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Virginia Bellido,1 Natalia Duque,2 Rachel S Newson,3 Esther Artime,2 Erik Spaepen,4 Miriam Rubio de Santos,2 Jennifer Redondo-Antón,2 Silvia Díaz-Cerezo,2 Jorge Navarro5 1Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Universitario Virgen del Rocío, Sevilla, Spain; 2Medical Department, Medical Affairs, Eli Lilly and Company, Madrid, Spain; 3NAPAC Real World Evidence, Medical Affairs, Eli Lilly and Company, Sydney, NSW, Australia; 4Statistics, HaaPACS GmbH, Schriesheim, Germany; 5Department of Medicine, University of Valencia, Valencia, SpainCorrespondence: Natalia Duque, Eli Lilly and Company, Alcobendas, Madrid, Spain, Email duque_natalia@lilly.comBackground: This study aimed to determine physicians’ perceptions of the extent of suboptimal insulin dosing and the barriers and solutions to optimal dosing in people with diabetes (PwD) treated with insulin.Methods: A cross-sectional online survey was conducted in four countries with primary care physicians and endocrinologists treating PwD using insulin pens, which included 53 questions on physicians’ characteristics and their perceptions of the behaviors of PwD in relation to insulin dosing routines, unmet needs and potential solutions. Analyses were descriptive.Results: Of the 160 physicians (80 primary care physicians, 80 specialists) surveyed in Spain, 58.1% were male and 88.8% had been qualified to practice for more than five years. Most physicians (> 65%) indicated that 0– 30% of PwD missed or skipped, mistimed, or miscalculated an insulin dose in the last 30 days. Common reasons for these actions were that PwD forgot, were out of their normal routine, were too busy or distracted, or were unsure of how much insulin to take. To optimize insulin dosing, over 75% of physicians considered it very helpful for PwD to have real-time insulin dosing calculation guidance, mobile app reminders, a device automatically recording glucose measurements and/or insulin, having insulin and glucose data in one place, and having the time for more meaningful conversations about insulin dosing routines.Conclusion: According to physicians’ perspectives, suboptimal insulin dosing remains common among PwD. This survey highlights the need for integrated and automated insulin dosing support to manage the complexity of insulin treatment, improve communications between PwD and physicians, and ultimately improve outcomes for PwD.Plain Language Summary: In Spain, more than 50% of people with diabetes (PwD) do not reach glycemic targets (glycated hemoglobin [HbA1C] under 7%). While there are many innovations in insulin therapy and device technology, treatment adherence is often poor.This study presents results from an online survey of physicians’ perceptions of insulin dosing and the barriers and solutions to optimal insulin dosing in Spain. Most physicians indicated that PwD missed or skipped, mistimed, or miscalculated an insulin dose. Common reasons included PwD being out of their normal routine, being too busy or distracted, or being unsure of how much insulin to take. To improve insulin dosing, physicians suggested real-time insulin dosing calculation guidance, mobile app reminders, and a device that automatically records glucose measurements and insulin. Furthermore, having time for more meaningful conversations about insulin dosing routines was found as a solution to improve insulin dosing.There is a need for integrated and automated insulin dosing support to manage insulin treatment, improve communications between PwD and physicians, and improve outcomes for PwD.Keywords: diabetes mellitus, type 1 diabetes mellitus, type 2 diabetes mellitus, insulin dosing, physicians, Spain, barriers, solutions

Background: The International Study of Wheezing in Infants defines recurrent wheezing as the presence of three or more medically documented episodes of wheezing within one year. To date, there is no evidence on the use of hypertonic saline (HS) combined with airway clearance techniques (ACT) for children with recurrent wheezing treated in an outpatient setting. Therefore, this is the first study to explore the use of such interventions in infants with recurrent wheezing., Objectives: To evaluate the effects and safety of a three-month protocol including HS and ACT for non-hospitalized infants with recurrent wheezing., Methods: Randomized, double-blind, controlled trial, including outpatient infants with recurrent wheezing. Children were randomized to either 3% HS or 0.9% saline groups and were treated with bronchodilator and nebulized with the respective solutions before ACT. The primary outcome was the Wang score. Secondary outcomes included the number of hospitalizations and respiratory crisis, need for rescue medication, and school absences. All variables were measured during the three previous months from inclusion and during intervention period. The study protocol was registered at ClinicalTrials.gov (NCT04331496) on March, 31, 2020., Results: Forty children were included. Regarding immediate effects, significant differences ( p < 0 . 001 ) were found for time, but not for group or interaction (group × time), in all outcome variables (increase in SpO 2 , decrease in heart and respiratory rate, wheezing episodes, retraction, and Wang score). Comparing the previous three months with the study period, there were significant differences in both groups for the severity of crisis ( p < 0 . 001 ) and medication steps ( p = 0 . 002 )., Conclusion: A three-month protocol including HS and ACT for outpatient infants with recurrent wheezing was safe and reduced morbidity. No differences were found between the use of HS and 0.9% saline., Competing Interests: The authors have no conflicts of interest to disclose., (© 2023, Hong Kong Physiotherapy Association.)

New metrics for assessing glycemic control beyond HbA1c have recently emerged due to the increasing use of continuous glucose monitoring (CGM) in diabetes clinical practice. Among them, time in range (TIR) has appeared as a simple and intuitive metric that correlates inversely with HbA1c and has also been newly linked to the risk of long-term diabetes complications. The International Consensus on Time in Range established a series of target glucose ranges (TIR, time below range and time above range) and recommendations for time spent within these ranges for different diabetes populations. These parameters should be evaluated together with the ambulatory glucose profile (AGP). Using standardized visual reporting may help people with diabetes and healthcare professionals in the evaluation of glucose control in frequent clinical situations. The objective of the present review is to provide practical insights to quick interpretation of patient-centered metrics based on flash glucose monitoring data, as well as showing some visual examples of common clinical situations and giving practical recommendations for their management.

Background: Diabetes is one of the most prevalent chronic diseases worldwide, and innovative patient support programmes can help and inform patients about their disease and improve their quality of life. The purpose of this study was to evaluate the effect of the T-Coach programme in terms of improvement of disease knowledge, self-management and adherence to treatment in a real-world setting in Spain between July 2016 and October 2018., Methods: We analyzed data from the T-Coach programme, a telephone platform that gives support to patients with type 2 diabetes mellitus treated with insulin glargine 300 U/ml (Gla-300). Support was provided by diabetes care nurses. Patients followed their treatment and aimed to achieve fasting blood glucose targets through diabetes education., Results: A total of 479 patients were included in the programme. The mean (SD) dose of Gla-300 was 28.5 (16.3) U at baseline and 31.8 (16.1) U, 31.4 (16.4) U and 32.2 (16.3) U, respectively, at 3, 6 and 12 months. A satisfaction survey was completed by 240 (50.1%) patients, who, on average, were very highly satisfied with the programme, general assistance provided, recommendations received, and calls from nurses., Conclusions: T-Coach could be an effective tool to help patients achieve their optimal dose of Gla-300 insulin and manage their blood glucose levels. It could also act as an effective support for diabetes education., Competing Interests: Disclosure and potential conflicts of interest: VB has received consulting fees, honoraria for lectures, and support for attending meetings and/or travel from Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Esteve, Janssen, Merck, Mundipharma, Novartis, Novo Nordisk, Roche and Sanofi. CM has received honoraria for lectures and participated on the advisory board for Novo Nordisk, Eli Lilly, Boehringer Ingelheim, Abbott, Sanofi, AstraZeneca, MSD and Amgen. BGA has received honoraria for lectures and support for attending meetings and/or travel from Novo Nordisk, Eli Lilly, Abbott, Fresenius and Nutricia. MLdlT has received grants and contracts from Eli Lilly as well as honoraria for lectures and support for attending meetings and/or travel from Novo Nordisk, Eli Lilly, Novartis, Sanofi, MSD, Boehringer Ingelheim, AstraZeneca, Esteve, Abbott, Amgen and Mundipharma. DB has received honoraria for lectures and support for attending meetings and/or travel and participated on the advisory board for Sanofi, Novo Nordisk, Abbott, Eli Lilly, Boehringer Ingelheim, Persan Pharma and Menarini. DB has also participated in a leadership role on boards or committees for SEEDO (Sociedade Española de Obesidad) and SEEN (Sociedad Española de Endocrinología y Nutrición). AMG, JMG and JLFM declare that they have no conflicts of interest. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2023/04/dic.2023-1-1-COI.pdf, (Copyright © 2023 Bellido V, Morales C, Muñoz Garach A, García Almeida JM, Fernández Morera JL, González Aguilera B, López de la Torre M, Bellido D.)

Disease-related malnutrition (DRM) affects approximately a third of hospitalized patients and is associated with an increased risk of morbimortality. However, DRM is often underdiagnosed and undertreated. Our aim is to evaluate the prognostic value of morphofunctional tools and tests for nutritional assessment in clinical practice. A systematic literature review was conducted to identify studies relating to the morphofunctional assessment of nutritional status and mortality or complications. Evidence was evaluated using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) method. Twelve GRADE recommendations were made and divided into seven topics: food intake and nutrient assimilation, anthropometry, biochemical analysis, hand grip strength, phase angle, muscle imaging, and functional status and quality of life. From these recommendations, 37 statements were developed and scored in a two-survey Delphi method by 183 experts. A consensus was reached on accepting 26/37 statements. Surveys had high internal consistency and high inter-rater reliability. In conclusion, evidence-based recommendations were made on the prognostic value of morphofunctional assessment tools and tests to assess malnutrition, most of which were found to be feasible in routine clinical practice, according to expert opinions.

Objectives: The aim of this study is to investigate in depth diabetes mellitus associated with immune checkpoint inhibitors (DM-ICIs) by analysing a case series. We also evaluated the clinical impact of flash glucose monitoring (FGM) systems in the management of this entity., Methods: We conducted an observational cohort study of DM-ICIs diagnosed in two hospitals in Seville (Spain). Patients with a new diagnosis of diabetes mellitus (DM) or with sudden worsening of preexisting DM after starting treatment with ICIs, with a random 5 hour-postprandial C-peptide value of <0.6 nmol/L and without possibility of subsequent withdrawal of insulin treatment, were included., Results: A total of 7 cases were identified, mostly males ( n = 6; 85.7%), with a mean age of 64.9 years. The mean glycated hemoglobin (HbA1c) upon diagnosis was 8.1%, with diabetic ketoacidosis (DKA) observed in 6 cases (85.7%). Subcutaneous flash glucose monitoring (FGM) systems were used in six cases, with a mean follow-up period of 42.7 weeks. During the first 90 days of use, mean average glucose was 167.5 mg/dL, with a coefficient of variation (CV) of 34.6%. The mean time in the range 70-180 mg/dL (TIR) was 59.7%, with a mean time above range (TAR) 181-250 mg/dL of 27.8% and a mean TAR > 250 mg/dL of 10.2%. The mean time below range (TBR) 54-69 mg/dL was 2%, while the mean TBR < 54 mg/dL was 0.3%. The mean glucose management indicator (GMI) was 7.3%. No significant differences were observed in FGM values for the following 90 days of follow-up. A progressive improvement in all parameters of glycaemic control was observed between the first month of FGM use and the sixth month of FGM use. Of note, there was a decrease in mean CV (40.6% to 34.1%, p = 0.25), mean TAR 181-250 (30.3% to 26%, p = 0.49), mean TAR > 250 mg/dL (16.3% to 7.7%, p = 0.09), mean TBR 54-69 mg/dL (5.2% to 2%, p = 0.16), and mean TBR < 54 mg/dL (1.8% to 0.2%, p = 0.31), along with an increase in mean values of TIR 70-180 mg/dL (46.5% to 60.5%, p = 0.09). The lack of statistical significance in the differences observed in the mean FGM values over the follow-up period may be related to the small sample size., Conclusion: DM-ICI is recognised by a state of sudden-onset insulinopenia, often associated with DKA. The use of FGM systems may be a valid option for the effective management of DM-ICIs and for the prevention of severe hyperglycaemic and hypoglycaemic episodes in this condition., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2022 Pablo Rodríguez de Vera-Gómez et al.)

Type 2 diabetes (T2D) is a complex disease for which an individualised treatment approach is recommended. Once-weekly (OW) semaglutide is a glucagon-like peptide-1 receptor agonist approved for the treatment of insufficiently controlled T2D. The aim of this study was to investigate the use of OW semaglutide in adults with T2D in a real-world context. SURE Spain, from the 10-country SURE programme, was a prospective, multicentre, open-label, observational study, approximately 30 weeks in duration. Adults with T2D and ≥1 documented HbA 1c value ≤12 weeks before semaglutide initiation were enrolled. Change in HbA 1c from baseline to end of study (EOS) was the primary endpoint, with change in body weight (BW), waist circumference, and patient-reported outcomes as secondary endpoints. Of the 227 patients initiating semaglutide, 196 (86.3%) completed the study on-treatment with semaglutide. The estimated mean changes in HbA 1c and body weight between baseline and EOS were -1.3%-points (95% confidence interval (CI) -1.51;-1.18%-points) and -5.7 kg (95% CI -6.36;-4.98 kg). No new safety concerns were identified. Therefore, in routine clinical practice in Spain, OW semaglutide was shown to be associated with statistically significant and clinically relevant reductions in HbA 1c and BW in adults with T2D.

Background: This study aims to evaluate dapagliflozin in patients with type 2 diabetes (T2D) in clinical practice in Spain., Methods: This is a retrospective study including adults with T2D under stable antidiabetic therapy, with either dapagliflozin or sitagliptin ≥6 months, before inclusion. Data about the effectiveness and safety of dapagliflozin are presented., Results: A total of 594 patients (61.8±9.9 years, 21.7% cardiovascular disease) were included. After 6 months, HbA1c, weight, blood pressure, urine albumin-to-creatinine ratio and uric acid significantly decreased (1.63%, 2.88 kg, 4.82/2.70 mmHg, -17.38 mg/g and -0.30 mg/dL, respectively), whereas glomerular filtration rate and haematocrit significantly increased (3.72 mL/min/1.73 m 2 and 1.8%, respectively). No cases of hypoglycaemia, diabetic ketoacidosis, Fournier gangrene, fractures or amputations were reported., Conclusion: Thus, dapagliflozin provides a comprehensive cardiometabolic protection in patients with T2D., Competing Interests: Disclosure and potential conflicts of interest: This work was supported by AstraZeneca. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2022/01/dic.2021-11-5-COI.pdf, (Copyright © 2022 Morales C, Merino-Torres JF, Moreno-Moreno P, Lainez M, Tejado I, Yoldi A, Gutiérrez Medina S, Soto A, Botana MA, Bellido V, Caballero I.)

Background: Despite major medical advances, Type 1 Diabetes (T1D) patients still have greater morbimortality than the general population. Our aim was to describe our cohort of T1D patients and identify potential risk factors susceptible to prevention strategies., Methods: Cross-sectional, observational study, including T1D patients treated at our center, from 1 March 2017 to 31 March 2020., Inclusion Criteria: T1D, age > 14 years and signed informed consent., Exclusion Criteria: diabetes other than T1D, age < 14 years and/or refusal to participate., Results: Study population n = 2181 (49.8% females, median age at enrollment 41 years, median HbA1c 7.7%; 38.24% had at least one comorbidity). Roughly 7.45% had severe hypoglycemia (SH) within the prior year. Macro/microvascular complications were present in 42.09% (5.83% and 41.14%, respectively). The most frequent microvascular complication was diabetic retinopathy (38.02%), and coronary disease (3.21%) was the most frequent macrovascular complication. The risk of complications was higher in males than in females, mainly macrovascular. Patients with SH had a higher risk of complications (OR 1.42; 1.43 in males versus 1.42 in females)., Conclusions: Our T1D population is similar to other T1D populations. We should minimize the risk of SH, and male patients should perhaps be treated more aggressively regarding cardiovascular risk factors.

Diabetes mellitus (DM) is one of the most common comorbid conditions in persons with COVID-19 and a risk factor for poor prognosis. The reasons why COVID-19 is more severe in persons with DM are currently unknown although the scarce data available on patients with DM hospitalized because of COVID-19 show that glycemic control is inadequate. The fact that patients with COVID-19 are usually cared for by health professionals with limited experience in the management of diabetes and the need to prevent exposure to the virus may also be obstacles to glycemic control in patients with COVID-19. Effective clinical care should consider various aspects, including screening for the disease in at-risk persons, education, and monitoring of control and complications. We examine the effect of COVID-19 on DM in terms of glycemic control and the restrictions arising from the pandemic and assess management of diabetes and drug therapy in various scenarios, taking into account factors such as physical exercise, diet, blood glucose monitoring, and pharmacological treatment. Specific attention is given to patients who have been admitted to hospital and critically ill patients. Finally, we consider the role of telemedicine in the management of DM patients with COVID-19 during the pandemic and in the future.

Telemedicine in diabetes care has been evolving over several years, particularly since the advent of cloud-connected technologies for diabetes management, such as glucose monitoring devices, including continuous glucose monitoring (CGM) systems, that facilitate sharing of glucose data between people with diabetes and their healthcare professionals in near-real time. Extreme social distancing and shielding in place for vulnerable patients during the COVID-19 pandemic has created both the challenge and the opportunity to provide care at a distance on a large scale. Available evidence suggests that glucose control has in fact improved during this period for people with diabetes who are able to use CGM devices for remote glucose monitoring. The development of telemedicine as part of the standard of care in diabetes faces significant challenges in the European context, particularly in terms of providing consistent and effective care at a distance to large populations of patients while using robust systems that can be supported by large regional and national healthcare services. These challenges include a fragmented approach to healthcare technology assessment and reimbursement, lack of eHealth education and literacy, particularly amongst healthcare professionals, lack of data integration, as well as concerns about electronic health records, patient consent and privacy. Here we review the benefits of and challenges to wider application of telemedicine and telemonitoring in the post-pandemic future, with the aim to ensure that the value of these eHealth services is provided to patients, healthcare providers and health systems., (© 2021. The Author(s).)

Background: Weight reduction and glycemic control are key goals during Type 2 diabetes management. However, there are few country-specific, real-world data on cotransporter 2 inhibitors. Materials & methods: DAPA-RWE was a retrospective, multicenter study comparing the efficacy of dapagliflozin versus sitagliptin in Type 2 diabetes patients in Spain. Results: The study population comprised 1046 patients (594 with dapagliflozin, 452 with sitagliptin). Age was 61.8 ± 10.0 and 66.2 ± 11.4 years and glycosylated hemoglobin (HbA1c) 8.9 and 8.8%, respectively. The main end point (reduction in weight and HbA1c) was reached by 24.4 and 56.1% of patients, respectively; p < 0.05. This was confirmed with a propensity score matching analysis balanced for obesity-related variables at baseline. Conclusion: DAPA-RWE confirmed dapagliflozin to be more effective than sitagliptin in reducing HbA1c and weight.

Background: No studies have investigated the use and safety of high-frequency chest wall compression (HFCWC) for non-hospitalized infants with acute viral bronchiolitis (AVB). The aim of the present study was to evaluate the immediate effects and safety of HFCWC as compared to airway clearance techniques in children with AVB., Methods: In this randomized clinical trial in non-hospitalized infants (0-12 months old) with mild to moderate AVB, children were randomized into 2 groups: airway clearance techniques (20 min of prolonged slow expiration and provoked cough) or HFCWC (15 min). A single session was performed and children were evaluated at baseline and at 10 min and 20 min after treatments. Outcomes measures were the Wang severity score, [Formula: see text], sputum wet-weight, and the presence of adverse events., Results: A total of 91 infant subjects, mean age 7.9 ± 2.6 months, were included. Significant ( P = .004) between-group differences were found in the Wang score, which was 0.28 points lower in the airway clearance techniques group. There was a greater increase of infants classified as normal and a greater decrease of those classified as mild according to the Wang score when airway clearance techniques were used compared to the use of HFCWC ( P = .009). The sputum wet-weight was lower in subjects treated with the airway clearance techniques ( P < .001). Although [Formula: see text]improved in both groups, no differences were found between them. There was also no difference for adverse events, and the majority of children did not present any adverse events after 20 min., Conclusions: The use of HFCWC induced similar clinical effects as airway clearance techniques and was safe for non-hospitalized infants with AVB. Both techniques reduced respiratory symptoms and acutely improved [Formula: see text]. (ClinicalTrials.gov: NCT03835936.)., Competing Interests: Dr Donadio is supported in part by Coordenação de Aperfeiçoamento de Pessoal de Nível Superior and Conselho Nacional de Desenvolvimento Científico e Tecnológico. The other authors have disclosed no conflicts of interests., (Copyright © 2021 by Daedalus Enterprises.)

Diabetes is one of the most common comorbidities in hospitalized patients with coronavirus disease 2019 (COVID-19). Inpatient hyperglycemia during this pandemic has been associated with worse outcomes, so it is mandatory to implement effective glycemic control treatment approaches for inpatients with COVID-19. The shortage of personal protective equipment, the need to prevent staff exposure, or the fact that many of the healthcare professionals might be relatively unfamiliar with the management of hyperglycemia may lead to worse glycemic control and, consequently, a worse prognosis. In order to reduce these barriers, we intend to adapt established recommendations to manage hyperglycemia during this pandemic in critical and noncritical care settings.

Introduction: Compare cost of the interstitial liquid glucose flash monitoring (FM) system (FreeStyle Libre 2) versus self-monitoring of blood glucose (SMBG) in adults with type 1 diabetes mellitus (T1DM) in Spain., Research Design and Methods: A model was developed to estimate, with the perspective of the Spanish health system, the annual costs associated with glucose monitoring and hypoglycemic events management in T1DM population, with multiple insulin daily doses (MDI). According to published evidence, rate of severe hypoglycemia (SHE) of 4.90 episodes per patient-year was applied. Reduction of SHE (58.6%) was modeled associated with FM use. Published rates of hospital care (20.2%) and subsequent admission (16%) were assumed for SHE. The daily consumption of strips and lancets was 9 in patients with SMBG (before and after 4 daily intakes and at bedtime) and 0.5 for FM users (according to IMPACT trial findings). Annual consumption of 26 FM sensors was considered (1 every 14 days). Unit costs (in € of 2019, excluding VAT) were obtained from literature and national databases. Sensitivity analyses (SA) were carried out to evaluate the model robustness., Results: The total annual cost/patient was €4437 for SMBG and €2526 for FM. The use of FM would be associated with an annual savings in the costs of monitoring and managing hypoglycemic events of €1911 per patient-year. In a hypothetical cohort of 1000 patients with T1DM MDI, FM could avoid in 1 year 4900 SHE, 93 hospitalizations for SHE. In addition, the use of FM would generate total savings of up to €1 910 000 per year. In the SA with alternative hypoglycemia events rates and use of strips and lancets, and including non-SHE episodes, savings from €370 000 to €1 760 000 were observed with FM., Conclusions: The use of the FM system to monitor glucose in adults with T1DM treated with MDI, would reduce hypoglycemic events and would result in cost savings for the health system., Competing Interests: Competing interests: Abbott Diabetes Care provided unconditioned financial support for performing the analysis. IO is an employee of PORIB, a consultant specialized in the economic evaluation of healthcare interventions, who provided technical and editorial support for conducting the study. FG-P, JFM-T, MB, FM-P, VB and RC-H received payment from Abbott Diabetes Care for consultant activities related to validation of the parameters and results. None of them received financial compensation for review and co-authorship of this manuscript. All the authors contributed to interpretation of the results and reviewed and approved the final version of the manuscript., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The flash glucose monitoring (FGM) system FreeStyle Libre® is a device that measures interstitial glucose in a very simple way and indicates direction and speed of glucose change. This allows persons with diabetes to prevent hypoglycemic and hyperglycemic events. Scientific evidence indicates that the system can improve glycemic control and quality of life. To obtain the maximum benefit, it is necessary to properly handle glucose values and trends. Due to the generalization of the system use, the purpose of the document is to provide recommendations for the optimal use of the device, not only in the management of glucose values and trends but also in the prevention of hypoglycemia, actuation in exercise, special situations, and retrospective analysis of the glucose data, among others.

Objective: Premixed insulin is a commonly prescribed formulation for the outpatient management of patients with type 2 diabetes. The safety and efficacy of premixed insulin formulations in the hospital setting is not known., Research Design and Methods: In a prospective, open-label trial, we randomized general medicine and surgery patients to receive a basal-bolus regimen with glargine once daily and glulisine before meals (n = 33) or premixed human insulin (30% regular insulin and 70% NPH insulin) twice daily (n = 39). Major outcomes included differences in daily blood glucose (BG) levels and frequency of hypoglycemic events (<70 mg/dL) between treatment groups., Results: At the first prespecified interim analysis, the study was stopped early because of an increased frequency of hypoglycemia >50% in patients treated with premixed human insulin. A total of 64% of patients treated with premixed insulin experienced one or more episodes of hypoglycemia compared with 24% in the basal-bolus group (P < 0.001). There were no differences in mean daily BG level after the first day of insulin treatment (175 ± 32 vs. 179 ± 43 mg/dL, P = 0.64) between groups. A BG target between 80 and 180 mg/dL before meals was achieved in 55.9% of BG readings in the basal-bolus group and 54.3% of BG readings in the premixed insulin group (P = 0.23). There was no difference in the length of hospital stay or mortality between treatment groups., Conclusions: Inpatient treatment with premixed human insulin resulted in similar glycemic control but in significantly higher frequency of hypoglycemia compared with treatment with basal-bolus insulin regimen in hospitalized patients with diabetes., (© 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.)