Search Results (18)

Background: Limited data exist on managing type 1 diabetes mellitus (T1DM) during long-distance endurance events such as marathons. This study aimed to assess glycemic control and participant safety during a marathon. Methods: Five men with T1DM, participating in the 22nd Poznan Marathon, were recruited. They completed health questionnaires and received training on glycemic management. Their physical capacity was assessed (including maximal oxygen uptake on a cycle ergometer). Participants reduced their insulin doses and consumed breakfast 2.5–3 h before the race. During the marathon, self-monitoring blood glucose (SMBG) and ketone levels were measured at five checkpoints (start, 10 km, 19 km, 30 km, and finish). The medical team followed a pre-approved protocol, providing carbohydrate and fluid supplementation as needed. Glycemia was monitored by two continuous glucose monitoring (CGM) systems (FreeStyle Libre 2 and Dexcom G6) and SMBG. Results: The participants’ median age was 44 years (34–48), with a diabetes duration of 10 years (6–14), and a BMI of 22.5 kg/m² (22.0–23.3). All finished the marathon in an average time of 4:02:56 (±00:43:11). Mean SMBG was 125.6 (±43.5) mg/dL, while CGM readings were 149.6 (±17.9) mg/dL (FreeStyle Libre 2) and 155.4 (±12.9) mg/dL (Dexcom G6). One participant experienced prolonged hypoglycemia undetected by CGM, whereas another developed symptomatic hypoglycemia between SMBG measurements. Conclusions: Safe marathon completion in people with T1DM requires individualized insulin dose adjustments, appropriate carbohydrate supplementation, and dedicated medical support at checkpoints. Combining CGM with periodic SMBG measurements further enhances safety and helps to detect potential glycemic excursions. Full article

Background: The need for frequent blood glucose (BG) monitoring and the inconveniences associated with self-monitoring of BG (SMBG) have driven the development of non-invasive approaches. Methods: This prospective study aimed to investigate the accuracy of glucose level calculation using the near-infrared spectroscopy (NIRS) technology Glucube^® system. People with Type 1 diabetes, Type 2 diabetes, prediabetes, and normal glucose metabolism were included. Over one week, individuals performed glucose measurements with the Glucube^® system and capillary blood fingersticks with a standard glucometer (Ascensia Contour^® Next). To assess the impact of the improvement in dexterity, the accuracy variables were compared with the point-of-care (POC) glucometer Accu-Chek^® Inform II in a one-week sub-study. Results: Overall, 105 subjects (mean age 53.8 ± 13.8 years, 50.5% female) participated, resulting in 1914 paired glucose measurements between 49 and 331 mg/dL. Total mean absolute relative difference (MARD) was 20.3%, MARD for values >100 mg/dL was 18.3%, and mean absolute deviation (MAD) for values <100 mg/dL was 24.9%. A total of 97.3% of measurements fell within A+B Parkes zones, and 58.8%, 76.9%, and 88.1% within +−20%, +−30%, or +−40% error, respectively. On completion, 62 participants (59%) fulfilled the one-week prospective sub-study. In this subgroup, the total MARD was reduced between day 1 and day 8 from 22.8 to 18.3% (p = 0.068). The percentages within Zone A were 51.6 vs. 61.2%, Zone B 46.8 vs. 33.9%, and Zone C 1.6 vs. 4.8%, and the sum of Parkes Zones A+B was 98.4 vs. 95.2% (p = 0.311) for day 1 and day 8, respectively. Conclusions: Glucube^® is a novel non-invasive system based on NIRS technology for monitoring blood glucose levels. Its promising capabilities support further research. Full article

Background: Gestational diabetes mellitus (GDM) occurs in approximately 9% of pregnancies, and proper glycemic control is of utmost importance in the prevention of GDM-associated obstetric complications. Flash glucose monitoring (FGM), a subtype of continuous glucose monitoring (CGM), offers intermittent blood glucose scanning and is considered a propitious alternative to the standard method of self-monitoring of blood glucose (SMBG). Aim: The aim of this review was to systematically assess the efficacy and acceptability of FGM in in pregnancies complicated by GDM. Methods: A systematic literature search was performed in the PubMed, MEDLINE, Scopus, and Cochrane databases. The review was conducted following the PRISMA guidelines, and the study protocol has been registered in the PROSPERO database with the registration number CRD42024545874. Results: A total of 872 articles were initially identified, 141 publications underwent an in-depth full-text analysis, resulting in 133 studies being excluded from further assessment. Eventually, eight studies were included in the analysis. Conclusions: The analysis revealed that FGM is a safe and efficient method of glycemic control in GDM. The majority of the studies consider its accuracy comparable to SMBG. Furthermore, FGM is well accepted by patients with numerous advantages in user-friendliness over SMBG. Full article

Background: Self-monitoring of blood glucose (SMBG) is of paramount relevance for type 2 diabetes mellitus (T2DM) patients. However, past evidence shows that there are physical and cognitive issues that might limit the usage of glucometers by T2DM patients aged 65 years and over. Objective: Our aim was to investigate the physical and cognitive issues related to the usage of glucometers by T2DM patients aged 65 years and over. Materials and Methods: The extant literature was analysed to define an original framework showing the logical nexus between physical and cognitive issues and quality of life. Then we collected evidence addressing the specific case of the Accu-Chek^® Instant glucometer produced by Roche Diabetes Care GmbH, which implements new features claiming to improve usability. We conducted 30 interviews with T2DM patients aged 65 years and over, three interviews with senior nurses, and a focus group with three senior physicians and three senior nurses. Results: From the interviews, both patients and nurses declared that they were generally satisfied with the Accu-Chek^® Instant glucometer’s characteristics. In the focus group, the results were commented on and, in the light of some diverging answers, improvements have been set up for future implementation. Conclusions: Our study produces evidence and future suggestions about the usage of glucometers by type 2 diabetes patients aged 65 years and over. Full article

Background: The International Diabetes Federation estimates that 16.2% of livebirths in 2017 were affected by hyperglycemia in pregnancy, with 85.1% due to gestational diabetes mellitus (GDM). Daily blood glucose monitoring compared with alternate day testing in mild GDM is associated with similar pregnancy outcomes. Data are sparse on the ideal frequency for self-monitoring of blood glucose (SMBG) in mild GDM for glycemic control. A higher HbA1c at late pregnancy is associated with adverse pregnancy outcomes. We sought to evaluate three days compared to one day per week of four-point self-monitoring of blood glucose (SMBG) in gestational diabetes mellitus (GDM) controlled by lifestyle changes for glycemic control. Methods: This randomized trial was conducted from February–December 2018. A total of 106 women with lifestyle-controlled GDM were randomized to three days (SMBG3) or one day (SMBG1) per week of four-point (fasting and two-hours post-meal) SMBG. The primary outcome was the change in the HbA1c level at recruitment and 36-weeks gestation within and across trial arms. The student t-test was used for between-arm analyses and a paired t-test for within-arm analyses. Results: The HbA1c level through pregnancy increased significantly in both trial arms: mean increase of 0.21% ± 0.26%, p < 0.001 (SMBG3), and 0.19% ± 0.24%, p < 0.001 (SMBG1), but the 0.02% difference across trial arms was not significant (p = 0.79). Maternal weight gain (3.1 ± 2.1 kg vs. 3.3 ± 3.0 kg, p = 0.72), cesarean delivery (24/52 (48%) vs. 23/53 (43%), RR 1.06, 95% CI: 0.69–1.62, p = 0.77), neonatal birthweight (3.1 ± 0.4 kg vs. 3.0 ± 0.4 kg, p = 0.53) and neonatal intensive care unit admission (4/52 (8%) vs. 3/53 (6%), RR 1.36, 95% CI: 0.32–5.78, p = 0.68) were not significantly different for SMBG3 vs. SMBG1, respectively. Other maternal and neonatal secondary outcomes were not significantly different. Conclusion: In mild GDM, three days compared to one day per week showed a similar HbA1c levels change at 36-weeks gestation. Maternal and neonatal outcomes were also not significantly different. Less frequent monitoring of SMBG as a standard of care in mild GDM deserves further study and consideration. Full article

Gestational diabetes mellitus (GDM) is one of the most common complications of pregnancy, affecting up to 14% of pregnant women. The population of patients with risk factors of GDM is increasing; thus, it is essential to improve management of this condition. One of the key factors affecting perinatal outcomes in GDM is glycaemic control. Until recently, glucose monitoring was only available with self-monitoring of blood glucose (SMBG). However, nowadays, there is a new method, continuous glucose monitoring (CGM), which has been shown to be safe in pregnancy. Since proper glycaemia assessment has been shown to affect perinatal outcomes, we decided to perform a systematic review to analyse the role of CGM in glycaemic control in GDM. We conducted a web search of the MEDLINE, EMBASE, Cochrane Library, Scopus, and Web of Science databases according to the PRISMA guidelines. The web search was performed by two independent researchers and resulted in 14 articles included in the systematic review. The study protocol was registered in the PROSPERO database with registration number CRD42021289883. The main outcome of the systematic review was determining that, when compared, CGM played an important role in better glycaemic control than SMBG. Furthermore, glycaemic control with CGM improved qualification for insulin therapy. However, most of the articles did not reveal CGM’s role in improving neonatal outcomes. Therefore, more studies are needed to analyse the role of CGM in affecting perinatal outcomes in GDM. Full article

Self-monitoring of blood glucose (SMBG) is common in patients with diabetes. The aim of this study was to explore how frequency/behavior of SMBG affect glucose control in patients with type 2 diabetes. This cross-sectional study was conducted at a regional teaching hospital in Taiwan. All participants completed a structured questionnaire about the frequency and behavior of SMBG, and hemoglobulin A1C (A1C) data were recorded from medical records. A total of 382 diabetes outpatients participated in the study. In the patients using insulin injections, A1C was better in patients with SMBG ≥ 28 times than in those with SMBG < 28 times per month (7.82 ± 1.86% vs. 8.33 ± 1.31%, p = 0.025). In the patients not using insulin, A1C was better in patients with SMBG > 14 times than those with SMBG ≤ 14 times per month (7.08 ± 0.23% vs. 7.55 ± 0.08%, p = 0.038). The patients who more frequently reviewed the causes of hypoglycemia and hyperglycemia had a better A1C level (p for linear trend <0.001). Our study suggested that SMBG ≥ 28 and >14 times could improve glycemic control for insulin-requiring and non-insulin-requiring type 2 diabetes patients, respectively. Further exploration of the cause of hyperglycemia or hypoglycemia shown by SMBG could also improve blood glucose control. Full article

Glucose monitoring technologies allow users to monitor glycemic fluctuations (e.g., blood glucose levels). This is particularly important for individuals who have diabetes mellitus (DM). Traditional self-monitoring blood glucose (SMBG) devices require the user to prick their finger and extract a blood drop to measure the blood glucose based on chemical reactions with the blood. Unlike traditional glucometer devices, noninvasive continuous glucose monitoring (NICGM) devices aim to solve these issues by consistently monitoring users’ blood glucose levels (BGLs) without invasively acquiring a sample. In this work, we investigated the feasibility of a novel approach to NICGM using multiple off-the-shelf wearable sensors and learning-based models (i.e., machine learning) to predict blood glucose. Two datasets were used for this study: (1) the OhioT1DM dataset, provided by the Ohio University; and (2) the UofM dataset, created by our research team. The UofM dataset consists of fourteen features provided by six sensors for studying possible relationships between glucose and noninvasive biometric measurements. Both datasets are passed through a machine learning (ML) pipeline that tests linear and nonlinear models to predict BGLs from the set of noninvasive features. The results of this pilot study show that the combination of fourteen noninvasive biometric measurements with ML algorithms could lead to accurate BGL predictions within the clinical range; however, a larger dataset is required to make conclusions about the feasibility of this approach. Full article

The aim of this study was to evaluate the accuracy and usability of a novel continuous glucose monitoring (CGM) system designed for needle-free insertion and reduced environmental impact. We assessed the sensor performance of two GlucoMen^® Day CGM systems worn simultaneously by eight participants with type 1 diabetes. Self-monitoring of blood glucose (SMBG) was performed regularly over 14 days at home. Participants underwent two standardized, 5-h meal challenges at the research center with frequent plasma glucose (PG) measurements using a laboratory reference (YSI) instrument. When comparing CGM to PG, the overall mean absolute relative difference (MARD) was 9.7 [2.6–14.6]%. The overall MARD for CGM vs. SMBG was 13.1 [3.5–18.6]%. The consensus error grid (CEG) analysis showed 98% of both CGM/PG and CGM/SMBG pairs in the clinically acceptable zones A and B. The analysis confirmed that GlucoMen^® Day CGM meets the clinical requirements for state-of-the-art CGM. In addition, the needle-free insertion technology is well tolerated by users and reduces medical waste compared to conventional CGM systems. Full article

The non-invasive self-monitoring of blood glucose (SMBG) has been the subject of intense investigation over recent decades. We conducted a pilot study designed to examine a novel non-invasive glucometer, the HGR GWave, utilizing radiofrequency (RF) sensing. Blood glucose levels assessed by this HGR prototype were compared to measurements performed by a hexokinase core laboratory assay during an oral glucose tolerance test (oGTT) for 5 subjects with type 2 diabetes. The HGR glucose meter readings were also compared to two Abbot Freestyle^® glucose meters, which were also used for calibration. The accuracy of the results was evaluated through the calculation of relative absolute difference (RAD), specified percentage differences between 43 reference glucose measurements, and using comparator measurements. The median RAD was −4.787. We detected 79.04%, 92.99% and 97.64% of HGR readings within ±10%, ±15% and ±20% of the reference glucose measurements. The HGR readings had a high correlation with reference lab glucose measurements with R² = 0.924 (95% CI 0.929–0.979; p < 0.0001). When compared to the Freestyle^® glucose meters 94.3% and 100% of the readings were within ±5% and ±10%, with R² = 0.975 (0.975–0.994; p < 0.0001). The HGR prototype glucose meter was found to be accurate in detecting real-time blood glucose during an oGTT in this small pilot study. A study with a broader range of blood glucose levels is needed to further assess its accuracy and its suitability for clinical use. Full article

Background and Objectives: In patients with diabetes mellitus, hypoglycaemic episodes, especially during night hours, carry a significant risk. Data about the occurrence of nocturnal hypoglycaemia in real-world settings are of clinical importance. The aim of our study was to evaluate the occurrence of nocturnal hypoglycaemia among patients with diabetes using self-monitoring of blood glucose (SMBG) with telemedicine support. Materials and Methods: We retrospectively analysed the central database of an internet-based supportive system between 2010 and 2020 when 8190 SMBG users uploaded nearly 10 million capillary blood glucose values. Nocturnal hypoglycaemia was defined as capillary blood glucose < 3.0 mmol/L measured between 00:00 and 05:59 h. Results: The database contained 914,146 nocturnal blood glucose values from 7298 users; 24,623 (2.7%) glucose values were below the hypoglycaemic threshold and 2363 patients (32.4%) had at least one hypoglycaemic glucose value. Nocturnal hypoglycaemia was more often found in patients with type 1 vs. type 2 diabetes (n = 1890 (80.0%) vs. n = 387 (16.4%), respectively). Hypoglycaemic blood glucose values were most frequently observed in the age group of 10.0–19.9 years (n = 481 (20.4%)). Patients with nocturnal hypoglycaemia were mostly on insulin treatment (1854 (78.5%) patients with 20,727 (84.1%) hypoglycaemic glucose values). Only 356 patients (15.1%) with nocturnal hypoglycaemia performed a retest within 120 min. Within a one-day-long (1440 min) timeframe, the elapsed median time until a retest, yielding a safe blood glucose value (>3.9 mml/L), was 273 min (interquartile range: 157–300 min). Conclusions: Nocturnal hypoglycaemia should be considered as a persisting challenge to antihyperglycaemic treatment in patients living with diabetes. Continuous efforts are needed to improve both antihyperglycaemic treatment and patient education for preventing nocturnal hypoglycaemia, and to act adequately if hypoglycaemic values are detected. Full article

The prevalence of diabetes mellitus (DM) rises constantly each year worldwide. Because of that, the funds allocated for the DM treatment have increased over time. Regarding the number of DM cases, Romania is among the top ten countries in Europe. Based on the National Diabetes Programme (NDP), antidiabetic drugs and other expenditures (Self-monitoring blood glucose (SMBG) test, HbA1c, insulin pumps/insulin pumps supplies) are free of charge. This programme has undergone many changes in drugs supply, in the last two decades: re-organizing the NDP, authorization of new molecules with high prices (e.g., SGLT-2 inhibitors, etc.) or new devices (e.g., insulin pumps, etc.) The main purpose of this study is to identify and analyse the impact of the DM costs on the Romanian health budget and to highlight the evolution of these costs. A retrospective longitudinal research on the official data regarding the DM costs from 2000 to 2017 was performed. The DM funds (DMF) were adjusted with the inflation rate. In this period, the average share of DMF in the total funds allocated for health programmes was 21.3 ± 3.4%, and DMF average growth rate was 25.4% (r = 0.488, p = 0.047). On the other hand, the DMF increased more than 14 times, in spite of the patients’ number having increased only about 2.5 times. Referring to the structure of DMF, the mean value of the antidiabetic drugs cost was of 96,045 ± 67,889 thousand EUR while for other expenditures it was of 11,530 ± 7922 thousand EUR (r = 0.945, p < 0.001). Between 2008 and 2017, the total DMF was 181,252 ± 74,278 thousand EUR/year. Moreover, the average patients’ number was 667,384 ± 94,938 (r = 0.73, p = 0.016), and the cost of treatment was 215 ± 36 EUR/patient/year. Even if the cost is rising, the correct and optimal treatment is a main condition for the diabetic patient’s health and for the prevention of its complications, which have multiple socio-economic repercussions. Full article

Diabetes patients suffer from abnormal blood glucose levels, which can cause diverse health disorders that affect their kidneys, heart and vision. Due to these conditions, diabetes patients have traditionally checked blood glucose levels through Self-Monitoring of Blood Glucose (SMBG) techniques, like pricking their fingers multiple times per day. Such techniques involve a number of drawbacks that can be solved by using a device called Continuous Glucose Monitor (CGM), which can measure blood glucose levels continuously throughout the day without having to prick the patient when carrying out every measurement. This article details the design and implementation of a system that enhances commercial CGMs by adding Internet of Things (IoT) capabilities to them that allow for monitoring patients remotely and, thus, warning them about potentially dangerous situations. The proposed system makes use of smartphones to collect blood glucose values from CGMs and then sends them either to a remote cloud or to distributed fog computing nodes. Moreover, in order to exchange reliable, trustworthy and cybersecure data with medical scientists, doctors and caretakers, the system includes the deployment of a decentralized storage system that receives, processes and stores the collected data. Furthermore, in order to motivate users to add new data to the system, an incentive system based on a digital cryptocurrency named GlucoCoin was devised. Such a system makes use of a blockchain that is able to execute smart contracts in order to automate CGM sensor purchases or to reward the users that contribute to the system by providing their own data. Thanks to all the previously mentioned technologies, the proposed system enables patient data crowdsourcing and the development of novel mobile health (mHealth) applications for diagnosing, monitoring, studying and taking public health actions that can help to advance in the control of the disease and raise global awareness on the increasing prevalence of diabetes. Full article

Freestyle Libre (FL) is a factory calibrated Flash Glucose Monitor (FGM). We investigated Mean Absolute Relative Difference (MARD) between Self Monitoring of Blood Glucose (SMBG) and FL measurements in the first day of sensor wear in 39 subjects with Type 1 diabetes. The overall MARD was 12.3%, while the individual MARDs ranged from 4% to 25%. Five participants had a MARD ≥ 20%. We estimated bias and lag between the FL and SMBG measurements. The estimated biases range from −1.8 $\mathrm{mmol}$ / $\mathrm{L}$ to 1.4 $\mathrm{mmol}$ / $\mathrm{L}$ , and lags range from 2 $\min$ to 24 $\min$ . Bias is identified as a main cause of poor individual MARDs. The biases seem to persist in days 2–7 of sensor usage. All cases of MARD ≥ 20% in the first day are eliminated by bias correction, and overall MARD is reduced from 12.3% to 9.2%, indicating that adding support for voluntary user-supplied bias correction in the FL could improve its performance. Full article

Background Formula diets can improve glycemic control or can even induce remission in type 2 diabetes. We hypothesized that especially an individualized intense meal replacement by a low-carbohydrate formula diet with accompanied self-monitoring of blood glucose (SMBG) contributes to long-term improvements in HbA1c, weight, and cardiometabolic risk factors in poorly controlled type 2 diabetes. Methods Type 2 diabetes patients were randomized into either a moderate group (M-group) with two meal replacements/day (n = 160) or a stringent group (S-group) with three meal replacements/day (n = 149) during the first week of intervention (1300–1500 kcal/day). Subsequently, both groups reintroduced a low-carbohydrate lunch based on individual adaption due to SMBG in weeks 2–4. After week 4, breakfast was reintroduced until week 12. During the follow-up period, all of the participants were asked to continue replacing one meal per day until the 52-weeks follow-up. Additionally, an observational control group (n = 100) remained in routine care. Parameters were compared at baseline, after 12 and 52 weeks within and between all of the groups. Results 321 participants (83%) completed the acute meal replacement phase after 12 weeks and 279 participants (72%) the whole intervention after 52 weeks. Both intervention groups achieved improvements in HbA1c, fasting blood glucose, blood pressure, and weight (all p < 0.001) within 12 weeks. However, these results were not significantly different between both of the intervention groups. The estimated treatment difference in HbA1c reduction was (mean (95% confidence interval [CI]) -0.10% with 95% CI [−0.40; 0.21] also (p > 0.05) (S-group vs. M-group) not statistically different after 12 weeks. However, only the S-group showed a clinically relevant improvement in HbA1c of −0.81% [−1.06; −0.55] (p < 0.001) after 52 weeks of follow-up, whereas HbA1c was not statistically different between the M- and control group. Conclusion Individualized meal replacement with SMBG demonstrated beneficial effects on HbA1c and cardiometabolic parameters in type 2 diabetes. Furthermore, the initiation of a weight loss program with one week of full meal replacement (three meals per day) resulted in a clinically relevant long-term HbA1c reduction, as compared to an observational control group that had standard care. Full article