Comparison of Control-IQ and open-source AndroidAPS automated insulin delivery systems in adults with type 1 diabetes: The CODIAC study.

AIM: To compare open-source AndroidAPS (AAPS) and commercially available Control-IQ (CIQ) automated insulin delivery (AID) systems in a prospective, open-label, single-arm clinical trial. METHODS: Adults with type 1 diabetes who had been using AAPS by their own decision entered the first 3-month AAPS phase then were switched to CIQ for 3 months. The results of this treatment were compared with those after the 3-month AAPS phase. The primary endpoint was the change in time in range (% TIR; 70-80 mg/dL). RESULTS: Twenty-five people with diabetes (mean age 34.32 ± 11.07 years; HbA1c 6.4% ± 3%) participated in this study. CIQ was comparable with AAPS in achieving TIR (85.72% ± 7.64% vs. 84.24% ± 8.46%; P = .12). Similarly, there were no differences in percentage time above range (> 180 and > 250 mg/dL), mean sensor glucose (130.3 ± 13.9 vs. 128.3 ± 16.9 mg/dL; P = .21) or HbA1c (6.3% ± 2.1% vs. 6.4% ± 3.1%; P = .59). Percentage time below range (< 70 and < 54 mg/dL) was significantly lower using CIQ than AAPS. Even although participants were mostly satisfied with CIQ (63.6% mostly agreed, 9.1% strongly agreed), they did not plan to switch to CIQ. CONCLUSIONS: The CODIAC study is the first prospective study investigating the switch between open-source and commercially available AID systems. CIQ and AAPS were comparable in achieving TIR. However, hypoglycaemia was significantly lower with CIQ.

Low Initial Adherence with Flash Glucose Monitoring is Not a Predictor of Long-Term Glycemic Outcomes: Longitudinal Analysis of the Association Between Experience, Adherence, and Glucose Control for FreeStyle Libre Users.

INTRODUCTION: Frequent scanning of FreeStyle Libre (FSL) flash glucose monitoring sensors is known to be important whilst wearing an active sensor, but adherence to sensor reapplication is also critical to effective glucose monitoring. We report novel measures of adherence for users of the FSL system and their association with improvements in metrics of glucose control. METHODS: Anonymous data were extracted for 1600 FSL users in the Czech Republic with ≥ 36 completed sensors from October 22, 2018 to December 31, 2021. "Experience" was defined by the number of sensors used (1-36 sensors). "Adherence" was defined by time between the end of one sensor and the start of the next (gap time). User adherence was analyzed for four experience levels after initiating FLASH; Start (sensors 1-3); Early (sensors 4-6); Middle (sensors 19-21); End (sensors 34-36). Users were split into two adherence levels based on mean gap time during Start period, "low" (> 24 h, n = 723) and "high" (≤ 8 h, n = 877). RESULTS: Low-adherence users reduced their sensor gap times significantly: 38.5% applied a new sensor within 24 h during sensors 4-6, rising to 65.0% by sensors 34-36 (p < 0.001). Improved adherence was associated with increased %TIR (time in range; mean + 2.4%; p < 0.001), reduced %TAR (time above range; mean - 3.1%; p < 0.001), and reduced glucose coefficient of variation (CV; mean - 1.7%; p < 0.001). CONCLUSIONS: With experience, FSL users became more adherent in sensor reapplication, with associated increases in %TIR, and reductions in %TAR and glucose variability.

Expert opinion on the cooperation of diabetologists and internists with nephrologists in the care of patients with chronic kidney diseases.

Chronic kidney disease (CKD) affects 10% of the population of developed countries and significantly affects the population health. In addition to the well-known renoprotection tools slowing down the progression of CKD, SGLT2 inhibitors have been newly introduced into clinical practice based on the results of extensive studies, both in diabetics and non-diabetics. This expert opinion discusses the classification of CKD, current renoprotection options, and the recent role of SGLT2 inhibitors in the care of patients with CKD.

The position of SGLT2 inhibitors in current medical practice - update 2022.

Cardiovascular diseases are still the most common cause of mortality in patients with type 2 diabetes. Studies on the cardiovascular safety of new antidiabetic treatments, that have significantly expanded the treatment options for type 2 diabetes over the last 20 years, have provided evidence not only for the cardiovascular safety of SGLT-2 inhibitors (SGLT-2i, gliflozins), but also unexpectedly showed a significant effect on the reduction of cardiovascular risk, incidence and progress of heart failure and nephroprotectivity. For the first time, a reduction in cardiovascular and overall mortality was demonstrated for empagliflozin in 2015 in patients at very high cardiovascular risk. Further studies with gliflozins in patients with diabetes, but also in non-diabetic individuals, show that gliflozins have more pharmacological similarities than differences, especially in terms of protection against the development and progression of heart failure and maintenance of glomerular filtration rate. The revolutionary contribution of SGLT-2i is therefore perceived today not only by diabetologists, but also by cardiologists and nephrologists. In ESC guidelines, SGLT-2i are recommended as a first-line antidiabetic treatment for patients with diabetes at high cardiovascular risk, attacking the hitherto unshakable position of metformin at this pole position, and their indications should be considered in patients with type 2 diabetes with atherosclerosis, heart and renal failure regardless of the level of diabetes control (values of HbA1c). In the treatment of heart failure with reduced ejection fraction (with or without diabetes), dapagliflozin and empagliflozin have been recommended by cardiologists since 2021 to prevent hospitalizations for heart failure and to reduce mortality with the strongest class and level of evidence.

Real-world characteristics, modern antidiabetic treatment patterns, and comorbidities of patients with type 2 diabetes in central and Eastern Europe: retrospective cross-sectional and longitudinal evaluations in the CORDIALLY® study.

BACKGROUND: Guidelines from 2016 onwards recommend early use of SGLT2i or GLP-1 RA for patients with type 2 diabetes (T2D) and cardiovascular disease (CVD), to reduce CV events and mortality. Many eligible patients are not treated accordingly, although data are lacking for Central and Eastern Europe (CEE). METHODS: The CORDIALLY non-interventional study evaluated the real-world characteristics, modern antidiabetic treatment patterns, and the prevalence of CVD and chronic kidney disease (CKD) in adults with T2D at nonhospital-based practices in CEE. Data were retrospectively collated by medical chart review for patients initiating empagliflozin, another SGLT2i, DPP4i, or GLP-1 RA in autumn 2018. All data were analysed cross-sectionally, except for discontinuations assessed 1 year ± 2 months after initiation. RESULTS: Patients (N = 4055) were enrolled by diabetologists (56.7%), endocrinologists (40.7%), or cardiologists (2.5%). Empagliflozin (48.5%) was the most prescribed medication among SGLT2i, DPP4i, and GLP-1 RA; > 3 times more patients were prescribed empagliflozin than other SGLT2i (10 times more by cardiologists). Overall, 36.6% of patients had diagnosed CVD. Despite guidelines recommending SGLT2i or GLP-1 RA, 26.8% of patients with CVD received DPP4i. Patients initiating DPP4i were older (mean 66.4 years) than with SGLT2i (62.4 years) or GLP-1 RA (58.3 years). CKD prevalence differed by physician assessment (14.5%) or based on eGFR and UACR (27.9%). Many patients with CKD (≥ 41%) received DPP4i, despite guidelines recommending SGLT2is owing to their renal benefits. 1 year ± 2-months after initiation, 10.0% (7.9-12.3%) of patients had discontinued study medication: 23.7-45.0% due to 'financial burden of co-payment', 0-1.9% due to adverse events (no patients discontinued DPP4i due to adverse events). Treatment guidelines were 'highly relevant' for a greater proportion of cardiologists (79.4%) and endocrinologists (72.9%) than diabetologists (56.9%), and ≤ 20% of physicians consulted other physicians when choosing and discontinuing treatments. CONCLUSIONS: In CORDIALLY, significant proportions of patients with T2D and CVD/CKD who initiated modern antidiabetic medication in CEE in autumn 2018 were not treated with cardioprotective T2D medications. Use of DPP4i instead of SGLT2i or GLP-1 RA may be related to lack of affordable access, the perceived safety of these medications, lack of adherence to the latest treatment guidelines, and lack of collaboration between physicians. Thus, many patients with T2D and comorbidities may develop preventable complications or die prematurely. Trial registration NCT03807440.

Lower Glycated Hemoglobin with Real-Time Continuous Glucose Monitoring Than with Intermittently Scanned Continuous Glucose Monitoring After 1 Year: The CORRIDA LIFE Study.

Background: The aim was to compare the efficacy of real-time continuous glucose monitoring (rtCGM) and intermittently scanned continuous glucose monitoring (isCGM) focusing on glycated hemoglobin (HbA1c) as the primary endpoint. Methods: The CORRIDA LIFE was a 12-month, real-world, nonrandomized study that is part of the CORRIDA clinical trials program. The study compared rtCGM (Dexcom G5 or G6) and isCGM (FreeStyle Libre 14-Day; Abbott) in adults with type 1 diabetes (T1D). Only patients on multiple daily insulin injections or continuous subcutaneous insulin infusion with no automatic functions were included in this study. Primary outcome was the difference in HbA1c between study groups at 12 months. Results: One hundred ninety-one adults with T1D (mean age 40 ± 13 years, HbA1c 8.1% ± 3.4% [65 ± 14 mmol/mol]) participated in this study; 81 patients initiated rtCGM and 110 initiated isCGM. After 12-months, HbA1c was significantly lower with rtCGM versus isCGM (7.1% ± 3.1% [54.1 ± 10.1 mmol/mol] vs. 7.7% ± 3.3% [61.2 ± 12.2 mmol/mol]), P = 0.0001. The percentage of time in hypoglycemia (<70 mg/dL [<3.9 mmol/L]) was lower among rtCGM vs. isCGM participants [4.3% ± 2.8% vs. 6.4% ± 5.3%], P = 0.003). Patients with rtCGM spent less time in clinically significant hypoglycemia (<54 mg/dL [<3.0 mmol/L]) (0.9% ± 1.0% vs. 2.3% ± 2.5%, P < 0.0001) and more time in target range (70-180 mg/dL [3.9-10 mmol/L]) than isCGM users (67.5% ± 14.8% vs. 57.8% ± 17.0%), P = 0.0002. Conclusions: rtCGM was superior to isCGM in HbA1c, hypoglycemia, and other glycemic outcomes. Our findings provide guidance to clinicians when discussing monitoring options with their patients. The study was registered at www.clinicaltrials.gov (NCT04759495).

Skin autofluorescence corresponds to microvascular reactivity in diabetes mellitus.

Advanced glycation accelerated by chronic hyperglycaemia contributes to the development of diabetic vascular complications throughout several mechanisms. One of these mechanisms is supposed to be impaired microvascular reactivity, that precedes significant vascular changes. The aim of this study was to find an association between advanced glycation, the soluble receptor for AGEs (sRAGE), and microvascular reactivity (MVR) in diabetes. Skin autofluorescence (SAF), which reflects advanced glycation, was assessed by AGE-Reader, MVR was measured by laser Doppler fluxmetry and evaluated together with sRAGE in 43 patients with diabetes (25 Type 1 and 18 Type 2) and 26 healthy controls of comparable age. SAF was significantly higher in patients with diabetes compared to controls (2.4 ± 0.5 vs. 2.0 ± 0.5 AU; p < 0.01). Patients with diabetes with SAF > 2.3 AU presented significantly worse MVR in both post-occlusive reactive hyperaemia (PORH) on the finger and forearm, and thermal hyperaemia (TH), compared to patients with SAF < 2.3 AU. SAF was age dependent in both diabetes (r = 0.41, p < 0.01) and controls (r = 0.45, p < 0.05). There was no association between SAF and diabetes control expressed by glycated haemoglobin. A significant relationship was observed between SAF and sRAGE in diabetes (r = 0.56, p < 0.001), but not in controls. A significant inverse association was found between SAF and MVR on the forearm in diabetes (PORH: r = -0.42, p < 0.01; TH: r = -0.46, p < 0.005). Both advanced glycation expressed by higher SAF or sRAGE and impaired MVR are involved in the pathogenesis of vascular complications in diabetes, and we confirm a strong interplay of these processes in this scenario.

Expert Panel Guidance and Narrative Review of Treatment Simplification of Complex Insulin Regimens to Improve Outcomes in Type 2 Diabetes.

Given the progressive nature of type 2 diabetes (T2D), most individuals with the disease will ultimately undergo treatment intensification. This usually involves the stepwise addition of a new glucose-lowering agent or switching to a more complex insulin regimen. However, complex treatment regimens can result in an increased risk of hypoglycaemia and high treatment burden, which may impact negatively on both therapeutic adherence and overall quality of life. Individuals with good glycaemic control may also be overtreated with unnecessarily complex regimens. Treatment simplification aims to reduce individual treatment burden, without compromising therapeutic effectiveness or safety. Despite data showing that simplifying therapy can achieve good glycaemic control without negatively impacting on treatment efficacy or safety, it is not always implemented in clinical practice. Current clinical guidelines focus on treatment intensification, rather than simplification. Where simplification is recommended, clear guidance is lacking and mostly focused on treatment of the elderly. An expert, multidisciplinary panel evaluated the current treatment landscape with respect to guidance, published evidence, recommendations and approaches regarding simplification of complex insulin regimens. This article outlines the benefits of treatment simplification and provides practical recommendations on simplifying complex insulin treatment strategies in people with T2D using illustrative cases.

Concomitant iGlarLixi and Sodium-Glucose Co-transporter-2 Inhibitor Therapy in Adults with Type 2 Diabetes: LixiLan-G Trial and Real-World Evidence Results.

INTRODUCTION: iGlarLixi, the once-daily fixed-ratio combination of insulin glargine 100 U/ml and lixisenatide, robustly improves glycaemic control in adults with type 2 diabetes irrespective of previous treatment [oral antihyperglycaemic drugs (OADs), basal insulin or glucagon-like peptide-1 receptor agonists (GLP-1 RAs)]. Sodium-glucose co-transporter-2 inhibitors (SGLT2is) are a recommended treatment option for people with type 2 diabetes with cardiovascular disease, kidney disease and/or heart failure because of their cardio- and renoprotective benefits. Herein, we assessed the effects of concomitant iGlarLixi and SGLT2i therapy. METHODS: We conducted subgroup analyses according to SGLT2i use in: (1) adults with suboptimally controlled type 2 diabetes on GLP-1 RAs and OADs switching to iGlarLixi in the 26-week LixiLan-G randomised controlled trial (RCT; NCT02787551) and (2) adults switching to or adding iGlarLixi in a 6-month, retrospective real-world evidence (RWE) observational study using data from the US Optum-Humedica electronic medical records database. Changes in HbA1c and hypoglycaemia prevalence and event rates were assessed. RESULTS: There were no major differences in baseline characteristics for those who initiated iGlarLixi while already using SGLT2i (n = 346) and those initiating iGlarLixi without concomitant SGLT2i therapy (n = 1285). HbA1c reductions from baseline to time of assessment and hypoglycaemia prevalence and event rates were similar for iGlarLixi users regardless of SGLT2i therapy. CONCLUSION: Evidence from an RCT and an RWE analysis supports the efficacy/effectiveness and safety of iGlarLixi when used concomitantly with SGLT2i. TRIAL REGISTRATION: NCT02787551.

People with type 2 diabetes require glucose-lowering drugs to attain and maintain blood glucose control, with many eventually requiring injectable therapies. iGlarLixi combines two injectable therapies (basal insulin glargine and a glucagon-like peptide-1 receptor agonist, lixisenatide) into a single fixed-ratio daily injection and has previously been shown to provide robust improvements in blood glucose control. However, previous studies have not assessed the potential effect that simultaneous use of sodium-glucose co-transporter-2 inhibitor (SGLT2i) therapy may have on iGlarLixi therapy. This is of interest because SGLT2is are a widely used oral blood-glucose-lowering therapy that also have a beneficial effect in people with type 2 diabetes who have cardiovascular or kidney disease or have risk factors for the development or progression of these conditions. Therefore, this study assessed whether there were relevant differences in terms of blood glucose control and safety when initiating iGlarLixi in people treated with SGLT2i versus initiating iGlarLixi in people not receiving SGLT2i. Results showed that iGlarLixi provided similarly good glucose control and safety profiles, regardless of whether SGLT2is were used or not, thereby supporting the simultaneous use of these two therapies.

The management of type 2 diabetes before, during and after Covid-19 infection: what is the evidence?

Patients with Covid-19 place new challenges on the management of type 2 diabetes, including the questions of whether glucose-lowering therapy should be adjusted during infection and how to manage a return to normal care after resolution of Covid-19 symptoms. Due to the sudden onset of the pandemic, physicians have by necessity made such important clinical decisions in the absence of robust evidence or consistent guidelines. The risk to patients is compounded by the prevalence of cardiovascular disease in this population, which alongside diabetes is a major risk factor for severe disease and mortality in Covid-19. We convened as experts from the Central and Eastern European region to consider what advice we can provide in the setting of type 2 diabetes and Covid-19, considering the evidence before, during and after infection. We review recommendations that have been published to date, and consider the best available-but currently limited-evidence from large observational studies and the DARE-19 randomized control trial. Notably, we find a lack of guidance on restarting patients on optimal antidiabetic therapy after recovering from Covid-19, and suggest that this may provide an opportunity to optimize treatment and counter clinical inertia that predates the pandemic. Furthermore, we emphasize that optimization applies not only to glycaemic control, but other factors such as cardiorenal protection. While we look forward to the emergence of new evidence that we hope will address these gaps, in the interim we provide a perspective, based on our collective clinical experience, on how best to manage glucose-lowering therapy as patients with Covid-19 recover from their disease and return to normal care.

Hybrid Closed-Loop Systems for the Treatment of Type 1 Diabetes: A Collaborative, Expert Group Position Statement for Clinical Use in Central and Eastern Europe.

In both pediatric and adult populations with type 1 diabetes (T1D), technologies such as continuous subcutaneous insulin infusion (CSII), continuous glucose monitoring (CGM), or sensor-augmented pumps (SAP) can consistently improve glycemic control [measured as glycated hemoglobin (HbA1c) and time in range (TIR)] while reducing the risk of hypoglycemia. Use of technologies can thereby improve quality of life and reduce the burden of diabetes management compared with self-injection of multiple daily insulin doses (MDI). Novel hybrid closed-loop (HCL) systems represent the latest treatment modality for T1D, combining modern glucose sensors and insulin pumps with a linked control algorithm to offer automated insulin delivery in response to blood glucose levels and trends. HCL systems have been associated with increased TIR, improved HbA1c, and fewer hypoglycemic events compared with CSII, SAP, and MDI, thereby potentially improving quality of life for people with diabetes (PwD) while reducing the costs of treating short- and long-term diabetes-related complications. However, many barriers to their use and regional inequalities remain in Central and Eastern Europe (CEE). Published data suggest that access to diabetes technologies is hindered by lack of funding, underdeveloped health technology assessment (HTA) bodies and guidelines, unfamiliarity with novel therapies, and inadequacies in healthcare system capacities. To optimize the use of diabetes technologies in CEE, an international meeting comprising experts in the field of diabetes was held to map the current regional access, to present the current national reimbursement guidelines, and to recommend solutions to overcome uptake barriers. Recommendations included regional and national development of HTA bodies, efficient allocation of resources, and structured education programs for healthcare professionals and PwD. The responsibility of the healthcare community to ensure that all individuals with T1D gain access to modern technologies in a timely and economically responsible manner, thereby improving health outcomes, was emphasized, particularly for interventions that are cost-effective.

Expert consensus on the practical aspects of the cooperation of cardiologist and diabetologist in the management of the patients with chronic heart failure and reduced ejection fraction.

Diabetes mellitus is an important risk factor for the development of heart failure and presence of diabetes significantly worsens heart failure outcome. Introduction of gliflozins to the therapy of heart failure is one of the most important novelty. Gliflozins reduce glucose level by the sodium-glucose contransporter 2 inhibition in proximal tubulus in the kidney. Gliflozins are used as effective antidiabetic drugs with improvement of glycemic control without risk of hypoglycemia, gliflozins decrease blood pressure and patients weight. Recent studies have shown that gliflozins significantly reduce risk of cardiovascular complications and heart failure hospitalizations in diabetic patients. Clinical trials with dapagliflozin and empagliflozin have shown reduction of the risk of cardiovascular death and heart failure hospitalization in the patients with heart failure and reduced ejection fraction both in the patients with diabetes and in the patients without diabetes. The aim of the expert consenzus is to summarize practical aspects in the cooperation of cardiologist and diabetologist in the management of the patients with heart failure and reduced ejection fraction in the context of the current guidelines and other treatment options.

The position of SGLT2 inhibitors in current medicine.

Cardiovascular disease is still the most common cause of mortality in patients with type 2 diabetes. Some prospective studies have produced unexpected results in connection with the requirements for the demonstration of cardiovascular safety of new antidiabetics, which have significantly expanded the treatment options for diabetes over the past 20 years. Although these studies were statistically designed to exclude excessive cardiovascular risk in patients with type 2 diabetes, some drugs have shown not only cardiovascular safety but also significant cardioprotective and nephroprotective effects in these studies. For the first time, a reduction in cardiovascular and overall mortality was demonstrated for the SGLT2 inhibitor empagliflozin in EMPA-REG OUTCOME trial in patients at very high cardiovascular risk. We already know that a beneficial effect on the risk of heart failure, but also renal failure, is a class effect in gliflozins. The revolutionary benefits of SGLT2 inhibitors are now perceived not only by diabetologists, but also by cardiologists and nephrologists. In European Society of Cardiology clinical guidelines, gliflozins even endanger the still unshakable position of metformin as the first line of antidiabetic therapy in patients with very high cardiovascular risk. Their indication should be today considered in all patients with type 2 diabetes and atherosclerosis, cardiac and renal failure regardless of diabetes control because they can reduce cardiovascular risk, risk of hospitalizations for heart failure and preserve glomerular filtration rate.

Real-time CGM Is Superior to Flash Glucose Monitoring for Glucose Control in Type 1 Diabetes: The CORRIDA Randomized Controlled Trial.

OBJECTIVE: The aim of this trial was to compare the efficacy of real-time and intermittently scanned continuous glucose monitoring (rtCGM and isCGM, respectively) in maintaining optimal glycemic control. RESEARCH DESIGN AND METHODS: In this randomized study, adults with type 1 diabetes (T1D) and normal hypoglycemia awareness (Gold score <4) used rtCGM (Guardian Connect Mobile) or isCGM (FreeStyle Libre) during 4 days of physical activity (exercise phase) and in the subsequent 4 weeks at home (home phase). Primary end points were time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) and time in range (3.9-10.0 mmol/L [70-180 mg/dL]). The isCGM group wore an additional masked Enlite sensor (iPro2) for 6 days to check for bias between the different sensors used by the rtCGM and isCGM systems. RESULTS: Sixty adults with T1D (mean age 38 ± 13 years; A1C 62 ± 12 mmol/mol [7.8 ± 1.1%]) were randomized to rtCGM (n = 30) or isCGM (n = 30). All participants completed the study. Percentage of time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) was lower among rtCGM versus isCGM participants in the exercise phase (6.8 ± 5.5% vs. 11.4 ± 8.6%, respectively; P = 0.018) and during the home phase (5.3 ± 2.5% vs. 7.3 ± 4.4%, respectively; P = 0.035). Hypoglycemia differences were significant and most notable during the night. rtCGM participants spent more time in range (3.9-10 mmol/L [70-180 mg/dL]) than isCGM participants throughout both the exercise (78.5 ± 10.2% vs. 69.7 ± 16%, respectively; P = 0.0149) and home (75.6 ± 9.7% vs. 67.4 ± 17.8%, respectively; P = 0.0339) phases. The results were robust to the insignificant bias between rtCGM and isCGM sensors that masked CGM found in the isCGM arm. CONCLUSIONS: rtCGM was superior to isCGM in reducing hypoglycemia and improving time in range in adults with T1D with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.

Incretin-Based Therapies Role in COVID-19 Era: Evolving Insights.

The current coronavirus disease 2019 (COVID-19) pandemic has led the scientific community to breach new frontiers in the understanding of human physiology and disease pathogenesis. It has been hypothesized that the human dipeptidyl peptidase 4 (DPP4) enzyme receptor may be a functional target for the spike proteins of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). Since DPP4-inhibitors are currently used for the treatment of patients with type-2 diabetes (T2DM), there is currently high interest in the possibility that these agents, or incretin-based therapies (IBTs) in general, may be of benefit against the new coronavirus infection. Diabetes is associated with increased COVID-19 severity and mortality, and accumulating evidence suggests that IBTs may favorably alter the clinical course of SARS-CoV-2 infection due to their inherent mechanisms of action. Further research into prognostic variables associated with various antidiabetic treatment regimens, and in particular the IBT, in patients with T2DM affected by the COVID-19 pandemic is therefore warranted.

Insulin Therapy in Adults with Type 1 Diabetes Mellitus: a Narrative Review.

Here, we review insulin management options and strategies in nonpregnant adult patients with type 1 diabetes mellitus (T1DM). Most patients with T1DM should follow a regimen of multiple daily injections of basal/bolus insulin, but those not meeting individual glycemic targets or those with frequent or severe hypoglycemia or pronounced dawn phenomenon should consider continuous subcutaneous insulin infusion. The latter treatment modality could also be an alternative based on patient preferences and availability of reimbursement. Continuous glucose monitoring may improve glycemic control irrespective of treatment regimen. A glycemic target of glycated hemoglobin < 7% (53 mmol/mol) is appropriate for most nonpregnant adults. Basal insulin analogues with a reduced peak profile and an extended duration of action with lower intraindividual variability relative to neutral protamine Hagedorn insulin are preferred. The clinical advantages of basal analogues compared with older basal insulins include reduced injection burden, better efficacy, lower risk of hypoglycemic episodes (especially nocturnal), and reduced weight gain. For prandial glycemic control, any rapid-acting prandial analogue (aspart, glulisine, lispro) is preferred over regular human insulin. Faster-acting insulin aspart is a relatively new option with the advantage of better postprandial glucose coverage. Frequent blood glucose measurements along with patient education on insulin dosing based on carbohydrate counting, premeal blood glucose, and anticipated physical activity is paramount, as is education on the management of blood glucose under different circumstances.Plain Language Summary: Plain language summary is available for this article.

Glycemic Outcomes in Adults With T1D Are Impacted More by Continuous Glucose Monitoring Than by Insulin Delivery Method: 3 Years of Follow-Up From the COMISAIR Study.

OBJECTIVE: This study assessed the clinical impact of four treatment strategies in adults with type 1 diabetes (T1D): real-time continuous glucose monitoring (rtCGM) with multiple daily insulin injections (rtCGM+MDI), rtCGM with continuous subcutaneous insulin infusion (rtCGM+CSII), self-monitoring of blood glucose with MDI (SMBG+MDI), and SMBG with CSII (SMBG+CSII). RESEARCH DESIGN AND METHODS: This 3-year, nonrandomized, prospective, real-world, clinical trial followed 94 participants with T1D (rtCGM+MDI, n = 22; rtCGM+CSII, n = 26; SMBG+MDI, n = 21; SMBG+CSII, n = 25). The main end points were changes in A1C, time in range (70-180 mg/dL [3.9-10 mmol/L]), time below range (<70 mg/dL [<3.9 mmol/L]), glycemic variability, and incidence of hypoglycemia. RESULTS: At 3 years, the rtCGM groups (rtCGM+MDI and rtCGM+CSII) had significantly lower A1C (7.0% [53 mmol/mol], P = 0.0002, and 6.9% [52 mmol/mol], P < 0.0001, respectively), compared with the SMBG+CSII and SMBG+MDI groups (7.7% [61 mmol/mol], P = 0.3574, and 8.0% [64 mmol/mol], P = 1.000, respectively), with no significant difference between the rtCGM groups. Significant improvements in percentage of time in range were observed in the rtCGM subgroups (rtCGM+MDI, 48.7-69.0%, P < 0.0001; and rtCGM+CSII, 50.9-72.3%, P < 0.0001) and in the SMBG+CSII group (50.6-57.8%, P = 0.0114). Significant reductions in time below range were found only in the rtCGM subgroups (rtCGM+MDI, 9.4-5.5%, P = 0.0387; and rtCGM+CSII, 9.0-5.3%, P = 0.0235). Seven severe hypoglycemia episodes occurred: SMBG groups, n = 5; sensor-augmented insulin regimen groups, n = 2. CONCLUSIONS: rtCGM was superior to SMBG in reducing A1C, hypoglycemia, and other end points in individuals with T1D regardless of their insulin delivery method. rtCGM+MDI can be considered an equivalent but lower-cost alternative to sensor-augmented insulin pump therapy and superior to treatment with SMBG+MDI or SMBG+CSII therapy.

Evidence from routine clinical practice: EMPRISE provides a new perspective on CVOTs.

EMPA-REG OUTCOME is recognised by international guidelines as a landmark study that showed a significant cardioprotective benefit with empagliflozin in patients with type 2 diabetes (T2D) and cardiovascular disease. To assess the impact of empagliflozin in routine clinical practice, the ongoing EMPRISE study is collecting real-world evidence to compare effectiveness, safety and health economic outcomes between empagliflozin and DPP-4 inhibitors. A planned interim analysis of EMPRISE was recently published, confirming a substantial reduction in hospitalisation for heart failure with empagliflozin across a diverse patient population. In this commentary article, we discuss the new data in the context of current evidence and clinical guidelines, as clinicians experienced in managing cardiovascular risk in patients with T2D. We also look forward to what future insights EMPRISE may offer, as evidence is accumulated over the next years to complement the important findings of EMPA-REG OUTCOME.

Use of epidemiological analyses in Clinical Practice Guideline development focused on the diabetic patients treated with insulin.

The prevalence of diabetes is on the rise worldwide especially in developed countries. The aim of glucose management in all types of diabetes is to minimize chronic and acute complications associated with diabetes. All patients with type 1 diabetes mellitus (T1DM) require insulin. Main areas of technology advances in diabetes are continuous subcutaneous insulin infusion (CSII) and also continuous glucose monitoring systems for the management of patients with both types of diabetes. It is very important to analyse the epidemiological situation within each country before and during the clinical practice guidelines (CPGs) development and implementation. The analyses will allow us to monitor the effect of the CPG after its implementation.The aim of this short communication is to analyse the epidemiology of prevalence and incidence of diabetes mellitus and use of CSII to inform development of CPGs in the Czech Republic.The analysis is developed based on the data managed by Institute of Health Information and Statistics of the Czech Republic. We used the National Register of Reimbursed Health Services 2015-2017 as primary source, and the annual report type A (Ministry of Health) 1-01: for Diabetology (A MH 004) 2007-2017 was used as validation source. The presented data are related to the year 2016 because we were able to validate them based on the data from 2015 to 2017 for this cohort of patients.The number of patients with T1DM is increasing in the Czech Republic with no significant sex difference. Life expectancy is about 11 years lower in the T1DM population. The majority of the patients are in older age; however, these are not treated with CSII compared with the younger population. From 61 533 patients with T1DM, 81% were reported with acute and chronic complications in 2016. Only 5011 of these patients were reported as using CSII.