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This consensus statement is a comprehensive update of the 2010 Society for Ambulatory Anesthesia (SAMBA) Consensus Statement on perioperative blood glucose management in patients with diabetes mellitus (DM) undergoing ambulatory surgery. Since the original consensus guidelines in 2010, several novel therapeutic interventions have been introduced to treat DM, including new hypoglycemic agents and increasing prevalence of insulin pumps and continuous glucose monitors. The updated recommendations were developed by an expert task force under the provision of SAMBA and are based on a comprehensive review of the literature from 1980 to 2022. The task force included SAMBA members with expertise on this topic and those contributing to the primary literature regarding the management of DM in the perioperative period. The recommendations encompass preoperative evaluation of patients with DM presenting for ambulatory surgery, management of preoperative oral hypoglycemic agents and home insulins, intraoperative testing and treatment modalities, and blood glucose management in the postanesthesia care unit and transition to home after surgery. High-quality evidence pertaining to perioperative blood glucose management in patients with DM undergoing ambulatory surgery remains sparse. Recommendations are therefore based on recent guidelines and available literature, including general glucose management in patients with DM, data from inpatient surgical populations, drug pharmacology, and emerging treatment data. Areas in need of further research are also identified. Importantly, the benefits and risks of interventions and clinical practice information were considered to ensure that the recommendations maintain patient safety and are clinically valid and useful in the ambulatory setting. What Other Guidelines Are Available on This Topic? Since the publication of the SAMBA Consensus Statement for perioperative blood glucose management in the ambulatory setting in 2010, several recent guidelines have been issued by the American Diabetes Association (ADA), the American Association of Clinical Endocrinologists (AACE), the Endocrine Society, the Centre for Perioperative Care (CPOC), and the Association of Anaesthetists of Great Britain and Ireland (AAGBI) on DM care in hospitalized patients; however, none are specific to ambulatory surgery. How Does This Guideline Differ From the Previous Guidelines? Previously posed clinical questions that were outdated were revised to reflect current clinical practice. Additional questions were developed relating to the perioperative management of patients with DM to include the newer therapeutic interventions., Competing Interests: Conflicts of Interest: See Disclosures at the end of the article., (Copyright © 2024 International Anesthesia Research Society.)

Competing Interests: SS is on the advisory boards of the following companies: Abbott, Dexcom, Menarini, Medtronic, Roche, Sanofi, Lilly, Glooko and received speaking fees from Berlin-Chemie, Dexcom, Lilly, Medtronic, Menarini, Novo, Roche.DD received remuneration from Ascensia Diabetes, Insulet, Roche Diagnostics and is a member of the Advisory Boards of Ascensia Diabetes, Glooko, Lilly.BG has received speaking and consulting fees from Ascensia, Dexcom, Diabeloop, Insulet, Lilly, Novartis, NovoNordisk, Medtronic, Roche, Vitalaire. KL states that she has served on Advisory Boards of Abbott, Roche Diabetes Care and Biomarin within the past 3 years, and has also received speaking honoraria from Astra Zeneca, BDI, BioMarin, Chiesi, Fachkommission Bayern, Glooko, Insulet, Lilly Deutschland, Medtronic, Menarini Berlin Chemie, Merck Serono, MSD SHARP & DOHME, NovoNordisk, Roche Diabetes Care, Sanofi-Aventis.SVS has participated in Advisory Boards of: Abbott, Dexcom, Insulet, Lilly, Medtronic and Novo Nordisk. SVS has received speaking fees from Abbott, Berlin-Chemie, Dexcom, Hexal/Sandoz, Infectopharm, Lilly, Medtronic, Merck-Serono, Novo Nordisk and Sanofi-Aventis.AT is an independent consultant, expert in CGM systems and diabetes technology, until April 2020 he was the scientific director of Medtronic Diabetes Germany, since then he has received grants and lecture fees from the companies Evivamed, Dexcom, Abbott, Berlin-Chemie, Novo-Nordisk, Sanofi.RZ is a member of the Advisory Boards of the following companies: Abbott, Dexcom, MySugr, NovoNordisk, Roche Diabetes Care and Vertex, and received speaking fees from Abbott, Dexcom, Glooko, Medtronic, NovoNordisk and Roche Diabetes Care as well as VitalAire.GF is general manager and medical director of the Institute for Diabetes Technology, Research and Development Company at the University of Ulm, Ulm, Germany, which carries out clinical studies e.g. with medical devices for diabetes therapy on its own initiative and on behalf of various companies.GF/IfDT have received research support, speakers’ honoraria or consulting fees in the last 3 years from Abbott, Ascensia, Berlin Chemie, Boydsense, Dexcom, Lilly Deutschland, Novo Nordisk, Perfood, Pharamsens, Roche, Sinocare, Terumo, Ypsomed.

Background: While glucometric benchmarking has been used to compare glucose management between institutions, the value of longitudinal intra-institution benchmarking to assess quality improvement changes is not established., Methods: A prospective six-month observational study (October 2019-March 2020 inclusive) of inpatients with diabetes or newly detected hyperglycemia admitted to eight medical and surgical wards at the Royal Melbourne Hospital. Networked blood glucose (BG) meters were used to collect capillary BG levels. Outcomes were measures of glycemic control assessed by mean and threshold glucometric measures and comparison with published glucometric benchmarks. Intra-institution comparison was over the 2016-2020 period., Results: In all, 620 admissions (588 unique individuals) met the inclusion criteria, contributing 15 164 BG results over 4023 admission-days. Compared with the 2016 cohort from the same institution, there was increased BG testing (3.8 [SD = 2.2) vs 3.3 [SD = 1.7] BG measurements per patient-day, P < .001), lower mean patient-day mean glucose (PDMG; 8.9 mmol/L [SD = 3.2] vs 9.5 mmol/L [SD = 3.3], P < .001), and reduced mean and threshold measures of hyperglycemia ( P < .001 for all). Comparison with institutions across the United States revealed lower incidence of mean PDMG >13.9 or >16.7 mmol/L, and reduced hypoglycemia (<3.9, <2.8, and <2.2 mmol/L), when compared with published benchmarks from an earlier period (2009-2014)., Conclusions: Comprehensive digital-based glucometric benchmarking confirmed institutional quality improvement changes were followed by reduced hyperglycemia and hypoglycemia in a five-year comparison. Longitudinal glucometric benchmarking enables evaluation and validation of changes to institutional diabetes care management practices., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective: The prevalence of depression among adolescents with type 1 diabetes is estimated to be 2-3 times higher than in the general population. In adults with type 1 diabetes and depression, short-term outcomes are worse compared to individuals just diagnosed with type 1 diabetes. This study aims to determine if depressive symptom endorsement is associated with glycemic outcomes and short-term complications in adolescents with type 1 diabetes., Research Design and Methods: Analysis was conducted using electronic medical records from the T1D Exchange Quality Improvement Collaborative. Adolescents with type 1 diabetes, aged 12-18, receiving treatment in a diabetes clinic who had been screened for depression with the PHQ-9 between 2016 and 2018 were eligible for inclusion. Individuals must have also had HbA1c data available from the day of depression screening and from 10 to 24 weeks after screening; the final sample size was 1714., Results: Almost 30% of adolescents endorsed mild or greater (PHQ-9 ≥ 5) depressive symptoms. Endorsement of mild or greater depressive symptoms was associated with an 18% increased risk of an HbA1c ≥7.5% and a 42% increased risk of an HbA1c ≥9.0% on the day of screener administration. Depressive symptom endorsement was also associated with an 82% increased risk for DKA., Conclusions: This study suggests that depression symptoms are associated with an increased risk for elevated HbA1c and short-term complications. With the rising incidence of type 1 diabetes in youth, routine screening, and appropriate management of depression is needed., (© 2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Blood glucose levels during pregnancy may reflect the severity of insulin secretory defects and/or insulin resistance during gestational diabetes mellitus (GDM) pregnancy. We hypothesized that suboptimal glycemic control in women with GDM could increase the risk of postpartum type 2 diabetes mellitus (T2DM) or prediabetes. Our objective was to evaluate the impact of plasma glucose levels throughout GDM pregnancy on the risk of postpartum T2DM or prediabetes., Methods: The medical records of 706 women with GDM who underwent a postpartum 75-g, 2-hour oral glucose tolerance test at our institution between January 2011 and December 2018 were reviewed. These women were classified into 2 groups according to glycemic control during pregnancy: ≤ 1 occasion of either fasting glucose ≥ 95 mg/dL or 2-hour postprandial glucose ≥ 120 mg/dL was defined as optimal glycemic control or else was classified as suboptimal glycemic control. Rates of postpartum T2DM and prediabetes were compared between women with optimal (n = 505) and suboptimal (n = 201) glycemic control., Results: The rates of postpartum T2DM and prediabetes were significantly higher in the suboptimal glycemic control group than in the optimal glycemic control group: 22.4% vs. 3.0%, P < 0.001 for T2DM and 45.3% vs. 23.5%, P < 0.001 for prediabetes. In a multivariate analysis, suboptimal glucose control during pregnancy was an independent risk factor for developing either postpartum T2DM or prediabetes. The adjusted odds ratios were 8.4 (95% confidence interval, 3.5-20.3) for T2DM and 3.9 (95% confidence interval, 2.5-6.1) for prediabetes., Conclusion: Our findings suggest that blood glucose levels during GDM pregnancy have an impact on the risk of postpartum T2DM and prediabetes., (© 2022. The Author(s).)

Aims: To investigate whether single use of 4 mm needles combined with education about injection technique and lipohypertrophy affects HbA1c, hypoglycaemia and glucose variability., Methods: Insulin-injecting people with diabetes recruited from nine Belgian diabetes centres were prospectively followed for 6 months. They were provided 4 mm pen needles and education concerning injection technique using an online platform (BD and Me™) based on the international Forum for Injection Technique & Therapy Recommendations focused on avoidance of lipohypertrophy zones and reduction of needle reuse., Results: A total of 171 people with diabetes were included of which 146 completed the study. At baseline, lipohypertrophy was present in 63.0% of those who completed the study, with 51.4% injecting in zones of lipohypertrophy, 37.0% incorrectly rotating and 95.9% reusing needles. After the intervention, 7.5% still injected in a lipohypertrophy zone, 4.1% rotated incorrectly and needle reuse decreased to 21.2%. The number of participants with severe hypoglycaemias (from 15.8% to 4.1%, p < 0.001), unexplained hypoglycaemias (from 46.6% to 16.4%, p < 0.001) and high glucose variability (from 64.4% to 29.5%, p < 0.001) was significantly reduced. HbA1c and total daily insulin dose remained stable., Conclusion: The combination of 4 mm pen needles and online education on injection techniques significantly reduced the number of people with severe hypoglycaemic episodes, unexplained hypoglycaemia and high glucose variability but did not improve HbA1c control nor lower insulin needs., Trial Registration: ClinicalTrials.gov NCT04659330., (© 2021 Diabetes UK.)

Aims: Type 1 diabetes is characterised by the destruction of pancreatic β-cells. Significant levels of β-cells remain at diagnosis. Preserving these cells improves glucose control and protects from long-term complications. We undertook a systematic review and meta-analyses of all randomised controlled trials (RCTs) of interventions to preserve β-cell function in people newly diagnosed with type 1 diabetes. This paper reports the results of interventions for improving glucose control to assess whether they preserve β-cell function., Methods: Searches for RCTs in MEDLINE, Embase, Cochrane CENTRAL, ClinicalTrials.gov and WHO International Clinical Trials Registry. Eligible studies included newly diagnosed patients with type 1 diabetes, any intervention to improve glucose control and at least 1 month of follow-up. Data were extracted using a pre-defined data-extraction sheet with 10% of extractions checked by a second reviewer., Results: Twenty-eight studies with 1662 participants were grouped by intervention into six subgroups (alternative insulins, subcutaneous and intravenous insulin delivery, intensive therapy, glucose sensing, adjuncts). Only three studies demonstrated an improvement in glucose control as well as β-cell function. These interventions included intensive insulin therapy and use of an alternative insulin., Conclusions: This is the largest comprehensive review of RCTs in this area. It demonstrates a lack of robust evidence that interventions to improve glucose control preserve β-cell function in new onset type 1 diabetes, although analysis was hampered by low-quality evidence and inconsistent reporting of studies. Development of guidelines to support the design of trials in this field is a priority., (© 2021 Diabetes UK.)

Background: Ranolazine is a second-line drug for the management of chronic coronary syndromes (CCS). Glucose-lowering and endothelial effects have also been reported with this agent. However, whether ranolazine may improve short-term glycemic variability (GV), strictly related to the prognosis of patients with type 2 diabetes (T2D), is unknown. Thus, we aimed to explore the effects of adding ranolazine to standard anti-ischemic and glucose-lowering therapy on long- and short-term GV as well as on endothelial function and oxidative stress in patients with T2D and CCS., Methods: Patients starting ranolazine ( n = 16) were evaluated for short-term GV, haemoglobin 1Ac (Hb1Ac) levels, endothelial-dependent flow-mediated vasodilation (FMD), and oxidative stress levels at enrolment and after 3-month follow-up. The same measurements were collected from 16 patients with CCS and T2D that did not receive ranolazine, matched for age, gender, and body mass index., Results: A significant decline in Hb1Ac levels was reported after 3-month ranolazine treatment (mean change -0.60%; 2-way ANOVA p = 0.025). Moreover, among patients receiving ranolazine, short-term GV indexes were significantly improved over time compared with baseline ( p = 0.001 for time in range; 2-way ANOVA p = 0.010). Conversely, no significant changes were reported in patients without ranolazine. Finally, greater FMD and lower oxidative stress levels were observed in patients on ranolazine at 3 months., Conclusions: Ranolazine added to standard anti-ischemic and glucose-lowering therapy demonstrated benefit in improving the glycemic status of patients with T2D and CCS. How this improvement contributes to the overall myocardial benefit of ranolazine requires further studies., Competing Interests: The authors declare that they have no conflict of interest related to the content of the manuscript., (Copyright © 2021 Annunziata Nusca et al.)

Background: We aim to provide a practical guidance on the use of intravenous insulin infusion for managing inpatient hyperglycemia., Methods and Results: This document was formulated based on the review of available literature and personal experience of authors. We have used various case scenarios to illustrate variables which should be taken into account when deciding adjustments in infusion rate, including but not restricted to ambient blood glucose level and magnitude of blood glucose change in the previous hour., Conclusion: The guidance can be generalized to any situation where dedicated protocols are lacking, trained manpower is not available and resource constraints are present., Competing Interests: Declaration of competing interest The authors declare that there are no conflicts of interest associated with this manuscript., (Copyright © 2021 Diabetes India. Published by Elsevier Ltd. All rights reserved.)

Aims/introduction: Painful diabetic peripheral neuropathy (pDPN) is associated with small nerve fiber degeneration and regeneration. This study investigated whether the presence of pDPN might influence nerve regeneration in patients with type 2 diabetes undergoing intensive glycemic control., Materials and Methods: This exploratory substudy of an open-label randomized controlled trial undertook the Douleur Neuropathique en 4 questionnaire and assessment of electrochemical skin conductance, vibration perception threshold and corneal nerve morphology using corneal confocal microscopy in participants with and without pDPN treated with exenatide and pioglitazone or basal-bolus insulin at baseline and 1-year follow up, and 18 controls at baseline only., Results: Participants with type 2 diabetes, with (n = 13) and without (n = 28) pDPN had comparable corneal nerve fiber measures, electrochemical skin conductance and vibration perception threshold at baseline, and pDPN was not associated with the severity of DPN. There was a significant glycated hemoglobin reduction (P < 0.0001) and weight gain (P < 0.005), irrespective of therapy. Participants with pDPN showed a significant increase in corneal nerve fiber density (P < 0.05), length (P < 0.0001) and branch density (P < 0.005), and a decrease in the Douleur Neuropathique en 4 score (P < 0.01), but no change in electrochemical skin conductance or vibration perception threshold. Participants without pDPN showed a significant increase in corneal nerve branch density (P < 0.01) and no change in any other neuropathy measures. A change in the severity of painful symptoms was not associated with corneal nerve regeneration and medication for pain., Conclusions: This study showed that intensive glycemic control is associated with greater corneal nerve regeneration and an improvement in the severity of pain in patients with painful diabetic neuropathy., (© 2021 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.)

Aims: Ramadan is a holy month for the Muslim community. Fasting Ramadan is directed by a systematic alteration in eating habits, sleeping times, and daily physical activities that optimize blood glucose levels. This study aims to evaluate the effects of structured education on safe fasting among diabetic patients., Methods: This study included diabetic patients with eligibility for the Ramadan fast. The control group included 494 patients who received standard diabetes education, while the intervention group included 407 patients who attained structured diabetes education. The patients were required to register their responses following the written, structured questionnaires before and after Ramadan fasts. In addition, patients were advised to keep a log of their hypoglycemic episodes., Result: This study showed that structured diabetes education improved the blood glucose levels/glycemic control and outcomes of patients during their Ramadan fasting. The structured diabetes education helped reduce the incidence of hypoglycemic events and hyperglycemic crises. It also increased the acceptance and frequency of blood sugar level measurements among patients during Ramadan., Conclusion: The standard diabetes management plan should include structured diabetes education measures to improve outcomes effectively. The providers should screen the patients with diabetes before Ramadan and educate them to improve their safe fasting practices., (Copyright © 2021 Diabetes India. Published by Elsevier Ltd. All rights reserved.)

Background: Diabetic microvascular complications are a major cause of morbidity and are related to glycaemic control and cardiovascular risk factors., Aims: We sought to determine the association of microvascular complications in relation to control of glycemia, blood pressure and lipids in T2DM patients attending secondary care in Qatar., Methods: This is a cross-sectional study undertaken in patients with T2DM attending Qatar's National Diabetes Centres. Patients underwent assessment of glycemia, blood pressure and lipids and prevalence of diabetic peripheral neuropathy (DPN), retinopathy and microalbuminuria., Results: We included 1114 subjects aged 52.1 ± 11.3 years with a duration of diabetes 10.0 ± 7.6 years and had a prevalence of 25.8% for DPN, 34.3% for painful DPN, 36.8% for microalbuminuria and 25.1% for retinopathy. Patients who achieved an HbA1c ≤ 7.0% compared to >7% had a significantly lower prevalence of DPN (P < 0.01), painful DPN (P < 0.01), retinopathy (P < 0.01) and microalbuminuria (P < 0.007). Patients who achieved a systolic BP ≤ 140 mmHg compared to >140 mmHg had a significantly lower prevalence of DPN (P < 0.001), painful DPN (P < 0.001), retinopathy (P < 0.001) and microalbuminuria (P < 0.001). Patients who achieved an LDL ≤2.6 mmol/l compared to >2.6 mmol/l had a significantly higher prevalence of DPN (P < 0.03), but no difference in other outcomes. There was no difference in microvascular complications between those who achieved a HDL-C ≥ 1.02 mmol/l, and among those who achieved triglycerides ≤1.7 mmol/l., Conclusions: Optimal control of glycemia and blood pressure, but not lipids is associated with a lower prevalence of diabetic microvascular complications., Competing Interests: Declaration of competing interest The authors report no conflict of interest in relation to this manuscript., (Copyright © 2021 Diabetes India. Published by Elsevier Ltd. All rights reserved.)

Aims/introduction: Currently, the impact of hospital-wide glycemic control interventions on length of hospital stay (LOS) and readmission rates are largely unknown. We investigated the impact of a 4-year hospital-wide remote glycemic management program on LOS and 30-day readmission rates among hospitalized adults who received glucose monitoring., Materials and Methods: In this retrospective study, hospitalized patients who received glucose monitoring were classified into groups 1 (high glucose variability), 2 (hypoglycemia), 3 (hyperglycemia) and 4 (relatively stable). The monthly percentage changes, and average monthly percentage changes of hyperglycemia, hypoglycemia and treat to target were determined using joinpoint regression analysis., Results: A total of 106,528 hospitalized patients (mean age 60.9 ± 18.5 years, 57% men) were enrolled. We observed a significant reduction in the percentage of inpatients in poor glycemic control groups (groups 1, 2 and 3, all P < 0.001), and a reciprocal increase in the relatively stable group (group 4) from 2016 to 2019. We found a significant reduction in LOS by 11.4% (10.5-9.3 days, P = 0.002, after adjustment for age, sex, and admission department). The 30-day readmission rate decreased from 29.9% to 29.3%, mainly among those in group 4 in 2019 (P < 0.001 after adjustment of sex, age, admission department and LOS)., Conclusions: Improved glycemic control through a hospital-wide electronic remote glycemic management system reduced LOS and 30-day readmission rates. Findings observed in this study might be associated with the reduction in cost of avoidable hospitalizations., (© 2021 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.)

Competing Interests: The authors declare that there is no conflict of interest.

Competing Interests: AB received honoraria for presentations from Bayer, Böhringer Ingelheim, Pfizer, Daiichi Sankyo, Lilly, NovoNordisk and Novartis. AZ received fees for lectures from Berlin-Chemie, Boehringer-Ingelheim, Lilly, Novo-Nordisk and Sanofi-Aventis. JW has received honoraria for lectures from Boehringer Ingelheim, Chiesi, Lilly, MSD, Novartis, Novo-Nordisk and Sanofi-Aventis.

Background: Since 2010, more than half of World population lives in Urban Environments. Urban Diabetes has arisen as a novel nosological entity in Medicine. Urbanization leads to the accrual of a number of factors increasing the vulnerability to diabetes mellitus and related diseases. Herein we report clinical-epidemiological data of the Milano Metropolitan Area in the contest of the Cities Changing Diabetes Program. Since the epidemiological picture was taken in January 2020, on the edge of COVID-19 outbreak in the Milano Metropolitan Area, a perspective addressing potential interactions between diabetes and obesity prevalence and COVID-19 outbreak, morbidity and mortality will be presented. To counteract lock-down isolation and, in general, social distancing a pilot study was conducted to assess the feasibility and efficacy of tele-monitoring via Flash Glucose control in a cohort of diabetic patients in ASST North Milano., Methods: Data presented derive from 1. ISTAT (National Institute of Statistics of Italy), 2. Milano ATS web site (Health Agency of Metropolitan Milano Area), which entails five ASST (Health Agencies in the Territories). A pilot study was conducted in 65 screened diabetic patients (only 40 were enrolled in the study of those 36 were affected by type 2 diabetes and 4 were affected by type 1 diabetes) of ASST North Milano utilizing Flash Glucose Monitoring for 3 months (mean age 65 years, HbA1c 7,9%. Patients were subdivided in 3 groups using glycemic Variability Coefficient (VC): a. High risk, VC > 36, n. 8 patients; Intermediate risk 20 < VC < 36, n. 26 patients; Low risk VC < 20, n. 4 patients. The control group was constituted by 26 diabetic patients non utilizing Flash Glucose monitoring., Results: In a total population of 3.227.264 (23% is over 65 y) there is an overall prevalence of 5.65% with a significant difference between Downtown ASST (5.31%) and peripheral ASST (ASST North Milano, 6.8%). Obesity and overweight account for a prevalence of 7.8% and 27.7%, respectively, in Milano Metropolitan Area. We found a linear relationship (R = 0.36) between prevalence of diabetes and aging index. Similarly, correlations between diabetes prevalence and both older people depending index and structural dependence index (R = 0.75 and R = 0.93, respectively), were found. A positive correlation (R = 0.46) with percent of unoccupied people and diabetes prevalence was also found. A reverse relationship between diabetes prevalence and University level instruction rate was finally identified (R = - 0.82). Our preliminary study demonstrated a reduction of Glycated Hemoglobin (p = 0.047) at 3 months follow-up during the lock-down period, indicating Flash Glucose Monitoring and remote control as a potential methodology for diabetes management during COVID-19 lock-down., Hypothesis and Discussion: The increase in diabetes and obesity prevalence in Milano Metropolitan Area, which took place over 30 years, is related to several environmental factors. We hypothesize that some of those factors may have also determined the high incidence and virulence of COVID-19 in the Milano area. Health Agencies of Milano Metropolitan Area are presently taking care of diabetic patients facing the new challenge of maintaining sustainable diabetes care costs in light of an increase in urban population and of the new life-style. The COVID-19 pandemic will modify the management of diabetic and obese patients permanently, via the implementation of approaches that entail telemedicine technology. The pilot study conducted during the lock-down period indicates an improvement of glucose control utilizing a remote glucose control system in the Milano Metropolitan Area, suggesting a wider utilization of similar methodologies during the present "second wave" lock-down.

Aims: The Italian Titration Approach Study (ITAS) demonstrated comparable HbA 1c reductions and similarly low hypoglycaemia risk at 6 months in poorly controlled, insulin-naïve adults with T2DM who initiated self- or physician-titrated insulin glargine 300 U/mL (Gla-300) in the absence of sulphonylurea/glinide. The association of patient characteristics with glycaemic and hypoglycaemic outcomes was assessed., Methods: This post hoc analysis investigated whether baseline patient characteristics and previous antihyperglycaemic drugs were associated with HbA 1c change and hypoglycaemia risk in patient- versus physician-managed Gla-300 titration., Results: HbA 1c change, incidence of hypoglycaemia (any type) and nocturnal rates were comparable between patient- and physician-managed arms in all subgroups. Hypoglycaemia rates across subgroups (0.03 to 3.52 events per patient-year) were generally as low as observed in the full ITAS population. Small increases in rates of 00:00-pre-breakfast and anytime hypoglycaemia were observed in the ≤ 10-year diabetes duration subgroup in the patient- versus physician-managed arm (heterogeneity of effect; p < 0.05)., Conclusions: Comparably fair glycaemic control and similarly low hypoglycaemia risk were achieved in almost all patient subgroups with patient- versus physician-led Gla-300 titration. These results reinforce efficacy and safety of Gla-300 self-titration across a range of phenotypes of insulin-naïve people with T2DM., Clinical Trial Registration: EudraCT 2015-001167-39.

Objective: Prior to the transfer from paediatric to adult health care transition, teens with type 1 diabetes seek increasing independence in diabetes self-care while parent involvement in care decreases. Yet, few teens attain glycaemic targets. This study aimed to assess changes in perceived readiness for independent self-care in teens with type 1 diabetes over 18 months, from both teens' and parents' perspectives, and to evaluate its predictive value for diabetes self-management and haemoglobin A1c (HbA 1c )., Research Design and Methods: At baseline, 6, 12 and 18 months, 178 teens with type 1 diabetes (mean ± SD age 14.9±1.3 years; HbA 1c 8.5 ± 1.0% (69 ± 11 mmol/mol); 48% female) and their parents completed the Readiness for Independent Self-Care Questionnaire (RISQ-T and RISQ-P, respectively) and a measure of self-management. Chart review provided HbA 1c values. Statistical analyses encompassed bivariate correlations, paired t-tests and multivariable longitudinal mixed models., Results: Teens perceived greater self-care readiness than their parents at baseline and over 18 months of follow-up. Both teen and parent perceptions of teen readiness for independent self-care increased over time, and significantly predicted higher teen self- and parent proxy-reported teen diabetes self-management, respectively, but not improved HbA 1c ., Conclusions: The current findings may point to a disconnect between how increased readiness for independent self-care may translate into better perceived diabetes self-management, but not into better HbA 1c . In an effort to optimize HbA 1c in teens with type 1 diabetes, future research is needed to design interventions that align perceived readiness for independent self-care with self-care behaviours that improve HbA 1c ., (© 2021 Diabetes UK.)

Introduction: Continuous glucose monitoring (CGM) provides detailed information about glucose level fluctuations over time. The method is increasingly being used in pregnant women with type 1 diabetes. However, only one previous study compared CGM results related to pregnancy outcomes in women using insulin pumps with those administering multiple daily injections (MDI). We performed a secondary analysis of CGM metrics from an observational cohort of pregnant women with type 1 diabetes and compared insulin pump and MDI therapies in relation to maternal and neonatal outcomes., Material and Methods: The study included 185 pregnant Swedish women with type 1 diabetes undergoing CGM throughout pregnancy. Women were divided according to insulin administration mode, ie MDI (n = 131) or pump (n = 54). A total of 91 women used real-time CGM and 94 women used intermittently viewed CGM. Maternal demographics and maternal and neonatal outcome data were collected from medical records. CGM data were analyzed according to predefined glycemic indices: mean glucose; standard deviation; percentage of time within, below and above glucose target range; mean amplitude of glycemic excursion; high and low glucose indices; and coefficient variation in percent. Associations between insulin administration mode and CGM data, on the one hand, and maternal and neonatal outcomes, on the other, were analyzed with analysis of covariance and logistic regression, respectively, adjusted for confounders., Results: There were no differences in maternal characteristics or glycemic indices between the MDI and pump groups, except for a longer duration of type 1 diabetes and higher frequencies of microangiopathy and real-time CGM among pump users. Despite improvement with each trimester, glucose levels remained suboptimal throughout pregnancy in both groups. There were no differences between the MDI and pump groups concerning the respective associations with any of the outcomes. The frequency of large for gestational age was high in both groups (MDI 49% vs pump 63%) and did not differ significantly., Conclusions: Pregnant women with type 1 diabetes did not differ in glycemic control or pregnancy outcome, related to MDI or pump administration of insulin. Glycemic control remained suboptimal throughout pregnancy, regardless of insulin administration mode., (© 2021 Nordic Federation of Societies of Obstetrics and Gynecology.)

Background: There are many continuous blood glucose monitoring (CGM) data-based indicators, and most of these focus on a single characteristic of abnormal blood glucose. An ideal index that integrates and evaluates multiple characteristics of blood glucose has not yet been established., Methods: In this study, we proposed the glycemic deviation index (GDI) as a novel integrating characteristic, which mainly incorporates the assessment of the glycemic numerical value and variability. To verify its effectiveness, GDI was applied to the simulated 24 h glycemic profiles and the CGM data of type 2 diabetes (T2D) patients (n = 30)., Results: Evaluation of the GDI of the 24 h simulated glycemic profiles showed that the occurrence of hypoglycemia was numerically the same as hyperglycemia in increasing GDI. Meanwhile, glycemic variability was added as an independent factor. One-way ANOVA results showed that the application of GDI showed statistically significant differences in clinical glycemic parameters, average glycemic parameters, and glycemic variability parameters among the T2D groups with different glycemic levels., Conclusions: In conclusion, GDI integrates the characteristics of the numerical value and the variability in blood glucose levels and may be beneficial for the glycemic management of diabetic patients undergoing CGM treatment.

Aim: In a world of data overload, clinical practice recommendations are needed to help practitioners and patients to take evidence-based decisions. However, in the field of type 2 diabetes mellitus (T2DM) recommendations on glycemic goals and treatment choice are controversial in spite of being supported by a common body of evidence. We hypothesize that internal and external validity of this body of evidence might not be as sound as expected. The aim of the current study is to appraise the studies supporting recommendations developed by influential medical societies dealing with glycemic goals and the choice of pharmacological treatment in adults with T2DM., Methods: Clinical practice recommendations and their references were extracted out of eight documents developed by influential scientific societies between 2016 and 2019. Internal and external validity of each study was then appraised with standard tools and in duplicate., Results: A total of 114 recommendations and their underlying 233 citations were extracted. Out of these 233 citations 81 (35%) corresponded to randomized controlled trials (RCT) and 45 (20%) to systematic reviews. After systematical appraisal only four RCT (5%) and eight systematic reviews (17%) were considered to be unflawed. Indirectness (lack of generalizability) was the most common caveat identified in RCTs. Out of the 114 recommendations analyzed (32 dealing with glycemic goals and 82 with treatment choice), only 21 (18.4%) were supported by at least one high-quality study., Conclusion: Only one in five recommendations regarding glycemic goals or pharmacological treatment choice in T2DM is based on at least one high-quality study. Clinical practice recommendations dealing with areas of uncertainty should be formulated more transparently to enable real evidence-based decisions.

Background: To minimize the spread of Coronavirus Disease-2019, Saudi Arabia imposed a nationwide lockdown for over 6 weeks. We examined the impact of lockdown on glycemic control in individuals with type 1 diabetes (T1D) using continuous glucose monitoring (CGM); and assessed whether changes in glycemic control differ between those who attended a telemedicine visit during lockdown versus those who did not., Materials and Methods: Flash CGM data from 101 individuals with T1D were retrospectively evaluated. Participants were categorized into two groups: Attended a telemedicine visit during lockdown (n = 61) or did not attend (n = 40). Changes in CGM metrics from the last 2 weeks pre-lockdown period (Feb 25 - March 9, 2020) to the last 2 weeks of complete lockdown period (April 7-20, 2020) were examined in the two groups., Results: Those who attended a telemedicine visit during the lockdown period had a significant improvement in the following CGM metrics by the end of lockdown: Average glucose (from 180 to 159 mg/dl, p < 0.01), glycemic management indicator (from 7.7 to 7.2%, p = 0.03), time in range (from 46 to 55%, p < 0.01), and time above range (from 48 to 35%, p < 0.01) without significant changes in time below range, number of daily scans or hypoglycemic events, and other indices. In contrast, there were no significant changes in any of the CGM metrics during lockdown in those who did not attend telemedicine., Conclusions: A six-week lockdown did not worsen, nor improve, glycemic control in individuals with T1D who did not attend a telemedicine visit. Whereas those who attended a telemedicine visit had a significant improvement in glycemic metrics; supporting the clinical effectiveness of telemedicine in diabetes care., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Aim: To describe the development of HbA 1c and BMI over time in Danish children with type 1 diabetes; and to investigate the association between HbA 1c and BMI including influence of age, gender, diabetes duration, severe hypoglycaemia and treatment method., Methods: We used the nationwide Danish Registry of Childhood and Adolescent Diabetes, DanDiabKids, including annual registrations of all children with diabetes treated at Danish hospitals. With linear mixed-effects models and splines we analyzed the HbA 1c and BMI development over time as well as the association between HbA 1c and BMI including effects of gender, age, disease duration, hypoglycaemia and treatment method. BMI z-scores were calculated for these analyses., Results: For the period from 2000 to 2018, 6097 children with type 1 diabetes were identified from the DanDiabKids database. The median (interquartile range) HbA 1c level was 65 (57-74) mmol/mol (8.1%) and the median BMI z-score was 0.85 in girls and 0.67 in boys. A non-linear association was found between HbA 1c and BMI z-score, with the highest BMI z-score observed for HbA 1c values in the range of approximately 60-70 mmol/mol (7.6-6.8%). The association was modified by gender, age and diabetes duration. Severe hypoglycaemia and insulin pump treatment had a small positive impact on BMI z-score., Conclusion: The association between HbA 1c and BMI z-score was non-linear, with the highest BMI z-score being observed for intermediate HbA 1c levels; however, specific patterns depended on gender, age and diabetes duration., (© 2020 Diabetes UK.)

Objectives: This study aims to estimate the national impact and cost-effectiveness of the 2018 American College of Physicians (ACP) guidance statements compared to the status quo., Methods: Survey data from the 2011-2016 National Health and Nutrition Examination were used to generate a national representative sample of individuals with diagnosed type 2 diabetes in the United States. Individuals with A1c <6.5% on antidiabetic medications are recommended to deintensify their A1c level to 7.0% to 8.0% (group 1); individuals with A1c 6.5% to 8.0% and a life expectancy of <10 years are recommended to deintensify their A1c level >8.0% (group 2); and individuals with A1c >8.0% and a life expectancy of >10 years are recommended to intensify their A1c level to 7.0% to 8.0% (group 3). We used a Markov-based simulation model to evaluate the lifetime cost-effectiveness of following the ACP recommended A1c level., Results: 14.41 million (58.1%) persons with diagnosed type 2 diabetes would be affected by the new guidance statements. Treatment deintensification would lead to a saving of $363 600 per quality-adjusted life-year (QALY) lost for group 1 and a saving of $118 300 per QALY lost for group 2. Intensifying treatment for group 3 would lead to an additional cost of $44 600 per QALY gain. Nationally, the implementation of the guidance would add 3.2 million life-years and 1.1 million QALYs and reduce healthcare costs by $47.7 billion compared to the status quo., Conclusions: Implementing the new ACP guidance statements would affect a large number of persons with type 2 diabetes nationally. The new guidance is cost-effective., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

This meta-analysis aimed to examine the effects of mobile-health-based (mHealth) interventions on improving glycemic stability and quality of life (QOL) in patients with type 1 diabetes (T1D). Various databases, including PubMed, Embase, CINAHL, Cochrane Library, ProQuest, Chinese Electronic Periodical Services, and China Knowledge Resource Integrated, were used to search for relevant articles. A fixed-effects model or random-effects model was used to examine the overall effect. Various methods, including Egger's test, Begg's test, and trim-and-fill, were adopted to examine publication bias. In total, 26 studies were recruited. Results of the random-effects model showed that the use of mHealth-based interventions significantly decreased glycated hemoglobin (HbA1c) (mean difference = -0.37, 95% confidence interval (CI) = -0.53 to -0.22, p < .001), and improved life satisfaction (Hedges' g = 0.30, 95% CI = 0.10 to 0.50, p = .003), worry of diabetes (Hedges' g = -0.25, 95% CI = -0.41 to 0.08, p = .004), and mental health (Hedges' g = 0.36, 95% CI = 0.08 to 0.64, p = .012). Both adults and youths with T1D can benefit from mHealth-based interventions to improve HbA1c (Hedges' g = -0.44, p = .002 vs. -0.30, p = .003). The effect of mHealth-based interventions on improving QOL in both adults and youths could not be examined due to only one study published in adults with T1D. Moreover, those studies that included the function of feedback from professionals showed a significant effect of decreasing HbA1c compared to those without that function (Hedges' g = -0.48 vs. -0.16, p = .019). Mobile devices are convenient, instantaneous, and easy to use to communicate. Applying mHealth-based interventions with the function of feedback from professionals can be considered an alternative healthcare service to achieve optimal glycemic stability in adults and youths with T1D., (© 2020 Wiley Periodicals LLC.)

Objectives: We hypothesize that men with diabetes mellitus whose inflatable penile prosthesis (IPP) implantation is delayed for unacceptably high hemoglobin A1c (HbA1c) will have durable improvements in their glycemic control after achieving acceptable HbA1c levels for surgery., Methods: Per institutional protocol, an A1c <9% must be documented prior to IPP placement. After IRB approval, a single surgeon IPP database was retrospectively queried for data specific to diabetes mellitus management. Men without HbA1c values at ≥1-year follow-up were excluded. Univariate and multivariate statistical analyses were performed to assess associations with sustained HbA1c control., Results: From January 2011 to March 2019, 138 diabetics undergoing IPP were identified. Thirty-seven were excluding for insufficient follow-up. Nineteen of the 101 analyzed men (18.8%) were delayed a median 4 months (range 2-17) for elevated HbA1c values (median 10.1, range 9.1-12.3). Following improvements, median preoperative HbA1c remained higher (8.2% vs 7.0%) in delayed men (P < .001). Among delayed recipients, 11 (58%) improved without medication changes while insulin was newly initiated (5) or dosage was increased (5) in 42%. At 32 months follow-up, a HbA1c <9% was similarly maintained in delayed and nondelayed men (74% vs 87%, P = .17). Delayed men more commonly required insulin therapy at follow-up (89.5% vs 54.9%, P = .008), but had a similar median change in BMI (+0.1 vs +0.1, P = .65). Device infection occurred in 1 nondelayed patient (0.7%)., Conclusion: Men who improve HbA1c for IPP surgery are likely to demonstrate persistent improvement. IPP implantation appears to be safe in diabetic men with HbA1c <9%., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Gestational diabetes mellitus is associated with adverse maternal and fetal outcomes and increases subsequent risk of Type 2 diabetes. Researchers have shown that breastfeeding may reduce diabetes risk in women with recent gestational diabetes., Research Aim: To assess association between infant feeding and postpartum glucose tolerance in mothers with recent gestational diabetes within 1 year postpartum., Methods: A literature search was performed up to December 31, 2019, retrieving articles related to infant feeding, gestational diabetes, and postpartum glucose regulation in four major databases (PubMed, Cochrane, CINAHL, and Embase). Methodological quality was assessed using tools from the United States National Institutes of Health and the National Heart, Lung, and Blood Institute., Results: The search yielded 15 cohort studies meeting the selection criteria. Of the 15 studies, 13 (86.7%) examined the influence of breastfeeding on postpartum glycemic status, and eight (53.4%) compared the mean blood glucose values between breastfeeding and non-breastfeeding participants. Of the 13 studies that compared postpartum glycemic status, nine (60%) of the research teams found that breastfeeding lowered rates of impaired glucose tolerance, and four (26.7%) showed no significant change. In eight of the studies reporting mean blood glucose values, six (75%) reported significantly lower fasting plasma glucose in breastfeeding participants, with reductions ranging from 3.7 to 7.4 mg/dL (0.2-0.4 mmol/L)., Conclusion: Breastfeeding has been associated with improved postpartum glucose regulation in mothers with gestational diabetes. In pregnant women with gestational diabetes, breastfeeding may reduce the risk of Type 2 diabetes, and women with gestational diabetes should be strongly encouraged and supported to breastfeed.

Backgrounds and Aims: To investigate relevant indicators of quality of care in a large population-based sample of people with diabetes representative of clinical practice in Italy in 2018., Methods and Results: We analyzed data from 11,300,750 subjects. All administrative healthcare claims collected in 2018 were scrutinized to identify subjects with diabetes and investigate several indicators of quality of care. Subjects with diabetes were identified by anti-hyperglycemic drug prescriptions, disease-specific co-payment exemption and hospital discharge codes. Indicators of quality of care pertained to monitoring (HbA1c, creatinine, lipid profile, microalbuminuria, eye examination, ECG, ultrasonography of carotid and lower limb arteries) and diabetes treatment (anti-hyperglycemic agents in subjects with cardiovascular disease, CVD). Subjects attending and nonattending Diabetes Clinics were compared. We identified 697,208 individuals with diabetes. HbA1c was assessed at least once in the year in 62.7%, creatinine in 62.3%, total cholesterol in 59.6%, microalbuminuria in 34.3%. Frequency of eye examination was 8.2%, ECG 23.5%, carotid ultrasonography 14.3%, lower limb ultrasonography 7.6%. Among anti-hyperglycemic drugs, SGLT-2 inhibitors were prescribed to ~5% and GLP-1 receptor agonists to ~5% although the proportion of subjects with CVD was ~45%. Subjects attending Diabetes Clinics had higher figures for all these monitoring and treatment indicators., Conclusions: The implementation of national and international guidelines regarding disease monitoring and treatment is far from being satisfactory, especially among subjects nonattending Diabetes Clinics. Further efforts and investments are needed for better disseminating guidelines, more efficaciously engaging healthcare professionals and more strongly empowering the healthcare system to improve diabetes care., Competing Interests: Declaration of competing interest EB received honoraria for participating in advisory boards of Abbott, Astrazeneca, Becton Dickinson, Boehringer Ingelheim, Bristol-Myers Squibb, Bruno Farmaceutici, Janssen, Johnson&Johnson, Lilly, MSD, Mundipharma, Novartis, Novo Nordisk, Roche, Sanofi, Servier, Takeda. GM received honoraria for participating in advisory boards from Pfizer, Gilead, Novartis, Eli Lilly, Mundipharma. GPF received honoraria or lecture fees from Abbott, AstraZeneca, Boehringer, Lilly, MSC, Mundipharma, Novartis, Novonordisk, Sanofi, Servier.pharma, Novartis, Novonordisk, Sanofi, Servier., (Copyright © 2020 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

Objective: International type 1 diabetes registries have shown that HbA 1c levels are highest in young people with type 1 diabetes; however, improving their glycemic control remains a challenge. We propose that use of the factory-calibrated Dexcom G6 CGM system would improve glycemic control in this cohort., Research Design and Methods: We conducted a randomized crossover trial in young people with type 1 diabetes (16-24 years old) comparing the Dexcom G6 CGM system and self-monitoring of blood glucose (SMBG). Participants were assigned to the interventions in random order during two 8-week study periods. During SMBG, blinded continuous glucose monitoring (CGM) was worn by each participant for 10 days at the start, week 4, and week 7 of the control period. HbA 1c measurements were drawn after enrollment and before and after each treatment period. The primary outcome was time in range 70-180 mg/dL., Results: Time in range was significantly higher during CGM compared with control (35.7 ± 13.5% vs. 24.6 ± 9.3%; mean difference 11.1% [95% CI 7.0-15.2]; P < 0.001). CGM use reduced mean sensor glucose (219.7 ± 37.6 mg/dL vs. 251.9 ± 36.3 mg/dL; mean difference -32.2 mg/dL [95% CI -44.5 to -20.0]; P < 0.001) and time above range (61.7 ± 15.1% vs. 73.6 ± 10.4%; mean difference 11.9% [95% CI -16.4 to -7.4]; P < 0.001). HbA 1c level was reduced by 0.76% (95% CI -1.1 to -0.4) (-8.5 mmol/mol [95% CI -12.4 to -4.6]; P < 0.001). Times spent below range (<70 mg/dL and <54 mg/dL) were low and comparable during both study periods. Sensor wear was 84% during the CGM period., Conclusions: CGM use in young people with type 1 diabetes improves time in target and HbA 1c levels compared with SMBG., (© 2020 by the American Diabetes Association.)

We elucidated diet and its association with glycemic status among adults clinically diagnosed with type 2 diabetes mellitus (T2DM) through across-sectional study in Malawi. Glycosylated hemoglobin (A1C) and dietary intakes were assessed. Consumption of cereals, roots, and tubers and sweet, sugary food, including sweetened beverages, was significantly higher among participants with A1C≥8%. Fruit and vegetable intake were disproportionately low overall. Consuming adiet high in carbohydrates (OR: 1.167; CI = 1.107-1.231; p < .001) and having <3 meals/day (OR: 2.680; CI = 1.445-4.970; p = .002) were both associated with A1C≥8%. Therefore, dietary interventions for T2DM focusing on carbohydrate counting, total dietary quality, and meal planning are needed in Malawi.

The aim of the study was to explore the relationship between daily glycemic variability (GV) and visit-to-visit glycemic variability (VVV) in patients with type 2 diabetes (T2DM). A total of 156 outpatients with T2DM who had undergone continuous glucose monitoring (CGM) for 5 days were included in this study. Indices of GV, i.e., standard deviation and coefficient of variation (CV) of glucose, mean amplitude of glycemic excursion (MAGE) and mean of the daily differences (MODD) were calculated from the CGM data. VVV was calculated as CV of HbA1c or glycated albumin (GA) from HbA1c or GA measured for 3 years. Relationships among clinical parameters, GV and VVV were evaluated. Age was positively, and BMI and C-peptide index were inversely correlated with GV such as CV glucose and MAGE, while BMI was positively correlated with VVV. Mean glucose rather than GV was correlated with VVV. In contrast, time in range (TIR, 70-180 mg/dL) was correlated with both mean HbA1c or GA and VVV. In conclusion, GV and VVV were differently correlated with clinical parameters and were hardly correlated with each other. TIR was correlated with both mean HbA1c and VVV, suggesting that efforts to achieve optimal TIR are practical strategies to reduce VVV in patients with T2DM.

Background: Although important achievements have been done in type 2 diabetes mellitus (T2D) treatment and glycemic control, new strategies may take advantage of non-pharmacological approaches and of other potential determinants of health (e.g., socioeconomic status, education, diabetes knowledge, physical activity, and self-care behavior). However, the relationships between these factors are not totally clear and have not been studied in the context of large urban settings. This study aimed to explore the relationship between these determinants of glycemic control (GC) in a low-income urban population from Mexico City, focused in exploring potential the mediation of self-care behaviors in the association between diabetes knowledge and GC., Methods: A multicenter cross-sectional study was conducted in patients with type 2 diabetes (T2D) from 28 primary care outpatient centers located in Mexico City. Using multivariable-adjusted models, we determined the associations between diabetes knowledge, self-care behaviors, and GC. The mediation analyses to determine the pathways on glycemic control were done using linear regression models, where the significance of indirect effects was calculated with bootstrapping., Results: The population (N = 513) had a mean age of 53.8 years (standard deviation: 11.3 yrs.), and 65.9% were women. Both socioeconomic status and level of education were directly associated with diabetes knowledge. Using multivariable-adjusted linear models, we found that diabetes knowledge was associated with GC (β: -0.102, 95% Confidence Interval [95% CI] -0.189, - 0.014). Diabetes knowledge was also independently associated with self-care behavior (for physical activity: β: 0.181, 95% CI 0.088, 0.273), and self-care behavior was associated with GC (for physical activity: β: -0.112, 95% CI -0.194, - 0.029). The association between diabetes knowledge and GC was not observed after adjustment for self-care behaviors, especially physical activity (β: -0.084, 95% CI -0.182, 0.014, p-value: 0.062). Finally, the mediation models showed that the effect of diabetes knowledge on GC was 17% independently mediated by physical activity (p-value: 0.049)., Conclusions: Socioeconomic and educational gradients influence diabetes knowledge among primary care patients with type 2 diabetes. Self-care activities, particularly physical activity, mediated the effect of diabetes knowledge on GC. Our results indicate that diabetes knowledge should be reinforced in low-income T2D patients, with an emphasis on the benefits physical activity has on improving GC.

Introduction: Diabetes mellitus (DM) is a highly prevalent disease worldwide. It has been associated with an important morbimortality due to its complications and sometimes as a result of adverse events related to treatment. Insulin pump therapy (IPT) is one of the options used to control this disease and reduces one of the most frequent complication associated with treatment: hypoglycemia, which has also a great impact on life quality and clinical status of patients., Materials and Methods: A descriptive and retrospective study was performed including patients treated and followed by the department of endocrinology from a high-complexity university hospital in Cali, Colombia, between 2012 and 2017. Patients were on IPT and continuous glucose monitoring (CGM): MiniMed Paradigm® Veo™ Insulin Pump (Medtronic®) and MiniMed 640G Insulin Pump-Enlite™ Sensor (Medtronic®). Presentation of hypoglycemia and variables associated with its development were evaluated., Results: 51 patients were included. The main indication for IPT initiation was the report of hypoglycemic episodes and inappropriate metabolic control. Initiation of IPT was related with a decrease in glycosylated hemoglobin (HbA1c) and also a decrease in severe hypoglycemic events and hospitalization due to hypoglycemia. The risk factors linked with clinically significant hypoglycemia were male gender, and standard deviation of glucose measures calculated by CGM. A diminished glomerular filtration rate (GFR) (<60 mL/min/1.73 m 2 ) was correlated with higher risk of severe hypoglycemia., Conclusion: IPT with CGM is a useful strategy in the management of patients with DM; it is associated with a reduction of adverse hypoglycemic events and hospitalizations due to hypoglycemia., Competing Interests: The authors have no conflicts of interest to declare., (Copyright © 2020 Guillermo Guzmán et al.)

Background: Time in range is a key glycemic metric, and comparisons of management technologies for this outcome are critical to guide device selection., Purpose: We conducted a systematic review and network meta-analysis to compare and rank technologies for time in glycemic ranges., Data Sources: We searched Evidenced-Based Medicine Reviews, CINAHL, Embase, MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, PROSPERO, PsycInfo, PubMed, and Web of Science until 24 April 2019., Study Selection: We included randomized controlled trials ≥2 weeks' duration comparing technologies for management of type 1 diabetes in adults (≥18 years of age), excluding pregnant women., Data Extraction: Data were extracted using a predefined template. Outcomes were percent time with sensor glucose levels 3.9-10.0 mmol/L (70-180 mg/dL), >10.0 mmol/L (180 mg/dL), and <3.9 mmol/L (70 mg/dL)., Data Synthesis: We identified 16,772 publications, of which 14 eligible studies compared eight technologies comprising 1,043 participants. Closed-loop systems led to greater percent time in range than any other management strategy, and mean percent time in range was 17.85 (95% predictive interval 7.56-28.14) longer than with usual care of multiple daily injections with capillary glucose testing. Closed-loop systems ranked best for percent time in range or above range with use of Surface Under the Cumulative RAnking curve (SUCRA) (98.5% and 93.5%, respectively). Closed-loop systems also ranked highly for time below range (SUCRA 62.2%)., Limitations: Overall risk of bias ratings were moderate for all outcomes. Certainty of evidence was very low., Conclusions: In the first integrated comparison of multiple management strategies considering time in range, we found that the efficacy of closed-loop systems appeared better than all other approaches., (© 2020 by the American Diabetes Association.)

The aim of this study was to determine the association between glucose control indices of parturient with type 1 diabetes (T1DM), treated with an insulin pump and utilizing continuous glucose monitoring (CGM), and clinically significant neonatal hypoglycemia. This was a retrospective cohort study which included 37 pregnant women with T1DM. All women were followed at a single tertiary center and had available CGM data. The association between maternal glucose indices before delivery and the risk for neonatal hypoglycemia requiring IV glucose (clinically significant hypoglycemia) was assessed using logistic regression. Mothers to neonates that experienced clinically significant hypoglycemia had a higher glucose standard deviation (SD) before delivery than did mothers to neonates who did not (25.5 ± 13 mg/dL vs. 14.7 ± 6.7 mg/dl respectively; p  = .008). This association persisted after adjustment for maternal age, maternal pregestational body mass index (BMI), gestational age at delivery, neonatal birth weight, large for gestational age (LGA) and gender. This study demonstrates an association between high maternal glucose standard deviation before delivery and the risk for clinically significant neonatal hypoglycemia. Larger studies are needed to confirm these results and further explore the role of intrapartum glucose variability in the prediction and prevention of significant neonatal hypoglycemia.

Objective: The association between high glycemic variability and all-cause mortality has been widely investigated in epidemiological studies but rarely validated in glucose-lowering clinical trials. We aimed to identify the prognostic significance of visit-to-visit HbA 1c variability in treated patients in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial population., Research Design and Methods: We studied the risk of all-cause mortality in relation to long-term visit-to-visit HbA 1c variability, expressed as coefficient of variation (CV), variability independent of the mean (VIM), and average real variability (ARV), from the 8th month to the transition from intensive to standard glycemic therapy. Multivariable Cox proportional hazards models were used to estimate adjusted hazard ratio (HR) and 95% CI., Results: Compared with the standard therapy group ( n = 4,728), the intensive therapy group ( n = 4,755) had significantly lower mean HbA 1c (6.6% [49 mmol/mol] vs. 7.7% [61 mmol/mol], P < 0.0001) and lower CV, VIM, and ARV ( P < 0.0001). In multivariate adjusted analysis, all three HbA 1c variability indices were significantly associated with total mortality in all patients as well as in the standard- and intensive-therapy groups analyzed separately. The hazard ratios for a 1-SD increase in HbA 1c variability indices for all-cause mortality were 1.19 and 1.23 in intensive and standard therapy, respectively. Cross-tabulation analysis showed the third tertile of HbA 1c mean and VIM had significantly higher all-cause mortality (HR 2.05; 95% CI 1.17-3.61; P < 0.01) only in the intensive-therapy group., Conclusions: Long-term visit-to-visit HbA 1c variability was a strong predictor of all-cause mortality. HbA 1c VIM combined with HbA 1c mean conferred an increased risk for all-cause mortality in the intensive-therapy group., (© 2020 by the American Diabetes Association.)

Objective: The prevalence of type 2 diabetes is increasing among adults under age 45. Onset of type 2 diabetes at a younger age increases an individual's risk for diabetes-related complications. Given the lasting benefits conferred by early glycemic control, we compared glycemic control and initial care between adults with younger onset (21-44 years) and mid-age onset (45-64 years) of type 2 diabetes., Research Design and Methods: Using data from a large, integrated health care system, we identified 32,137 adults (aged 21-64 years) with incident diabetes (first HbA 1c ≥6.5% [≥48 mmol/mol]). We excluded anyone with evidence of prior type 2 diabetes, gestational diabetes mellitus, or type 1 diabetes. We used generalized linear mixed models, adjusting for demographic and clinical variables, to examine differences in glycemic control and care at 1 year., Results: Of identified individuals, 26.4% had younger-onset and 73.6% had mid-age-onset type 2 diabetes. Adults with younger onset had higher initial mean HbA 1c values (8.9% [74 mmol/mol]) than adults with onset in mid-age (8.4% [68 mmol/mol]) ( P < 0.0001) and lower odds of achieving an HbA 1c <7% (<53 mmol/mol) 1 year after the diagnosis (adjusted odds ratio [aOR] 0.70 [95% CI 0.66-0.74]), even after accounting for HbA 1c at diagnosis. Adults with younger onset had lower odds of in-person primary care contact (aOR 0.82 [95% CI 0.76-0.89]) than those with onset during mid-age, but they did not differ in telephone contact (1.05 [0.99-1.10]). Adults with younger onset had higher odds of starting metformin (aOR 1.20 [95% CI 1.12-1.29]) but lower odds of adhering to that medication (0.74 [0.69-0.80])., Conclusions: Adults with onset of type 2 diabetes at a younger age were less likely to achieve glycemic control at 1 year following diagnosis, suggesting the need for tailored care approaches to improve outcomes for this high-risk patient population., Competing Interests: This article is featured in a podcast available at https://www.diabetesjournals.org/content/diabetes-core-update-podcasts., (© 2020 by the American Diabetes Association.)

Objective: To investigate factors related to glycemic management among members of a professional cycling team with type 1 diabetes over a 7-day Union Cycliste Internationale World Tour stage race., Research Design and Methods: An observational evaluation of possible factors related to glycemic management and performance in six male professional cyclists with type 1 diabetes (HbA 1c 6.4 ± 0.6%) during the 2019 Tour of California., Results: In-ride time spent in euglycemia (3.9-10.0 mmol/L glucose) was 63 ± 11%, with a low percentage of time spent in level 1 (3.0-3.9 mmol/L; 0 ± 1% of time) and level 2 (<3.0 mmol/L; 0 ± 0% of time) hypoglycemia over the 7-day race. Riders spent 25 ± 9% of time in level 1 (10.1-13.9 mmol/L) and 11 ± 9% in level 2 (>13.9 mmol/L) hyperglycemia during races. Bolus insulin use was uncommon during races, despite high carbohydrate intake (76 ± 23 g ⋅ h -1 ). Overnight, the riders spent progressively more time in hypoglycemia from day 1 (6 ± 12% in level 1 and 0 ± 0% in level 2) to day 7 (12 ± 12% in level 1 and 2 ± 4% in level 2) (χ 2 [1] > 4.78, P < 0.05)., Conclusions: Professional cyclists with type 1 diabetes have excellent in-race glycemia, but significant hypoglycemia during recovery overnight, throughout a 7-day stage race., (© 2020 by the American Diabetes Association.)

Background: Continuous glucose monitoring (CGM) provides important information to aid in achieving glycemic targets in people with diabetes., Purpose: We performed a meta-analysis of randomized controlled trials (RCTs) comparing CGM with usual care for parameters of glycemic control in both type 1 and type 2 diabetes., Data Sources: Many electronic databases were searched for articles published from inception until 30 June 2019., Study Selection: We selected RCTs that assessed both changes in HbA 1c and time in target range (TIR), together with time below range (TBR), time above range (TAR), and glucose variability expressed as coefficient of variation (CV)., Data Extraction: Data were extracted from each trial by two investigators., Data Synthesis: All results were analyzed by a random effects model to calculate the weighted mean difference (WMD) with the 95% CI. We identified 15 RCTs, lasting 12-36 weeks and involving 2,461 patients. Compared with the usual care (overall data), CGM was associated with modest reduction in HbA 1c (WMD -0.17%, 95% CI -0.29 to -0.06, I 2 = 96.2%), increase in TIR (WMD 70.74 min, 95% CI 46.73-94.76, I 2 = 66.3%), and lower TAR, TBR, and CV, with heterogeneity between studies. The increase in TIR was significant and robust independently of diabetes type, method of insulin delivery, and reason for CGM use. In preplanned subgroup analyses, real-time CGM led to the higher improvement in mean HbA 1c (WMD -0.23%, 95% CI -0.36 to -0.10, P < 0.001), TIR (WMD 83.49 min, 95% CI 52.68-114.30, P < 0.001), and TAR, whereas both intermittently scanned CGM and sensor-augmented pump were associated with the greater decline in TBR., Limitations: Heterogeneity was high for most of the study outcomes; all studies were sponsored by industry, had short duration, and used an open-label design., Conclusions: CGM improves glycemic control by expanding TIR and decreasing TBR, TAR, and glucose variability in both type 1 and type 2 diabetes., (© 2020 by the American Diabetes Association.)

Introduction: In Malaysia, Diabetes Medication Therapy Adherence Clinic (DMTAC) in hospital settings significantly improved patients' glycaemic control and cardiovascular risk. Until now no randomised controlled trial of DMTAC has been done in a primary care setting where the access to subspecialist services (endocrinologists, expensive medication, etc.) is limited. The objective of this research is to compare the glycaemic control among diabetes mellitus (DM) patients between those received additional DMTAC service and those received normal clinic service in primary care settings., Materials and Method: This was a parallel, randomised controlled study. The selected participants were patients aged 18 to 70 years with type 2 DM on diabetic medication who were being treated in Kota Samarahan Health Clinic with HbA1c above 8% and who never attended any education of DM prior to the study. The control group received normal clinic visits with consultations by a medical officer. The intervention group received four or more DMTAC visits in addition to normal clinic visits. The primary outcomes were HbA1c while the secondary outcomes were the occurrence of severe hypoglycaemia, weight gain and medication compliance of patients. The subjects were randomised by numbered envelope opened chronologically by the investigator during the initial assessment. All health care professionals (nurse, lab staff and medical officer) except DMTAC pharmacist managing the subjects were blinded as there were no markings on the patients notes indicating that they were in this study. The demographic data was collected during screening while health data including glycated haemoglobin (HbA1c) levels were collected at baseline, sixth month and one year., Results: In all, 100 patients were randomised into control and intervention groups (n=50 per arm). The change of HbA1c in the intervention group (mean=-1.58) was significantly more than the control group (mean=-0.48) at 12 months with a mean difference of -1.10% (p=0.005, Cohen's d=0.627). Both study groups had similar significant changes of subjects from non-compliance to compliance (control group, n=11 vs. intervention group, n=10). The changes of BMI after 12 months between control group (0.24 kg/m2) and intervention group (0.24 kg/m2) was not significant (p=0.910). There were no episodes of severe hypoglycaemia detected in both groups., Conclusion: The addition of DMTAC service in primary care can improve glycaemic control among patients. The study was registered in the National Medical Research Register (Malaysia): NMRR-13-1449-18955.

Purpose: This study evaluated a novel composite measure of health literacy and numeracy by assessing its predictive validity for diabetes self-care activities and glycemic control., Methods: Patients (N = 102) with type 2 diabetes were recruited from a family medicine clinic at an academic medical center. Combined health literacy was assessed by combining the results of the Health Literacy Scale and the Subjective Numeracy Scale. Self-management activities were assessed by the Summary of Diabetes Self-Care Activities scale. Hemoglobin A1c (A1c) values were extracted from patients' medical records to assess glycemic control. Path models were used to test the predicted pathways linking health literacy and numeracy, independently and together, to self-management activities and glycemic control., Results: The mean combined literacy score was 72.0 (range, 33-104); the mean health literacy score alone was 43.9 (range, 14-56); and the mean numeracy score alone was 28.1 (range, 8-48). The direct effects results showed that the combined health literacy score (B = 0.107, P < .05) and the health literacy score alone (B = 0.234, P < .05) were significantly associated with self-care activities. The health literacy score alone also had a significant direct effect on A1c (B = -0.081, P < .05). The indirect effects of the combined health literacy on glycemic control through self-care activities were not statistically significant., Conclusions: Findings from this study suggest that the combined health literacy has predictive validity for self-care activities whereas the health literacy alone has predictive validity for glycemic control. More research is needed to validate these findings. Higher patient health literacy skills were not consistently associated with higher perceived numeracy skills. Additional attention and efforts should be made to make sure patients understand medical instructions involving numerical calculations.

Background/objective: The importance of metabolic control in childhood regarding excess risk of death in young persons has not been well studied. This registry-based study aimed to investigate mortality rates and cause of death related to metabolic control in young persons (≤29 years) in Sweden with type 1 diabetes., Methods: All 12 652 subjects registered in the Swedish pediatric diabetes quality register, from 2006 to 2014, were included. Data were merged with the Swedish Cause of Death Register. Standardized mortality rates were calculated using the official Swedish population register., Results: Of 68 deaths identified, 38.2% of the deaths were registered as being due to diabetes whereof the major cause of death was acute complications. Overall standardized mortality ratio was 2.7 (2.1-3.4, 95% CI). Subjects who died from diabetes had a mean HbA1c of 74 ± 19 mmol/mol (8.9 ± 1.7%) during childhood vs 62 ± 12 mmol/mol (7.8 ± 1.1%) in those still alive (P < .001)., Conclusions: In this nationwide cohort of young subjects with type 1 diabetes, there was a high mortality rate compared to the general population. Mean HbA1c in childhood was significantly higher in those who died from diabetes, compared to subjects who were still alive. To decrease mortality in young persons with type 1 diabetes it is essential not only to achieve but also to maintain a good metabolic control during childhood and adolescence., (© 2020 The Authors. Pediatric Diabetes published by John Wiley & Sons Ltd.)

Objective: To analyze the differences in health care costs according to glycemic control in people with type 2 diabetes., Research Design and Methods: Data on health care resource utilization from 100,391 people with type 2 diabetes were extracted from the electronic database used at the Catalan Health Institute. Multivariate regression models were carried out to test the impact of glycemic control (HbA 1c ) on total health care, hospital admission, and medication costs; model 1 adjusted for a variety of covariates, and model 2 also included micro- and macrovascular complications. Glycemic control was classified as good for HbA 1c <7%, fair for ≥7% to <8%, poor for ≥8% to <10%, and very poor for ≥10%., Results: Mean per patient annual direct medical costs were €3,039 ± SD €6,581. Worse glycemic control was associated with higher total health care costs: compared with good glycemic control, health care costs increased by 18% (€509.82) and 23% (€661.35) in patients with very poor and poor glycemic control, respectively, when unadjusted and by €428.3 and €395.1, respectively, in model 2. Medication costs increased by 12% in patients with fair control and by 28% in those with very poor control (model 2). Patients with poor control had a higher probability of hospitalization than those with good control (5% in model 2) and a greater average cost when hospitalization occurred (€811)., Conclusions: Poor glycemic control was directly related to higher total health care, hospitalization, and medication costs. Preventive strategies and good glycemic control in people with type 2 diabetes could reduce the economic impact associated with this disease., (© 2020 by the American Diabetes Association.)

Objective: Self-management education and support are essential for improved diabetes control. A 1-year randomized telephonic diabetes self-management intervention (Bronx A1C) among a predominantly Latino and African American population in New York City was found effective in improving blood glucose control. To further those findings, this current study assessed the intervention's impact in reducing health care utilization and costs over 4 years., Research Design and Methods: We measured inpatient ( n = 816) health care utilization for Bronx A1C participants using an administrative data set containing all hospital discharges for New York State from 2006 to 2014. Multilevel mixed modeling was used to assess changes in health care utilization and costs between the telephonic diabetes intervention (Tele/Pr) arm and print-only (PrO) control arm., Results: During follow-up, excess relative reductions in all-cause hospitalizations for the Tele/Pr arm compared with PrO arm were statistically significant for odds of hospital use (odds ratio [OR] 0.89; 95% CI 0.82, 0.97; P < 0.01), number of hospital stays (rate ratio [RR] 0.90; 95% CI 0.81, 0.99; P = 0.04), and hospital costs (RR 0.90; 95% CI 0.84, 0.98; P = 0.01). Reductions in hospital use and costs were even stronger for diabetes-related hospitalizations. These outcomes were not significantly related to changes observed in hemoglobin A 1c during individuals' participation in the 1-year intervention., Conclusions: These results indicate that the impact of the Bronx A1C intervention was not just on short-term improvements in glycemic control but also on long-term health care utilization. This finding is important because it suggests the benefits of the intervention were long-lasting with the potential to not only reduce hospitalizations but also to lower hospital-associated costs., (© 2020 by the American Diabetes Association.)

Aims: To explore parental perspectives after flash glucose monitoring commencement in adolescents and young adults with type 1 diabetes who were not meeting glycaemic targets., Methods: Twelve semi-structured interviews were conducted among parents of adolescents and young adults between the ages of 14 and 20 years (inclusive) with type 1 diabetes and not meeting glycaemic targets [HbA 1c 81-130 mmol/mol (9.6-14.0%)] participating in a randomized controlled trial. Interviews were transcribed, then thematic analysis was performed to identify themes regarding parental experiences., Results: Four key themes were found: flash glucose monitoring improved parental emotional well-being; flash glucose monitoring reduced diabetes-specific conflict within families; flash glucose monitoring facilitated the parental role in diabetes management; and sensor-related challenges, particularly sensors falling off, interfered with using flash glucose monitoring for diabetes management. The cost of self-funded sensors was the only barrier to continuing flash glucose monitoring that parents reported., Conclusions: This study provides new insights into the potential benefits and challenges of flash glucose monitoring use, drawn from the perspective of parents of adolescents and young adults not meeting glycaemic targets. As parents are often key partners in obtaining or purchasing this technology, these findings can be used to further inform parental expectations of this technology., (© 2019 Diabetes UK.)

Aims: Increased adiposity is a risk factor for suboptimal diabetes control and cardiovascular disease (CVD) complications. Our goal was to identify modifiable behavioral characteristics of overweight and obese pediatric patients with type 1 diabetes mellitus (T1DM) who achieve optimal glycemic control and to evaluate their CVD risk compared to lean patients. Our hypothesis was that optimally controlled obese and overweight participants require more total daily insulin and are at higher CVD risk compared to optimally controlled lean participants., Methods: We analyzed a cohort of 9263 participants with T1DM aged <21 years in the T1D Exchange Registry. Optimal diabetes control was defined as HbA1c ≤ 7.5% (58 mmol/mol). We compared factors that influence glycemic control in lean, overweight and obese participants with optimal vs. suboptimal control, using logistic regression., Results: Age, race, overweight status, continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) use were important variables influencing glycemic control. In the optimally controlled cohort, 27% of participants were overweight or obese versus 30% in the suboptimally controlled cohort (P < 0.001). Overweight and obese participants with optimal control were not significantly different from lean participants in terms of CSII use, total daily insulin dosage per kg of bodyweight, glucose checks per day, boluses with bedtime snack, use of CGM, but had higher LDL cholesterol and triglycerides, and lower HDL cholesterol (P < 0.05)., Conclusions: There were no differences in modifiable behavioral characteristics between the obese, overweight and lean optimally controlled participants. However, predictors of cardiovascular disease were higher in the overweight and obese group., Competing Interests: Declaration of competing interest The authors have no conflict of interest to declare., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Achieving optimal blood glucose control in Type 1 diabetes is a delicate balance between ensuring tight glycaemic control and achieving this without the expense of hypoglycaemia and weight gain, two major factors impacting quality of life. This is a real challenge for people with Type 1 diabetes and underpins many of the struggles they face in self-managing on a day-to-day basis. The main goals of insulin delivery are to try to simulate the physiology of β-cell insulin secretion as closely as possible and to overcome the challenges of peripheral insulin administration by achieving rapidity of onset with mealtime insulins and stability of the glucose-lowering effects of long-acting insulins. Since the early days of human insulin use, there have been many developments in insulin formulations that aim to achieve these goals as much as possible, thus contributing to better glycaemic control whilst minimizing hypoglycaemia. In the present review we discuss the currently available insulin analogues and the challenges of achieving glucose control using current analogues in those on multiple daily injections, and appraise the evidence base for newer-generation insulin analogues, such as insulin degludec, glargine U300, faster-acting insulin aspart and BioChaperone lispro. We also highlight new insulins in development and unmet needs in people with Type 1 diabetes., (© 2018 Diabetes UK.)

In 2011, the James Lind Alliance published a 'top 10' list of priorities for Type 1 diabetes research based on a structured consultation process. Whether reducing fluctuations in blood glucose can prevent long-term microvascular and macrovascular complications was one of these. In this narrative review, 8 years on, we have assessed the updated evidence for the assertion that increased glucose variability plays an independent and clinically important role in the complications of Type 1 diabetes, over and above mean blood glucose and the effects of hypoglycaemia: the 'glucose variability hypothesis'. Although studies in cultured cells and ex vivo vessels have been suggestive, most studies in Type 1 diabetes have been small and/or cross-sectional, and based on 'finger-prick' glucose measurements that capture glucose variability only in waking hours and are affected by missing data. A recent analysis of the Diabetes Control and Complications Trial that formally imputed missing data found no independent effect of short-term glucose variability on long-term complications. Few other high-quality longitudinal studies have directly addressed the glucose variability hypothesis in Type 1 diabetes. We conclude that there is little substantial evidence to date to support this hypothesis in Type 1 diabetes, although increasing use of continuous glucose monitoring provides an opportunity to test it more definitively. In the meantime, we recommend that control of glycaemia in Type 1 diabetes should continue to focus on the sustained achievement of target HbA 1c and avoidance of hypoglycaemia., (© 2019 Diabetes UK.)