Diabetes Research and Resource Sharing During the COVID-19 Pandemic: A Systematic Review and Experience from an Academic/Non-Profit Resource Website.

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.

Digital Connectivity: The Sixth Vital Sign.

Digital health and telehealth connectivity have become important aspects of clinical care. Connected devices, including continuous glucose monitors and automated insulin delivery systems for diabetes, are being used increasingly to support personalized clinical decisions based on automatically collected data. Furthermore, the development, demand, and coverage for telehealth have all recently expanded, as a result of the COVID-19 pandemic. Medical care, and especially diabetes care, are therefore becoming more digital through the use of both connected digital health devices and telehealth communication. It has therefore become necessary to integrate digital data into the electronic health record and maintain personal data confidentiality, integrity, and availability. Connected digital monitoring combined with telehealth communication is known as virtual health. For this virtual care paradigm to be successful, patients must have proper skills, training, and equipment. We propose that along with the five current vital signs of blood pressure, pulse, respiratory rate, temperature, and pain, at this time, digital connectivity should be considered as the sixth vital sign. In this article, we present a scale to assess digital connectivity.

Continuous Ketone Monitoring Consensus Report 2021.

This article is the work product of the Continuous Ketone Monitoring Consensus Panel, which was organized by Diabetes Technology Society and met virtually on April 20, 2021. The panel consisted of 20 US-based experts in the use of diabetes technology, representing adult endocrinology, pediatric endocrinology, advanced practice nursing, diabetes care and education, clinical chemistry, and bioengineering. The panelists were from universities, hospitals, freestanding research institutes, government, and private practice. Panelists reviewed the medical literature pertaining to ten topics: (1) physiology of ketone production, (2) measurement of ketones, (3) performance of the first continuous ketone monitor (CKM) reported to be used in human trials, (4) demographics and epidemiology of diabetic ketoacidosis (DKA), (5) atypical hyperketonemia, (6) prevention of DKA, (7) non-DKA states of fasting ketonemia and ketonuria, (8) potential integration of CKMs with pumps and automated insulin delivery systems to prevent DKA, (9) clinical trials of CKMs, and (10) the future of CKMs. The panelists summarized the medical literature for each of the ten topics in this report. They also developed 30 conclusions (amounting to three conclusions for each topic) about CKMs and voted unanimously to adopt the 30 conclusions. This report is intended to support the development of safe and effective continuous ketone monitoring and to apply this technology in ways that will benefit people with diabetes.

Green Diabetes Summit 2021.

On July 21, 2021, Diabetes Technology Society convened the virtual Green Diabetes Summit. The event consisted of 23 representatives from key stakeholder groups based in both the United States and Europe. The purposes of the summit were to (1) provide background on the complexity of addressing sustainability-related issues, including waste management, of diabetes devices from many different perspectives along the products' life cycle stages, and (2) determine the feasibility and role of a coalition of stakeholders to find solutions, particularly in the design, use, and proper disposal of diabetes devices used in home care that no one stakeholder can resolve on their own.

The Need for Sharps Waste Disposal Guidelines for Commercial Airports.

Travelers frequently eat at an airport before their flight. Travelers with diabetes also frequently need to lance their fingertips to check a blood glucose concentration and/or inject themselves with insulin. These actions generate medical sharps waste. Bloody sharps can be a source of needlestick injuries for other travelers or waste handlers if the waste is not safely disposed of. There are currently no guidelines or standards for medical sharps waste disposal in commercial airports or similar public places. We advocate for the establishment of guidelines for medical sharps waste disposal in commercial airports. These guidelines should include four elements: (1) design of sharps disposal bins, (2) placement of sharp disposal bins, (3) publication of locations with sharps disposal bins, and (4) safety protocols for both sharps disposal and handling sharps waste. In this article, we present the background and reasons behind our recommendation for establishing guidelines for medical waste disposal in commercial airports.

The Availability of Sharps Disposal Bins: A Survey of Airports in California.

BACKGROUND: Sharps waste, especially medical sharps waste, can put those who come into contact with it at risk for injury and exposure to blood-borne pathogens. Options for self-injectors to dispose of their sharps while traveling vary greatly - from sharps containers in limited locations in some public restrooms to large kiosks centrally located to no containers at all. Currently, there is a lack of published data on sharps disposal bins in commercial airports. We surveyed commercial airports in California to assess the current state of sharps waste disposal. Many people with diabetes routinely use sharps every day for injecting medications or for self-monitoring glucose concentrations and these people, along with others who self-inject medications, must have a safe mechanism for sharps disposal when travelling by air. METHODS: A five-question survey was sent to 30 commercial airports in California. Responses were collected and then analyzed based on the following three metrics: (1) the percentage of airports that responded and indicated that they had any sharps disposal bins, (2) the percentage of airports that responded and indicated that they had sharps disposal bins in over half their restrooms, and (3) the average percentage of bathrooms that have available sharps disposal bins in airports that responded to our survey. RESULTS: Out of 30 commercial airports in California, we received survey responses from 13 airport representatives and direct email responses from 5 airport representatives. Out of 18 total responses, 11 airports (61.1%) reported that they had some form of available sharps disposal options. Out of the 13 survey responses, 6 airports (46.2%) reported that they had sharps disposal in over 50% of their restrooms. CONCLUSION: There is a lack of consistency in sharps waste disposal options among commercial airports in California. While many commercial airports in California offer sharps waste disposal options, not all commercial airports have sharps waste disposal options in all their public restrooms. There is room for improved availability of sharps disposal bins in California's commercial airports.

Products for Monitoring Glucose Levels in the Human Body With Noninvasive Optical, Noninvasive Fluid Sampling, or Minimally Invasive Technologies.

BACKGROUND: Conventional home blood glucose measurements require a sample of blood that is obtained by puncturing the skin at the fingertip. To avoid the pain associated with this procedure, there is high demand for medical products that allow glucose monitoring without blood sampling. In this review article, all such products are presented. METHODS: In order to identify such products, four different sources were used: (1) PubMed, (2) Google Patents, (3) Diabetes Technology Meeting Startup Showcase participants, and (4) experts in the field of glucose monitoring. The information obtained were filtered by using two inclusion criteria: (1) regulatory clearance, and/or (2) significant coverage in Google News starting in the year 2016, unless the article indicated that the product had been discontinued. The identified bloodless monitoring products were classified into three categories: (1) noninvasive optical, (2) noninvasive fluid sampling, and (3) minimally invasive devices. RESULTS: In total, 28 noninvasive optical, 6 noninvasive fluid sampling, and 31 minimally invasive glucose monitoring products were identified. Subsequently, these products were characterized according to their regulatory, technological, and consumer features. Products with regulatory clearance are described in greater detail according to their advantages and disadvantages, and with design images. CONCLUSIONS: Based on favorable technological features, consumer features, and other advantages, several bloodless products are commercially available and promise to enhance diabetes management. Paths for future products are discussed with an emphasis on understanding existing barriers related to both technical and non-technical issues.

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.

Continuous Ketone Monitoring: A New Paradigm for Physiologic Monitoring.

In this issue of JDST, Alva and colleagues present for the first time, development of a continuous ketone monitor (CKM) tested both in vitro and in humans. Their sensor measured betahydroxybutyrate (BHB) in interstitial fluid (ISF). The sensor was based on wired enzyme electrochemistry technology using BHB dehydrogenase. The sensor required only a single retrospective calibration without a need for further adjustments over 14 days. The device produced a linear response over the 0-8 mM range with good accuracy. This novel CKM could provide a new dimension of useful automatically collected information for managing diabetes. Passively collected ISF ketone information would be useful for predicting and managing ketoacidosis in patients with type 1 diabetes, as well as other states of abnormal ketonemia. Although additional studies of this CKM will be required to assess performance in intended patient populations and prospective factory calibration will be required to support real time measurements, this novel monitor has the potential to greatly improve outcomes for people with diabetes. In the future, a CKM might be integrated with a continuous glucose monitor in the same sensor platform.

Advances in Insulin Pump Infusion Sets Symposium Report.

Continuous subcutaneous insulin infusion (CSII) is becoming increasingly used for achieving target glycemic control as well as providing flexibility in lifestyle. In a widely used version of CSII, the insulin pump itself is attached to one end of an insulin infusion set (IIS), which delivers insulin via a thin flexible plastic tube to the patient's body via a cannula or needle that is inserted under the skin at the other end of the IIS. Despite the increased use of CSII by patients with diabetes, there have been few recent advances in IIS technology, especially when compared to the many recent advances made in insulin pump technology and in insulin pharmacokinetics. To discuss recent developments in, and future plans for IIS development, Diabetes Technology Society virtually hosted the Advances in Insulin Pump Infusion Sets Symposium on December 1, 2020. This symposium featured experts in the field of IISs, including representatives from Medtronic and ConvaTec (which are two manufacturers that are currently developing IISs), Stanford University, Steno Diabetes Center Copenhagen, and Science Consulting in Diabetes. The webinar's six speakers covered (1) patient burden, (2) extended wear technology, and (3) future directions in IIS development.

Continuous Glucose Monitoring in the Hospital.

Continuous glucose monitors (CGMs) have suddenly become part of routine care in many hospitals. The coronavirus disease 2019 (COVID-19) pandemic has necessitated the use of new technologies and new processes to care for hospitalized patients, including diabetes patients. The use of CGMs to automatically and remotely supplement or replace assisted monitoring of blood glucose by bedside nurses can decrease: the amount of necessary nursing exposure to COVID-19 patients with diabetes; the amount of time required for obtaining blood glucose measurements, and the amount of personal protective equipment necessary for interacting with patients during the blood glucose testing. The United States Food and Drug Administration (FDA) is now exercising enforcement discretion and not objecting to certain factory-calibrated CGMs being used in a hospital setting, both to facilitate patient care and to obtain performance data that can be used for future regulatory submissions. CGMs can be used in the hospital to decrease the frequency of fingerstick point of care capillary blood glucose testing, decrease hyperglycemic episodes, and decrease hypoglycemic episodes. Most of the research on CGMs in the hospital has focused on their accuracy and only recently outcomes data has been reported. A hospital CGM program requires cooperation of physicians, bedside nurses, diabetes educators, and hospital administrators to appropriately select and manage patients. Processes for collecting, reviewing, storing, and responding to CGM data must be established for such a program to be successful. CGM technology is advancing and we expect that CGMs will be increasingly used in the hospital for patients with diabetes.

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.

Pharmacoadherence: An Opportunity for Digital Health to Inform the Third Dimension of Pharmacotherapy for Diabetes.

The basis of pharmacotherapy requires knowledge of two properties of a drug: pharmacokinetics (PK) and pharmacodynamics (PD). In the era of precision medicine, there is growing interest in determining between-individual variations in PK and PD. While these two dimensions of pharmacotherapy are key foci of investigation, a third property is also emerging as a critical factor in understanding how a drug affects an individual. This third property of a drug is known as phamacoadherence (PA). There can be wide variation in PA among people with diabetes, whether they are using oral or injectable medications. The use of new digital health interventions and telehealth communication tools, such as smart insulin pens, is now creating opportunities for health care professionals to have a more complete understanding of the PA of drugs, which allows for more personalized prescribing practices.

Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline.

This article is the work product of the Continuous Glucose Monitor and Automated Insulin Dosing Systems in the Hospital Consensus Guideline Panel, which was organized by Diabetes Technology Society and met virtually on April 23, 2020. The guideline panel consisted of 24 international experts in the use of continuous glucose monitors (CGMs) and automated insulin dosing (AID) systems representing adult endocrinology, pediatric endocrinology, obstetrics and gynecology, advanced practice nursing, diabetes care and education, clinical chemistry, bioengineering, and product liability law. The panelists reviewed the medical literature pertaining to five topics: (1) continuation of home CGMs after hospitalization, (2) initiation of CGMs in the hospital, (3) continuation of AID systems in the hospital, (4) logistics and hands-on care of hospitalized patients using CGMs and AID systems, and (5) data management of CGMs and AID systems in the hospital. The panelists then developed three types of recommendations for each topic, including clinical practice (to use the technology optimally), research (to improve the safety and effectiveness of the technology), and hospital policies (to build an environment for facilitating use of these devices) for each of the five topics. The panelists voted on 78 proposed recommendations. Based on the panel vote, 77 recommendations were classified as either strong or mild. One recommendation failed to reach consensus. Additional research is needed on CGMs and AID systems in the hospital setting regarding device accuracy, practices for deployment, data management, and achievable outcomes. This guideline is intended to support these technologies for the management of hospitalized patients with diabetes.

Biological, molecular and pharmacological characteristics of chloroquine, hydroxychloroquine, convalescent plasma, and remdesivir for COVID-19 pandemic: A comparative analysis.

OBJECTIVES: The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, also known as COVID-19 pandemic has caused an alarming situation worldwide. Since the first detection, in December 2019, there have been no effective drug therapy options for treating the SARS-CoV-2 pandemic. However, healthcare professionals are using chloroquine, hydroxychloroquine, remdesivir, convalescent plasma and some other options of treatments. This study aims to compare the biological, molecular, pharmacological, and clinical characteristics of these three treatment modalities for SARS-COV-2 infections, Chloroquine and Hydroxychloroquine, Convalescent Plasma, and Remdesivir. METHODS: A search was conducted in the "Institute of Science Information (ISI)-Web of Science, PubMed, EMBASE, ClinicalTrials.gov, Cochrane Library databases, Scopus, and Google Scholar" for peer reviewed, published studies and clinical trials through July 30, 2020. The search was based on keywords "COVID-19" SARS-COV-2, chloroquine, hydroxychloroquine, convalescent plasma, remdesivir and treatment modalities. RESULTS: As of July 30, 2020, a total of 36,640 relevant documents were published. From them 672 peer reviewed, published articles, and clinical trials were screened. We selected 17 relevant published original articles and clinical trials: 05 for chloroquine and/or hydroxychloroquine with total sample size (n = 220), 05 for Remdesivir (n = 1,781), and 07 for Convalescent Plasma therapy (n = 398), with a combined total sample size (n = 2,399). Based on the available data, convalescent plasma therapy showed clinical advantages in SARS-COV-2 patients. CONCLUSIONS: All three treatment modalities have both favorable and unfavorable characteristics, but none showed clear evidence of benefit for early outpatient disease or prophylaxis. Based on the current available data, convalescent plasma therapy appears to show clinical advantages for inpatient use. In the future, ongoing large sample size randomized controlled clinical trials may further clarify the comparative efficacy and safety of these three treatment classes, to conclusively determine whom to treat with which drug and when to treat them.