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Ketone bodies are an energy substrate produced by the liver and used during states of low carbohydrate availability, such as fasting or prolonged exercise. High ketone concentrations can be present with insulin insufficiency and are a key finding in diabetic ketoacidosis (DKA). During states of insulin deficiency, lipolysis increases and a flood of circulating free fatty acids is converted in the liver into ketone bodies-mainly beta-hydroxybutyrate and acetoacetate. During DKA, beta-hydroxybutyrate is the predominant ketone in blood. As DKA resolves, beta-hydroxybutyrate is oxidized to acetoacetate, which is the predominant ketone in the urine. Because of this lag, a urine ketone test might be increasing even as DKA is resolving. Point-of-care tests are available for self-testing of blood ketones and urine ketones through measurement of beta-hydroxybutyrate and acetoacetate and are cleared by the US Food and Drug Administration (FDA). Acetone forms through spontaneous decarboxylation of acetoacetate and can be measured in exhaled breath, but currently no device is FDA-cleared for this purpose. Recently, technology has been announced for measuring beta-hydroxybutyrate in interstitial fluid. Measurement of ketones can be helpful to assess compliance with low carbohydrate diets; assessment of acidosis associated with alcohol use, in conjunction with SGLT2 inhibitors and immune checkpoint inhibitor therapy, both of which can increase the risk of DKA; and to identify DKA due to insulin deficiency. This article reviews the challenges and shortcomings of ketone testing in diabetes treatment and summarizes emerging trends in the measurement of ketones in the blood, urine, breath, and interstitial fluid., 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: R.M.B. has received research support, consulted, or has been on a scientific advisory board for Abbott Diabetes Care, Ascensia, Bigfoot Biomedical, CeQur, Dexcom, Hygieia, Insulet, Lilly, Medtronic, Novo Nordisk, Onduo, Roche Diabetes Care, Sanofi, Tandem Diabetes Care, United Healthcare, Vertex Pharmaceutical and Zealand Pharma. His technology research is funded in part by NIH/NIDDK and Helmsley Charitable Trust. R.M.B.’s employer, nonprofit HealthPartners Institute, contracts for his services, and no personal income goes to him. K.C. receives research support provided to her institution from Dexcom, Abbott, Medtronic, Altimmune, Lilly, Novo Nordisk, and Insulet and has received consulting fees from Dexcom. E.C. is an advisory board member and consultant for Novo Nordisk, Eli Lilly, Adocia, MannKind, Lexicon, Arecor. E.C. was also a speaker for Novo Nordisk. K.D. is the chair of the Joint British Diabetes Societies for Inpatient Care and has received speaker fees, travel, or taken part in advisory boards for AstraZeneca, Sanofi Diabetes, Boehringer Ingelheim, Lilly, and Novo Nordisk. J.L.S. has conducted clinical trials for Eli Lilly, Insulet, and Medtronic and has received in-kind support for research studies from Dexcom and Medtronic. She has consulted for Eli Lilly, Lexicon, Medtronic, and Sanofi. She has been a member of advisory boards for Bigfoot Biomedical, Cecelia Health, Eli Lilly, Insulet, the T1D Fund, and Vertex. G.E.U. reports research funds to Emory University from Astra Zeneca, Abbott, and Dexcom. The support from Astra Zeneca ended in 2022. D.C.K. is a consultant to EOFlow, Fractyl Health, Integrity, Lifecare, Rockley Photonics, and Thirdwayv. J.H., A.M.Y., and I.N. have nothing to disclose.

Painful diabetic neuropathy is a common vexing problem for people with diabetes and a costly problem for society. The pathophysiology is not well understood, and no safe and effective mechanistically-based treatment has been identified. Poor glycemic control is a risk factor for painful diabetic neuropathy. Excessive intraneuronal glucose in people with diabetes can be shunted away from physiological glycolysis into multiple pathological pathways associated with neuropathy and pain. The first three treatments that are traditionally offered consist of risk factor reduction, lifestyle modifications, and pharmacological therapy, which includes only three drugs that are approved for this indication by the United States Food and Drug Administration. All of these traditional treatments are often inadequate for relieving neuropathic pain, and thus, new approaches are needed. Modern devices based on neuromodulation technology, which act directly on the nervous system, have been recently cleared by the United States Food and Drug Administration for painful diabetic neuropathy and offer promise as next-in-line therapy when traditional therapies fail., 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: DCK is a consultant for EOFlow, Fractyl Health, Integrity, Lifecare, Rockley Photonics, and Thirdwayv. AMY, JH, KTN, NYX, LTH, BKA, and NE have nothing relevant to disclose.

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., 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: DCK is a consultant for Better Therapeutics, EOFlow, Integrity, Lifecare, Nevro, Novo, Sanofi, and Thirdwayv. DK has received research support from Abbott Diabetes Care. AW receives research salary support from UnitedHealth Group. REA, TT, AMY, JH, CEM, WAL have no disclosures.

Introduction: Diabetes Technology Society virtually hosted the first meeting of the Integration of Connected Diabetes Device Data Into the Electronic Health Record #2 (iCoDE-2) Standards Project on May 31, 2023, via Zoom., Methods: Clinicians, patients, data aggregators, informaticists, manufacturers, attorneys, and cybersecurity experts discussed dosing data currently available from insulin delivery devices and data aggregators and the types of information that patients and clinicians want to see. This information along with technical and regulatory aspects of (1) data standards and (2) integration into the electronic health record (EHR) are the basis of iCoDE-2., Results: Six sessions were hosted discussing themes including (1) What's Currently Available: The Continuous Glucose Monitor Experience; (2) What's Currently Available: The Aggregator Experience; (3) What's Currently Available: The Insulin Pump Experience; (4) What's Currently Available: The Insulin Pen Experience; (5) What Do Clinicians and Patients Want Out of iCoDE-2 Data?; and (6) Technical and Regulatory Aspects of Data Aggregation., Conclusion: Additional working group meetings to discuss data standard and clinical workflow will be held to create additional technical specifications and clinical workflows to aid in insulin dosing data integration into the EHR. A mid-project meeting will convene in the second half of 2023., 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: D.C.K. is a consultant for Better Therapeutics, EOFlow, Integrity, Lifecare, Nevro, NovoNordisk, Sanofi, and Thirdwayv. J.C.E. receives federal funding from FDA, NIMHD, and NCATS and is a consultant for Sanofi. R.E.A., T.T., A.M.Y., and J.H. have no disclosures.

Spinal cord stimulation (SCS) technology has been recently approved by the US Food and Drug Administration (FDA) for painful diabetic neuropathy (PDN). The treatment involves surgical implantation of electrodes and a power source that delivers electrical current to the spinal cord. This treatment decreases the perception of pain in many chronic pain conditions, such as PDN. The number of patients with PDN treated with SCS and the amount of data describing their outcomes is expected to increase given four factors: (1) the large number of patients with this diagnosis, (2) the poor results that have been obtained for pain relief with pharmacotherapy and noninvasive non-pharmacotherapy, (3) the results to date with investigational SCS technology, and (4) the recent FDA approval of systems that deliver this treatment. Whereas traditional SCS replaces pain with paresthesias, a new form of SCS, called high-frequency 10-kHz SCS, first used for pain in 2015, can relieve PDN pain without causing paresthesias, although not all patients experience pain relief by SCS. This article describes (1) an overview of SCS technology, (2) the use of SCS for diseases other than diabetes, (3) the use of SCS for PDN, (4) a comparison of high-frequency 10-kHz and traditional SCS for PDN, (5) other SCS technology for PDN, (6) deployment of SCS systems, (7) barriers to the use of SCS for PDN, (8) risks of SCS technology, (9) current recommendations for using SCS for PDN, and (10) future developments in SCS., 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: KTN is a consultant to Abbott Diabetes Care. NYX s a consultant to Abbott Diabetes Care. DCK is a consultant for EOFlow, Fractyl Health, Integrity, Lifecare, Rockley Photonics, and Thirdwayv. AMY, JH, LTH, BKA, and NE have nothing relevant to disclose.

This commentary article discusses the recent trends and changes in popularity of telehealth usage as well as the most recent efforts to redefine telehealth value and usability. Six strategies to improve the patient experience and increase telehealth acceptance by overcoming simultaneous barriers are presented, which include (1) creating a new healthcare paradigm using telehealth, (2) scheduling the telehealth visit, (3) preparing for the telehealth visit, (4) conducting the telehealth visit, (5) using data and biomarkers, and (6) providing digital equity. With the application of these strategies, we believe that the recent decline in the popularity of telehealth can be reversed., 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: DCK is a consultant to EOFlow, Fractyl Health, Integrity, Lifecare, Rockley Photonics, and Thirdwayv. ESH is an employee of Verily and is a founding advisor for kēlaHealth, Clinetic, and Stratus Medicine. LE is an Advisory Board Member for Cecelia Health, Roche, Sanofi, and Provention Bio. AMY, JH, and JKR have nothing to disclose.

Lipohypertrophy is a common skin complication associated with insulin-treated diabetes. The impact of lipohypertrophy as a contributing factor to suboptimal glycemic control, glucose variability, and hypoglycemia is often under-recognized by health care professionals. In a recent Webinar on April 26, 2023, Diabetes Technology Society asked international experts to provide updates on the latest knowledge related to lipohypertrophy for practicing clinicians and educators, researchers, and industries involved in insulin delivery. A recording of the Webinar is freely available on the Diabetes Technology Society Web site (https://www.diabetestechnology.org/)., 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: L.H. is a consultant for a number of companies that are developing novel diagnostic and therapeutic options for diabetes treatment. He is a shareholder of the Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany. D.K. has received remuneration for participation in Advisory Boards from Sanofi, Novo Nordisk, and Abbott Diabetes Care. He also has received research support from Novo Nordisk and Abbott Diabetes Care and has financial interests in Glooko, Proteomics, Better Therapeutics, Hi.Health, and SNAQ. D.C.K. is a consultant to Better, Eoflow, Integrity, Lifecare, Nevro, Novo, Sanofi, and Thirdwayv.T.T., R.E.A., J.H., A.M.Y., J.S., S.G., A.F., and J.J.S. have no relevant discloses.

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., 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: EKS was partially supported by the VA MERIT award (#1I01CX001825) and CSP #2002 from the United States (U.S.) Department of Veterans Affairs. EKS has received unrestricted research support from Dexcom, MannKind Cooperation and Tandem (to Baltimore VA Medical Center and to University of Maryland) for the conduction of clinical trials. EKS has received fees from the Medscape and the Endocrine Society (ESAP). JAA receives research funding from Abbott Diabetes. LB has product and research support for investigator-initiated studies from Dexcom and Ypsomed in addition to speaker honoraria from Dexcom and Ypsomed. GD has received research support from Insulet and has consulted for Medscape. KMD received research support from Abbott, Dexcom, Sanofi, Viacyte, and Insulet, consulting fees from Dexcom, Eli Lilly, advisory board fees from Elsevier, and honoraria from UpToDate, Medscape, Academy for Continued Healthcare Learning, Med Learning Group, Cardiometabolic Health Congress. FJP has received research support: Dexcom, Insulet, Tandem, Ideal Medical technologies, Novo Nordisk and consults for Dexcom. FJP has received research support: Dexcom, Insulet, Tandem, Ideal Medical technologies, Novo Nordisk and consulting fees from Dexcom. GEU is partly supported by research grants from National Institutes of Health (NIH/NATS UL 3UL1TR002378-05S2) from the Clinical and Translational Science Award program, and from National Institutes of Health and National Center for Research Resources (NIH/NIDDK 2P30DK111024-06). GEU has received research support (to Emory University) from Abbott, Bayer, Dexcom and Sanofi. DCK is a consultant for Better Therapeutics, EOflow, Integrity, Lifecare, Nevro, Novo, Sanofi, and Thirdwayv. The remaining authors have no disclosures.

Increasingly, people with diabetes (PWD) are using wearable and other devices to support self-management. During air travel, there are 4 stakeholders involved in maximizing the safety of wireless devices for diabetes care used in flight: (1) manufacturers of the devices, (2) airlines, (3) the Transportation Security Administration, and (4) the U.S. Food and Drug Administration. These stakeholders have all developed technologies and policies that assist PWD who prepare for and take appropriate actions during long-haul flights. This article discusses the performance and use of 6 classes of specific wireless diabetes devices during an airplane flight, including the following: (1) blood glucose monitors, (2) continuous glucose monitors, (3) insulin pumps, (4) smart pens for dosing insulin injections, (5) advanced hybrid closed-loop systems, and (6) spinal cord stimulators for painful diabetic neuropathy. Through the policies and safeguards of the 4 stakeholders and the proper self-care measures that insulin-using PWD can take, it is possible to maintain safe glycemic levels on flights across multiple time zones., Competing Interests: Disclosure D.C.K. is a consultant to Better, EOFlow, Integrity, Lifecare, Nevro, Novo, Sanofi, and Thirdwayv. A.A.-M. is the retired EVP & CTO of Insulet Corporation. D.T.A. has received speaker’s honoraria from Lilly Diabetes, Novo Nordisk, Xeris Pharmaceuticals, and Mannkind and consulting fees from Ascensia Diabetes Care, Roche Diagnostics, and Senseonics. D.K. has received remuneration for participation in Advisory Boards from Sanofi, Novo Nordisk, and Abbott Diabetes Care and research support from Novo Nordisk and Abbott Diabetes Care and has financial interests in Glooko, Proteomics, Better Therapeutics, Hi.Health, and SNAQ. The other authors have no multiplicity of interest to disclose., (Copyright © 2023 AACE. Published by Elsevier Inc. All rights reserved.)

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: The use of continuous subcutaneous insulin infusion (CSII) therapy in pregnancies affected by pregestational diabetes mellitus (DM) has generated mixed outcome data worthy of further investigation. This systematic review and meta-analysis aims to evaluate clinical outcomes associated with CSII versus multiple daily injections (MDIs) in pregnant persons with pregestational DM., Methods: A predefined, systematic, librarian-assisted search of MEDLINE (PubMed), Embase, Cochrane Library, Scopus, ClinicalTrials.gov, and World Health Organization International Clinical Trial Registry Platform (published from 2010 to 2022) yielded 3003 studies describing pregnancy outcomes associated with CSII and/or MDI for pregestational DM. The primary exposure was mode of insulin administration, with cesarean delivery and neonatal hypoglycemia as the primary maternal and neonatal outcomes, respectively. Secondary outcomes included hypertensive disorders of pregnancy, first and third-trimester glycemic control, large-for-gestational age (LGA) neonate, preterm birth, neonatal intensive care unit admission, need for respiratory support, hyperbilirubinemia, 5-minute Apgar <7, shoulder dystocia, and perinatal mortality. We calculated pooled odds ratios (OR) with 95% confidence intervals (CI) using random-effects models., Results: Among 39 eligible studies, 39% of the 5518 pregnancies included were exposed to CSII. Odds of cesarean delivery were higher with CSII (20 studies: 63% vs 56%, odds ratio [OR] 1.3 [95% confidence interval (CI) 1.2-1.5]), but we did not identify a difference in the odds of neonatal hypoglycemia (23 studies: 31% vs 34%, OR 1.1 [95% CI 0.9-1.5]). Among secondary outcomes, only the odds of LGA (20 studies: 47% vs 38%, OR 1.4 [95% CI 1.2-1.6]) were higher in individuals using CSII versus MDI., Conclusions: Use of CSII (vs MDI) for pregestational DM in pregnancy is associated with higher odds of cesarean delivery and delivery of an LGA neonate. Further evaluation of how CSII use may influence neonatal size and delivery route is warranted., 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.

Integration of insulin dosing data into the electronic health record (EHR), combined with other patient-generated health care data, would facilitate the use of wirelessly connected insulin delivery systems, including smart insulin pens, insulin pumps, and advanced hybrid closed-loop systems. In 2022, Diabetes Technology Society developed the Integration of Continuous Glucose Monitoring Data into the EHR (iCoDE) Project, which is the first consensus standard for integrating data from a wearable device into the EHR. The iCoDE Standard is a comprehensive guide for any health care delivery organization or hospital for automatically integrating continuous glucose monitoring data into the EHR. Diabetes Technology Society is following iCoDE with the Integration of Connected Diabetes Device Data into the EHR (iCoDE-2) Project, to similarly provide guidance for integrating insulin delivery data into the EHR alongside continuous glucose monitoring data.

Background: The magnitude of the response of the diabetes professional community to the COVID-19 pandemic is not known. We aimed to examine diabetes technology research trends and resources offered by professional organizations during this period., Methods: We explored patterns of the response from the professional diabetes community to the pandemic by (1) systematically searching for articles related to diabetes, COVID-19, and diabetes technologies; (2) examining publication trends of research protocols (clinicaltrials.gov) and preprints (medRxiv); and (3) reviewing online resources from professional organizations including our website (COVIDinDiabetes.org; an Emory University-Diabetes Technology Society collaboration)., Results: We identified 492 articles published between December 2019 and December 2022 meeting our inclusion criteria. Telemedicine and continuous glucose monitoring were the most common reported technologies from most parts of the world. The largest number of preprint articles was published in 2020, with a decline in 2021 and 2022. The number of research protocols related to COVID-19 was the highest in 2020 and declined in 2021 and 2022. Resources from organizations included protocols adapted to treat patients with diabetes and COVID-19, training programs, emergency preparedness, and literature on diabetes and COVID-19. On our website (COVIDinDiabetes.org), there were 12 236 visits and 18 149 pageviews, with 1.6 actions per visits, with most visits coming from North America (N = 7233, 54.2%), South America (N = 2663, 21.8%), and Europe (N = 1219)., Conclusions: We conclude that the COVID-19 pandemic promoted unprecedented global research productivity related to diabetes and COVID-19 and that the transition to the use of technology resources has been evident during this period.

Objective: To review the current status of practical knowledge related to insulin-associated lipohypertrophy (LH) - an accumulation of fatty subcutaneous nodules commonly caused by repeated injections and/or infusions of insulin into the same site., Methods: Review of published literature with additional contributions from leading multidisciplinary experts with the emphasis on clinical aspects including pathophysiology, clinical and economic consequences, diagnosis, prevention and treatment., Results: LH is the most common dermatologic complication of insulin therapy. Risk factors for the development of lipohypertrophy include repeated delivery of large amounts of insulin into the same location over time, repeated injection trauma to the skin and subcutaneous tissue, and multiple injections using the same needle. Subcutaneous insulin injection in skin areas with lipohypertrophy is associated with reduced pain; however, this problem can interfere with insulin absorption, thereby increasing the likelihood of glucose variability, hypo- and hyperglycemia when a site is changed. Modern visualization technology of the subcutaneous space with ultrasound can demonstrate lipohypertrophy early in the course of its development., Conclusions: The physiological and psychological consequences of developing insulin lipohypertrophy can be prevented and treated with education focusing on insulin injection techniques., Competing Interests: Disclosure D.K. has received remuneration for participation in Advisory Boards from Sanofi, Novo Nordisk, and Abbott Diabetes Care. He also has received research support from Novo Nordisk and Abbott Diabetes Care and has financial interests in Glooko, Hi.Health and SNAQ. L.H. is a consultant for a number of companies that are developing novel diagnostic and therapeutic options for diabetes treatment. He is a shareholder of the Profil Institut fur Stoffwechselforschung GmbH, Neuss, Germany. M.A. has served on an advisory panel for Abbott, Medtronic, Insulet, VitalAire, Sanofi; and has received honoraria for speaking from Abbott, Eli Lilly, Medtronic, Novo Nordisk, Sanofi, VitalAire; and is a part-time diabetes consultant at Eli Lilly. J.I.J. is a founder, equity owner, and consultant to Capillary Biomedical and has received research support. DCK is a consultant to EOFlow, Integrity, Lifecare, Novo Nordisk, and Thirdwayv. J.H., A.M.Y., S.G., and J.J.S. have nothing relevant to disclose., (Copyright © 2023 AACE. Published by Elsevier Inc. All rights reserved.)

This commentary article discusses the benefits of utilizing telemedicine to conduct shared medical appointments for people with type 1 diabetes and type 2 diabetes. We conducted a literature review of articles about shared medical appointments or group medical visits in people with diabetes with associated clinical data. We identified 43 articles. Models of this approach to care have demonstrated positive outcomes in adults and children with type 1 diabetes. Shared telemedicine appointments also have the potential to improve diabetes self-management, reduce the treatment burden, and improve psychosocial outcomes in adults with type 2 diabetes. Ten key recommendations for implementation are presented to guide the development of shared telemedicine appointments for diabetes. These recommendations can improve care for diabetes.

Diabetes Technology Society assembled a panel of clinician experts in diabetology, cardiology, clinical chemistry, nephrology, and primary care to review the current evidence on biomarker screening of people with diabetes (PWD) for heart failure (HF), who are, by definition, at risk for HF (Stage A HF). This consensus report reviews features of HF in PWD from the perspectives of 1) epidemiology, 2) classification of stages, 3) pathophysiology, 4) biomarkers for diagnosing, 5) biomarker assays, 6) diagnostic accuracy of biomarkers, 7) benefits of biomarker screening, 8) consensus recommendations for biomarker screening, 9) stratification of Stage B HF, 10) echocardiographic screening, 11) management of Stage A and Stage B HF, and 12) future directions. The Diabetes Technology Society panel recommends 1) biomarker screening with one of two circulating natriuretic peptides (B-type natriuretic peptide or N-terminal prohormone of B-type natriuretic peptide), 2) beginning screening five years following diagnosis of type 1 diabetes (T1D) and at the diagnosis of type 2 diabetes (T2D), 3) beginning routine screening no earlier than at age 30 years for T1D (irrespective of age of diagnosis) and at any age for T2D, 4) screening annually, and 5) testing any time of day. The panel also recommends that an abnormal biomarker test defines asymptomatic preclinical HF (Stage B HF). This diagnosis requires follow-up using transthoracic echocardiography for classification into one of four subcategories of Stage B HF, corresponding to risk of progression to symptomatic clinical HF (Stage C HF). These recommendations will allow identification and management of Stage A and Stage B HF in PWD to prevent progression to Stage C HF or advanced HF (Stage D HF)., Competing Interests: Declaration of Competing Interests APandey has received research support from the National Institute on Aging GEMSSTAR Grant (1R03AG067960-01), and the National Institute on Minority Health and Disparities (R01MD017529). APandey has received grant funding from Applied Therapeutics and Gilead Sciences; has received honoraria outside of the present study as an advisor/consultant for Tricog Health Inc., Lilly USA, Rivus, Cytokinetics, Pieces Technologies, and Roche Diagnostics, and has received nonfinancial support from Pfizer and Merck. APandey is also a consultant for Palomarin Inc. with stock compensation. CMR has received funding from AstraZeneca, Dexcom Inc., Fresenius, Nutricia, and Recor. VNS' employer, University of Colorado, receives research support from Sanofi, NovoNordisk, Insulet, Dexcom, Tandem Diabetes Care, JDRF and NIH, and received honorarium from Dexcom, Insulet, NovoNordisk, Medscape, Lifescan and Tandem Diabetes Care for speaking or advisory role. ABG has received honoraria for lectures/ advisory boards from Abbott, AstraZeneca, Boehirnger Ingelheim, Roche Diagnostics, and Vifor. JB is a consultant for Abbott, Adrenomed, Amgen, Applied Therapeutics, American Regent, Astra Zeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CVRx, G3 Pharma, Impulse Dynamics, Innolife, Janssen, LivaNova, Medtronic, Merck, Novartis, NovoNordisk, Occlutech, Relypsa, Roche, Sequana, and Vifor. RMB has received research support, has acted as a consultant, or has been on the scientific advisory board for Abbott Diabetes Care, Ascensia, Bigfoot Biomedical, Inc., CeQur, DexCom, Eli Lilly, Hygieia, Insulet, Medtronic, Novo Nordisk, Onduo, Roche Diabetes Care, Sanofi, United Healthcare, Vertex Pharmaceuticals and Zealand Pharma. RMB's employer, non-profit HealthPartners Institute, contracts for his services for which he receives no personal income. SJG has received research support from the Duke University Department of Medicine Chair's Research Award, American Heart Association (#929502), Amgen, AstraZeneca, Bristol Myers Squibb, Cytokinetics, Merck, Novartis, Pfizer, and Sanofi; has served on advisory boards for Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim/Lilly, Cytokinetics, Roche Diagnostics, scPharmaceuticals, and Sanofi; has received speaker fees from Boehringer Ingelheim and Cytokinetics; and serves as a consultant for Amgen, Bayer, Bristol Myers Squibb, Corteria Pharmaceuticals, CSL Vifor, Merck, PharmaIN, Roche Diagnostics, Sanofi, Tricog Health, and Urovant Pharmaceuticals. MNK is a consultant or on the advisory board for Alnylam, Amgen, Applied Therapeutics, Astra Zeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Dexcom, Eli Lilly, Esperion Therapeutics, Janssen, Lexicon, Merck (Diabetes and Cardiovascular), Novo Nordisk, Pharmacosmos, Pfizer, Sanofi, Vifor Pharma, and Youngene. MNK received other research support from Astra Zeneca. MNK received honorariums from Astra Zeneca, Boehringer Ingelheim, and Novo Nordisk. LAL has received research funding from, has provided CME on behalf of and/or has acted as an advisor to Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Esperion, HLS, Kowa, Merck, Novartis, Novo Nordisk, Pfizer, Sanofi and Servier and is on a DSMB for Applied Therapeutics. BM was speaker honorarium and member of advisory board of Astra Zeneca, Boehringer Ingelheim, Novo Nordisk. CM serves or has served on the advisory panel for Novo Nordisk, Sanofi, Merck Sharp and Dohme Ltd., Eli Lilly and Company, Novartis, AstraZeneca, Boehringer Ingelheim, Roche, Medtronic, ActoBio Therapeutics, Pfizer, Imcyse, Insulet, Zealand Pharma, Avotres, Mannkind, Sandoz and Vertex. Financial compensation for these activities has been received by KU Leuven; KU Leuven has received research support for CM from Medtronic, Imcyse, Novo Nordisk, Sanofi and ActoBio Therapeutics; CM serves or has served on the speakers bureau for Novo Nordisk, Sanofi, Eli Lilly and Company, Boehringer Ingelheim, Astra Zeneca and Novartis. Financial compensation for these activities has been received by KU Leuven. TWM provides research support and speaking support for Abbott Diabetes Care, Dexcom, Medtronic, Novo Nordisk, Lilly Diabetes, and Sanofi; research support for Insulet Corporation and Novo Nordisk; and is on the advisory panel for Dexcom and Medscape. All funds from all activities are managed by his employer, non-profit HealthPartners Institute dba International Diabetes Center and TWM receives no personal income from these activities. VM has acted as consultant and speaker, received research or educational grants from Sanofi, Novo Nordisk, MSD, Eli Lilly, Novartis, Boehringer Ingelheim, Lifescan J & J, Roche Diagnostics, Abbott, USV, Dr. Reddy’s Laboratories, Sun Pharma and from several Indian pharmaceutical companies. KVP has served as a consultant to Novo Nordisk. APeters received research support from Abbott, Dexcom, and Insulet; was on the advisory board for Zealand, Vertez, and Medscape; and has stock options in Omada/Teladoc. YS was on the advisory board for Roche Diagnostics and Abbott Diagnostics and was a a speaker for Roche Diagnostics. YS has a patent: 20210401347. JJS is faculty at Lifescan Diabetes Institute. GU has received research grant support from Dexcom and Abbott. GU's employer, Emory University, has received funding from Bayer. DCK is a consultant for EOFlow, Integrity, Lifecare, Rockley Photonics, and Thirdwayv. AMY, JH, DK, RP-B, LB, YMB, GAF, GG, ER, GMCR, DBS, KW, EEW, and AHBW have nothing relevant to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Diabetes Technology Society hosted its annual Diabetes Technology Meeting from November 3 to November 5, 2022. Meeting topics included (1) the measurement of glucose, insulin, and ketones; (2) virtual diabetes care; (3) metrics for managing diabetes and predicting outcomes; (4) integration of continuous glucose monitor data into the electronic health record; (5) regulation of diabetes technology; (6) digital health to nudge behavior; (7) estimating carbohydrates; (8) fully automated insulin delivery systems; (9) hypoglycemia; (10) novel insulins; (11) insulin delivery; (12) on-body sensors; (13) continuous glucose monitoring; (14) diabetic foot ulcers; (15) the environmental impact of diabetes technology; and (16) spinal cord stimulation for painful diabetic neuropathy. A live demonstration of a device that can allow for the recycling of used insulin pens was also presented.

Artificial intelligence can use real-world data to create models capable of making predictions and medical diagnosis for diabetes and its complications. The aim of this commentary article is to provide a general perspective and present recent advances on how artificial intelligence can be applied to improve the prediction and diagnosis of six significant complications of diabetes including (1) gestational diabetes, (2) hypoglycemia in the hospital, (3) diabetic retinopathy, (4) diabetic foot ulcers, (5) diabetic peripheral neuropathy, and (6) diabetic nephropathy.

The annual Virtual Hospital Diabetes Meeting was hosted by Diabetes Technology Society on April 1 and April 2, 2022. This meeting brought together experts in diabetes technology to discuss various new developments in the field of managing diabetes in hospitalized patients. Meeting topics included (1) digital health and the hospital, (2) blood glucose targets, (3) software for inpatient diabetes, (4) surgery, (5) transitions, (6) coronavirus disease and diabetes in the hospital, (7) drugs for diabetes, (8) continuous glucose monitoring, (9) quality improvement, (10) diabetes care and educatinon, and (11) uniting people, process, and technology to achieve optimal glycemic management. This meeting covered new technology that will enable better care of people with diabetes if they are hospitalized.

The authors present 3 patients from this retrospective case series to review the clinical findings, imaging, pathology, and treatment of orbital atypical lipomatous tumor/well-differentiated liposarcoma. Pathology of biopsy specimens ranged from spindle cell proliferations mimicking neurofibroma to proliferations of well-differentiated adipocytes. Immunohistochemical stains were positive for murine double minute 2 in 1 case, and fluorescent in situ hybridization showed amplification of murine double minute 2 in 2 cases. Treatments ranged from serial debulking, proton beam irradiation, and exenteration. None of the patients developed metastases. A literature review supported the low-grade nature of this lesion. Orbital atypical lipomatous tumor/well-differentiated liposarcoma is a low-grade, indolent liposarcoma that may be locally invasive. The histologic diagnosis is enhanced with immunohistochemical staining for murine double minute 2 and fluorescent in situ hybridization analysis for amplification of murine double minute 2. Although treatment may vary according to the individual, conservative therapies may be attempted prior to radical surgery., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2021 The American Society of Ophthalmic Plastic and Reconstructive Surgery, Inc.)

Secondary ocular malignancies most commonly spread to the choroid. Previously, the prognosis was poor however, with newer treatments including immunotherapy, patient's life expectancy have increased. It is therefore, important that ophthalmologists diagnose this condition in a timely manner and offer treatment to maximize visual potential and refer them on to oncology colleagues in order to optimize their systemic treatment for their primary cancer., (© 2021 Royal Australian and New Zealand College of Ophthalmologists.)

Purpose: Adult vitelliform lesions (AVL) are associated with age related macular degeneration (AMD) and subretinal drusenoid deposits (SRDD). We evaluated the natural course of AVL, assessing the influence of SRDD on disease progression, visual function and incidence of macular atrophy (MA) and choroidal neovascular membranes (CNVM)., Methods: A retrospective cohort study was conducted between January 2011 and March 2016. Demographic, clinical and imaging data from 26 consecutive AVL patients were analysed following case note review. Optical coherence tomography images were graded for SRDD and patients divided into those with/without SRDD. Outcomes included presenting/changes in best corrected visual acuity (BCVA) and incidence of MA/CNVM., Results: Mean age was 78.6 ± 7.6 years. Mean follow-up was 51.5 ± 25.6 months. Twelve patients (46.2%) had SRDD at presentation with 3 more (11.5%) developing them. Subjects with SRDD were older (mean 81.7 ± 6.1 years vs 74.3 ± 7.6 years, p = 0.010). Mean presenting BCVA was worse in SRDD eyes (0.39 ± 0.31 logMAR vs 0.19 ± 0.18 logMAR, p = 0.017). Eight of 15 patients with SRDD (53.3%) developed incident MA or CNVM; higher than those with no SRDD (1/11, 9.1%; p = 0.036). Two patients (7.7%) developed full thickness macular holes., Conclusions: Patients with AVL and SRDD likely represent an advanced pathological stage or phenotype with worse visual outcome and higher risk of MA/CNVM. Possible overlap with AMD exists. Follow-up, counselling and provisions for early detection/treatment of complications should be made. Better classification including improved understanding of phenotypic and genetic variations with reference to comorbid diseases including AMD is required. Presence of SRDD in AVL offers a dichotomous classification, indicating risk of future MA/CNVM formation.

PurposeFibrin glue has been used successfully in numerous ophthalmic surgical procedures. Recently, fibrin glue has been used in limbal stem cell transplantation to reduce both operative time and to negate the need for sutures. The aim of this study was to determine the effects of fibrin glue on epithelial cell migration in vitro.MethodsCorneoscleral rims were split to retain the epithelial layer, Bowman's layer, and anterior stroma. Rims were cut into eight equal-sized pieces and were placed directly on culture plates or affixed with fibrin glue. Rims were maintained in culture for 25 days and epithelial cell growth was monitored. Cells were photographed to measure area or growth and immunofluorescence staining of explants for fibrin was performed.ResultsExplants that were glued demonstrated significantly delayed epithelial cell growth and migration as compared with explants without glue. By day 16, all fibrin glue had dissolved and coincided with onset of cell growth from glued explants. Cell growth commenced between days 3 and 4 for control explants without glue and around days 14-16 for explants with fibrin glue.ConclusionsFibrin glue delays epithelial cell migration by acting as a physical barrier and can potentially interfere with explant-derived limbal epithelial cell migration on to the corneal surface. We propose that glue should be used to attach the conjunctival frill of the limbal explant but care should be taken to ensure that the glue does not wrap around the explant if used to secure the explant as well. Strategic use of glue, to attach the recessed conjunctiva, can be advantageous in delaying conjunctival cell migration and reducing the need for sequential sector conjunctival epitheliectomy.

Purpose: Floppy eyelid syndrome is a condition that is difficult to identify and diagnose and with no clear guidelines on its management. We propose a method of reliably grading this syndrome and have proposed a management algorithm based on the grading., Materials and Methods: Retrospective data collection of patients diagnosed with Floppy eyelid syndrome and treated under the care of a single oculoplastic surgeon over a 9 year period., Results: First, 102 patients were included and were classified into 3 groups. Grade 1 (F1) 7.5%, Grade 2 (F2) 36.5% and Grade 3 (F3) 56%. Only 12% of our cohort required surgery, and 92% of these patients demonstrated improvement in their symptoms., Discussion: Clinical grading of Floppy eyelid syndrome patients will help determine patient's management plan. In our experience, operating on both upper and lower eyelids at the same time where indicated helps to maintain the normal anatomical relationship and improve epiphora.

Background: The trabecular meshwork (TM) located at the angle of the anterior chamber of the eye contributes to aqueous drainage. A novel layer in the posterior part of the human cornea has recently been reported (the pre-Descemet's layer (Dua's layer (PDL)). We examined the peripheral part of this layer in relation to the origin of the TM., Methods: The PDL and TM of 19 human donor eyes and one exenterated sample were studied. Samples were examined by light and electron microscopy (EM) for tissue architecture and by immunohistology for four matricellular proteins, five collagen types and CD34., Results: EM revealed that beams of collagen emerged from the periphery of PDL on the anterior surface of the Descemet's membrane and divided and subdivided to continue as the beams of the TM. Long-spacing collagen was seen in the PDL and TM. Trabecular cells (CD34-ve) associated with basement membrane were seen in the peripheral part of the PDL and corresponded to the start of the separation of the collagen lamellae of PDL. Collagen VI was present continuously in PDL and extended into the TM. Matricellular proteins were seen predominantly in the TM with only laminin extending into the periphery of PDL., Conclusions: This study provides an insight into the origins of the collagen core of the TM as an extension of the PDL of the cornea. This finding adds to the knowledge base of the TM and cornea and has the potential to impact future research into the TM and glaucoma.

Background: The Limbal epithelial crypt (LEC) is a solid cord of cells, approximately 120 microns long. It arises from the undersurface of interpalisade rete ridges of the limbal palisades of Vogt and extends deeper into the limbal stroma parallel or perpendicular to the palisade. There are up to 6 or 7 such LEC, variably distributed along the limbus in each human eye. Morphological and immunohistochemical studies on the limbal epithelial crypt (LEC) have demonstrated the presence of limbal stem cells in this region. The purpose of this microarray study was to characterise the transcriptional profile of the LEC and compare with other ocular surface epithelial regions to support our hypothesis that LEC preferentially harbours stem cells (SC)., Results: LEC was found to be enriched for SC related Gene Ontology (GO) terms including those identified in quiescent adult SC, however similar to cornea, limbus had significant GO terms related to proliferating SC, transient amplifying cells (TAC) and differentiated cells (DC). LEC and limbus were metabolically dormant with low protein synthesis and downregulated cell cycling. Cornea had upregulated genes for cell cycling and self renewal such as FZD7, BTG1, CCNG, and STAT3 which were identified from other SC populations. Upregulated gene expression for growth factors, cytokines, WNT, Notch, TGF-Beta pathways involved in cell proliferation and differentiation were noted in cornea. LEC had highest number of expressed sequence tags (ESTs), downregulated and unknown genes, compared to other regions. Genes expressed in LEC such as CDH1, SERPINF1, LEF1, FRZB1, KRT19, SOD2, EGR1 are known to be involved in SC maintenance. Genes of interest, in LEC belonging to the category of cell adhesion molecules, WNT and Notch signalling pathway were validated with real-time PCR and immunofluorescence., Conclusions: Our transcriptional profiling study identifies the LEC as a preferential site for limbal SC with some characteristics suggesting that it could function as a 'SC niche' supporting quiescent SC. It also strengthens the evidence for the presence of "transient cells" in the corneal epithelium. These cells are immediate progeny of SC with self-renewal capacity and could be responsible for maintaining epithelial turn over in normal healthy conditions of the ocular surface (OS). The limbus has mixed population of differentiated and undifferentiated cells.

Tamsulosin is an alpha(1)-adrenergic antagonist known to be linked with intraoperative floppy-iris syndrome (IFIS), which is characterized by iris atonicity and a propensity toward progressive intraoperative pupil constriction and iris prolapse. We present 2 strategies for managing IFIS-associated iris prolapse. Placement of a single subincisional iris retractor following reposition of the prolapsed iris was the more successful approach. We recommend consideration of this approach in all cases of iris prolapse.

Purpose: To report a case of silicone oil-induced corneal perforation following complex retinal detachment surgery., Methods: Case report., Results: Two months following a second retinal detachment repair, the patient presented to eye casualty with a corneal perforation secondary to silicone oil keratopathy., Conclusion: The pathophysiology of silicone oil-related perforation is not clearly understood. Poor corneal nutrition due to the presence of oil may be an important contributory factor. Close monitoring of patients for early signs of silicone oil keratopathy could preempt perforation.

Objective: To study and characterize the epithelial cells in patients with a central "island" of normal epithelial cells surrounded with 360 degrees of clinically apparent limbal stem cell (SC) deficiency with conjunctivalization of the limbus and peripheral cornea., Design: Observational, prospective, consecutive case series., Participants: Five human subjects (8 eyes) who presented with total limbal SC deficiency in 1 or both eyes with a central area of normal corneal epithelial cells., Methods: Clinical slit-lamp examination, aided with fluorescein staining, for evidence of conjunctivalization and in vivo confocal microscopy (IVCM) of the conjunctivalized limbus and peripheral cornea and the normal central corneal epithelium., Main Outcome Measure: Long term survival of normal stratified corneal epithelial cell sheet in the presence of total limbal SC deficiency., Results: In all 8 eyes the diagnosis of limbal SC deficiency was confirmed by clinical and IVCM examination. The conjunctivalized area extended circumferentially along the entire limbus, seen clinically by the presence of fluorescein staining cells, epithelial irregularity, and vascularization and by IVCM showing bright conjunctival epithelial cells, superficial and deep blood vessels, and goblet cells. The central corneal epithelial cells had a normal appearance with polygonal superficial cells, well-defined wing cells, and smaller basal cells. The central "islands" of normal epithelial cells remained unchanged over the mean follow-up period of 60 months (range, 8-12 years)., Conclusions: The existence and survival of a healthy sheet of corneal epithelial cells over the follow-up period, in the presence of clinically apparent total limbal SC deficiency, suggests a limited role of limbal epithelial SC in physiologic homeostasis of the corneal epithelium., Financial Disclosure(s): The authors have no proprietary or commercial interest in any materials discussed on this article.

Introduction: Amniotic membrane (AM) has gained increasing popularity as a useful carrier for ex vivo-expanded cells for tissue engineering, particularly in ocular surface reconstruction. However, current methods employed for denuding AM are highly variable, and the consequent effects on the structural and molecular composition of the AM basement membrane (BM) are ambiguous. We compare the effects of the main denuding procedures, and propose a highly effective standardized alternative., Methods: AMs preserved for transplantation were denuded using published ethylenediaminetetraacetic acid (EDTA)- and dispase-based methodologies and our novel thermolysin-based procedure. Scanning and transmission electron microscopy and immunohistochemistry, for BM components (collagens IV and VII, laminin 5, and integrins alpha6 and beta4), were used to assess effectiveness of denuding epithelium, whilst maintaining the integrity of the BM., Results: EDTA- and dispase-based denuding techniques resulted in the disaggregation and even destruction of the BM structure and molecular composition. Employing thermolysin effectively denuded epithelium whilst maintaining BM structural and molecular integrity., Conclusion: Current procedures for preparing AM are variable and often ineffective, resulting in nonstandard membranes. Our novel thermolysin-based technique effectively denudes the AM whilst preserving an essentially intact and consistent BM. Therefore, we propose that this novel thermolysin procedure may potentially improve overall generation of tissue-engineered constructs using AM.

Objective: To determine the distribution of cell membrane proteins and extracellular matrix proteins around the limbal epithelial crypt (LEC) compared with adjacent limbus and corneal epithelium., Methods: Serial histological sections of human corneoscleral limbus rims were stained with antibodies of interest by standard immunohistochemistry., Results: Superficial cells of the limbus were desmoglein 3 positive, compared with the negative basal cells of the limbus that correspond to cells with more stemlike properties. The LEC had a much lower proportion of desmoglein 3 staining in comparison. Tenascin C staining demonstrated regional variations of the limbus depending on their association with the LEC. Limbus that was associated with or adjacent to the LEC had a greater tenascin C expression compared with normal limbus, whereas the LEC demonstrated the greatest tenascin C expression., Conclusions: Based on these and similar results previously reported for connexin 43, we propose a novel model on the mechanism of corneal surface epithelium maintenance involving 3 different limbal regions: zone 1, limbus including the LEC; zone 2, limbus associated with the LEC; and zone 3, limbus distant to the LEC., Clinical Relevance: The noted limbal variations may influence the selection of the donor site for limbal grafts in the future.