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BackgroundA composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data.MethodsWe assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low-glucose and low-glucose hypoglycemia; very high-glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation.ResultsThe analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals.ConclusionThe GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.

ObjectiveWe examined whether diabetic ketoacidosis (DKA), a serious complication of type 1 diabetes (T1D) was more prevalent among Non-Hispanic (NH) Black and Hispanic patients with T1D and laboratory-confirmed coronavirus disease 2019 (COVID-19) compared with NH Whites.MethodThis is a cross-sectional study of patients with T1D and laboratory-confirmed COVID-19 from 52 clinical sites in the United States, data were collected from April to August 2020. We examined the distribution of patient factors and DKA events across NH White, NH Black, and Hispanic race/ethnicity groups. Multivariable logistic regression analysis was performed to examine the odds of DKA among NH Black and Hispanic patients with T1D as compared with NH White patients, adjusting for potential confounders, such as age, sex, insurance, and last glycated hemoglobin A1c (HbA1c) level.ResultsWe included 180 patients with T1D and laboratory-confirmed COVID-19 in the analysis. Forty-four percent (n = 79) were NH White, 31% (n = 55) NH Black, 26% (n = 46) Hispanic. NH Blacks and Hispanics had higher median HbA1c than Whites (%-points [IQR]: 11.7 [4.7], P

Objective Emerging adults (EAs) with type 1 diabetes (T1D) have difficulty meeting glycemic targets and have a high prevalence of mental health comorbidities. Resilience, the ability to harness resources needed to sustain one's emotional and physical well-being, may be a key factor impacting poor mental health and glycemic outcomes. We aimed to (a) evaluate the association between resilience, HbA1c, and key psychosocial factors and (b) explore whether resilience moderates the relationship between psychosocial factors (depression, diabetes-related distress, anxiety) and HbA1c in EAs with T1D. Method EAs with T1D (N  =   233) (mean age = 19.9 years (SD  = 1.6), range 16.8–24.7) seen at an EA-specific diabetes clinic completed resilience, diabetes-related distress, depression, and anxiety measures and had their HbA1c level evaluated. We used linear regression models and conducted moderation analyses for the resilience factor. Results Resilience was strongly associated with HbA1c, depression, diabetes-related distress, and anxiety in EAs with T1D. We did not find evidence that resilience moderates the relationship between depression, anxiety, or diabetes-related distress and HbA1c. Conclusions This study found that resilience is a highly relevant psychological factor associated with HbA1c and a key mental health factor for EAs with T1D. Novel interventions are needed to ameliorate high diabetes-related distress and HbA1c, and bolstering resilience may be one avenue to explore. Future research on resilience should longitudinally characterize and evaluate whether resilience may be a mechanism underlying the relationship between poor psychosocial outcomes and not meeting glycemic targets in EAs with T1D. [ABSTRACT FROM AUTHOR]

The American Diabetes Association (ADA), European Association for the Study of Diabetes (EASD), Joint British Diabetes Societies for Inpatient Care (JBDS), American Association of Clinical Endocrinology (AACE), and Diabetes Technology Society (DTS) convened a panel of internists and diabetologists to update the ADA consensus statement on hyperglycemic crises in adults with diabetes, published in 2001 and last updated in 2009. The objective of this consensus report is to provide up-to-date knowledge about the epidemiology, pathophysiology, clinical presentation, and recommendations for the diagnosis, treatment, and prevention of diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar state (HHS) in adults. A systematic examination of publications since 2009 informed new recommendations. The target audience is the full spectrum of diabetes health care professionals and individuals with diabetes. [ABSTRACT FROM AUTHOR]

ObjectiveTo assess the frequency of continuous glucose monitoring (CGM) device use, factors associated with its use, and the relationship of CGM with diabetes outcomes (HbA1c, severe hypoglycemia [SH], and diabetic ketoacidosis [DKA]).Research design and methodsSurvey questions related to CGM device use 1 year after enrollment in the T1D Exchange clinic registry were completed by 17,317 participants. Participants were defined as CGM users if they indicated using real-time CGM during the prior 30 days.ResultsNine percent of participants used CGM (6% of children

The incidence and prevalence of diabetes mellitus have grown significantly throughout the world, due primarily to the increase in type 2 diabetes. This overall increase in the number of people with diabetes has had a major impact on development of diabetic kidney disease (DKD), one of the most frequent complications of both types of diabetes. DKD is the leading cause of end-stage renal disease (ESRD), accounting for approximately 50% of cases in the developed world. Although incidence rates for ESRD attributable to DKD have recently stabilized, these rates continue to rise in high-risk groups such as middle-aged African Americans, Native Americans, and Hispanics. The costs of care for people with DKD are extraordinarily high. In the Medicare population alone, DKD-related expenditures among this mostly older group were nearly $25 billion in 2011. Due to the high human and societal costs, the Consensus Conference on Chronic Kidney Disease and Diabetes was convened by the American Diabetes Association in collaboration with the American Society of Nephrology and the National Kidney Foundation to appraise issues regarding patient management, highlighting current practices and new directions. Major topic areas in DKD included (1) identification and monitoring, (2) cardiovascular disease and management of dyslipidemia, (3) hypertension and use of renin-angiotensin-aldosterone system blockade and mineralocorticoid receptor blockade, (4) glycemia measurement, hypoglycemia, and drug therapies, (5) nutrition and general care in advanced-stage chronic kidney disease, (6) children and adolescents, and (7) multidisciplinary approaches and medical home models for health care delivery. This current state summary and research recommendations are designed to guide advances in care and the generation of new knowledge that will meaningfully improve life for people with DKD.

Abstract The renin-angiotensin system (RAS), bone morphogenetic protein (BMP), and WNT pathways are involved in pathogenesis of diabetic kidney disease (DKD). This study characterized assays for urinary angiotensinogen (AGT), gremlin-1, and matrix metalloproteinase 7 (MMP-7), components of the RAS, BMP, and WNT pathways and examined their excretion in DKD. We measured urine AGT, gremlin-1, and MMP-7 in individuals with type 1 diabetes and prevalent DKD (n = 20) or longstanding (n = 61) or new-onset (n = 10) type 1 diabetes without DKD. These urine proteins were also quantified in type 2 DKD (n = 11) before and after treatment with candesartan. The utilized immunoassays had comparable inter- and intra-assay and intraindividual variation to assays used for urine albumin. Median (IQR) urine AGT concentrations were 226.0 (82.1, 550.3) and 13.0 (7.8, 20.0) μg/g creatinine in type 1 diabetes with and without DKD, respectively (P < 0.001). Median (IQR) urine gremlin-1 concentrations were 48.6 (14.2, 254.1) and 3.6 (1.7, 5.5) μg/g, respectively (P < 0.001). Median (IQR) urine MMP-7 concentrations were 6.0 (3.8, 10.5) and 1.0 (0.4, 2.9) μg/g creatinine, respectively (P < 0.001). Treatment with candesartan was associated with a reduction in median (IQR) urine AGT/creatinine from 23.5 (1.6, 105.1) to 2.0 (1.4, 13.7) μg/g, which did not reach statistical significance. Urine gremlin-1 and MMP-7 excretion did not decrease with candesartan. In conclusion, DKD is characterized by markedly elevated urine AGT, MMP-7, and gremlin-1. AGT decreased in response to RAS inhibition, suggesting that this marker reflects therapeutic response. Urinary components of the RAS, BMP, and WNT pathways may identify risk of DKD and aid development of novel therapeutics.

Context The outcome of patients requiring intensive care can be influenced by the presence of previously undiagnosed diabetes (undiagDM). Objective This work aimed to define the clinical characteristics, glucose control metrics, and outcomes of patients admitted to the intensive care unit (ICU) with undiagDM, and compare these to patients with known DM (DM). Methods This case-control investigation compared undiagDM (glycated hemoglobin A1c [HbA1c] ≥ 6.5%, no history of diabetes) to patients with DM. Glycemic ratio (GR) was calculated as the quotient of mean ICU blood glucose (BG) and estimated preadmission glycemia, based on HbA1c ([28.7 × HbA1c] – 46.7 mg/dL). GR was analyzed by bands: less than 0.7, 0.7 to less than or equal to 0.9, 0.9 to less than 1.1, and greater than or equal to 1.1. Risk-adjusted mortality was represented by the Observed:Expected mortality ratio (OEMR), calculated as the quotient of observed mortality and mortality predicted by the severity of illness (APACHE IV prediction of mortality). Results Of 5567 patients 294 (5.3%) were undiagDM. UndiagDM had lower ICU mean BG (P <.0001) and coefficient of variation (P <.0001) but similar rates of hypoglycemia (P =.08). Mortality and risk-adjusted mortality were similar in patients with GR less than 1.1 comparing undiagDM and DM. However, for patients with GR greater than or equal to 1.1, mortality (38.5% vs 10.3% [ P =.0072]) and risk-adjusted mortality (OEMR 1.18 vs 0.52 [ P <.0001]) were higher in undiagDM than in DM. Conclusion These data suggest that DM patients may develop tolerance to hyperglycemia that occurs during critical illness, a protective mechanism not observed in undiagDM, for whom hyperglycemia remains strongly associated with higher risk of mortality. These results may shed light on the natural history of diabetes. [ABSTRACT FROM AUTHOR]

Background: Adult patients with diabetes or newly recognized hyperglycemia account for over 30% of noncritically ill hospitalized patients. These patients are at increased risk for adverse clinical outcomes in the absence of defined approaches to glycemic management. Objective: To review and update the 2012 Management of Hyperglycemia in Hospitalized Patients in Non-Critical Care Settings: An Endocrine Society Clinical Practice Guideline and to address emerging areas specific to the target population of noncritically ill hospitalized patients with diabetes or newly recognized or stress-induced hyperglycemia. Methods: A multidisciplinary panel of clinician experts, together with a patient representative and experts in systematic reviews and guideline development, identified and prioritized 10 clinical questions related to inpatient management of patients with diabetes and/or hyperglycemia. The systematic reviews queried electronic databases for studies relevant to the selected questions. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make recommendations. Results: The panel agreed on 10 frequently encountered areas specific to glycemic management in the hospital for which 15 recommendations were made. The guideline includes conditional recommendations for hospital use of emerging diabetes technologies including continuous glucose monitoring and insulin pump therapy; insulin regimens for prandial insulin dosing, glucocorticoid, and enteral nutrition–associated hyperglycemia; and use of noninsulin therapies. Recommendations were also made for issues relating to preoperative glycemic measures, appropriate use of correctional insulin, and diabetes self-management education in the hospital. A conditional recommendation was made against preoperative use of caloric beverages in patients with diabetes. Conclusion: The recommendations are based on the consideration of important outcomes, practicality, feasibility, and patient values and preferences. These recommendations can be used to inform system improvement and clinical practice for this frequently encountered inpatient population. [ABSTRACT FROM AUTHOR]

The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) convened a writing group to develop a consensus statement on the management of type 1 diabetes in adults. The writing group has considered the rapid development of new treatments and technologies and addressed the following topics: diagnosis, aims of management, schedule of care, diabetes self-management education and support, glucose monitoring, insulin therapy, hypoglycemia, behavioral considerations, psychosocial care, diabetic ketoacidosis, pancreas and islet transplantation, adjunctive therapies, special populations, inpatient management, and future perspectives. Although we discuss the schedule for follow-up examinations and testing, we have not included the evaluation and treatment of the chronic microvascular and macrovascular complications of diabetes as these are well-reviewed and discussed elsewhere. The writing group was aware of both national and international guidance on type 1 diabetes and did not seek to replicate this but rather aimed to highlight the major areas that health care professionals should consider when managing adults with type 1 diabetes. Though evidence-based where possible, the recommendations in the report represent the consensus opinion of the authors. [ABSTRACT FROM AUTHOR]

Glycemic control immediately upon hospitalization is difficult. Endocrine Society guidelines suggest starting scheduled insulin therapy at 0.2–0.5 units/kg/day, but there has been no rigorous study to support this recommendation. To understand the variability of current practice, we surveyed starting insulin algorithms for noncritically ill patients among the top-ranking academic hospitals in the United States. Among the 20 hospitals with reported algorithms, 12 specified which patients should start with basal/nutritional insulin, whereas 5 specified who should start with only correction insulin. Weight-based and/or home-dose-based calculations were used to estimate the initial insulin requirements with various modifiers. In addition, various factors were considered when choosing among the correction dose algorithms. In summary, among the U.S. academic hospitals, there is variability in methods for determining insulin dosing on admission for noncritically ill patients. This inconsistency suggests that future studies to estimate initial insulin requirements are required. [ABSTRACT FROM AUTHOR]

Numerous studies have demonstrated the clinical benefits of continuous glucose monitoring (CGM) in individuals with diabetes. Within ongoing innovations in CGM technology, individuals now have an expanding array of options that allow them to select the device that meets their individual needs and preferences. Although demand for CGM in primary care continues to grow, many clinicians are reluctant to prescribe this technology due to their unfamiliarity with the various devices, uncertainty about which devices are best suited to each patient and the feasibility of using CGM. This article reviews the features and functionality of the most recent commercially available CGM devices and provides guidance for integrating CGM use into clinical practices. [ABSTRACT FROM AUTHOR]

Objective: Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal safety study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets.Research Design and Methods: This single-arm, multicenter, prospective study enrolled 112 children (age 6-13.9 years) and 129 adults (age 14-70 years). A 2-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery. Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA1c and percent time in sensor glucose range 70-180 mg/dL ("time in range").Results: A total of 235 participants (98% of enrolled, including 111 children and 124 adults) completed the study. HbA1c was significantly reduced in children by 0.71% (7.8 mmol/mol) (mean ± SD: 7.67 ± 0.95% to 6.99 ± 0.63% [60 ± 10.4 mmol/mol to 53 ± 6.9 mmol/mol], P < 0.0001) and in adults by 0.38% (4.2 mmol/mol) (7.16 ± 0.86% to 6.78 ± 0.68% [55 ± 9.4 mmol/mol to 51 ± 7.4 mmol/mol], P < 0.0001). Time in range was improved from standard therapy by 15.6 ± 11.5% or 3.7 h/day in children and 9.3 ± 11.8% or 2.2 h/day in adults (both P < 0.0001). This was accomplished with a reduction in time in hypoglycemia <70 mg/dL among adults (median [interquartile range]: 2.00% [0.63, 4.06] to 1.09% [0.46, 1.75], P < 0.0001), while this parameter remained the same in children. There were three severe hypoglycemia events not attributable to automated insulin delivery malfunction and one diabetic ketoacidosis event from an infusion site failure.Conclusions: This tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA1c levels and time in target glucose range with a very low occurrence of hypoglycemia. [ABSTRACT FROM AUTHOR]

The increasing prevalence of diabetes, combined with a growing global shortage of health care professionals (HCP), necessitates the need to develop new approaches to diabetes care delivery to expand access to care, lessen the burden on people with diabetes, improve efficiencies, and reduce the unsustainable financial liability on health systems and payers. Use of digital diabetes technologies and telehealth protocols within a digital/virtual diabetes clinic has the potential to address these challenges. However, several issues must be resolved to move forward. In February 2020, organizers of the Advanced Technologies & Treatments for Diabetes Annual Conference convened an international panel of HCP, researchers, patient advocates, and industry representatives to review the status of digital diabetes technologies, characterize deficits in current technologies, and identify issues for consideration. Since that meeting, the importance of using telehealth and digital diabetes technologies has been demonstrated amid the global coronavirus disease (COVID-19) pandemic. This article summarizes the panel's discussion of the opportunities, obstacles, and requisites for advancing the use of these technologies as a standard of care for the management of diabetes. [ABSTRACT FROM AUTHOR]

Full realization of the benefits of continuous glucose monitoring (CGM) depends on addressing barriers such as cost, accuracy, burdens of daily use, and uncertainty about applying the data. Lack of systematic education has also hampered widespread adoption among patients and health care professionals. This article describes the practical application of an affordable and intuitive category of CGM called "flash" that requires users to scan the sensor with a handheld reader for on-demand access to continuous data. The data may be used for in-the-moment therapy adjustment, retrospective review of glucose patterns, and observation of glucose trending in response to behavior. Higher rates of flash CGM scanning have been associated with increased time in the glycemic target range and reduced time in hyper- and hypoglycemia. Growing interest in this technology suggests new opportunities for helping more patients incorporate CGM into their daily self-care. [ABSTRACT FROM AUTHOR]

Faster-acting insulins, new noninsulin drug classes, more flexible insulin-delivery systems, and improved continuous glucose monitoring devices offer unprecedented opportunities to improve postprandial glucose (PPG) management and overall care for adults with insulin-treated diabetes. These developments led the Endocrine Society to convene a working panel of diabetes experts in December 2018 to assess the current state of PPG management, identify innovative ways to improve self-management and quality of life, and align best practices to current and emerging treatment and monitoring options. Drawing on current research and collective clinical experience, we considered the following issues for the ∼200 million adults worldwide with type 1 and insulin-requiring type 2 diabetes: (i) the role of PPG management in reducing the risk of diabetes complications; (ii) barriers preventing effective PPG management; (iii) strategies to reduce PPG excursions and improve patient quality of life; and (iv) education and clinical tools to support endocrinologists in improving PPG management. We concluded that managing PPG to minimize or prevent diabetes-related complications will require elucidating fundamental questions about optimal ways to quantify and clinically assess the metabolic dysregulation and consequences of the abnormal postprandial state in diabetes and recommend research strategies to address these questions. We also identified practical strategies and tools that are already available to reduce barriers to effective PPG management, optimize use of new and emerging clinical tools, and improve patient self-management and quality of life. [ABSTRACT FROM AUTHOR]

Objective: Higher serum uric acid (SUA) is associated with diabetic kidney disease (DKD). Preventing Early Renal Loss in Diabetes (PERL) evaluates whether lowering SUA with allopurinol slows glomerular filtration rate (GFR) loss in people with type 1 diabetes (T1D) and mild to moderate DKD. We present the PERL rationale, design, and baseline characteristics.Research Design and Methods: This double-blind, placebo-controlled, multicenter trial randomized 530 participants with T1D, estimated GFR (eGFR) of 40-99.9 mL/min/1.73 m2, SUA ≥4.5 m/dL, and micro- to macroalbuminuric DKD or normoalbuminuria with declining kidney function (NDKF) (defined as historical eGFR decline ≥3 mL/min/1.73 m2/year) to allopurinol or placebo. The primary outcome is baseline-adjusted iohexol GFR (iGFR) after 3 years of treatment plus a 2-month washout period.Results: Participants are 66% male and 84% white. At baseline, median age was 52 years and diabetes duration was 35 years, 93% of participants had hypertension, and 90% were treated with renin-angiotensin system inhibitors (median blood pressure 127/71 mmHg). Median HbA1c was 8%, SUA 5.9 mg/dL, iGFR 68 mL/min/1.73 m2, and historical eGFR slope -3.5 mL/min/1.73 m2/year. Compared with participants with albuminuria (n = 419), those with NDKF (n = 94) were significantly older (56 vs. 52 years), had lower HbA1c (7.7 vs. 8.1%) and SUA (5.4 vs. 6.0 mg/dL), and had higher eGFR (82 vs. 74 mL/min/1.73 m2) and historical eGFR loss (-4.7 vs. -2.5 mL/min/1.73 m2/year). These differences persisted when comparing groups with similar rates of historical eGFR loss.Conclusions: PERL will determine the effect of allopurinol on mild to moderate DKD in T1D, with or without albuminuria. Participants with normoalbuminuria and rapid GFR loss manifested many DKD risk factors of those with albuminuria, but with less severity. [ABSTRACT FROM AUTHOR]

The article offers information on a study related to the validation of time in range metrics with microvascular outcomes. It notes the diabetes control and complications trial (DCCT) which identified the relationship between intensive diabetes management for those with type 1 diabetes (T1D) and a delay in progression of microvascular complications.

In academia, there are more evaluations from students, residents, and fellows, but all of us who see patients are now dependent on patient evaluations that come in all forms. I received a hospital discharge summary from an outside hospital where a patient of mine with type 1 diabetes was admitted for intravenous antibiotics for sepsis. Currently, it is family advocacy that is the primary protector for patient safety when admitted to certain hospitals for type 1 diabetes. [Extracted from the article]

Objective: Health care spending on diabetes in the U.S. has increased dramatically over the past several decades. This research describes health care spending on diabetes to quantify how that spending has changed from 1996 to 2013 and to determine what drivers are increasing spending.Research Design and Methods: Spending estimates were extracted from the Institute for Health Metrics and Evaluation's Disease Expenditure 2013 database. Estimates were produced for each year from 1996 to 2013 for each of 38 age and sex groups and six types of care. Data on disease burden were extracted from the Global Burden of Disease 2016 study. We analyzed the drivers of spending by measuring the impact of population growth and aging and changes in diabetes prevalence, service utilization, and spending per encounter.Results: Spending on diabetes in the U.S. increased from $37 billion (95% uncertainty interval $32-$42 billion) in 1996 to $101 billion ($97-$107 billion) in 2013. The greatest amount of health care spending on diabetes in 2013 occurred in prescribed retail pharmaceuticals (57.6% [53.8-62.1%] of spending growth) followed by ambulatory care (23.5% [21.7-25.7%]). Between 1996 and 2013, pharmaceutical spending increased by 327.0% (222.9-456.6%). This increase can be attributed to changes in demography, increased disease prevalence, increased service utilization, and, especially, increases in spending per encounter, which increased pharmaceutical spending by 144.0% (87.3-197.3%) between 1996 and 2013.Conclusions: Health care spending on diabetes in the U.S. has increased, and spending per encounter has been the biggest driver. This information can help policy makers who are attempting to control future spending on diabetes. [ABSTRACT FROM AUTHOR]

After assessing patient perspectives on the success of current diabetes therapies and the factors that have the greatest impact on daily life, we show that time-in-range is a crucial outcome for people with diabetes and that current therapies are falling short on this metric. We also show that patients feel significant stress and worry, and they believe they are falling short in diet, exercise, and weight maintenance. In addition, they believe diet and exercise and in-range blood glucose are the biggest drivers of improved diabetes management and mindset. Together, these findings support the need for therapies that improve outcomes including and beyond A1C. [ABSTRACT FROM AUTHOR]

Decreasing glycated hemoglobin (A1C) is the primary goal of current diabetes management due to intervention studies in type 1 and type 2 diabetes associating levels <7.0% (53 mmol/mol) with lower complication risk. Strategic self-monitoring of blood glucose (SMBG) is also recommended to achieve greater time in range, with fewer extremes of hypo- or hyperglycemia. Unlike A1C, SMBG can distinguish among fasting, prandial, and postprandial hyperglycemia; uncover glycemic variability, including potentially dangerous hypoglycemia; and provide feedback to patients about the effects of behavior and medication on glycemic control. However, it has the drawback of capturing only static glucose readings and users are often dependent on time-pressed clinicians to interpret numerous data points. A novel flash continuous glucose monitoring (FCGM) device used for a single 2-week period with a readily interpretable data report know as the ambulatory glucose profile (AGP) has the potential to overcome limitations of conventional technologies, with less cost and greater convenience. This review summarizes the rationale for using intermittent FCGM as a supplement to A1C in primary care, and provides a stepwise approach to interpreting the AGP visual display for efficient individualized therapy. [ABSTRACT FROM PUBLISHER]

We review clinical instances in which A1C should not be used and reflect on the use of other glucose metrics that can be used, in substitution of or in combination with A1C and SMBG, to tailor an individualized approach that will result in better outcomes and patient empowerment. [ABSTRACT FROM AUTHOR]

The article presents the author's views on insulin therapy for type- diabetic patients.

The article discusses various factors responsible for the management of glycemia in patients with chronic kidney disease (CKD) including approximated testing of hemoglobin A1C in people with CKD and antidiabetic medication adjustment. The various antidiabetic medicines used for controlling CKD includes metformin, thiazolidinediones and glucagon-like peptide-1 receptor agonists (GLP-1).

The article discusses research studies on the hemoglobin A1c (HbA1c) targets in children with type 1 diabetes. Details about the Diabetes Control and Complications Trial (DCCT), the Epidemiology of Diabetes Interventions and Complications (EDIC), and the Hvidoere Childhood Diabetes Study Group Centre Differences Study are provided. Some research findings are given related to the adverse effects of hypoglycemia and the association of lower HbA1c targets with benchmarking results.

Management of individuals with type 2 diabetes involves complex decision-making to attain good glycemic control. A personalized approach to the care of these individuals provides a unique management plan for each patient. This article reviews some of the important variables that require consideration for management of individuals with type 2 diabetes. We also provide a scoring scale to help clinicians make appropriate decisions regarding A1C targets while caring for these patients. [ABSTRACT FROM AUTHOR]

OBJECTIVE--To evaluate efficacy and tolerability of a co-formulation of insulin degludec and insulin aspart (IDegAsp) with insulin aspart (IAsp) at other meals compared with basal-bolus therapy using insulin detemir (IDet) and IAsp. RESEARCH DESIGN AND METHODS--Adults (n = 548) with type 1 diabetes (A1C 7.0-10.0%; BMI ≤35.0 kg/m²) were randomized 2:1 in a 26-week, multinational, parallel-group, treat-to-target trial to IDegAsp or IDet. IDegAsp was given with a meal, and IDet was given in the evening, with a second (breakfast) dose added if needed. RESULTS--Non-inferiority for IDegAsp versus IDet was confirmed; A1C improved by 0.75% with IDegAsp and 0.70% with IDet to 7.6% in both groups (estimated treatment difference IDegAsp -- IDet: -0.05% [95% CI -0.18 to 0.08]). There was no statistically significant difference between IDegAsp and IDet in the rates of severe hypoglycemia (0.33 and 0.42 episodes/ patient-year, respectively) or overall confirmed (plasma glucose <3.1 mmol/L) hypoglycemia (39.17 and 44.34 episodes/patient-year, respectively). Nocturnal confirmed hypoglycemia rate was 37% lower with IDegAsp than IDet (3.71 vs. 5.72 episodes/patient-year, P < 0.05). Weight gain was 2.3 and 1.3 kg with IDegAsp and IDet, respectively (P < 0.05). Total insulin dose was 13% lower in the IDegAsp group (P < 0.0001). No treatment differences were detected in Health-Related Quality of Life, laboratory measurements, physical examination, vital signs, electrocardiograms, fundoscopy, or adverse events. CONCLUSIONS--IDegAsp in basal-bolus therapy with IAsp at additional mealtimes improves overall glycemic control and was non-inferior to IDet, with a reduced risk of nocturnal hypoglycemia and fewer injections in comparison with IDet + IAsp basal-bolus therapy. [ABSTRACT FROM AUTHOR]

This article reviews the advantages and limitations of the current glycemic biomarkers, including A1C, 1,5-anhydroglucitol, and the glycated proteins fructosamine and glycated albumin. It provides patient encounter case studies and related discussion to guide health care professionals on the appropriate use of the various glycemic biomarkers in clinical practice. [ABSTRACT FROM AUTHOR]

Administration of exogenous insulin for the treatment of diabetes is often accompanied by the development of insulin antibodies (IA). These antibodies may affect the patient’s requirement for insulin by acting as an insulin binding reservoir. The improvement of insulin purification in the 1970s and the development of human recombinant insulin both reduced the incidence of IA and their binding levels. This study investigates the parameters affecting IA frequency and binding levels in a cohort of type 1 diabetes (T1D) patients. All patients were treated with human recombinant insulin. About half of the patients had received animal insulin prior to the introduction of human recombinant insulin. We tested the IA frequency and binding level for all serum samples. IA were further analyzed for their epitope specificity comparing human and porcine insulin binding. We found that T1D patients who received animal insulin in the past show significantly higher IA binding levels as compared to patients treated exclusively with human recombinant insulin (IA binding level of 0.9 and 0.25 index, respectively, P = 0.005). T1D patients who received animal insulin in the past showed a relative bias towards porcine insulin, as compared to T1D patients who were treated with human recombinant insulin exclusively ( P < 0.0001). We conclude that IA binding level and epitope specificity are biased by treatment with animal insulin. This bias remains for over 20 years after animal insulin treatment is terminated. [ABSTRACT FROM AUTHOR]

This JAMA Insights Clinical Update reviews indications and timing of insulin therapy for management of type 2 diabetes, emphasizing the likely benefit of its use as first-line therapy in patients with HbA1c levels less than 9.0%. [ABSTRACT FROM AUTHOR]

Diabetes mellitus is the fourth most common comorbid condition among hospitalized patients, and 30% of patients undergoing open-heart surgery have diabetes. The link between hyperglycemia and poor outcome has been well described, and large clinical trials have shown that aggressive control of blood glucose with an insulin infusion can improve these outcomes. The barriers to implementing an insulin infusion protocol are numerous, despite the fact that doing so is paramount to clinical success. Barriers include safety concerns, such as fear of hypoglycemia, insufficient nursing staff to patient ratios, lack of administrative and physician support, various system and procedural issues, and resistance to change. Key steps to overcome the barriers include building support with multidisciplinary champions, involving key staff, educating staff, and administrators of the clinical and economic benefits of improving glycemic control, setting realistic goals, selecting a validated insulin infusion protocol, and internally marketing the success of the protocol. [Copyright &y& Elsevier]

OBJECTIVE -- Night-eating syndrome is characterized by excessive eating in the evening and nocturnal awakening with ingestion of food. Psychosocial variables and emotional triggers may be associated with these behaviors. In patients with diabetes, such behaviors may lead to glucose dysregulation and contribute to obesity and complications. RESEARCH DESIGN AND METHODS -- In 714 tertiary care patients with type 1 and 2 diabetes, we determined the proportion of patients reporting eating >25% of their daily food intake after regular suppertime. We also screened patients for major depression, childhood maltreatment histories, nonsecure attachment styles, and emotional eating triggers. We examined whether patients reporting night-eating behaviors had greater psychosocial distress, higher HbA[sub 1c] (A1C) levels, more obesity, and more diabetes complications compared with patients without night-eating behaviors. RESULTS -- Night-eating behaviors were reported in 9.7% of patients. Compared with patients without night-eating behaviors, those with these behaviors were less adherent with diet, exercise, and glucose monitoring and more likely to he depressed, to report childhood maltreatment histories, to have nonsecure attachment styles, and to report eating in response to anger, sadness, loneliness, worry, and being upset. Controlling for age, sex, race, and major depression, patients with night-eating behaviors, compared with patients without night-eating behaviors, were more likely to be obese (odds ratio 2.6 [95% CI 1.5-4.5]), to have A1C values >7% (2.2 [1.1- 4.1]) and to have two or more diabetes complications (2.6 [1.5- 4.5]). CONCLUSIONS -- Night-eating behaviors are associated with adverse outcomes in patients with diabetes. Use of clinical screening tools may help identify patients with night-eating behaviors. [ABSTRACT FROM AUTHOR]

The article presents a study on the effectiveness of sertraline for prevention of depression recurrence in diabetes melliltus (DM) in the U.S. Using a random, double-blind, and controlled trial, it examines the prevalence of depression and recurrent problems among patients with DM that could adversely affect the medical prognosis.

The current paradigm for pharmacologic management of type 2 diabetes mellitus (DM) is to progress with oral agents until severe insulin deficiency develops, at which time insulin can be initiated. Reexamination of data from the Diabetes Control and Complications Trial (DCCT) suggests that glycemic variability may be an important factor involved in the pathogenesis of microvascular complications. It is now appreciated that oxidative stress from overproduction of reactive oxygen species may be the result of this glycemic variability, suggesting that an overemphasis of basal insulin may not be the ideal strategy for insulin replacement, even though basal insulin is often the only insulin used initially. Although finding the best insulin program for treatment of type 2 DM is an important area of research, almost all patients with severe insulin deficiency will require both basal and prandial replacement. Use of adequate lag times (time between injecting the prandial insulin and eating), U-500 insulin (500 U/mL human regular insulin), and home blood glucose monitoring to determine “glycemic trend” are important tools that are readily available to all patients. [Copyright &y& Elsevier]

OBJECTIVE -- Multiple daily injection (MDI) therapy of bolus insulin aspart and basal insulin glargine was compared with continuous subcutaneous insulin infusion (CSII) with aspart in type 1 diabetic patients previously treated with CSII. RESEARCH DESIGN AND METHODS -- One hundred patients were enrolled in a randomized, multicenter, open-label, crossover study. After a 1-week run-in period with aspart by CSII, 50 subjects were randomly assigned to MDI therapy (aspart immediately before each meal and glargine at bedtime) and 50 subjects continued CSII. After 5 weeks of the first treatment, subjects crossed over to the alternate treatment for 5 weeks. During the last week of each treatment period, subjects wore a continuous glucose monitoring system for 48-72 h. RESULTS -- Mean serum fructosamine levels were significantly lower after CSII therapy than after MDI therapy (343 ± 47 vs. 355 ± 50 µmol/l, respectively; P = 0.0001). Continuous glucose monitoring profiles over a 24-h time period showed that glucose exposure was 24 and 40% lower for CSII than MDI as measured by area under the curve (AUC) glucose ≥80 mg/dl (1,270 ± 742 vs. 1,664 ± 1,039 mg ⋅ h ⋅ dl[sup -1]; P < 0.001) and AUC glucose ≥140 mg/dl (464 ± 452 vs. 777 ± 746 mg ⋅ h ⋅ d[sup -1], CSII vs. MDI, respectively; P < 0.001). Similar percentages of subjects reported hypoglycemic episodes (CSII: 92%, MDI: 94%) and nocturnal (12:00 A.M. to 8:00 A.M.) hypoglycemic episodes (CSII: 73%, MDI: 72%). Major hypoglycemia was infrequent (CSII: two episodes, MDI: five episodes). CONCLUSIONS -- In a trial of short duration, CSII therapy with insulin aspart resulted in lower glycemic exposure without increased risk of hypoglycemia, as compared with MDI with insulin aspart and glargine. [ABSTRACT FROM AUTHOR]

Context: Newer insulin therapies, including the concept of physiologic basal-prandial insulin and the availability of insulin analogues, are changing clinical diabetes care. The key to effective insulin therapy is an understanding of principles that, when implemented, can result in improved diabetes control. Objective: To systematically review the literature regarding insulin use in patients with type 1 and type 2 diabetes mellitus (DM). Data Sources: A MEDLINE search was performed to identify all English-language articles of randomized controlled trials involving insulin use in adults with type 1 or type 2 DM from January 1, 1980, to January 8, 2003. Bibliographies and experts were used to identify additional studies. Study Selection and Data Extraction: Studies were included (199 for type 1 DM and 144 for type 2 DM, and 38 from other sources) if they involved human insulins or insulin analogues, were at least 4 weeks long with at least 10 patients in each group, and glycemic control and hypoglycemia were reported. Studies of insulin-oral combination were similarly selected. Data Synthesis: Twenty-eight studies for type 1 DM, 18 for type 2 DM, and 48 for insulin-oral combination met the selection criteria. In patients with type 1 DM, physiologic replacement, with bedtime basal insulin and a mealtime rapid-acting insulin analogue, results in fewer episodes of hypoglycemia than conventional regimens. Rapid-acting insulin analogues are preferred over regular insulin in patients with type 1 DM since they improve HbA[sub 1C] and reduce episodes of hypoglycemia. In patients with type 2 DM, adding bedtime neutral protamine Hagedorn (isophane) insulin to oral therapy significantly improves glycemic control, especially when started early in the course of disease. Bedtime use of insulin glargine results in fewer episodes of nighttime hypoglycemia than neutral protamine Hagedorn regimens. For patients with more severe insulin deficiency, a physiologic insulin regimen... [ABSTRACT FROM AUTHOR]

Objective: in an academic family practice clinic, we performed a controlled trial of a multifaceted intervention versus usual care for managing diabetes. Providers received didactic training and computerized compliance feedback to support staged diabetes management, an evidenced-based approach to diabetes care. Research design and methods: one firm of the clinic practice received the intervention, the other served as the control group during a 14-month baseline period and a 14-month study period. HbA1c was the principal outcome measure. Results: there was a significant 0.71% difference in change in HbA1c values between the intervention and control firms (P=0.02). The subgroup with the greatest improvement in HbA1c was those subjects who started the intervention with a HbA1c above 8%. The overall improvement in glycemic control could not be explained by differences in visit frequency or the aggressiveness of drug therapy. There were no changes in healthcare utilization or costs between the two firms. Conclusion: in an academic family practice clinic, a multifaceted intervention in support of diabetes treatment guidelines modestly improved glycemic control without incurring additional costs. The improvement was mostly due to mitigation of the natural deterioration in control usually seen. Further efforts are required to involve all patients in co-managing their diabetes. [Copyright &y& Elsevier]

Objective: Insulin glargine (21A-Gly-30Ba-L-Arg-30Bb-L-Arg-human insulin) is a biosynthetic insulin analog with a prolonged duration of action compared with NPH human insulin. This study compared insulin glargine with NPH human insulin in subjects with type 1 diabetes who had been previously treated with multiple daily injections of NPH insulin and regular insulin.Research Design and Methods: This study was a multicenter randomized parallel-group study in which subjects were randomized to receive premeal regular insulin and either insulin glargine (at bedtime) or NPH insulin (at bedtime for patients on once-daily therapy and at bedtime and in the morning for patients on twice-daily therapy) for up to 28 weeks. Dose titration of both basal insulins was based on capillary fasting whole blood glucose (FBG) levels; the goal was a premeal blood glucose concentration of 4.4-6.7 mmol/l.Results: A total of 534 well-controlled type 1 diabetic subjects (mean GHb 7.7%, mean fasting plasma glucose [FPG] 11.8 mmo/l) were treated. A small decrease in GHb levels was noted with both insulin glargine (-0.16%) and NPH insulin (-0.21%; P > 0.05). Significant reductions in median FPG levels from baseline (-1.67 vs. -0.33 mmol/l with NPH insulin, P = 0.0145) and a trend for a reduction in capillary FBG levels were achieved with insulin glargine. After the 1-month titration phase, significantly fewer subjects receiving insulin glargine experienced symptomatic hypoglycemia (39.9 vs. 49.2%, P = 0.0219) or nocturnal hypoglycemia (18.2 vs. 27.1%, P = 0.0116) with a blood glucose level <2.0 mmol/l compared with subjects receiving NPH insulin.Conclusions: Lower FPG levels with fewer episodes of hypoglycemia were achieved with insulin glargine compared with once- or twice-daily NPH insulin as part of a basal-bolus regimen in patients with type 1 diabetes. [ABSTRACT FROM AUTHOR]

A recent finding is that GIP/GLP-1 receptor co-agonists like tirzepatide have efficacy superior to selective GLP-1 receptor agonists with respect to glycemic control as well as body weight; this finding has renewed interest in GIP, which previously was thought to be without any therapeutic potential. The final abstract illustrates the same neuroprotective abilities of GLP-1 and GIP receptor agonists in patients with Alzheimer disease, Parkinson disease, and other diabetes-induced memory impairments. Materials and Methods Several clinical trials have been conducted to test GLP-1 receptor agonists in patients with Alzheimer disease, Parkinson disease, or diabetes-induced memory impairments. Globally, there has been an increase in patients diagnosed with type 1 (T1D) and type 2 (T2D) diabetes (International Diabetes Federation Atlas, 2022), especially in emerging economies. [Extracted from the article]

Background: Connected insulin pens capture data on insulin dosing/timing and can integrate with continuous glucose monitoring (CGM) devices with essential insulin and glucose metrics combined into a single platform. Standardization of connected insulin pen reports is desirable to enhance clinical utility with a single report. Methods: An international expert panel was convened to develop a standardized connected insulin pen report incorporating insulin and glucose metrics into a single report containing clinically useful information. An extensive literature review and identification of examples of current connected insulin pen reports were performed serving as the basis for creation of a draft of a standardized connected insulin pen report. The expert panel participated in three virtual standardization meetings and online surveys. Results: The Ambulatory Glucose Profile (AGP) Report: Connected Insulin Pen brings all clinically relevant CGM-derived glucose and connected insulin pen metrics into a single simplified two-page report. The first page contains the time in ranges bar, summary of key insulin and glucose metrics, the AGP curve, and detailed basal (long-acting) insulin assessment. The second page contains the bolus (mealtime and correction) insulin assessment periods with information on meal timing, insulin-to-carbohydrate ratio, average bolus insulin dose, and number of days with bolus doses recorded. The report's second page contains daily glucose profiles with an overlay of the timing and amount of basal and bolus insulin administered. Conclusion: The AGP Report: Connected Insulin Pen is a standardized clinically useful report that should be considered by companies developing connected pen technology as part of their system reporting/output. [ABSTRACT FROM AUTHOR]