Search

The increasing prevalence of diabetes mellitus has been accompanied by a rapid expansion in wearable continuous glucose monitoring (CGM) devices and insulin pumps. Systems combining these components in a "closed loop," where interstitial glucose measurement guides automated insulin delivery (AID, or closed loop) based on sophisticated algorithms, are increasingly common. While these devices' efficacy in achieving near-normoglycemia is contributing to increasing usage among patients with diabetes, the management of these patients in operative and procedural environments remains understudied with limited published guidance available, particularly regarding AID systems. With their growing prevalence, practical management advice is needed for their utilization, or for the rational temporary substitution of alternative diabetes monitoring and treatments, during surgical care. CGM devices monitor interstitial glucose in real time; however, there are potential limitations to use and accuracy in the perioperative period, and, at the present time, their use should not replace regular point-of-care glucose monitoring. Avoiding perioperative removal of CGMs when possible is important, as removal of these prescribed devices can result in prolonged interruptions in CGM-informed treatments during and after procedures, particularly AID system use. Standalone insulin pumps provide continuous subcutaneous insulin delivery without automated adjustments for glucose concentrations and can be continued during some procedures. The safe intraoperative use of AID devices in their hybrid closed-loop mode (AID mode) requires the CGM component of the system to continue to communicate valid blood glucose data, and thus introduces the additional need to ensure this portion of the system is functioning appropriately to enable intraprocedural use. AID devices revert to non-AID insulin therapy modes when paired CGMs are disconnected or when the closed-loop mode is intentionally disabled. For patients using insulin pumps, we describe procedural factors that may compromise CGM, insulin pump, and AID use, necessitating a proactive transition to an alternative insulin regimen. Procedure duration and invasiveness is an important factor as longer procedures increase the risk of stress hyperglycemia, tissue malperfusion, and device malfunction. Whether insulin pumps should be continued through procedures, or substituted by alternative insulin delivery methods, is a complex decision that requires all parties to understand potential risks and contingency plans relating to patient and procedural factors. Currently available CGMs and insulin pumps are reviewed, and practical recommendations for safe glycemic management during the phases of perioperative care are provided., Competing Interests: Conflicts of Interest: See Disclosures at the end of the article., (Copyright © 2024 International Anesthesia Research Society.)

Competing Interests: We declare no competing interests.

Objective: To evaluate whether continuous glucose monitoring (CGM) could assist providers in intensifying glycemic management in hospitalized patients with type 2 diabetes., Research Design and Methods: At six academic hospitals, adults with type 2 diabetes hospitalized in a non-intensive care setting were randomly assigned to either standard therapy with glucose target 140-180 mg/dL (standard group) or intensive therapy with glucose target 90-130 mg/dL guided by CGM (intensive group). The primary outcome was mean glucose measured with CGM (blinded in standard group), and the key secondary outcome was CGM glucose <54 mg/dL., Results: For the 110 participants included in the primary analysis, mean ± SD age was 61 ± 12 years and mean HbA1c was 8.9 ± 2.3% (73.8 ± 1.6 mmol/mol). During the study, CGM-measured mean glucose was 170 mg/dL for the intensive group (n = 60) vs. 175 mg/dL for the standard group (n = 50; risk-adjusted difference -7 mg/dL, 95% CI -19 to 5; P = 0.25). Only 7% of the intensive group achieved the mean glucose target range of 90-130 mg/dL. CGM readings <54 mg/dL were infrequent (0.2% for intensive and 0.4% for standard; adjusted treatment group difference -0.1%, 95% CI -0.6 to 0.3). One severe hypoglycemia event occurred in the standard group., Conclusions: The study's glucose management approach using CGM did not improve glucose levels compared with standard glucose management in the non-intensive care unit hospital setting. A glucose target of 90-130 mg/dL may not be realistic in the current environment of insulin management in the hospital., (© 2024 by the American Diabetes Association.)

Objective: To evaluate a regimen of inhaled Technosphere insulin (TI) plus insulin degludec in adults with type 1 diabetes, who prestudy were predominately using either an automated insulin delivery (AID) system or multiple daily insulin injections (MDI) with continuous glucose monitoring., Research Design and Methods: At 19 sites, adults with type 1 diabetes were randomly assigned to TI plus insulin degludec (N = 62) or usual care (UC) with continuation of prestudy insulin delivery method (N = 61) for 17 weeks., Results: Prestudy, AID was used by 48% and MDI by 45%. Mean ± SD HbA1c was 7.57% ± 0.97% at baseline and 7.62% ± 1.06% at 17 weeks in the TI group and 7.59% ± 0.80% and 7.54% ± 0.77%, respectively, in the UC group (adjusted difference 0.11%, 95% CI -0.10 to 0.33, P value for noninferiority = 0.01). HbA1c improved from baseline to 17 weeks by >0.5% (5.5 mmol/mol) in 12 (21%) in the TI group and in 3 (5%) in the UC group and worsened by >0.5% (5.5 mmol/mol) in 15 (26%) in the TI group and in 2 (3%) in the UC group. The most common TI side effect was a brief cough; eight participants discontinued TI due to side effects., Conclusions: In adults with type 1 diabetes, HbA1c after 17 weeks with a regimen of TI and degludec was noninferior to UC, which consisted predominately of either AID or MDI. TI should be considered an option for people with type 1 diabetes, particularly those who are motivated to further reduce postprandial hyperglycemia., (© 2024 by the American Diabetes Association.)

Ongoing innovation in diabetes technologies has led to the development of advanced tools such as automated insulin delivery (AID) systems that adjust insulin delivery in response to current and predicted glucose levels, residual insulin action, and other inputs (eg, meal and exercise announcements). However, infusion sets continue to be the "Achilles heel" of accurate and precise insulin delivery and continued device use. A recent study by Kalus et al (DERMIS Study) revealed higher vessel density and signals of inflammation by optical coherence tomography (OCT), in addition to increased inflammation, fat necrosis, fibrosis, and eosinophilic infiltration by histopathology. Although the study provided a comprehensive description of what was happening, the results raise important questions that require additional research. On February 29, 2024, the Leona M. and Harry B. Helmsley Charitable Trust sponsored a conference to begin addressing these issues. This article summarizes the DERMIS study findings and testing methodologies discussed at the conference and proposes the next steps for developing insulin infusion sets that reduce the variability in insulin delivery and extend wear., 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: 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., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: To examine the efficacy and safety of the tubeless Omnipod 5 automated insulin delivery (AID) system compared with pump therapy with a continuous glucose monitor (CGM) in adults with type 1 diabetes with suboptimal glycemic outcomes., Research Design and Methods: In this 13-week multicenter, parallel-group, randomized controlled trial performed in the U.S. and France, adults aged 18-70 years with type 1 diabetes and HbA1c 7-11% (53-97 mmol/mol) were randomly assigned (2:1) to intervention (tubeless AID) or control (pump therapy with CGM) following a 2-week standard therapy period. The primary outcome was a treatment group comparison of time in range (TIR) (70-180 mg/dL) during the trial period., Results: A total of 194 participants were randomized, with 132 assigned to the intervention and 62 to the control. TIR during the trial was 4.2h/day higher in the intervention compared with the control group (mean difference 17.5% [95% CI 14.0%, 21.1%]; P < 0.0001). The intervention group had a greater reduction in HbA1c from baseline compared with the control group (mean ± SD -1.24 ± 0.75% [-13.6 ± 8.2 mmol/mol] vs. -0.68 ± 0.93% [-7.4 ± 10.2 mmol/mol], respectively; P < 0.0001), accompanied by a significantly lower time <70 mg/dL (1.18 ± 0.86% vs. 1.75 ± 1.68%; P = 0.005) and >180 mg/dL (37.6 ± 11.4% vs. 54.5 ± 15.4%; P < 0.0001). All primary and secondary outcomes were met. No instances of diabetes-related ketoacidosis or severe hypoglycemia occurred in the intervention group., Conclusions: Use of the tubeless AID system led to improved glycemic outcomes compared with pump therapy with CGM among adults with type 1 diabetes, underscoring the clinical benefit of AID and bolstering recommendations to establish AID systems as preferred therapy for this population., (© 2024 by the American Diabetes Association.)

Glucagon-like peptide-1 receptor agonist (GLP-1RA) medications have been shown to be effective in achieving optimal glucose control and reducing all-cause death, cardiovascular death, nonfatal myocardial infarction, hospitalization for heart failure, and end-stage kidney disease in individuals with type 1 (T1D) and type 2 diabetes (T2D). However, use of these medications has been associated with increased hypoglycaemia risk in patients treated with concomitant antihyperglycaemic medications. The risk is particularly high in patients with T1D due to their loss of glucagon counter-regulatory response. This article reviews the effect of GLP-1RA formulations on the development of hypoglycaemia in individuals with T1D and T2D treated with insulin therapy, discusses the benefits of continuous glucose monitoring with GLP-1RA treatment, and presents strategies for safely initiating GLP-1RA therapy in these individuals., (© 2024 John Wiley & Sons Ltd.)

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.

Aim: The real-world benefits of continuous glucose monitoring (CGM) in the broad type 2 diabetes (T2D) population are not well studied. Our study evaluated the impact of CGM use on health care resource utilization over 12 months in adults with T2D., Materials and Methods: This retrospective cohort analysis used Optum's de-identified Market Clarity data of >79 million people to evaluate CGM use in people with T2D who were treated with non-insulin (NIT), basal insulin (BIT) and prandial insulin therapy (PIT). The primary outcomes were changes in all-cause hospitalizations, acute diabetes-related hospitalizations and acute diabetes-related emergency room visits during the 6- and 12-month post-index period following transition from blood glucose monitoring to CGM. A pre-specified subgroup analysis assessed glucose control and medication changes among people with T2D over 1 year., Results: The analysis included 74 679 adults with T2D (NIT; n = 25 269), (BIT; n = 16 264) and (PIT; n = 33 146). Significant reductions in all-cause hospitalizations, acute diabetes-related hospitalizations and acute diabetes-related emergency room visits were observed in the 6-month post-index period that were sustained during the 6-12 month post-index period (NIT, -10.1%, -31.0%, -30.7%; BIT, -13.9%, -47.6%, -28.2%; and PIT, -22.6%, -52.7%, -36.6%, respectively). A subgroup analysis of 6030 people showed mean glycated haemoglobin reductions at approximately 3 months, which were also sustained throughout the post-index period: NIT, -1.1 (0.05)%; BIT, -1.1 (0.06)%; and PIT, -0.9 (0.04)%, p < 0.0001., Conclusions: CGM use in real-life across different therapeutic regimens in adults with T2D was associated with reductions in health care resource utilization with improved glucose control over 1 year., (© 2024 The Author(s). Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

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.

Background: The increasing prevalence of diabetes in the United States continues to drive a steady rise in health care resource utilization, especially emergency department visits and all-cause hospitalizations, and the associated costs., Objective: To investigate the impact of continuous glucose monitoring (CGM) on emergency department visits and all-cause hospitalizations among Medicaid beneficiaries with type 2 diabetes (T2D) treated with multiple daily insulin injections (MDIs) or basal insulin therapy (BIT) in a real-world setting., Methods: In this retrospective, 12-month analysis, we used the Inovalon Insights claims dataset to evaluate the effects of CGM acquisition on emergency department visits and all-cause hospitalizations in the Managed Medicaid population. The analysis included 44,941 beneficiaries with T2D who were treated with MDIs (n = 35,367) or BIT (n = 9,574). Primary outcomes were changes in the number of emergency department visits and all-cause hospitalizations following 6 months after acquisition of CGM (post-index period) compared with 6 month prior to CGM acquisition (pre-index period). The first claim for CGM was the index date. Inclusion criteria were as follows: aged younger than 65 years, diagnosis of T2D, claims for short- or rapid-acting insulin (MDI group) or basal insulin (not rapid-acting) (BIT group), acquisition of a CGM device between January 1, 2017, and September 30, 2022, and continuous enrollment in their health plan throughout the pre-index and post-index periods., Results: In the MDI group, all-cause inpatient hospitalization rates decreased from 3.25 to 2.29 events/patient-year (hazard ratio = 0.12; 95% CI = 0.11-0.13; P < 0.001) and emergency department visit rates decreased from 2.15 to 1.86 events/patient-year (hazard ratio = 0.52; 95% CI = 0.50-0.53; P < 0.001). In the BIT group, all-cause inpatient hospitalization rates decreased from 1.63 to 1.39 events/patient-year (hazard ratio = 0.11; 95% CI = 0.09-0.12; P < 0.001) and emergency department visit rates decreased from 1.60 to 1.43 events/patient-year (hazard ratio = 0.47; 95% CI = 0.44-0.50; P < 0.001)., Conclusions: Acquisition of CGM is associated with significant reductions in emergency department visits and all-cause hospitalizations among people with T2D treated with MDIs or BIT.

Objective: Since the introduction of continuous glucose monitoring (CGM) technology, developers have rigorously researched the feasibility of creating a noninvasive glucose monitoring device. In a recent pilot study, investigators reported a strong correlation between glucose values obtained from novel noninvasive monitoring device (GWave) values to venous and capillary glucose measurements. Research Design and Methods: We investigated whether the level of accuracy observed in the pilot study could be reproduced in a larger cohort, using a smaller third-generation manufacturable device (Gen III GWave) containing a standardized sensor chip that can be mass produced for commercial use. The evaluation assessed concordance with capillary blood glucose, reproducibility between two Gen III devices, and accuracy during insulin-induced hypoglycemia. Results: Assessment of samples from 75 subjects (type 2 diabetes, n  = 6; type 1 diabetes, n  = 28; nondiabetic pregnant subjects, n  = 10; and nondiabetic, n  = 31) showed that 97% of values were in Zone A with 3% in Zone B of the Clarke Error Grid, with a mean absolute relative difference of 6.7% from reference blood glucose. Comparison between two independent Gen III GWave devices demonstrated reproducibility between the sensors ( R 2  = 0.95), with 100% of values within Zone A. In the hypoglycemia assessment, measurements from the Gen III sensor tightly followed the capillary glucose measurements down to 42 mg/dL (2.3 mmol/L), whereas the CGM measurements from two different CGM only converged with the GWave and capillary glucose readings after 90 min of decreasing glucose levels. Conclusion: Our results show promise as potentially the first noninvasive technology. Future studies will focus on larger number of people in all glucose ranges. Real-time noninvasive blood glucose monitoring is possible using GWave technology.

Objective: To compare postprandial glucose excursions following a bolus with inhaled technosphere insulin (TI) or subcutaneous rapid-acting analog (RAA) insulin., Research Design and Methods: A meal challenge was completed by 122 adults with type 1 diabetes who were using multiple daily injections (MDI), a nonautomated pump, or automated insulin delivery (AID) and who were randomized to bolus with their usual RAA insulin (n = 61) or TI (n = 61)., Results: The primary outcome, the treatment group difference in area under the curve for glucose >180 mg/dL over 2 h, was less with TI versus RAA (adjusted difference -12 mg/dL, 95% CI -22 to -2, P = 0.02). With TI, the glucose excursion was smaller (P = 0.01), peak glucose lower (P = 0.01), and time to peak glucose shorter (P = 0.006). Blood glucose <70 mg/dL occurred in one participant in each group., Conclusions: Postmeal glucose excursion was smaller with TI than with RAA insulin in a cohort that included both AID and MDI users., (© 2024 by the American Diabetes Association.)

Quality Improvement Success Stories are published by the American Diabetes Association in collaboration with the American College of Physicians and the National Diabetes Education Program. This series is intended to highlight best practices and strategies from programs and clinics that have successfully improved the quality of care for people with diabetes or related conditions. Each article in the series is reviewed and follows a standard format developed by the editors of Clinical Diabetes . The following article describes a quality improvement project focused on increasing the use of continuous glucose monitoring among emerging adults with type 1 diabetes enrolled in a health care transition program in the state of Washington., Competing Interests: I.B.H. has served as an independent consultant for Abbott, Hagar, and Roche separate from this work and has received research funding from Dexcom and Tandem. No other potential conflicts of interest relevant to this article were reported., (© 2024 by the American Diabetes Association.)

Aims/hypothesis: Previous studies have shown that individuals with similar mean glucose levels (MG) or percentage of time in range (TIR) may have different HbA 1c values. The aim of this study was to further elucidate how MG and TIR are associated with HbA 1c ., Methods: Data from the randomised clinical GOLD trial (n=144) and the follow-up SILVER trial (n=98) of adults with type 1 diabetes followed for 2.5 years were analysed. A total of 596 paired HbA 1c /continuous glucose monitoring measurements were included. Linear mixed-effects models were used to account for intra-individual correlations in repeated-measures data., Results: In the GOLD trial, the mean age of the participants (± SD) was 44±13 years, 63 (44%) were female, and the mean HbA 1c (± SD) was 72±9.8 mmol/mol (8.7±0.9%). When correlating MG with HbA 1c , MG explained 63% of the variation in HbA 1c (r=0.79, p<0.001). The variation in HbA 1c explained by MG increased to 88% (r=0.94, p value for improvement of fit <0.001) when accounting for person-to-person variation in the MG-HbA 1c relationship. Time below range (TBR; <3.9 mmol/l), time above range (TAR) level 2 (>13.9 mmol/l) and glycaemic variability had little or no effect on the association. For a given MG and TIR, the HbA 1c of 10% of individuals deviated by >8 mmol/mol (0.8%) from their estimated HbA 1c based on the overall association between MG and TIR with HbA 1c . TBR and TAR level 2 significantly influenced the association between TIR and HbA 1c . At a given TIR, each 1% increase in TBR was related to a 0.6 mmol/mol lower HbA 1c (95% CI 0.4, 0.9; p<0.001), and each 2% increase in TAR level 2 was related to a 0.4 mmol/mol higher HbA 1c (95% CI 0.1, 0.6; p=0.003). However, neither TIR, TBR nor TAR level 2 were significantly associated with HbA 1c when accounting for MG., Conclusions/interpretation: Inter-individual variations exist between MG and HbA 1c , as well as between TIR and HbA 1c , with clinically important deviations in relatively large groups of individuals with type 1 diabetes. These results may provide important information to both healthcare providers and individuals with diabetes in terms of prognosis and when making diabetes management decisions., (© 2024. The Author(s).)

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., (© 2024 by the American Diabetes Association and the European Association for the Study of Diabetes.)

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 hyperglycaemic 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 hyperglycaemic hyperosmolar state (HHS) in adults. A systematic examination of publications since 2009 informed new recommendations. The target audience is the full spectrum of diabetes healthcare professionals and individuals with diabetes., (© 2024. American Diabetes Association and European Association for the Study of Diabetes.)

Background: The role of glycemic control and its variability on the rate of kidney function decline after the onset of diabetic kidney disease (DKD) remains unclear., Methods: The association between baseline glycated hemoglobin (HbA1c) and rates of estimated glomerular filtration rate (eGFR) loss during follow-up was examined by mixed-effects linear regression in 530 individuals with type 1 diabetes and early-to-moderate DKD from the Preventing Early Renal Loss (PERL) trial and 2378 individuals with type 2 diabetes and established DKD from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. The benefit of intensive vs standard glycemic control in slowing eGFR decline was examined in ACCORD. The associations between continuous glucose monitoring-derived short-term glycemic variability indices and rate of eGFR decline were also evaluated in PERL., Results: A higher baseline HbA1c was associated with a more negative eGFR slope in both PERL and ACCORD (-0.87 and -0.27 mL/min/1.73 m2/year per Hba1c unit increment, P < .0001 and P = .0002, respectively). In both studies, the strength of this association progressively increased with increasing levels of albuminuria (P for interaction <.05). Consistent with this, the benefit of intensive glycemic control on eGFR decline was greater in ACCORD participants with severe rather than moderate albuminuria (+1.13 vs + 0.26 mL/min/1.73 m2/year, P = .01). No independent associations were found in PERL between short-term glycemic variability indices and rate of eGFR decline., Conclusion: In both type 1 and type 2 diabetes, poor glycemic control is associated with a more rapid rate of glomerular filtration rate decline after DKD onset, especially in persons with severe albuminuria., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: The relationship between critical care mortality and combined impact of malglycemia remains undefined., Methods: We assessed the risk-adjusted relationship (n = 4790) between hospital mortality with malglycemia, defined as hypergycemia (hours Glycemic Ratio ≥ 1.1, where GR is quotient of mean ICU blood glucose (BG) and estimated average BG), absolute hypoglycemia (hours BG < 70 mg/dL) and relative hypoglycemia (excursions GR < 0.7 in those with HbA1c ≥ 8%)., Results: Each malglycemia was independently associated with mortality - hyperglycemia (OR 1.0020/h, 95%CI 1.0009-1.0031, p = 0.0004), absolute hypoglycemia (OR 1.0616/h, 95%CI 1.0190-1.1061, p = 0.0043), and relative hypoglycemia (OR 1.2813/excursion, 95%CI 1.0704-1.5338, p = 0.0069). Absolute (7.4%) and relative hypoglycemia (6.7%) exposure dominated the first 24 h, decreasing thereafter. While hyperglycemia had lower risk association with mortality, it was persistently present across the length-of-stay (68-76% incidence daily), making it the dominant form of malglycemia. Relative contributions in the first five days from hyperglycemia, absolute hypoglycemia and relative hypoglycemia were 60%, 21% and 19% respectively., Conclusions: Absolute and relative hypoglycemia occurred largely in the first 24 h. Relative to all hypoglycemia, the associated mortality from the seemingly less potent but consistently more prevalent hyperglycemia steadily accumulated with increasing length-of-stay. This has important implications for interpretation of study results., (Copyright © 2023. Published by Elsevier Inc.)

Aims: To study the effects of a bridging dose of U-100 glargine (U-100G) with the first dose of degludec in type 1 diabetes (T1D) patients transitioning from glargine to degludec, by comparing the glucose metrics 48 h before and after the transition., Materials and Methods: Patients with T1D on a stable U-100G regimen and with glycated haemoglobin concentration <75 mmol/mol were randomized (double-blind) to one dose of placebo or U-100G with first dose of degludec, administered at 9:00 pm. Patients on once-daily U-100G at baseline received 50% of total U-100G dose (bridging dose), while patients on twice-daily U-100G received 50% of the evening U-100G dose. Participants wore a continuous glucose monitor during the study., Results: Forty participants were randomized, of whom 37 completed the study. The cohort was 65% male, the mean age was 47 years, duration of T1D 22 years, BMI 26 kg/m 2 , HbA1c 51 mmol/mol and total daily insulin dose 0.7 units/kg body weight. The bridging group included 19 participants (once-daily U-100G: n = 12; twice-daily U-100G: n = 7) and the placebo group included 18 participants (once-daily U-100G: n = 12; twice-daily U-100G: n = 6). Change in time in range (TIR) was not significantly different between the two treatment groups. In secondary analyses, among twice-daily U-100G users, TIR (3.9-10 mmol/L) increased 8% in the bridging group in the 48 h after first dose of degludec compared to the preceding 48 h, while participants in the placebo group had a 9.5% decrease (p = 0.027)., Conclusions: A subgroup of well-controlled twice-daily U-100G users transitioning to degludec benefited from a 50% bridging dose of evening U-100G with the first dose of degludec in a small pilot study., (© 2024 John Wiley & Sons Ltd.)

Early initiation of intensive insulin therapy has been demonstrated to be effective in controlling glycemia and possibly preserving beta-cell function. Innovations in insulin formulations and delivery systems continue. However, we have seen an acceleration in the development of new classes of diabetes medications for individuals with type 2 diabetes and obesity, such as, for example, glucagon-like peptide-1 receptor agonists (GLP-1 RAs). These formulations have been shown to confer significant benefits in achieving good glycemic control with reduced hypoglycemia risk, weight loss, and cardiorenal protection. Therefore, it is reasonable to question whether there is still a role for insulin therapy in the management of type 2 diabetes. However, there are clear limitations inherent to GLP-1 RA therapy, including high rates of suboptimal adherence and treatment discontinuation due to high cost and side effects, which diminish long-term efficacy, and supply issues. In addition, newer formulations have shown improvements in convenience and tolerability, and have been shown to be even more effective when used in conjunction with basal insulin. In this narrative review, we discuss current evidence that supports GLP-1 RA use in combination with insulin therapy and the potential pitfalls of reliance on GLP-1 RAs as a substitute for insulin therapy., (© 2024. The Author(s).)

Malglycemia, defined as hyperglycemia, hypoglycemia, or increased glycemic variability, has been associated with increased mortality after allogeneic hematopoietic cell transplantation (HCT). Among critically ill non-HCT recipients with diabetes and poor glycemic control, compared to those without diabetes, stringent blood glucose control has been associated with increased mortality. This study investigated whether a pre-HCT diagnosis of diabetes and the type of pre-HCT diabetes treatment modulate the previously reported negative impact of malglycemia on post-HCT nonrelapse mortality (NRM). We performed a single-institution retrospective analysis of mortality outcomes after allogeneic HCT as a function of post-HCT blood glucose levels, pre-HCT diagnosis of diabetes, and type of pre-HCT diabetes treatment (insulin, no insulin). A total of 1062 patients who underwent allogeneic HCT between 2015 and 2020 were included in this study. Among these patients, 84 (8%) had a pre-HCT diagnosis of diabetes, of whom 38 (4%) used insulin and 46 (4%) used a noninsulin antiglycemic agent. Post-HCT blood glucose values measured within 100 days from HCT, modeled as a continuous nonlinear time-varying covariate, were associated with day-200 NRM, with both lower and higher glycemic values associated with higher NRM compared to normoglycemic values (adjusted P < .0001). The association between post-HCT blood glucose and NRM varied, however, depending on the presence or absence of a pre-HCT diagnosis of diabetes; that is, there was evidence of a statistical interaction between blood glucose levels and diabetes (adjusted P = .008). In particular, the detrimental impact of hyperglycemic values was more pronounced in patients without a pre-HCT diagnosis of diabetes compared to those with a pre-HCT diagnosis of diabetes. As reported previously, higher and lower blood glucose levels measured within 100 days after allogeneic HCT were associated with an increased risk of NRM; however, this association was more pronounced among patients without a pre-HCT diagnosis of diabetes compared to those with a pre-HCT diagnosis of diabetes, suggesting that patients with diabetes are relatively protected from the downstream effects of hyperglycemia. These data support the notion that patients with pre-HCT diabetes may need a different approach to blood glucose management after transplantation compared to those without diabetes. © 2024 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc., (Copyright © 2024 The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.)

Background: Interventional studies investigating blood glucose (BG) management in intensive care units (ICU) have been inconclusive. New insights are needed. We assessed the ability of a new metric, the Glycemic Ratio (GR), to determine the relationship of ICU glucose control relative to preadmission glycemia and mortality., Methods: Retrospective cohort investigation (n = 4790) in an adult medical-surgical ICU included patients with minimum four BGs, hemoglobin (Hgb), and hemoglobin A1c (HbA1c). The GR is the quotient of mean ICU BGs (mBG) and estimated preadmission BG, derived from HbA1c., Results: Mortality displayed a J-shaped curve with GR (nadir GR 0.9), independent of background glycemia, consistent for HbA1c <6.5% vs >6.5%, and Hgb >10 g/dL vs <10 g/dL and medical versus surgical. An optimal range of GR 0.80 to 0.99 was associated with decreased mortality compared with GR above and below this range. The mBG displayed a linear relationship with mortality at lower HbA1c but diminished for HbA1c >6.5%, and dependent on preadmission glycemia. In adjusted analysis, GR remained associated with mortality (odds ratio = 2.61, 95% confidence interval = 1.48-4.62, P = .0012), but mBG did not (1.004, 1.000-1.009, .059). A single value on admission was not independently associated with mortality., Conclusions: The GR provided new insight into malglycemia that was not apparent using mBG, or an admission value. Mortality was associated with acute change from preadmission glycemia (GR). Further assessment of the impact of GR deviations from the nadir in mortality at GR 0.80 to 0.99, as both relative hypo- and hyperglycemia, and as duration of exposure and intensity, may further define the multifaceted nature of malglycemia., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: JSK and J-CP disclosed that they are advisory board members and consultants for Edwards Life Sciences, OptiScan Biomedical, and Roche Diagnostics. IBH’s institution received funding from Insulet and Beta Bionics; he disclosed that he is a consultant for Abbott, Roche, LifeScan, and GWave. GEU’s institution received funding from Dexcom, Abbott, and Baxter. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Introduction: The relationship between critical care mortality and hypoglycemia, both relative (>30% below average preadmission glycemia) and absolute (blood glucose (BG) <70 mg/dL (<10 mmol/L)) requires further definition., Methods: We assessed the risk-adjusted relationship between hospital mortality with relative hypoglycemia using the Glycemic Ratio (GR), and with absolute hypoglycemia using BG in a retrospective cohort investigation (n = 4790)., Results: Relative hypoglycemia excursions below GR 0.7 with a of 24-h non-exposure period between excursions in those with HbA1c ≥ 8% were independently associated with mortality (n = 373, OR 2.49, 95% CI 1.54-4.04, p = 0.0002) but not those with HbA1c < 8% (n = 4417, OR 0.98 95% CI 0.89-1.08, p = 0.70). Hours below GR 0.7 (1.0037, 0.9995-1.0080, 0.0846) or minimum GR (0.0896, 0.0030-2.6600, 0.1632) were not independently associated with outcome. Absolute hypoglycemia occurred across the HbA1c spectrum in a U-shaped pattern. There was no difference in mortality associated with exposure to BG < 70 mg/dL for HbA1c ≥ 6.5% vs <6.5% (29.7% vs 24.3%, p = 0.77). Hours below 70 mg/dL demonstrated strongest association with outcome, while minimum BG, and excursions below 70 mg/dL were also independently associated., Conclusions: Relative hypoglycemia represented by excursions below GR 0.7 in those with HbA1c ≥ 8% occurred commonly and was independently associated with mortality. Absolute hypoglycemia had similar association with mortality regardless of HbA1c., Competing Interests: Declaration of Competing Interest Drs. Krinsley is a consultant for Dexcom. Dr. Hirsch's institution received funding from Insulet, and Beta Bionics; he disclosed that he is a consultant for Abbott, Roche, Lifescan, and GWave. Dr. Umpierrez institution received funding from Dexcom, Abbott, and Baxter. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Type 1 diabetes is an autoimmune condition resulting in insulin deficiency and eventual loss of pancreatic β cell function requiring lifelong insulin therapy. Since the discovery of insulin more than 100 years ago, vast advances in treatments have improved care for many people with type 1 diabetes. Ongoing research on the genetics and immunology of type 1 diabetes and on interventions to modify disease course and preserve β cell function have expanded our broad understanding of this condition. Biomarkers of type 1 diabetes are detectable months to years before development of overt disease, and three stages of diabetes are now recognized. The advent of continuous glucose monitoring and the newer automated insulin delivery systems have changed the landscape of type 1 diabetes management and are associated with improved glycated hemoglobin and decreased hypoglycemia. Adjunctive therapies such as sodium glucose cotransporter-1 inhibitors and glucagon-like peptide 1 receptor agonists may find use in management in the future. Despite these rapid advances in the field, people living in under-resourced parts of the world struggle to obtain necessities such as insulin, syringes, and blood glucose monitoring essential for managing this condition. This review covers recent developments in diagnosis and treatment and future directions in the broad field of type 1 diabetes., Competing Interests: Competing interests: We have read and understood the BMJ policy on declaration of interests and declare the following interests: SS has received an honorarium from Abbott Diabetes Care; IBH has received honorariums from Abbott Diabetes Care, Lifescan, embecta, and Hagar and research support from Dexcom and Insulet., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Patient-generated device data play an important role in diabetes management. However, acquiring these data remains a challenge. This project aimed to understand whether implementing dedicated "Technology Navigator" (TN) personnel at a large academic diabetes clinic could facilitate access to device data without increasing work for clinic staff. A sample of visits pre- and post-TN implementation ( n  = 173) showed a 22% (41% vs. 19%) increase in patients who successfully shared their data from home before their visit and a 52% (67% vs. 15%) increase in visits where data were available to the provider for review before the appointment, whereas billing claims for continuous glucose monitor interpretation increased by 86% during the same period. Time analysis suggests that home uploads could save up to 747 h in medical assistant labor annually. Incorporating a TN may improve data availability, decrease time spent on nonbillable activities, and support data interpretation and billing.

Background: People with type 1 diabetes generally view it easier to exercise when having continuous information of the glucose levels. We evaluated whether patients with type 1 diabetes managed with multiple daily insulin injections (MDI) exercised more after initiating continuous glucose monitoring (CGM) and whether the improved glycemic control and well-being associated with CGM translates into improved blood lipids and markers of inflammation., Method: The GOLD trial was a randomized cross-over trial over 16 months where patients used either CGM or capillary self-monitoring of blood glucose (SMBG) over six months, with a four-month wash-out period between the two treatment periods. We compared grade of physical activity, blood lipids, apolipoproteins, and high-sensitivity C-reactive protein (hsCRP) levels during CGM and SMBG., Results: There were 116 patients with information of physical activity estimated by the International Physical Activity Questionnaire (IPAQ) during both CGM and SMBG. No changes were found during CGM or SMBG, IPAQ scores 3305 versus 3878 ( P = .16). In 136 participants with information of blood lipid levels with no change in lipid-lowering medication during the two treatment periods, HbA1c differed by 4.2 mmol/mol (NGSP 0.39%) between SMBG and CGM treatment ( P < .001). No significant changes existed in low-density lipoprotein, high-density lipoprotein, triglycerides, total cholesterol, apolipoprotein A1, apolipoprotein B1, or hsCRP, during CGM and SMBG., Conclusion: Although many patients experience it easier to perform physical activity when monitoring glucose levels with CGM, it does not influence the amount of physical activity in persons with type 1 diabetes. Blood lipids, apolipoprotein, and hsCRP levels were similar during CGM and SMBG., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: TN has received unrestricted grants from AstraZeneca and NovoNordisk and has served on national advisory boards of Abbot, Amgen, Novo Nordisk, Sanofi-Aventis, Eli Lilly, MSD, and Boehringer Ingelheim. ML has received research grants from Eli Lilly and Novo Nordisk and been consultant or received honoraria from Astra Zeneca, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. JH has served on advisory boards or lectured for Novo Nordisk, Sanofi, Lilly, Abbot, Rubin Medical, MSD, and Boehringer Ingelheim. MW has served on advisory boards or lectured for MSD, Lilly, Novo Nordisk, and Sanofi and has organized a professional regional meeting sponsored by Lilly, Rubin Medical, Sanofi, Novartis, and Novo Nordisk. JB has received honoraria for consulting and/or lecture fees from Abbott Diabetes Care, Novo Nordisk, and Sanofi.

Background: The Omnipod ® 5 Automated Insulin Delivery (AID) System was shown to be safe and effective following 3 months of use in people with type 1 diabetes (T1D); however, data on the durability of these results are limited. This study evaluated the long-term safety and effectiveness of Omnipod 5 use in people with T1D during up to 2 years of use. Materials and Methods: After a 3-month single-arm, multicenter, pivotal trial in children (6-13.9 years) and adolescents/adults (14-70 years), participants could continue system use in an extension phase. HbA1c was measured every 3 months for up to 15 months; continuous glucose monitor metrics were collected for up to 2 years. Results: Participants ( N  = 224) completed median (interquartile range) 22.3 (21.7, 22.7) months of AID. HbA1c was reduced in the pivotal trial from 7.7% ± 0.9% in children and 7.2% ± 0.9% in adolescents/adults to 7.0% ± 0.6% and 6.8% ± 0.7%, respectively, ( P  < 0.0001), and was maintained at 7.2% ± 0.7% and 6.9% ± 0.6% after 15 months ( P  < 0.0001 from baseline). Time in target range (70-180 mg/dL) increased from 52.4% ± 15.6% in children and 63.6% ± 16.5% in adolescents/adults at baseline to 67.9% ± 8.0% and 73.8% ± 10.8%, respectively, during the pivotal trial ( P  < 0.0001) and was maintained at 65.9% ± 8.9% and 72.9% ± 11.3% during the extension ( P  < 0.0001 from baseline). One episode of diabetic ketoacidosis and seven episodes of severe hypoglycemia occurred during the extension. Children and adolescents/adults spent median 96.1% and 96.3% of time in Automated Mode, respectively. Conclusion: Our study supports that long-term use of the Omnipod 5 AID System can safely maintain improvements in glycemic outcomes for up to 2 years of use in people with T1D. Clinical Trials Registration Number: NCT04196140.

Background: Whether biomarkers of tubular injury and inflammation indicate subclinical structural kidney pathology early in type 1 diabetes remains unknown., Methods: We investigated associations of biomarkers of tubular injury and inflammation with kidney structural features in 244 adults with type 1 diabetes from the Renin-Angiotensin System Study, a randomized, placebo-controlled trial testing effects of enalapril or losartan on changes in glomerular, tubulointerstitial, and vascular parameters from baseline to 5-year kidney biopsies. Biosamples at biopsy were assessed for kidney injury molecule 1 (KIM-1), soluble TNF receptor 1 (sTNFR1), arginine-to-citrulline ratio in plasma, and uromodulin and epidermal growth factor (EGF) in urine. We examined cross-sectional correlations between biomarkers and biopsy features and baseline biomarker associations with 5-year changes in biopsy features., Results: Participants' mean age was 30 years (SD 10) and diabetes duration 11 years (SD 5); 53% were women. The mean GFR measured by iohexol disappearance was 128 ml/min per 1.73 m 2 (SD 19) and median urinary albumin excretion was 5 μ g/min (interquartile range, 3-8). KIM-1 was associated with most biopsy features: higher mesangial fractional volume (0.5% [95% confidence interval (CI), 0.1 to 0.9] greater per SD KIM-1), glomerular basement membrane (GBM) width (14.2 nm [95% CI, 6.5 to 22.0] thicker), cortical interstitial fractional volume (1.1% [95% CI, 0.6 to 1.6] greater), fractional volume of cortical atrophic tubules (0.6% [95% CI, 0.2 to 0.9] greater), and arteriolar hyalinosis index (0.03 [95% CI, 0.1 to 0.05] higher). sTNFR1 was associated with higher mesangial fractional volume (0.9% [95% CI, 0.5 to 1.3] greater) and GBM width (12.5 nm [95% CI, 4.5 to 20.5] thicker) and lower GBM surface density (0.003 μ m 2 / μ m 3 [95% CI, 0.005 to 0.001] lesser). EGF and arginine-to-citrulline ratio correlated with severity of glomerular and tubulointerstitial features. Baseline sTNFR1, uromodulin, and EGF concentrations were associated with 5-year glomerular and tubulointerstitial feature progression., Conclusions: Biomarkers of tubular injury and inflammation were associated with kidney structural parameters in early type 1 diabetes and may be indicators of kidney disease risk., Clinical Trial Registry Name and Registration Number: Renin Angiotensin System Study (RASS/B-RASS), NCT00143949., Podcast: This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast/CJASN/2023&#95;11&#95;17&#95;CJN0000000000000333.mp3., (Copyright © 2023 by the American Society of Nephrology.)

Background: The greatest change in the treatment of people living with type 1 diabetes in the last decade has been the explosion of technology assisting in all aspects of diabetes therapy, from glucose monitoring to insulin delivery and decision making. As such, the aim of our systematic review was to assess the utility of these technologies as well as identify any precision medicine-directed findings to personalize care., Methods: Screening of 835 peer-reviewed articles was followed by systematic review of 70 of them (focusing on randomized trials and extension studies with ≥50 participants from the past 10 years)., Results: We find that novel technologies, ranging from continuous glucose monitoring systems, insulin pumps and decision support tools to the most advanced hybrid closed loop systems, improve important measures like HbA1c, time in range, and glycemic variability, while reducing hypoglycemia risk. Several studies included person-reported outcomes, allowing assessment of the burden or benefit of the technology in the lives of those with type 1 diabetes, demonstrating positive results or, at a minimum, no increase in self-care burden compared with standard care. Important limitations of the trials to date are their small size, the scarcity of pre-planned or powered analyses in sub-populations such as children, racial/ethnic minorities, people with advanced complications, and variations in baseline glycemic levels. In addition, confounders including education with device initiation, concomitant behavioral modifications, and frequent contact with the healthcare team are rarely described in enough detail to assess their impact., Conclusions: Our review highlights the potential of technology in the treatment of people living with type 1 diabetes and provides suggestions for optimization of outcomes and areas of further study for precision medicine-directed technology use in type 1 diabetes., (© 2023. Springer Nature Limited.)

Introduction: Stress-induced hyperglycemia (SIH) is conventionally represented by Blood Glucose (BG) although recent evidence indicates the Glycemic Ratio (GR, quotient of mean BG and estimated preadmission BG) is a superior prognostic marker. We assessed the association between in-hospital mortality and SIH, using BG and GR in an adult medical-surgical ICU., Methods: We included patients with hemoglobin A1c (HbA1c) and minimum four BGs in a retrospective cohort investigation (n = 4790)., Results: A critical SIH threshold of GR 1.1 was identified. Mortality increased with increasing exposure to GR ≥ 1.1 (r 2  = 0.94, p = 0.0007). Duration of exposure to BG ≥ 180 mg/dL demonstrated a less robust association with mortality (r 2  = 0.75, p = 0.059). In risk-adjusted analyses, hours GR ≥ 1.1 (OR 1.0014, 95%CI (1.0003-1.0026), p = 0.0161) and hours BG ≥ 180 mg/dL (OR 1.0080, 95%CI (1.0034-1.0126), p = 0.0006) were associated with mortality. In the cohort with no exposure to hypoglycemia however, only hours GR ≥ 1.1 was associated with mortality (OR 1.0027, 95%CI (1.0012-1.0043), p = 0.0007), not BG ≥ 180 mg/dL (OR 1.0031, 95%CI (0.9949-1.0114), p = 0.50) and this relationship remained intact for those who never experienced BG outside the 70-180 mg/dL range (n = 2494)., Conclusions: Clinically significant SIH commenced above GR 1.1. Mortality was associated with hours of exposure to GR ≥ 1.1 which was a superior marker of SIH compared to BG., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Precision medicine is part of the logical evolution of contemporary evidence-based medicine that seeks to reduce errors and optimize outcomes when making medical decisions and health recommendations. Diabetes affects hundreds of millions of people worldwide, many of whom will develop life-threatening complications and die prematurely. Precision medicine can potentially address this enormous problem by accounting for heterogeneity in the etiology, clinical presentation and pathogenesis of common forms of diabetes and risks of complications. This second international consensus report on precision diabetes medicine summarizes the findings from a systematic evidence review across the key pillars of precision medicine (prevention, diagnosis, treatment, prognosis) in four recognized forms of diabetes (monogenic, gestational, type 1, type 2). These reviews address key questions about the translation of precision medicine research into practice. Although not complete, owing to the vast literature on this topic, they revealed opportunities for the immediate or near-term clinical implementation of precision diabetes medicine; furthermore, we expose important gaps in knowledge, focusing on the need to obtain new clinically relevant evidence. Gaps include the need for common standards for clinical readiness, including consideration of cost-effectiveness, health equity, predictive accuracy, liability and accessibility. Key milestones are outlined for the broad clinical implementation of precision diabetes medicine., (© 2023. The Author(s), under exclusive licence to Springer Nature America, Inc.)

Numerous studies have demonstrated the clinical benefits of continuous glucose monitoring (CGM) in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D) who are treated with intensive insulin regimens. Based on this evidence, CGM is now a standard of care for individuals within these diabetes populations and widely covered by commercial and public insurers. Moreover, recent clinical guidelines from the American Diabetes Association and American Association of Clinical Endocrinology now endorse CGM use in individuals treated with nonintensive insulin regimens. However, despite increasing evidence supporting CGM use for individuals treated with less-intensive insulin therapy or noninsulin medications, insurance coverage is limited or nonexistent. This narrative review reports key findings from recent randomized, observational, and retrospective studies investigating use of CGM in T2D individuals treated with basal insulin only and/or noninsulin therapies and presents an evidence-based rationale for expanding access to CGM within this population.

Objective: Continuous subcutaneous insulin infusion (CSII) for type 1 diabetes is increasing in use. Pump site failures are common, but little is known about skin changes from pump use. Using noninvasive optical coherence tomography (OCT), OCT angiography (OCTA), and skin biopsies, we evaluated skin changes from chronic insulin infusion., Research Design and Methods: In this cross-sectional study, OCT operating at a 1,310-nm central wavelength with a bandwidth of 100 nm was performed immediately before skin punch biopsies were collected at three sites: the current site, with the infusion set removed at time of OCT and biopsy; the recovery site, with the infusion set removed 3 days before biopsy; and the control site, which was never used for any insulin infusion or injection., Results: OCT and OCTA identified characteristics of increased inflammation and vessel density at pump sites compared with control sites. Histologic analysis of pump sites showed differences in skin architecture, including fibrosis, inflammation (including increased tissue eosinophils), and fat necrosis. Immunohistochemical staining showed differences between infusion and control sites regarding staining of ILGF-I and transforming growth factor-β3., Conclusions: These findings support allergic sensitization as a potentially common reaction at CSII sites. The leading candidates causing this include insulin preservatives, plastic materials, and adhesive glue used in device manufacturing. The inflammatory response caused by these common allergic responses may result in tissue changes responsible for the infusion site failures seen frequently in clinical practice., (© 2023 by the American Diabetes Association.)

The annual Virtual Hospital Diabetes Meeting was hosted by the Diabetes Technology Society on April 14 and 15, 2023, with the goal of reviewing the progress made in the hospital use of continuous glucose monitors (CGMs). Meeting topics included (1) Nursing Issues, Protocols, Order Sets, and Staff Education for Using CGMs, (2) Implementing CGM Programs for Use in the Wards, (3) Quality Metrics and Financial Implications of CGMs in the Hospital, (4) CGMs in the Critical Care Setting, (5) Special Situations: Labor/Delivery and Hemodialysis, (6) Research Session on CGMs in the Hospital, (7) Starting a CGM on Hospitalized Patients, (8) Automated Insulin Delivery Systems in the Hospital, (9) CGMs in Children, (10) Data Integration of CGMs for Inpatient Use and Telemetry, (11) Accuracy of CGMs/Comparison with Point-of-care Blood Glucose Testing, and (12) Discharge Planning with CGMs. Outcome data as well as shared collective real-life experiences were reviewed, and expert recommendations for CGM implementation were formulated.

Background: A 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., Methods: We 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., Results: The 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., Conclusion: The 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.

The integration of technologies such as continuous glucose monitors, insulin pumps, and smart pens into diabetes management has the potential to support the transformation of health care services that provide a higher quality of diabetes care, lower costs and administrative burdens, and greater empowerment for people with diabetes and their caregivers. Among people with diabetes, older adults are a distinct subpopulation in terms of their clinical heterogeneity, care priorities, and technology integration. The scientific evidence and clinical experience with these technologies among older adults are growing but are still modest. In this review, we describe the current knowledge regarding the impact of technology in older adults with diabetes, identify major barriers to the use of existing and emerging technologies, describe areas of care that could be optimized by technology, and identify areas for future research to fulfill the potential promise of evidence-based technology integrated into care for this important population., (© 2023 by the American Diabetes Association.)

Objective: This consensus statement provides (1) visual guidance in concise graphic algorithms to assist with clinical decision-making of health care professionals in the management of persons with type 2 diabetes mellitus to improve patient care and (2) a summary of details to support the visual guidance found in each algorithm., Methods: The American Association of Clinical Endocrinology (AACE) selected a task force of medical experts who updated the 2020 AACE Comprehensive Type 2 Diabetes Management Algorithm based on the 2022 AACE Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan and consensus of task force authors., Results: This algorithm for management of persons with type 2 diabetes includes 11 distinct sections: (1) Principles for the Management of Type 2 Diabetes; (2) Complications-Centric Model for the Care of Persons with Overweight/Obesity; (3) Prediabetes Algorithm; (4) Atherosclerotic Cardiovascular Disease Risk Reduction Algorithm: Dyslipidemia; (5) Atherosclerotic Cardiovascular Disease Risk Reduction Algorithm: Hypertension; (6) Complications-Centric Algorithm for Glycemic Control; (7) Glucose-Centric Algorithm for Glycemic Control; (8) Algorithm for Adding/Intensifying Insulin; (9) Profiles of Antihyperglycemic Medications; (10) Profiles of Weight-Loss Medications (new); and (11) Vaccine Recommendations for Persons with Diabetes Mellitus (new), which summarizes recommendations from the Advisory Committee on Immunization Practices of the U.S. Centers for Disease Control and Prevention., Conclusions: Aligning with the 2022 AACE diabetes guideline update, this 2023 diabetes algorithm update emphasizes lifestyle modification and treatment of overweight/obesity as key pillars in the management of prediabetes and diabetes mellitus and highlights the importance of appropriate management of atherosclerotic risk factors of dyslipidemia and hypertension. One notable new theme is an emphasis on a complication-centric approach, beyond glucose levels, to frame decisions regarding first-line pharmacologic choices for the treatment of persons with diabetes. The algorithm also includes access/cost of medications as factors related to health equity to consider in clinical decision-making., Competing Interests: Disclosures The Task Force was empaneled in accordance with the AACE Conflict of Interest (COI) Policy and approved by the AACE COI Subcommittee, Clinical Practice Guidelines Oversight Committee, and AACE executive leadership. All members of the expert Task Force completed disclosures related to commercial and direct financial relationships within the preceding 12 months with companies that develop products connected with endocrine disorders. Categories for disclosure included employment, stock or other ownership, direct financial relationships (eg, speaker or consultant), research funding, authorship or panel involvement on a guideline or white paper related to an overlapping topic, or other situations related to a perceived COI. The AACE COI Subcommittee reviewed disclosures of potential authors against an AACE-approved list of affected companies related to the topic of this consensus statement and made recommendations regarding who could serve on the Task Force in the nonconflicted majority, those who could serve in the conflicted minority with management strategy, and those who were disqualified from serving on the Task Force. Members of this Task Force were reminded throughout development to update potential disclosures if any new relationships/potential COI arose during their appointments and to verify currency of disclosures. AACE made every effort to minimize the potential for COI that could influence guidance provided in this consensus statement. S.L.S. is a member of the AACE Board of Directors and Executive Committee and has received research support to Mayo Clinic from Corcept, served on a steering committee, and been a national or overall principal investigator from Chiasma and Novartis, and is ABIM Chair, Longitudinal Knowledge Assessment Approval Committee for Endocrinology, Diabetes, and Metabolism. P.V. is a consultant for Takeda Pharmaceutical Company and has been a national or overall principal investigator for National Institutes of Health grant K23 DK 11324-01A1. L.B. is a consultant, with payment to Ochsner Health, for Corcept Therapeutics, Merck, Novo Nordisk, Salix Pharmaceuticals, and Sanofi. E.A.C. received research support to company from Abbott and AbbVie; is a consultant for Ascendis, Boehringer Ingelheim, and Novo Nordisk; is a speaker for Amryt, AstraZeneca, Bayer, Corcept, Eli Lilly, Boehringer Ingelheim, and Novo Nordisk; designed study protocol and is a national principal investigator for the GLITTER1 diabetes mellitus trial funded by Gan & Lee pharmaceuticals; is owner of Endocrinology Associates, Inc; and is part-owner of MediZen. R.J.G. is or has been a consultant for Bayer, Boehringer Ingelheim, Eli Lilly and Company, Novo Nordisk, Pfizer, Sanofi, and Weight Watchers; has received research support to Emory University for investigator-initiated studies and been a national or overall principal investigator for Dexcom, Eli Lilly and Company, and Novo Nordisk; and has been partially supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health under Award Numbers P30DK111024-04S, 1K23DK123384. I.B.H. is on the advisory boards of Abbott, Bigfoot, GWave, and Roche; received research support from Beta Bionics, Insulet, and Medtronic Diabetes Care; participated in development of a consensus report on the Management of Type 1 Diabetes in Adults for the American Diabetes Association and European Association for the Study of Diabetes and an Endocrine Society guideline on inpatient diabetes management. S.D.I. is a member of the AACE Board of Directors and Executive Committee and is a consultant (without pay) for Myovant Sciences, Madrigal Pharmaceuticals, Siemens, and Novo Nordisk. K.E.I. is a member of the AACE Board of Directors and has received research support from Novo Nordisk and is on the board of the Nevada Clinical Endocrinologists Association. C.C.L. receives research support to Jaeb Coordinating Center and the University of Colorado for investigator-initiated studies from Dexcom, Inc, is treasurer of the American College of Diabetology, secretary of the Clinical Diabetes and Endocrine Institute, and chair of the Advisory Committee for the FDA on Endocrinologic and Metabolic Drugs, whose views are not represented herein. G.E.U. has received research support and been a national or overall principal investigator for AstraZeneca, Dexcom, and Novo Nordisk; serves as president, Medicine & Science, for the American Diabetes Association; and participated in development of the Endocrine Society guideline on hospital diabetes and Society of Critical Care guideline on ICU diabetes. W.M.V. and C.L.T. have no conflicts of interest to disclose., (Copyright © 2023 AACE. Published by Elsevier Inc. All rights reserved.)

Background: Identifying cases of diabetes caused by single gene mutations between the more common type 1 diabetes (T1D) and type 2 diabetes (T2D) is a difficult but important task. We report the diagnosis of ATP-binding cassette transporter sub-family C member 8 (ABCC8)-related monogenic diabetes in a 35-year-old woman with a protective human leukocyte antigen (HLA) allele who was originally diagnosed with T1D at 18 years of age., Case Report: Patient A presented with polyuria, polydipsia, and hypertension at the age of 18 years and was found to have a blood glucose > 500 mg/dL (70-199 mg/dL) and an HbA1C (hemoglobin A1C) >14% (4%-5.6%). She had an unmeasurable C-peptide but no urine ketones. She was diagnosed with T1D and started on insulin therapy. Antibody testing was negative. She required low doses of insulin and later had persistence of low but detectable C-peptide. At the age of 35 years, she was found to have a protective HLA allele, and genetic testing revealed a pathogenic mutation in the ABCC8 gene. The patient was then successfully transitioned to sulfonylurea therapy., Discussion: Monogenic diabetes diagnosed in adolescence typically presents with mild to moderate hyperglycemia, positive family history and, in some cases, other organ findings or dysfunction. The patient in this report presented with very high blood glucose, prompting the diagnosis of T1D. When she was found to have a protective HLA allele, further investigation revealed the mutation in the sulfonylurea receptor gene, ABCC8., Conclusion: Patients suspected of having T1D but with atypical clinical characteristics such as negative autoantibodies, low insulin requirements, and persistence of C-peptide should undergo genetic testing for monogenic diabetes., Competing Interests: J.B.M. reports consulting for Bayer, Boehringer Ingelheim, Mannkind, and Thermo Fisher and grant funding from Novo Nordisk and JDRF. M.S.A. owns stock in Medtronic and Merck and is a consultant for Imcyse and Sana. The other authors have no multiplicity of interest to disclose., (© 2023 AACE. Published by Elsevier Inc.)

The significant and growing global prevalence of diabetes continues to challenge people with diabetes (PwD), healthcare providers, and payers. While maintaining near-normal glucose levels has been shown to prevent or delay the progression of the long-term complications of diabetes, a significant proportion of PwD are not attaining their glycemic goals. During the past 6 years, we have seen tremendous advances in automated insulin delivery (AID) technologies. Numerous randomized controlled trials and real-world studies have shown that the use of AID systems is safe and effective in helping PwD achieve their long-term glycemic goals while reducing hypoglycemia risk. Thus, AID systems have recently become an integral part of diabetes management. However, recommendations for using AID systems in clinical settings have been lacking. Such guided recommendations are critical for AID success and acceptance. All clinicians working with PwD need to become familiar with the available systems in order to eliminate disparities in diabetes quality of care. This report provides much-needed guidance for clinicians who are interested in utilizing AIDs and presents a comprehensive listing of the evidence payers should consider when determining eligibility criteria for AID insurance coverage., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Endocrine Society.)