose may be an alternative to ven-glucose in Africans where the prevalence of undetected T2D is high and resources are limited. Disclosure A.J.Niwaha: None. A.E.Sumner: None. H.Nkabura: None. R.J.Mukasa: None. N.Mubiru: None. P.A.Balungi: None. I.Sekitoleko: None. B.Mpairwe: None.

Patient and nursing experience of flash glucose monitoring following kidney transplantation.

Flash glucose monitoring (FGM) is increasingly used for blood glucose assessment due to ease of use and is now subsidized in Australia for blood glucose measurement for patients with Type 1 Diabetes Mellitus. Dysglycaemia is common following kidney transplantation and is associated with worse outcomes and there are data to support the use of FGM post-transplant to better detect and manage changes in blood glucose levels. There is, however, no data on patient or staff perceptions of FGM, or resource implications in this setting. We prospectively evaluated patients and nursing staff experiences of FGM compared to traditional capillary glucose measurement in the immediate post-transplant setting, along with resource utilization, cost of testing, staff time taken to test and accuracy. Twenty-one kidney transplant recipients had a FGM sensor applied in the post-operative period and results compared to capillary blood glucose monitoring (CBGM) measured at least four times a day. Six-hundred-fifty-six glucose measurements were obtained, median per patient of 30 readings (IQR 10). Pearson's correlation between FGM and CBGM readings is 0.95 (p < .001). FGM readings were lower than CBGM by an average of 1.2 mmol/L (SD 0.7). Using a 5-point preference questionnaire (with ratings varying from strongly disagree-strongly agree), both patients and nurses were highly satisfied with the usability and convenience of FGM, with all preferring FGM over CBGM. Average time to perform FGM was 3.6 s versus 64 s for CBGM. In average, cost of FGM was $58 less than traditional testing per patient. FGM is an accurate, convenient and cost-effective tool that may support optimal management of glycaemic control in the post-transplant period.

Glucocorticoid-induced hyperglycemia and diabetes: Practical points

Glucocorticoids are widely used in medical practice for their anti-inflammatory action, but lead to hyperglycemia in 30% of cases, due to rapid reduction of insulin secretion and action. Endogenous glucose production is less strongly suppressed by insulin, even small doses such as 7.5mg/day. As they are administered in the morning, glucocorticoids induce hyperglycemic excursion in the afternoon, and at this time screening can be performed by capillary glucose measurement. It is also critical to determine, on medical history and HbA1c assay, whether the patient had prior diabetes, sometimes overlooked, in which case diabetes will not resolve after glucocorticoid discontinuation, and poorly controlled diabetes will often require a basal-bolus insulin therapy in the meantime. This heavy therapy is not suitable for de novo diabetes, as it incurs a risk of nocturnal hypoglycemia, whereas intermediate-acting morning insulin injection provides better cover of hyperglycemia in the afternoon. The British Diabetology Societies recently reported that an even simpler prescription of gliclazide in the morning may be sufficient for some patients. The antidiabetic treatment will have to be monitored, and reduced when glucocorticoid dose is scaled off. Other antidiabetic agents are being tested in trials to develop simple alternatives without risk of hypoglycemia.

PSUN218 The Impact of Mandatory Pre-Operative Endocrinology Outpatient Consultation Before Elective Surgery in Patients with Diabetes Mellitus

Abstract Introduction A multi-departmental quality improvement initiative by endocrinology, internal medicine, surgery, and anesthesia became effective, making it the standard of care to call for an outpatient endocrinology consult for diabetic patients undergoing elective surgery in our hospital. Aim We tested our hypothesis that mandatory endocrinology consults prior to elective surgery decreases negative outcome parameters in patients with poorly controlled diabetes. Material and Method: Patients with diabetes mellitus (T2DM) who had an HbA1C 8% and above and who were planned to have elective surgery were seen by Endocrinology Service as an outpatient before the surgery date and were cleared until fasting glucose is less than 200 mg/dl or HbA1c is less than 8%. Retrospective analysis of 64 inpatient elective T2DM surgical patients, with no endocrine consults from 09/2019-12/2019 (Group I), comparing with 51 inpatient elective T2DM surgical patients from 09/2020-12/2020, with endocrine consults prior to surgery (Group II). Exclusion criteria: Emergency surgical patients and patients who received endocrine consults prior to surgery from September – December 2019. Primary outcome measure: Average capillary glucose, length of stay (LOS), the number of patients with hypoglycemic episodes (&amp;lt;70 mg/dl), hypoglycemia rate (number of glucose readings less than 70 mg/dl/the total number of capillary glucose measurements), readmission rate and infection rate. Mainly non-parametric statistical tests were utilized. Results There were 64 patients without endocrinology consult in 2019 (Group I) and 51 patients with endocrinology consult in 2020 (Group II). Although it was a mandatory policy, only 11 out of 51 patients were consulted to endocrinology. There was no difference in baseline characteristics of age, gender, average HbA1c, and type of surgery between the two groups. Average glucose during hospital stay, the number of patients who had hypoglycemia (13% versus 6%), average LOS, readmission within 30 days and postoperative infection rate were not statistically different between Group I and II. In Group I hypoglycemic events were 2% of all the capillary glucose measurements performed (17 hypoglycemia out of 852) and in Group II hypoglycemic events were %0.5 (3 out of 653) of all the capillary glucose measurements performed during surgical admission (p&amp;lt;0.05). The number of hypoglycemic events were lower with preoperative endocrine consults. Limitations of this study include fewer elective surgeries in 2020 due to Covid-19. Conclusion The number of hypoglycemic events were lower in patients with diabetes and preoperative mandatory endocrinology consultation. There was no difference in average glucose, LOS, the number of subjects with hypoglycemia, readmission or infection rate. The study should be repeated after more education about mandatory preoperative endocrinology consults to surgeons is delivered and after the COVID pandemic is over, when there are no restrictions on elective surgery. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.

Factory-Calibrated Continuous Glucose Monitoring System Accuracy During Exercise in Adolescents With Type 1 Diabetes Mellitus.

Continuous glucose monitors (CGMs) are widely used for individuals with diabetes mellitus, particularly those with type 1 diabetes (T1D). Advancements in CGM technology allow for glycemic assessment without capillary glucose measurements as many come factory calibrated. However, exercise, an essential component of diabetes care, has been reported to alter accuracy of earlier generation CGM. Considering the importance of physical activity for individuals with T1D and the progression of CGM technology, we aimed to investigate the accuracy of the Dexcom G6 during physical activity. Adolescents (ages 13-20 years) exercised on a treadmill for 40 minutes, with a 10-minute break at minute 20. We obtained paired CGM and glucometer measurements before and every 10 minutes during and after exercise. Accuracy analysis was determined by mean absolute relative difference (MARD), mean absolute difference (MAD), and Clarke Error Grid Analyses. Mean absolute relative difference and MAD increased during exercise (14%-33% and 24.3-34 mg/dL) but improved after exercise. We noted certain CGM locations produced greater changes in accuracy as MARD and MAD increased markedly when the CGM was on the buttocks (18%-46% and 30-41 mg/dL). We also noted decreased odds of Zone A in the Clarke error grid when the CGM was on the buttocks compared to the abdomen (odds ratio [OR]: 0.146; P = 0.0003; 95% CI = 0.052-0.415). This CGM system showed alterations in accuracy during exercise. Our findings additionally suggest interstitial fluid changes in muscles during exercise alter accuracy of CGM; however, additional research is required.

Glucose measurement: Comparison of venous and capillary glucose measurements in type II diabetes mellitus.

Objective: To determine the comparison between the capillary glucose and venous plasma glucose in type II diabetic patients. Study Design: Cross Sectional Observational study. Setting: Al–Tibri Medical College and Hospital Karachi. Period: 1st January 2020 to 30th April 2020. Material &amp; Methods: A total of 86 diabetic patients from the out-patient department with non-probability consecutive sampling were selected. Subjects were diagnosed cases of type II diabetes based on the screening recommendation by the American Diabetes Association between 35-75 years of age of either gender included in this study. Patients with type I diabetes, pregnant females and hematocrit of more than 55% or less than 35%, and patients taking medications like Acetaminophen, and Ascorbic acid were excluded from the study. Each participant was measured for the capillary blood glucose levels by using Accu Chek, Easy max and On-call EZII, using strips by Glucose Oxidase Method. A venous sample was collected within 5 minutes of finger-prick test in a sodium fluoride tube. A Statistical Package for Social Sciences version 22 was used for data analysis. Results: Out of 86 patients in the study, 48(55.8%) were females and 38((44.2%) were males with a mean age of 47.16±9.916. The mean blood sugars by venous plasma glucose were 249.58±110.75 mg/dl, by Accu Chek 250.47±117.071 mg/dl, by EasyMax 259.26±119.751 mg/dl, and by On-call EZII 249.33±124.380 mg/dl which shows statistically significant correlation with a p value of &lt;0.001. The glucometers accuracy was determined by using Error grid analysis showed a strong positive correlation between the Accu Chek R2= 0.917, EasyMax R2= 0.917, and Oncall glucometers R2= 0.868 with venous plasma glucose with a statistically significant (p &lt;0.001). Conclusion: This study shows a strong positive correlation between capillary and venous glucose measurements.

Association of fat mass and obesity-associated (FTO) gene rs9939609 with obesity-related traits and glucose intolerance in an indigenous population, the Xavante

Background and aimsCommon variants in fat mass and obesity-associated (FTO) gene have been implicated as a susceptibility locus for obesity and type 2 diabetes in different populations. Here, in an indigenous population-based study, we examined whether FTO rs9939609 has a role in susceptibility to glucose intolerance and obesity. MethodsThe study population comprised 949 full Xavante indigenous people (465 men) aged 18–99 years. The participants were submitted to clinical examination, anthropometrical measures and basal and 2-h post 75g oral glucose load capillary glucose measurements. FTO rs9939609 was genotyped and logistic regression was carried out to test the additive effect of the risk allele. ResultsThe frequency of the minor allele of the FTO rs9939609 (0.06) was lower in Xavante than observed in some populations. A significant association between the variant and overweight was observed (OR = 1.56 (95% CI:1.06–2.29, p = 0.02), using an additive model of inheritance, adjusted by age and gender and considering the family structure. We found no associations with obesity or glucose intolerance. ConclusionsThe FTO rs9939609 is associated with overweight, but not with obesity or glucose intolerance. The low frequency of the A allele suggests that it is not an important risk determinant for these conditions in Xavante indigenous people.

Self-administered oral glucose tolerance test with capillary glucose measurements for the screening of diabetes mellitus in high-risk adults: a feasibility study

IntroductionEarly diagnosis of prediabetes based on blood sampling for the oral glucose tolerance test (OGTT) is crucial for intervention but multiple barriers hinder its uptake. This study aimed to assess...

954-P: In Gestational Diabetes, Patient-Led Insulin Titration Is Rapidly Effective without Detrimental Hypoglycaemia

Introduction: Elevated fasting blood glucose in gestational diabetes (GDM) is the strongest predictor of adverse pregnancy outcomes but is difficult to treat. We assessed the effectiveness and safety of a novel patient-led insulin dose titration algorithm, targeting rapid reduction in fasting glucose. Research Design and Methods: In women with GDM commenced on insulin, we initiated a patient-led approach to basal dose titration. Women were asked to increase their basal insulin dose by 4 units after every elevated fasting blood glucose (&amp;gt;90 mg/dL). We retrospectively reviewed the records of 50 women with GDM, after initiating this approach. Daily fasting capillary glucose measurements and insulin dose were collected from GDM diagnosis to delivery. Results: Basal insulin was commenced at a median 30+4 weeks gestation in 28 (56%) women. At insulin initiation median fasting glucose was 104.4 mg/dL. Fasting glucose control (defined as the first of three consecutive readings &amp;lt;95 mg/dL) was achieved by all women after a median 4 days (IQR: 1-13). This was successfully maintained for the remainder of pregnancy with additional patient-led titrations. Basal insulin dose at delivery (median 38+2 weeks gestation) was a median 34 units (IQR 18-62; 0.31 units/kg; IQR 0.23-0.71) with a birthweight less than half a standard deviation above normal (birthweight z-score 0.47 vs. 0.81 [n=34 insulin treated prior to implementation]). Hypoglycaemia &amp;lt;63 mg/dL was uncommon in those on basal insulin (1.86% of all fasting glucose readings) with just five values &amp;lt;54 mg/dL (0.34% of all readings). By comparison, in women never started on basal insulin (n=22), 0.45% of fasting readings were &amp;lt;63 mg/dL with just one value &amp;lt;54 mg/dL (0.09% of all readings). No patients experienced hypoglycaemia requiring assistance. Conclusions: In GDM, fasting glycaemic control is achieved within a week by using intensive patient-led insulin titration and is not at the expense of detrimental hypoglycaemia. Disclosure I. K. Mayne: None. N. Thomas: None. A. T. Hattersley: None. A. P. Mcgovern: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc.

Epidemiological characteristics of hypertension, impaired fasting capillary glucose and their comorbidity: a retrospective cross-sectional population-based study of rural adolescents in Southeast Nigeria

ObjectiveTo assess the prevalence of hypertension, impaired fasting capillary glucose (IFCG) and coexistence of both as well as determinants of these conditions among rural adolescents.DesignA retrospective cross-sectional population-based study.SettingThree rural...

Evaluating the effectiveness and utility of a novel culturally-adapted telemonitoring system in improving the glycaemic control of Asians with type-2 diabetes mellitus: a mixed method study protocol

BackgroundRegular supervision of patients with type-2 diabetes mellitus (T2DM) by healthcare providers is essential to optimise their glycaemic control but is challenging to achieve in current care models. Telemonitoring is postulated to bridge this gap by leveraging on internet-of-things and mobile-health technology. This study aims to determine the effectiveness of a novel telemonitoring system (OPTIMUM) in improving the glycaemic control of patients with T2DM compared with standard of care alone.MethodsThis mixed-method study comprises an initial randomised controlled trial involving 330 Asian adults with T2DM, aged 26–65 years old with an HbA1c of 7.5–10%, with 115 in the intervention and control arms each. Those in the intervention arm will use standardised Bluetooth-enabled devices to transmit their capillary glucose, blood pressure and weight measurements to the OPTIMUM system. Primary care physicians and nurses will remotely supervise them according to an embedded management algorithm for 6 months, including tele-education via weekly videos over 8 weeks and asynchronous tele-consultation if abnormal or absent parameters are detected. Patients in both arms will be assessed at baseline, 6, 12 and 24 months post-recruitment. The primary outcome will be their HbA1c difference between both arms at baseline and 6 months. Blood pressure and weight control; quality of life, medication adherence, confidence in self-management, diabetic literacy and related distress and healthcare utilisation using validated questionnaires; and incident retinal, renal, cardiac and cerebrovascular complications will be compared between the two arms as secondary outcomes at stipulated time-points. Intervention arm patients will be interviewed using qualitative research methods to understand their experience, acceptance and perceived usefulness of the OPTIMUM system.DiscussionOverall, this study seeks to evaluate the effectiveness of cultural-adapted telemonitoring system in improving glycaemic control of Asians with type-2 diabetes mellitus compared to standard of care. The results of this trial will better inform policy makers in adopting telemedicine for population health management.Trial registrationClinicalTrials.gov NCT04306770. Registered on March 13, 2020.

High Impact of Unachieved Hypoglycaemia Management in Type 2 Diabetes: From Inadequate Treatment to Non-Perception

Background: Hypoglycaemias represent a frequent acute complication in people with type 2 diabetes on insulin regimens, potentiated by symptoms, associated complications and quality of life reduction. Additionally, frequent episodes and inadequate treatment contribute to a gradual reduction of the ability to perceive hypos. Objective: To identify the occurrence of perceived and unperceived hypoglycaemias in persons with type 2 diabetes on insulin, especially through the use of a continuous glucose monitoring system (CGMS) device, the possible causes for the perceived episodes, and followed treatment. Methods People with type 2 diabetes used CGMS during 7 days, filling in data related with hypoglycaemias occurrence, including recorded glycaemia values, symptoms, estimated causes treatment and the need to get help from others. Results: The participating people with type 2 diabetes (n=60) had a mean age of 60.8±0.9 years, and a mean HbA1c of 7.5±0.1% (58 mmol/mol). One third of the participants reported hypoglycaemia symptoms, identifying 42 situations. 57% of those were confirmed by capillary glucose measurement, 17% were related only with symptoms, and 26% were pseudo-hypoglycaemias. Regarding these documented hypoglycaemias, the most common symptoms were: tremors (63%), visual difficulties (33%), perspiration (29%), hunger (17%), and heat (17%). On the other hand, 45% of participants had 89 episodes of non-perceived hypoglycaemias, of which 15% were of level 2 (≤54mg/dl). We identified non-perceived hypoglycaemias in both people who reported hypoglycaemia symptoms (56%) and people who didn´t report hypoglycaemia symptoms (40%). The causes reported by participants were related with intense or unexpected physical activity (23%), delay between meals (8%), less carbohydrate ingestion at last meal (8%), and excess of insulin administration (8%). Participants were not able to identify any cause in 42% of hypoglycaemia episodes. Taking into account hypoglycaemia therapeutic guidelines, we observed that only 50% were treated accordingly to recommendations (namely, glucose ingestion). Conclusion: A considerable proportion of non-perceived hypoglycaemias was uncovered through the CGMS, in people with type 2 diabetes on insulin, with or without perceived hypoglycaemias. Furthermore, half of the situations where the hypoglycaemia episode was symptomatic were treated in a less than adequate way. Funding Information: This research was supported by the Portuguese NovoNordisk. Declaration of Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Ethics Approval Statement: Ethical and regulatory approvals were obtained from the local Ethics Committee at APDP (117/2017).

Accuracy of Flash Glucose Monitoring in Patients with Diabetes Mellitus on Hemodialysis and Its Relationship with Hydration Status.

The use of flash-glucose monitoring system FreeStyle Libre (FSL) has demonstrated benefits in metabolic control and quality of life in different populations with diabetes mellitus (DM), being funded in many countries. Due to this, DM subjects on hemodialysis (HD) are using FSL despite the accuracy in this population being unclear. The aims of the present study are to assess the accuracy of FSL in DM subjects on HD, its relationship to hydration status, and patient satisfaction. A prospective study in 16 patients with DM in a chronic HD program was conducted. Interstitial glucose values from FSL during a 14-day period were compared to capillary glucose measurements obtained at the same time. Hydration status was measured via bioimpedance spectroscopy. Satisfaction with FSL was obtained from an ad hoc satisfaction questionnaire. A total of 766 paired interstitial and capillary glucose levels were analyzed. A correlation coefficient of 0.936 was determined and a mean absolute relative difference (MARD) value of 23%, increasing to 29% during HD. MARD was not related to hydration status. Interstitial glucose values were lower during HD (100.1 ± 17 mg/dL) than within the 12 hours after (125.1 ± 39 mg/dL; P = .012) and the days without HD (134.2 ± 32 mg/dL; P = .001). Subjects showed high satisfaction with FSL. The accuracy of FSL in DM patients on HD is lower than in other populations, especially during HD sessions and is not related with the hydration status. Despite this, the degree of patient satisfaction with FSL is very high.

Kalman-Based Calibration Algorithm for AgaMatrix Continuous Glucose Monitoring System

A continuous glucose monitoring system is composed of a glucose sensor and an estimation (calibration) algorithm. The glucose sensor is composed of an electrode that is inserted under the skin and generates a noisy electrical current in response to interstitial glucose levels. The relationship between the electrical current and the interstitial glucose levels varies between individuals and within the same individual (with sensor wear time). The estimation algorithm infers the glucose levels in the blood from the noisy electrical current signal and uses intermittent capillary glucose measurements to account for intra-and inter-individual variability. In this article, we propose a novel real-time Kalman filter-based estimation algorithm that is composed of three steps: 1) noise filtering step; 2) compartment matching step using sequential Kalman filter; and 3) parameters estimation step using the conventional Kalman filter. The initial estimate of the parameters and covariance matrix are extracted offline using a nonlinear cubature Kalman filter. Our algorithm is compared with four alternative algorithms using 20 sensor data sets. Each data set was generated over a seven-day sensor wear period, during which patients were tested on three in-clinic days (days 1, 4, and 7). The comparison is based on the mean absolute relative difference (MARD) between frequent reference glucose measurements and the sensor glucose levels. MARD for days 1, 4, and 7 were 10.3%, 10.7%, and 11.9% for our algorithm and 12.46%, 15.75%, and 14.17% for the alternative algorithm, respectively. Our algorithm is currently being integrated into a commercial continuous glucose monitoring system (AgaMatrix, Inc., Salem, NH, USA).

888-P: Day vs. Nighttime Performance of Continuous Glucose Monitoring Systems in Children with Type 1 Diabetes during a Diabetes Summer Camp

Continuous subcutaneous glucose monitoring (CGM) use is increasing in diabetes care. Still there are concerns with regard to sensor accuracy especially at night. Aim of the Study: To assess accuracy of commonly used CGM systems at a 2 week diabetes camp in children with type 1 diabetes (T1D) ages 9-14 years. Out of 38 children, 37 routinely wore a CGM system throughout the camp. Baseline characteristics: age 11.0 (9.9;12.1) years; 57% girls; HbA1c 7.2% (6.9; 7.7); diabetes duration 3.6 (2.7; 6.3) years (median (interquartile range)). Capillary glucose measurements were performed prior to main meals, at bedtime and whenever deemed necessary by medical staff after thoroughly cleaning the finger tips. Calibrations of Medtronic Enlite was performed twice daily when glycemia was stable. All concomitantly available data pairs were used for the analysis. Night-time was defined as period when children were supposed to be in bed (10 PM until 7 AM). Sensor distribution: 51% Abbott Libre, 35% Medtronic Enlite, 14% Dexcom G6. CGM accuracy shown in Table 1: MARD in % (interquartile range)). Sensor performance of the adequately calibrated Medtronic system outperformed the factory-calibrated sensors in most situations. All sensors performed worse in hypoglycaemia. During the nights the MARD was higher, potentially due to pressure artefacts. Disclosure B. Rami-Merhar: Advisory Panel; Self; Abbott. Speaker’s Bureau; Self; Eli Lilly and Company, Medtronic. K. Nagl: None. G. Berger: None. A. Schütz: None. F. Aberer: None. J.K. Mader: Advisory Panel; Self; Becton, Dickinson and Company, Eli Lilly and Company, Medtronic, Prediktor Medical, Sanofi-Aventis. Speaker’s Bureau; Self; Abbott, Eli Lilly and Company, Medtronic, Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis.

The extended internal QC (eIQC): a new practical approach for quality assurance in point-of-care glucose testing using the POCTopus Software – a pilot study

Abstract Background Quality assurance (QA) in point-of-care testing (POCT) is an important issue for organizing POCT structures within the healthcare sector. In Germany, only one device needs to participate in an external QA program, if the responsible core laboratory is supervising internal quality controls of all other identical POCT devices. This flexible definition of quality control (QC) testing is in line with the fundamentals of ISO 22870 and the ISO 15189, but can only be regarded as a minimum requirement. Methods We present a pilot study for an inexpensive new approach for additional POCT QC measurement similar to the external QA program within the medical laboratory using capillary glucose measurement as an example. This new system, referred to as “extended internal QC (eIQC)”, uses in-house generated QC material from leftover full blood from routine diagnostics. We provide information on calculation of target values and acceptance ranges and preliminary data on stability and comparison between POCT and core laboratory testing (COBAS 8000). Additionally, we simulated the approach using three devices within the laboratory as surrogate for three POCT sites. In this pilot study, measurements of QC material beyond the mandatory QA plan are structured and optimized through the use of the POCTopus Software solution. Results QC material was easily generated including specification of target values. The software aided in automatized processing of the samples. The software showed limitations in evaluation and monitoring without relevant use of resources. We found a significant bias between measurements on POCT and COBAS 8000 instruments. Conclusions The presented new approach for additional QAs for POCT enables POCT coordinators to establish an additional safety and QC level. Further software improvements are required. Further studies are needed for validation and comparison measurements between methods. Overall, this approach offers great potential for POCT structures seeking higher quality standards.