Occurrence Of Hypoglycemia Research Articles

Abstract 4134308: Re-evaluating the safety profile of Semaglutide: An updated meta-analysis

Background: Semaglutide is increasingly used in the management of type 2 diabetes mellitus and obesity. Ensuring safety of this medication is crucial for its clinical use. This meta-analysis evaluates the safety profile of semaglutide across patient populations and treatment durations. Methods: Randomized controlled trials assessing the safety of semaglutide versus placebo, with specified treatment durations were identified. The primary outcome was occurrence of any cardiovascular adverse events. Secondary outcomes included sudden cardiac death, adverse events leading to death, adverse events, gastrointestinal side effects, occurrence of hypoglycemia and new-onset neoplasm. Results: A total of 23 studies met the inclusion criteria with a combined sample size of 57,911 participants. The meta-analysis revealed that the adverse event associated with semaglutide is gastrointestinal in nature (nausea and vomiting). No significant differences were observed between semaglutide and comparator groups. (See Figure 1) Conclusion: Semaglutide appears to have a favorable safety profile across diverse patient populations and treatment durations, supporting its continued use in the management of type 2 diabetes mellitus and obesity. It is generally well-tolerated, with a low incidence of adverse events. Clinicians should be aware of these findings and monitor patients accordingly. Further long-term studies are warranted to assess the safety of semaglutide in clinical practice.

Flash glucose monitoring system help reduce the frequency of hypoglycemia and hypoglycemic fear behavior in type 1 diabetes patients

ObjectiveHypoglycemia represents a serious acute complication in individuals with type 1 diabetes mellitus (T1DM). In order to more effectively identify and discriminate the occurrence of hypoglycemic events in patients with T1DM, this study aims to evaluate the impact of two distinct glucose monitoring systems—Flash Glucose Monitoring (FGM) and Continuous Glucose Monitoring (CGM)—on the management of blood glucose levels and the emotional responses associated with hypoglycemic episodes in individuals with T1DM.MethodIn this study, a total of 113 patients with type 1 diabetes mellitus were enrolled and allocated to two groups for the implementation of Glucose Monitoring Systems (GMS). The groups consisted of the FreeStyle Libre group (FGM, n=56) and the ipro2 group (CGM, n=57). Participants in both groups utilized GMS at least biannually and completed a set of three questionnaires: the Diabetes Monitoring and Treatment Satisfaction Questionnaire (DMTSQ), the Diabetes Specific Quality of Life (DQOL), and the Chinese Version of the Hypoglycemia Fear Survey II (CFHSII). Clinical data, CGM metrics, and questionnaire scores were collected at the initial visit and after a one-year follow-up period.ResultsThe glucose coefficient of variation (GCV) and the standard deviation of blood glucose (SDBG) were independently associated with Time Below Range (TBR). Specifically, GCV could predict TBR ≥12%, with a cut-off point of 40.55. This yielded a specificity of 88.10% and a sensitivity of 68.18% in the overall patient population. For the FreeStyle Libre group and the iPro2 group, the cut-off points were 38.69 and 40.55, respectively, with specificities of 0.74 and 0.92, and sensitivities of 0.73 and 0.86, respectively. In the FreeStyle Libre group, where the frequency of use was greater than or equal to five times per year, the hypoglycemic episodes (time/month) and CHFSII-B scores were significantly reduced at follow-up compared to baseline (7.80 ± 10.25 vs 13.95 ± 14.87; 27.37 ± 11.05 vs 38.90 ± 21.61, respectively, all P <0.05).ConclusionThe utilization of multiple Flash Glucose Monitoring (FGM) implementations proved to be valuable in discriminating the occurrence of hypoglycemia and mitigating the fear of hypoglycemic episodes in patients with type 1 diabetes. Within the parameters of Glucose Monitoring Systems (GMS), the glucose glycemic variability (GCV) was identified as a predictive factor for the risk of severe hypoglycemia (TBR > 12%). The optimal cut-off point for GCV was determined to be 40.55.

Importance of the Hemoglobin Glycation Index for Risk of Cardiovascular and Microvascular Complications and Mortality in Individuals with Type 2 Diabetes.

This study investigated the prognostic importance of the hemoglobin glycation index (HGI) for macrovascular and microvascular outcomes, mortality, and hypoglycemia occurrence in a type 2 diabetes cohort and compared it to glycated hemoglobin (HbA1c). Baseline and mean first-year HGI and HbA1c, and the variability thereof, were assessed in 687 individuals with type 2 diabetes (median follow-up, 10.6 years). Multivariable Cox regression was conducted to evaluate the associations of HGI and HbA1c parameters with macrovascular (total and major cardiovascular events) and microvascular outcomes (microalbuminuria, advanced renal failure, retinopathy, and peripheral neuropathy), mortality (all-cause and cardiovascular), and moderate/severe hypoglycemia occurrence. During follow-up, there were 215 total cardiovascular events (176 major) and 269 all-cause deaths (131 cardiovascular). Microalbuminuria developed in 126 patients, renal failure in 104, retinopathy in 161, and neuropathy in 177. There were 90 hypoglycemia episodes. Both HGI and HbA1c predicted all adverse outcomes, except microalbuminuria and hypoglycemia. Their adjusted risks were roughly equivalent for all outcomes. For example, the adjusted hazard ratios (HRs) with 95% confidence intervals (CIs), estimated for 1 standard deviation increments, of mean first-year HGI were 1.23 (1.05 to 1.44), 1.20 (1.03 to 1.38), 1.36 (1.11 to 1.67), 1.28 (1.09 to 1.67), and 1.29 (1.09 to 1.54), respectively, for cardiovascular events, all-cause mortality, renal failure, retinopathy, and neuropathy; whereas the respective HRs (95% CIs) of mean HbA1c were 1.31 (1.12 to 1.53), 1.28 (1.11 to 1.48), 1.36 (1.11 to 1.67), 1.33 (1.14 to 1.55), and 1.29 (1.09 to 1.53). HGI was no better than HbA1c as a predictor of adverse outcomes in individuals with type 2 diabetes, and its clinical use cannot be currently advised.

The frequency of postoperative hypoglycemia after pheochromocytoma surgery is decreasing.

Hypoglycemia after pheochromocytoma resection is one of the most common postoperative complications, with a reported incidence of 12%-43%. In recent years, we have rarely experienced postoperative hypoglycemia after pheochromocytoma surgery at our institution. We reviewed our own experience and examined factors associated with postoperative hypoglycemia in pheochromocytoma patients. We collected and retrospectively reviewed medical information from 53 patients with pheochromocytoma who underwent initial surgery in our department between 1996 and 2022, who did not receive steroids in the perioperative period and received the same alpha-blocker preoperatively. Subjects were divided into two groups by the midpoint of the study period: Group 1 (G1), 1996-2009; and Group 2 (G2), 2010-2022. The two groups were compared. Hypoglycemia occurred significantly less often in G2 (0 patients, 0%) than in G1 (7 patients, 28%; p=0.003). Preoperative diabetes was significantly less frequent in G2 (2 patient, 7.1%) than in G1 (8 patients, 32%; p=0.03). Preoperative alpha-blocker dosage was significantly higher in G2 than in G1 (p=0.04). Multivariate logistic regression analysis showed that only alpha-blockers dosage was significantly associated with the occurrence of postoperative hypoglycemia (p=0.004). The current study suggest that the alpha-blocker dosage might be related to the lower incidence of postoperative hypoglycemia in Pheochromocytoma patients.

The Interplay between Dietary Habits and Glycemic Control in Type 1 Diabetes: A Comprehensive Prospective FGM Study.

Type 1 diabetes has become prevalent among the adult population, who have increasingly gained access to sensing technology. This study delved into the impact of diet, nutritional status, and the use of a continuous glucose monitoring system (CGM) on glycemic regulation among adults diagnosed with T1D. Employing a prospective design, data were gathered from 151 participants aged 18-60 across multiple cycles. Participants utilized the FreeStyle Libre (FSL) Flash Glucose Monitoring (FGM) System and provided dietary details via questionnaires and diaries. The findings unveiled correlations between dietary patterns and glycemic control, with higher protein intake associated with improved glycated hemoglobin A1C values (p = 0.019), yet elevated fat and protein consumption was linked to heightened rates of hyperglycemia. Conversely, no significant relationship was observed between dietary variables and hypoglycemia occurrence. Interestingly, subjects with more readings of glucose levels consumed fewer carbohydrates (p = 0.004) and more proteins (p = 0.000). Furthermore, physical activity and marital status correlated with glycemic stability, while higher education was associated with enhanced glycemic control (p = 0.021). This study confirmed the importance of structured education on glycemic regulation and the importance of dietary patterns in glucose management. Also, the educational role of the FGM system in changing dietary habits was confirmed, which is one of the key factors for improving glycemic regulation in continuous glucose monitoring system users.

Pancreatic islet cells in microfluidic-spun hydrogel microfibers for the treatment of diabetes

Islet transplantation has been developed as an effective cell therapy strategy to treat the progressive life-threatening disease Type 1 diabetes (T1DM). To mimic the natural islets and achieve immune isolation, hydrogel encapsulation of multiple islet cell types is the current endeavor. Here, we present a microfiber loading with pancreatic α and β cells by microfluidic spinning for diabetes treatment. Benefiting from microfluidic technology, the cells could be controllably and continuously loaded in the alginate and methacrylated hyaluronic acid (Alg-HAMA) microfiber and maintained their high bioactivity. The resultant microfiber could then hold the capacity of dual-mode glucose responsiveness attributed to the glucagon and insulin secreted by the encapsulated pancreatic α and β cells. After transplantation into the brown adipose tissue (BAT), these cell-laden microfibers showed successful blood glucose control in rodents and avoided the occurrence of hypoglycemia. These results conceived that the multicellular microfibers are expected to provide new insight into artificial islet preparation, diabetes treatment, and regenerative medicine as well as tissue engineering. Statement of significance•The microfibers were generated with a double network of alginate and methacrylated hyaluronic acid.•The microfibers could simultaneously encapsulate pancreatic α and β cells and showed dual-mode glucose responsiveness.•The cell-laden microfibers maintained a long-term hormone-releasing function in vivo.•Cell-laden microfibers transplanted into diabetic mice could achieve glycemic control for 6 weeks.

Hybrid Control Policy for Artificial Pancreas Via Ensemble Deep Reinforcement Learning.

The artificial pancreas (AP) has shown promising potential in achieving closed-loop glucose control for individuals with type 1 diabetes mellitus (T1DM). However, designing an effective control policy for the AP remains challenging due to the complex physiological processes, delayed insulin response, and inaccurate glucose measurements. While model predictive control (MPC) offers safety and stability through the dynamic model and safety constraints, it lacks individualization and is adversely affected by unannounced meals. Conversely, deep reinforcement learning (DRL) provides personalized and adaptive strategies but faces challenges with distribution shifts and substantial data requirements. We propose a hybrid control policy for the artificial pancreas (HyCPAP) to address the above challenges. HyCPAP combines an MPC policy with an ensemble DRL policy, leveraging the strengths of both policies while compensating for their respective limitations. To facilitate faster deployment of AP systems in real-world settings, we further incorporate meta-learning techniques into HyCPAP, leveraging previous experience and patient-shared knowledge to enable fast adaptation to new patients with limited available data. We conduct extensive experiments using the FDA-accepted UVA/Padova T1DM simulator across three scenarios. Our approaches achieve the highest percentage of time spent in the desired euglycemic range and the lowest occurrences of hypoglycemia. The results clearly demonstrate the superiority of our methods for closed-loop glucose management in individuals with T1DM. The study presents novel control policies for AP systems, affirming the great potential of proposed methods for efficient closed-loop glucose control.

Severe hypoglycemia in a diabetic patient with pituitary apoplexy: a case report

IntroductionHypoglycemia is a common occurrence in diabetic patients. But unlike non diabetic patients, its causes are frequently related to drugs they are receiving to control blood glucose. But this may not always be the case. Here we report a type 2 diabetic patient with severe hypoglycemia owing to acute hypopituitarism secondary to pituitary apoplexy.Case presentationA 45 year old male diabetic patient from Ethiopia taking 2 mg of oral glimepiride daily who presented with change in mentation of 30 minutes and blood glucose recording of 38 mg/dl upon arrival to the emergency room. Brain magnetic resonance imaging showed pituitary macroadenoma with hemorrhage suggestive of pituitary apoplexy. Blood work up showed low adrenocorticotropic hormone, cortisol, and serum sodium levels. Subsequently transsphenoidal hypophysectomy was done.ConclusionThe occurrence of hypoglycemia in a diabetic patient taking sulphonylurea monotherapy is common. But when it is severe enough to cause altered mentation, patients should be approached differently. In the presence of clinical clues suggesting cortisol deficiency, hypopituitarism can be a possible cause.

Evaluating the safety profile of semaglutide: an updated meta-analysis

Background Semaglutide is increasingly used in the management of type 2 diabetes mellitus and obesity. Ensuring the safety of this medication is crucial for its clinical use. This meta-analysis evaluates the safety profile of semaglutide across patient populations and treatment durations. Methods Randomized controlled trials assessing the safety of semaglutide vs. placebo, with specified treatment durations were identified. The primary outcome was occurrence of any cardiovascular adverse events. Secondary outcomes included sudden cardiac death, adverse events leading to death, adverse events, gastrointestinal side effects, occurrence of hypoglycemia, and new-onset neoplasm. Results A total of 23 studies met the inclusion criteria with a combined sample size of 57,911 participants. The meta-analysis revealed that the adverse event associated with semaglutide is gastrointestinal in nature (nausea and vomiting). No significant differences were observed between semaglutide and comparator groups. Conclusion Semaglutide appears to have a favorable safety profile across diverse patient populations and treatment durations, supporting its continued use in the management of type 2 diabetes mellitus and obesity. It is generally well-tolerated, with a low incidence of adverse events. Clinicians should be aware of these findings and monitor patients accordingly. Further long-term studies are warranted to assess the safety of semaglutide in clinical practice.

Evaluating the effectiveness and safety of empagliflozin versus liraglutide in managing diabetic dyslipidemia: An observational study

Background: Diabetic dyslipidemia poses a significant risk factor for cardiovascular complications in patients with diabetes mellitus. Empagliflozin and liraglutide are two commonly used medications in diabetes management, yet their comparative efficacy and safety in treating diabetic dyslipidemia remain under-explored. Aims and Objectives: This study aimed to assess the effectiveness and safety of Empagliflozin versus liraglutide in managing diabetic dyslipidemia. Materials and Methods: The study enrolled 100 participants with diabetes and dyslipidemia, divided equally into empagliflozin and liraglutide treatment groups. Baseline characteristics, including age, gender distribution, ethnicity, and duration of diabetes, were assessed and compared between the groups. Lipid profiles, encompassing total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides, were evaluated at baseline and after 6 months of treatment. Safety outcomes, such as the occurrence of mild gastrointestinal symptoms, hypoglycemia, and serious adverse events, were also monitored. Results: Both treatment groups exhibited comparable baseline characteristics. Following 6 months of treatment, both empagliflozin and liraglutide demonstrated significant improvements in lipid profiles. Reductions in total cholesterol, LDL cholesterol, and triglycerides, along with increases in HDL cholesterol, were observed in both groups. Moreover, there were no significant differences in the occurrence of adverse events between the two treatment groups, indicating similar safety profiles. Conclusion: This study provides evidence supporting the effectiveness and safety of empagliflozin and liraglutide in managing diabetic dyslipidemia. These findings highlight the potential of both medications as viable therapeutic options for patients with diabetes and dyslipidemia.

Glucose evaluation and management in the ICU (GEM-ICU): Protocol for a bi-centre cohort study.

Hyperglycaemia is common in intensive care unit (ICU) patients. Glycaemic monitoring and effective glycaemic control with insulin are crucial in the ICU to improve patient outcomes. However, glycaemic control and insulin use vary between ICU patients and hypo- and hyperglycaemia occurs. Therefore, we aim to provide contemporary data on glycaemic control and management, and associated outcomes, in adult ICU patients. We hypothesise that the occurrence of hypoglycaemia in acutely admitted ICU patients is lower than that of hyperglycaemia. We will conduct a bi-centre cohort study of 300 acutely admitted adult ICU patients. Routine data will be collected retrospectively at baseline (ICU admission) and daily during ICU stay up to a maximum of 30 days. The primary outcome will be the number of patients with hypoglycaemia during their ICU stay. Secondary outcomes will be occurrence of severe hypoglycaemia, occurrence of hyperglycaemia, time below blood glucose target range, time above target range, all-cause mortality at Day 30, number of days alive without life support at Day 30 and number of days alive and out of hospital at Day 30. Process outcomes include the number of in-ICU days, glucose measurements (number of measurements and method) and use of insulin (including route of administration and dosage). All statistical analyses will be descriptive. This cohort study will provide a contemporary overview of glucose evaluation and management practices in adult ICU patients and, thus, highlight potential areas for improvement through future clinical trials in this area.

Yoga as an alternative to cycling in type 1 diabetes: A preliminary study of acute effects on glucose levels

We evaluated the acute effects of yoga compared to cycling on glucose change and variability, and the occurrence of hypoglycemia in adults with type 1 diabetes. Fifteen participants performed 50 min of cycling or yoga. Glucose values were collected before and after exercise. Coefficient of variation (CV) and hypoglycemic episodes were evaluated from the start up to 12 h after exercise. Cycling and yoga significantly reduced glucose values during exercise, and CV was lower after yoga. One hypoglycemic episode occurred with yoga and seven with cycling. Yoga is a safe exercise that acutely reduces glucose values, but with lower risk of hypoglycemia compared to cycling.

The Frequency of Hypoglycemia and Its Symptoms in Preterm Neonates in the First 24 Hours.

Introduction Hypoglycemia is a critical concern in neonatal care, particularly among preterm infants. This study aims to investigate the frequency of hypoglycemia within the first 24 hours of life in preterm neonates, considering factors such as gestational age (GA), birth weight, and gender. Materials and methods A cross-sectional study was conductedfrom February to August 2021. The sample comprised 186 preterm infants selected through consecutive sampling. Data collection involved demographic information, glucose level monitoring, and symptom assessment. Results Of the 186 preterm neonates, 31.7% (n=59) experienced hypoglycemia within the first 24 hours, with feeding refusal being the predominant symptom. There was a significant difference in hypoglycemia occurrence between infants born before and after 32 weeks of gestation (p<0.05). Males were slightly more affected than females, although not statistically significant. Infants weighing less than 2 kg showed a higher susceptibility to hypoglycemia. Conclusion The early detection and management of hypoglycemia are crucial in preterm neonatal care. Close monitoring, especially in the initial four hours, is essential to prevent complications. Larger studies are warranted to confirm these findings and improve understanding and management strategies for hypoglycemia in preterm neonates, particularly within the first 24 hours of life.

Frequency of hypoglycaemia with basal insulin treatments in adults with type 1 diabetes treated with basal-bolus insulin regimens in treat-to-target trials: A narrative review.

To summarise, in a narrative review, published data on hypoglycaemia occurrence with basal insulin therapy in adults with type 1 diabetes treated with basal-bolus insulin regimens in treat-to-target randomised controlled trials. Data were included from 21 eligible trials, which mainly used self-measured blood glucose or plasma glucose to detect hypoglycaemia. All-day self-measured blood glucose or plasma glucose level 2 (glucose threshold of 3.1 or 3.0 mmol/L) and level 3 (severe, requiring assistance) hypoglycaemic events were reported, respectively, by a range of 69.0%-97.5% and 0%-13.4% adults when receiving basal-bolus insulin therapy, with rates of 10.6-68.1 and 0.0-0.4 events per patient-year of exposure, respectively. Hypoglycaemia rates measured using continuous glucose monitoring (three studies) were numerically, yet consistently, higher than with either other method, except when limiting to symptomatic events. Nocturnal hypoglycaemia rates were generally less than 30% of the equivalent all-day rates. Differences across the studies in design (e.g., titration targets) and participant characteristics hindered comparison of hypoglycaemia rates by insulin formulation. Consequently, few trends were identified by insulin formulation, study methodology or individuals' characteristics, suggesting that further research is required to identify treatment strategies that facilitate development of individualised recommendations to lower hypoglycaemia risk. These findings are useful to understand hypoglycaemia risk with available basal insulin therapies when used in a multiple daily injection regimen, as well as to provide context for the results of ongoing and future clinical trials, including those for two once-weekly basal insulins, insulin icodec and basal insulin Fc.

Oral Glyburide for the Prevention of Cerebral Edema in Acute Ischemic Stroke

The purpose of this study was to describe the impact of enteral glyburide on cerebral edema formation and hypoglycemia when used in patients diagnosed with acute ischemic stroke (AIS). This study was a single-center, retrospective chart review that included all patients at least 18 years of age diagnosed with AIS who received at least one dose of enteral glyburide for the prevention of cerebral edema from January 1st, 2018 to March 31st, 2022. The primary outcome was to describe the percentage of patients requiring intervention for cerebral edema management following glyburide initiation, and the safety outcome was to describe the occurrence of hypoglycemia in this patient population. The final evaluation included 44 patients, with 6 (14%) patients requiring intervention for cerebral edema after glyburide initiation. Average baseline NIHSS was 19. Overall, in-hospital mortality was 17 (36%), and hypoglycemia occurred in 7 (15%) patients. Twenty (45%) patients received a partial duration of enteral glyburide (1-4 doses) and 24 (55%) patients received a full duration of enteral glyburide (5-7 doses). There was a lower rate of intervention for cerebral edema (10% vs 17%) and hypoglycemia (5% vs 23%) in the partial duration versus the full duration group, respectively. In-hospital all-cause mortality rate was higher in the partial duration versus the full duration group (43% vs 31%). Despite relatively low rates of intervention for cerebral edema, hypoglycemia was common, particularly in patients receiving 5-7 doses of enteral glyburide for the prevention of cerebral edema in patients with moderate-to-severe AIS.

Transitional Neonatal Hypoglycemia and Adverse Neurodevelopment in Midchildhood

The circumstances under which neonatal hypoglycemia leads to brain damage remain unclear due to a lack of long-term data on the neurodevelopment of affected children. As a result, diagnostic strategies and treatment recommendations are inconsistent. To evaluate whether the occurrence of severe transitional neonatal hypoglycemia (defined as having at least 1 blood glucose measurement of 30 mg/dL or below) is associated with adverse neurodevelopment in midchildhood. This cohort study using neurodevelopmental testing of a retrospectively recruited cohort was conducted at a single-center tertiary hospital in Germany between March 2022 and February 2023. Children with neonatal blood glucose screening data were randomly selected from all births between 2010 and 2015. Frequency matching for sex, birth weight, gestational age, socioeconomic status, and primary risk factors for neonatal hypoglycemia was performed. Children with persistent hypoglycemia diseases or any risk factor for adverse neurodevelopment except hypoglycemia were excluded. Data were analyzed between February 2023 and March 2023. At least 1 neonatal hypoglycemia measurement with blood glucose measuring 30 mg/dL or below vs all measured blood glucose levels above 30 mg/dL during postnatal blood glucose screening starting on the first day of life. Cognitive function measured by full-scale IQ test. Secondary outcomes included standardized scales of motor, visual, and executive functions, and child behavior, each measured at ages 7 to 11 years. A total of 140 children (mean [SD] age 9.1 [1.3] years; 77 male [55.0%]) participated in the study. Children with severe neonatal hypoglycemia had a 4.8 points lower mean full-scale IQ than controls (107.0 [95% CI, 104.0-109.9] vs 111.8 [95% CI, 108.8-114.8]). They showed a 4.9-fold (95% CI, 1.5-15.5) increased odds of abnormal fine motor function and a 5.3-fold (95% CI, 2.1-13.3) increased odds of abnormal visual-motor integration. Significantly higher T scores for attention problems (58.2 [95% CI, 56.1-60.2] vs 54.6 [95% CI, 52.6-56.6]) and attention-deficit/hyperactivity disorder symptoms (58.2 [95% CI, 56.2-60.2] vs 54.7 [95% CI, 52.8-56.7]) were reported by parents. Neonatal hypoglycemia with blood glucose levels of 30 mg/dL or below was associated with an increased risk for suboptimal neurodevelopmental outcomes in midchildhood. These findings imply that treatment strategies should aim to prevent episodes of hypoglycemia at these severely low levels.

Continuous glucose monitoring metrics in pregnancy with type 1 diabetes mellitus.

Managing diabetes during pregnancy is challenging, given the significant risk it poses for both maternal and foetal health outcomes. While traditional methods involve capillary self-monitoring of blood glucose level monitoring and periodic HbA1c tests, the advent of continuous glucose monitoring (CGM) systems has revolutionized the approach. These devices offer a safe and reliable means of tracking glucose levels in real-time, benefiting both women with diabetes during pregnancy and the healthcare providers. Moreover, CGM systems have shown a low rate of side effects and high feasibility when used in pregnancies complicated by diabetes, especially when paired with continuous subcutaneous insulin infusion pump as hybrid closed loop device. Such a combined approach has been demonstrated to improve overall blood sugar control, lessen the occurrence of preeclampsia and neonatal hypoglycaemia, and minimize the duration of neonatal intensive care unit stays. This paper aims to offer a comprehensive evaluation of CGM metrics specifically tailored for pregnancies impacted by type 1 diabetes mellitus.

Development of hypoglycemia in patients with COVID-19: coincidence or the result of treatment?

Hypoglycemia is a common complication of diabetes mellitus (DM), which also complicates the course of COVID-19. The aim: The purpose of this work is to analyze the available scientific information on the causes and risk factors of hypoglycemia during the treatment of patients with COVID-19. Materials and methods. Full-text articles were searched and analysed in the PubMed, Web of Science, Google Scholar, and Scopus databases. The search was conducted using the keywords: "hypoglycemia in COVID-19 patients", "treatment of COVID-19 and hypoglycemia" and "COVID-19 vaccination and hypoglycemia" from the beginning of the pandemic in December 2019 to February 1, 2024. Results. The analysis of literary sources showed that hypoglycemia can occur when using drugs from many pharmacotherapeutic groups for the treatment and vaccination of patients with COVID-19. In addition, patients with DM often have chronic complications that contribute to hypoglycemia occurrence in the case of COVID-19. The lockdown during the COVID-19 pandemic has further complicated the problem of hypoglycemia by restricting access to food, clinics, health services, and medicines. Conclusions: Hypoglycemia can be an incidental clinical finding. But it can also be a natural consequence of treatment if it is carried out without taking into account the possible hypoglycemic effects of drugs and without careful monitoring of the patient's condition. In the case of determining the program of treatment and vaccination against COVID-19 in patients with DM, the known and possible hypoglycemic effects of drugs and vaccines should be taken into account, the level of glycemia should be carefully controlled, and sudden changes in the type and dose of drugs, polypharmacy and the use of dangerous combinations of drugs should be avoided. _________________________________________________________________________________________ Keywords: COVID-19, hypoglycemia, treatment, vaccination

Breaking through diabetes management barriers: Assessing the accuracy of Freestyle Libre Pro flash continuous glucose monitoring in diabetes patients with myocardial infarction.

The objective of this study was to assess the accuracy of FreeStyle Libre Pro (FSL-Pro) flash continuous glucose monitoring (CGM) in patients with type 2 diabetes mellitus (T2DM) and acute myocardial infarction (AMI). A single-arm, single-center prospective study was conducted in the cardiac care unit from January 2021 to September 2023. Patients underwent finger-prick blood glucose (FPBG) testing before breakfast (6:00 am) and after meals (at 9:00, 13:00, 19:00 pm), along with CGM during their hospitalization. Statistical analyses included mean differences (MDs), mean absolute relative difference (MARDs) of blood glucose levels, and hypoglycemia occurrences. A Bland-Altman plot analysis and Pearson correlation were performed. Ninety-seven T2DM and AMI patients underwent CGM for up to 72 h (1142 monitoring point). Mean daily BG, Fasting plasma glucose (FPG) and mean postprandial plasma glucose (PPG) were significantly lower by CGM than by FPBG with an estimated MD of -0.89 mmol/L in BG, -0.88 mmol/L in FPG, and -0.90 mmol/L in PPG, respectively. The maximum effect was mainly in the first day and then the difference was gradually declined (falling range, Day1, -1.24; Day 2, -0.70; Day 3, -0.68, mmol/L, respectively). The incidence rates of hypoglycemia and potential hypoglycemia was 1.57% and 8.5% higher, respectively, in CGM than in FBPG. A Bland-Altman Plot revealed some variability and bias between the two methods of measurement of glucose monitoring (p < .001). Pearson's correlation coefficient demonstrated a significant correlation between the mean BG, FPG, and PPG of CGM and FBPG (Pearson's coefficient: 0.92, 0.87, 0.92, respectively, p < .001). Compared with FPBG, FSL Pro-CGM showed lower mean glucose and higher hypoglycemia detection in T2DM and AMI patients, especially in the first 24 h.

Cost-utility of real-time continuous glucose monitoring versus self-monitoring of blood glucose in people with insulin-treated Type II diabetes in France.

Aim: Clinical trials and real-world data for Type II diabetes both show that glycated hemoglobin (HbA1c) levels and hypoglycemia occurrence can be reduced by real-time continuous glucose monitoring (rt-CGM) versus self-monitoring of blood glucose (SMBG). The present cost-utility study investigated the long-term health economic outcomes associated with using rt-CGM versus SMBG in people with insulin-treated Type II diabetes in France. Materials & methods: Effectiveness data were obtained from a real-world study, which showed rt-CGM reduced HbA1c by 0.56% (6.1mmol/mol) versus sustained SMBG. Analyses were conducted using the IQVIA Core Diabetes Model. A French payer perspective was adopted over a lifetime horizon for a cohort aged 64.5years with baseline HbA1c of 8.3% (67mmol/mol). A willingness-to-pay threshold of €147,093 was used, and future costs and outcomes were discounted at 4% annually. Results: The analysis projected quality-adjusted life expectancy was 8.50 quality-adjusted life years (QALYs) for rt-CGM versus 8.03QALYs for SMBG (difference: 0.47QALYs), while total mean lifetime costs were €93,978 for rt-CGM versus €82,834 for SMBG (difference: €11,144). This yielded an incremental cost-utility ratio (ICUR) of €23,772 per QALY gained for rt-CGM versus SMBG. Results were particularly sensitive to changes in the treatment effect (i.e., change in HbA1c), annual price and quality of life benefit associated with rt-CGM, SMBG frequency, baseline patient ageand complication costs. Conclusion: The use of rt-CGM is likely to be cost-effective versus SMBG for people with insulin-treated Type II diabetes in France.