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.
Highlights d Radio-frequency (RF) waves activate ferritin-tagged channels via a biochemical pathway d RF interacts with ferritins, increasing the levels of free iron (labile iron pool) d Free iron produces reactive oxygen species and oxidizes membrane lipids d RF activates ferritin-tagged channels via iron-induced lipid oxidation
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.
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.
FBN1 encodes asprosin, a glucogenic hormone, following furin cleavage of the C‐terminus of profibrillin 1. Based on evolutionary conservation between FBN1 and FBN2, together with conserved furin cleavage sites, we identified a peptide hormone placensin encoded by FBN2 based on its high expression in trophoblasts of human placenta. In primary and immortalized murine hepatocytes, placensin stimulates cAMP production, protein kinase A (PKA) activity, and glucose secretion, accompanied by increased expression of gluconeogenesis enzymes. In situ perfusion of liver and in vivo injection with placensin also stimulate glucose secretion. Placensin is secreted by immortalized human trophoblastic HTR‐8/SVneo cells, whereas placensin treatment stimulates cAMP‐PKA signaling in these cells, accompanied by increases in MMP9 transcripts and activities, thereby promoting cell invasion. In pregnant women, levels of serum placensin increase in a stage‐dependent manner. During third trimester, serum placensin levels of patients with gestational diabetes mellitus are increased to a bigger extent compared to healthy pregnant women. Thus, placensin represents a placenta‐derived hormone, capable of stimulating glucose secretion and trophoblast invasion.
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.
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.
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.
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