NIH Fifth Artificial Pancreas Workshop 2023: Meeting Report: The Fifth Artificial Pancreas Workshop: Enabling Fully Automation, Access, and Adoption.

The Fifth Artificial Pancreas Workshop: Enabling Fully Automation, Access, and Adoption was held at the National Institutes of Health (NIH) Campus in Bethesda, Maryland on May 1 to 2, 2023. The organizing Committee included representatives of NIH, the US Food and Drug Administration (FDA), Diabetes Technology Society, Juvenile Diabetes Research Foundation (JDRF), and the Leona M. and Harry B. Helmsley Charitable Trust. In previous years, the NIH Division of Diabetes, Endocrinology, and Metabolic Diseases along with other diabetes organizations had organized periodic workshops, and it had been seven years since the NIH hosted the Fourth Artificial Pancreas in July 2016. Since then, significant improvements in insulin delivery have occurred. Several automated insulin delivery (AID) systems are now commercially available. The workshop featured sessions on: (1) Lessons Learned from Recent Advanced Clinical Trials and Real-World Data Analysis, (2) Interoperability, Data Management, Integration of Systems, and Cybersecurity, Challenges and Regulatory Considerations, (3) Adaptation of Systems Through the Lifespan and Special Populations: Are Specific Algorithms Needed, (4) Development of Adaptive Algorithms for Insulin Only and for Multihormonal Systems or Combination with Adjuvant Therapies and Drugs: Clinical Expected Outcomes and Public Health Impact, (5) Novel Artificial Intelligence Strategies to Develop Smarter, More Automated, Personalized Diabetes Management Systems, (6) Novel Sensing Strategies, Hormone Formulations and Delivery to Optimize Close-loop Systems, (7) Special Topic: Clinical and Real-world Viability of IP-IP Systems. "Fully automated closed-loop insulin delivery using the IP route," (8) Round-table Panel: Closed-loop performance: What to Expect and What are the Best Metrics to Assess it, and (9) Round-table Discussion: What is Needed for More Adaptable, Accessible, and Usable Future Generation of Systems? How to Promote Equitable Innovation? This article summarizes the discussions of the Workshop.

A Consensus Statement for Continuous Glucose Monitoring Metrics for Inpatient Clinical Trials.

Diabetes Technology Society organized an expert consensus panel to develop metrics for research in the use of continuous glucose monitors (CGMs) in a hospital setting. The experts met virtually in small groups both before and after an April 13, 2023 virtual meeting of the entire panel. The goal of the panel was to develop consensus definitions in anticipation of greater use of CGMs in hospital settings in the future. Establishment of consensus definitions of inpatient analytical metrics will be easier to compare outcomes between studies. Panelists defined terms related to 10 dimensions of measurements related to the use of CGMs including (1) hospital hypoglycemia, (2) hospital hyperglycemia, (3) hospital time in range, (4) hospital glycemic variability, (5) hospital glycemia risk index, (6) accuracy of CGM devices and reference methods for CGMs in the hospital, (7) meaningful time blocks for hospital glycemic goals, (8) hospital CGM data sufficiency, (9) using CGM data for insulin dosing, and (10) miscellaneous factors. The panelists voted on 51 proposed recommendations. Based on the panel vote, 51 recommendations were classified as either strong (43) or mild (8). Additional research is needed on CGM performance in the hospital. This consensus report is intended to support that type of research intended to improve outcomes for hospitalized people with diabetes.

Use of Continuous Glucose Monitors in the Hospital: The Diabetes Technology Society Hospital Meeting Report 2023.

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.

Evidence-based therapeutics for hyperglycemia in hospitalized noncritically ill patients.

Hyperglycemia in hospitalized patients, either with or without diabetes, is a common, serious, and costly healthcare problem. Evidence accumulated over 20 years has associated hyperglycemia with a significant increase in morbidity and mortality, both in surgical and medical patients. Based on this documented link between hyperglycemia and poor outcomes, clinical guidelines from professional organizations recommend the treatment of hospital hyperglycemia with a therapeutic goal of maintaining blood glucose (BG) levels less than 180 mg/dL. Insulin therapy remains a mainstay of glycemic management in the inpatient setting. The use of non-insulin antidiabetic drugs in the hospital setting is limited because little data are available regarding their safety and efficacy. However, information about the use of incretin-based therapy in inpatients has increased in the past 15 years. This review aims to summarize the different treatment strategies for hyperglycemia in hospitalized noncritical patients that are supported by observational studies or clinical trials with insulin and non-insulin drugs. In addition, we propose a protocol to help with the management of this important clinical problem.

MOVE! Enhanced: A Virtual Multidisciplinary Weight and Diabetes Management Program for High-Risk Veterans. A Feasibility Pilot.

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 feasibility study assessing a multidisciplinary, virtual weight and diabetes management program aimed at high-risk veterans with obesity and diabetes in Milwaukee, WI.

Preoperative Management of Gastrointestinal and Pulmonary Medications: Society for Perioperative Assessment and Quality Improvement (SPAQI) Consensus Statement.

Perioperative medication management is integral to preoperative optimization but remains challenging because of a paucity of literature guidance. Published recommendations are based on the expert opinion of a small number of authors without collaboration from multiple specialties. The Society for Perioperative Assessment and Quality Improvement (SPAQI) recognized the need for consensus recommendations in this area as well as the unique opportunity for its multidisciplinary membership to fill this void. In a series of articles within this journal, SPAQI provides preoperative medication management guidance based on available literature and expert multidisciplinary consensus. The aim of this consensus statement is to provide practical guidance on the preoperative management of gastrointestinal and pulmonary medications. A panel of experts with anesthesiology, perioperative medicine, hospital medicine, general internal medicine, and medical specialty experience was drawn together and identified the common medications in each of these categories. The authors then used a modified Delphi approach to review the literature and to generate consensus recommendations.

Diabetes Technology Meeting 2020.

Diabetes Technology Society hosted its annual Diabetes Technology Meeting on November 12 to November 14, 2020. This meeting brought together speakers to cover various perspectives about the field of diabetes technology. The meeting topics included artificial intelligence, digital health, telemedicine, glucose monitoring, regulatory trends, metrics for expressing glycemia, pharmaceuticals, automated insulin delivery systems, novel insulins, metrics for diabetes monitoring, and discriminatory aspects of diabetes technology. A live demonstration was presented.

Using a Diabetes Risk Score to Identify Patients Without Diabetes at Risk for New Hyperglycemia in the Hospital.

OBJECTIVE: To assess the value of a validated diabetes risk test, the Cambridge Risk Score (CRS), to identify patients admitted to hospital without diabetes at risk for new hyperglycemia (NH). METHODS: This retrospective cross-sectional study included adults admitted to a hospital over a 4-year period. Patients with no diabetes diagnosis and not on antidiabetics were included. The CRS was calculated for each patient, and those with available glycated hemoglobin (HbA1C) results were investigated in a second analysis. Multivariate regression analyses were performed to assess the association among CRS, HbA1C, and the risk for NH. RESULTS: A total of 19,830 subjects comprised the sample, of which 38% were found to have developed NH, defined as a blood glucose level ≥140 mg/dL. After accounting for covariates, the CRS was significantly associated with NH (odds ratio [OR], 1.19 [1.16, 1.22]; P < .001). Only 17% of patients had their HbA1C values checked within 6 months of admission. Compared with patients without diabetes, patients with prediabetes based on their HbA1C level (OR, 1.59 [1.37, 1.86]; P < .001) and patients with undiagnosed diabetes (OR, 5.95 [3.50, 10.65]; P < .001) were also significantly more likely to have NH. CONCLUSION: Results of this study show that the CRS and HbA1C levels were significantly associated with the risk of developing NH in inpatient adults without diabetes. Given that an HbA1C level was missing in most medical records of hospitalized patients without diabetes, the CRS could be a useful tool for early identification and management of NH, possibly leading to better outcomes.

Preoperative Management of Endocrine, Hormonal, and Urologic Medications: Society for Perioperative Assessment and Quality Improvement (SPAQI) Consensus Statement.

Perioperative medical management is challenging due to the rising complexity of patients presenting for surgical procedures. A key part of preoperative optimization is appropriate management of long-term medications, yet guidelines and consensus statements for perioperative medication management are lacking. Available resources utilize the recommendations derived from individual studies and do not include a multidisciplinary focus or formal consensus. The Society for Perioperative Assessment and Quality Improvement (SPAQI) identified a lack of authoritative clinical guidance as an opportunity to utilize its multidisciplinary membership to improve evidence-based perioperative care. SPAQI seeks to provide guidance on perioperative medication management that synthesizes available literature with expert consensus. The aim of this Consensus Statement is to provide practical guidance on the preoperative management of endocrine, hormonal, and urologic medications. A panel of experts with anesthesiology, perioperative medicine, hospital medicine, general internal medicine, and medical specialty experience was drawn together and identified the common medications in each of these categories. The authors then utilized a modified Delphi approach to critically review the literature and generate consensus recommendations.

How to Best Protect People With Diabetes From the Impact of SARS-CoV-2: Report of the International COVID-19 and Diabetes Summit.

The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus has rapidly involved the entire world and exposed the pressing need for collaboration between public health and other stakeholders from the clinical, scientific, regulatory, pharmaceutical, and medical device and technology communities. To discuss how to best protect people with diabetes from serious outcomes from COVID-19, Diabetes Technology Society, in collaboration with Sansum Diabetes Research Institute, hosted the "International COVID-19 and Diabetes Virtual Summit" on August 26-27, 2020. This unique, unprecedented real-time conference brought together physicians, scientists, government officials, regulatory experts, industry representatives, and people with diabetes from six continents to review and analyze relationships between COVID-19 and diabetes. Over 800 attendees logged in. The summit consisted of five sessions: (I) Keynotes, (II) Preparedness, (III) Response, (IV) Recovery, and (V) Surveillance; eight parts: (A) Background, (B) Resilience, (C) Outpatient Care, (D) Inpatient Care, (E) Resources, (F) High-Risk Groups, (G) Regulation, and (H) The Future; and 24 sections: (1) Historic Pandemics and Impact on Society, (2) Pathophysiology/Risk Factors for COVID-19, (3) Social Determinants of COVID-19, (4) Preparing for the Future, (5) Medications and Vaccines, (6) Psychology of Patients and Caregivers, (7) Outpatient Treatment of Diabetes Mellitus and Non-Pharmacologic Intervention, (8) Technology and Telehealth for Diabetes Outpatients, (9) Technology for Inpatients, (10) Management of Diabetes Inpatients with COVID-19, (11) Ethics, (12) Accuracy of Diagnostic Tests, (13) Children, (14) Pregnancy, (15) Economics of Care for COVID-19, (16) Role of Industry, (17) Protection of Healthcare Workers, (18) People with Diabetes, (19) International Responses to COVID-19, (20) Government Policy, (21) Regulation of Tests and Treatments, (22) Digital Health Technology, (23) Big Data Statistics, and 24) Patient Surveillance and Privacy. The two keynote speeches were entitled (1) COVID-19 and Diabetes-Meeting the Challenge and (2) Knowledge Gaps and Research Opportunities for Diabetes and COVID-19. While there was an emphasis on diabetes and its interactions with COVID-19, the panelists also discussed the COVID-19 pandemic in general. The meeting generated many novel ideas for collaboration between experts in medicine, science, government, and industry to develop new technologies and disease treatment paradigms to fight this global pandemic.

Challenges and Strategies for Inpatient Diabetes Management in Older Adults.

Adults older than 65 years of age are the fastest growing segment of the U.S. population. Aging is also one of the most important risk factors for diabetes, and about one-third of all individuals with diabetes are in this age-group. Older people with diabetes are more likely to have comorbidities such as hypertension, ischemic heart disease, chronic kidney disease, and cognitive impairment, which lead to higher rates of hospital admissions compared with individuals without diabetes. Professional organizations have recommended patient-centric individualized glycemic reduction approaches, with an emphasis on potential harms of intensive glycemic control and overtreatment in older adults. Insulin therapy remains a mainstay of diabetes management in the inpatient setting regardless of patients' age; however, there is uncertainty about optimal glycemic targets during the hospital stay. Increasing evidence supports selective use of dipeptidyl peptidase-4 inhibitors, alone or in combination with low-dose basal insulin, in older noncritically ill patients with mild to moderate hyperglycemia. This article reviews the prevalence, diagnosis, and monitoring of, and the available treatment strategies for, diabetes among elderly patients in the inpatient setting.

Hospital Diabetes Meeting 2020.

Patients with diabetes may experience adverse outcomes related to their glycemic control when hospitalized. Continuous glucose monitoring systems, insulin-dosing software, enhancements to the electronic health record, and other medical technologies are now available to improve hospital care. Because of these developments, new approaches are needed to incorporate evolving treatments into routine care. With the goal of educating healthcare professionals on the most recent practices and research for managing diabetes in the hospital, Diabetes Technology Society hosted the Virtual Hospital Diabetes Meeting on April 24-25, 2020. Because of the coronavirus disease 2019 (COVID-19) pandemic, the meeting was restructured to be held virtually during the national lockdown to ensure the safety of the participants and allow them to remain at their posts treating COVID-19 patients. The meeting focused on (1) inpatient management and perioperative care, (2) diabetic ketoacidosis and hyperglycemic hyperosmolar state, (3) computer-guided insulin dosing, (4) Coronavirus Disease 2019 and diabetes, (5) technology, (6) hypoglycemia, (7) data and cybersecurity, (8) special situations, (9) glucometrics and insulinometrics, and (10) quality and safety. This meeting report contains summaries of each of the ten sessions. A virtual poster session will be presented within two months of the meeting.

Transitioning to non-insulin therapy in a patient receiving high dose insulin.

In people with type 2 diabetes with evidence of obesity-related insulin resistance, use of insulin to treat hyperglycemia has not been shown to reduce macrovascular complications, despite widespread use for many years. However, newer classes of diabetes medications, designed to address the prevalent pathophysiologic defect of type 2 diabetes, have emerged. Consequently, in many patients, reduction of insulin doses or even total elimination is possible after the addition of these newer agents. The authors suggest a cautious approach in which people with type 2 diabetes and established cardiovascular disease who are on high insulin doses (>1.0 unit/kg/day) be treated with diabetes medications that showed evidence of cardiovascular benefit (such as glucagon-like peptide-1 receptor agonists [GLP-1RAs]), on whom close monitoring is crucial because they may be at particular risk for developing hypoglycemia. This approach can be labor intensive and may be challenging for busy primary care providers for who may have limited time to evaluate and follow the patient. The authors present a case report of adding a GLP-1RA to high insulin doses. If the hemoglobin A1c is <8.0% when GLP-1RA is added, insulin doses should be reduced by 20%. Patients should be monitored at least every 4 weeks initially until it is confirmed there is no hypoglycemia risk. If glycemic targets (defined as fasting or preprandial glucose level between 80 and 130 mg/dl) are consistently achieved, providers may consider proactively reducing insulin doses by 10-20% to avoid hypoglycemia. The authors recommend creating appropriate goals and expectation before initiating this process.

Insulin therapy in patients with type 2 diabetes and high insulin resistance is associated with increased risk of complications and mortality.

Objective: To investigate the relationship between insulin use and clinical outcomes in patients with type 2 diabetes stratified by level of insulin resistance (IR).Methods: Cross sectional analysis of the NHANES database from 2001 to 2010. Sample was comprised of 3,124 individuals with diabetes, representing a US population of 16,713,593. Insulin use was self-reported. Fasting glucose and insulin levels were used to assess IR by HOMA-IR determination. Subjects were allocated within High or Low HOMA-IR groups based on the sample median. Outcome variables were mortality, major adverse cardiovascular events (MACE), and diabetic kidney disease (DKD). Logistic regression adjusting for covariates including glycemic control and comorbidities were performed.Results: In the adjusted model, insulin use was significantly associated with increased risk of mortality (OR: 2.39, 95% CI: 1.136-5.010) having a MACE (OR: 2.45, 95% CI: 1.137-4.550), and developing DKD (OR: 1.89, 95% CI: 1.119-3.198) in the high HOMA-IR group. The association between insulin use and the outcome variables was not statistically significant in patients within the low HOMA-IR group.Conclusions: Insulin use was associated with increased risk of mortality, MACE, and DKD in patients within the high IR group, but the association was not significant within the low IR group. Our findings indicate that insulin therapy could be less beneficial in patients with high IR. Prospective studies are needed to identify subsets of individuals with type 2 diabetes who would benefit the most from insulin therapy, and for which patients, insulin should be avoided.

Glucose Management Technologies for the Critically Ill.

Hyperglycemia is common in the intensive care unit (ICU) both in patients with and without a previous diagnosis of diabetes. The optimal glucose range in the ICU population is still a matter of debate. Given the risk of hypoglycemia associated with intensive insulin therapy, current recommendations include treating hyperglycemia after two consecutive glucose >180 mg/dL with target levels of 140-180 mg/dL for most patients. The optimal method of sampling glucose and delivery of insulin in critically ill patients remains elusive. While point of care glucose meters are not consistently accurate and have to be used with caution, continuous glucose monitoring (CGM) is not standard of care, nor is it generally recommended for inpatient use. Intravenous insulin therapy using paper or electronic protocols remains the preferred approach for critically ill patients. The advent of new technologies, such as electronic glucose management, CGM, and closed-loop systems, promises to improve inpatient glycemic control in the critically ill with lower rates of hypoglycemia.

Preoperative Diabetes Optimization Program.

IN BRIEF "Quality Improvement Success Stories" are published by the American Diabetes Association in collaboration with the American College of Physicians, Inc., 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 successful effort to improve glycemic control in presurgical patients with an A1C >8%.

Management of Type 1 Diabetes in the Hospital Setting.

PURPOSE OF REVIEW: The purpose of this article was to review recent guideline recommendations on glycemic target, glucose monitoring, and therapeutic strategies, while providing practical recommendations for the management of medical and surgical patients with type 1 diabetes (T1D) admitted to critical and non-critical care settings. RECENT FINDINGS: Studies evaluating safety and efficacy of insulin pump therapy, continuous glucose monitoring, electronic glucose management systems, and closed loop systems for the inpatient management of hyperglycemia are described. Due to the increased prevalence and life expectancy of patients with type 1 diabetes, a growing number of these patients require hospitalization every year. Inpatient diabetes management is complex and is best provided by a multidisciplinary diabetes team. In the absence of such resource, providers and health care staff must become familiar with the features of this condition to avoid complications such as severe hyperglycemia, ketoacidosis, hypoglycemia, or glycemic variability. We reviewed most recent guidelines and relevant literature in the topic to provide practical recommendations for the inpatient management of patients with T1D.

Hyperglycemia and Acute Kidney Injury During the Perioperative Period.

Hyperglycemia and acute kidney injury (AKI) are frequently observed during the perioperative period. Substantial evidence indicates that hyperglycemia increases the prevalence of AKI as a surgical complication. Patients who develop hyperglycemia and AKI during the perioperative period are at significantly elevated risk for poor outcomes such as major adverse cardiac events and all-cause mortality. Early observational and interventional trials demonstrated that the use of intensive insulin therapy to achieve strict glycemic control resulted in remarkable reductions of AKI in surgical populations. However, more recent interventional trials and meta-analyses have produced contradictory evidence questioning the renal benefits of strict glycemic control. Although the exact mechanisms through which hyperglycemia increases the risk of AKI have not been elucidated, multiple pathophysiologic pathways have been proposed. Hypoglycemia and glycemic variability may also play a significant role in the development of AKI. In this literature review, the complex relationship between hyperglycemia and AKI as well as its impact on clinical outcomes during the perioperative period is explored.