Newly Diagnosed Diabetes in Patients with COVID-19: Different Types and Short-Term Outcomes

A great global concern is currently focused on the coronavirus disease 2019 (COVID-19) pandemic and its associated morbidities. The goal of this study was to determine the frequency of newly diagnosed diabetes mellitus (DM) and its different types among COVID-19 patients, and to check the glycemic control in diabetic cases for three months. After excluding known cases of DM, 570 patients with confirmed COVID-19 were studied. All participants were classified as non-diabetic or newly discovered diabetic. According to hemoglobin A1c (HbA1c) and fasting insulin, newly discovered diabetic patients were further classified into pre-existing DM, new-onset type 1 DM, and new-onset type 2 DM. Glycemic control was monitored for three months in newly diagnosed diabetic patients. DM was diagnosed in 77 patients (13.5%); 12 (2.1%) with pre-existing DM, 7 (1.2%) with new-onset type 1 DM, and 58 (10.2%) with new-onset type 2 DM. Significantly higher rates of severe infection and mortality (p < 0.001 and p = 0.046) were evident among diabetic patients. Among survived diabetic patients (n = 63), hyperglycemia and the need for anti-diabetic treatment persisted in 73% of them for three months. COVID-19 was associated with a new-onset of DM in 11.4% of all participants and expression of pre-existing DM in 2.1% of all participants, both being associated with severe infection. COVID-19 patients with newly diagnosed diabetes had high risk of mortality. New-onset DM persisted for at least three months in more than two-thirds of cases

The Impact of Inadequate Temperature Storage Conditions on Aggregate and Particle Formation in Drugs Containing Tumor Necrosis Factor-Alpha Inhibitors

PURPOSE: To measure aggregate and particle formation in tumor necrosis factor-alpha (TNF-α) inhibitors etanercept, adalimumab and certolizumab pegol product samples after exposure to freezing temperature conditions similar to storage conditions previously observed in patients' homes. METHODS: TNF-α inhibitors in their original primary and secondary packaging were exposed to 32 freeze-thaw cycles (-10°C for 120min/5°C for 60 min) or continuous low storage temperature (-20°C for 96 h) before thawing at 2-8°C. Non-stressed products were used as controls. The products were analyzed by high pressure size exclusion chromatography (HP-SEC), dynamic light scattering (DLS), nanoparticle tracking analysis (NTA), micro-flow imaging (MFI) and second derivative ultraviolet (UV) spectroscopy. RESULTS: Ten out of twenty-one stressed product samples (47.6%) showed increased particle numbers in the submicron and micron size range when compared to controls. For each product, DLS, MFI and NTA detected an increase in particle level in at least one stressed syringe (both continuous freezing and freeze-thaw), whereas HP-SEC and UV spectroscopy showed no differences between stressed and non-stressed products. CONCLUSION: TNF-α inhibitors are relatively resistant to freezing temperatures similar to storage conditions previously observed in patients' homes. However, almost half of the stressed product samples showed formation of particles in the submicron and micron size range

The Impact of Inadequate Temperature Storage Conditions on Aggregate and Particle Formation in Drugs Containing Tumor Necrosis Factor-Alpha Inhibitors

PURPOSE: To measure aggregate and particle formation in tumor necrosis factor-alpha (TNF-α) inhibitors etanercept, adalimumab and certolizumab pegol product samples after exposure to freezing temperature conditions similar to storage conditions previously observed in patients' homes. METHODS: TNF-α inhibitors in their original primary and secondary packaging were exposed to 32 freeze-thaw cycles (-10°C for 120min/5°C for 60 min) or continuous low storage temperature (-20°C for 96 h) before thawing at 2-8°C. Non-stressed products were used as controls. The products were analyzed by high pressure size exclusion chromatography (HP-SEC), dynamic light scattering (DLS), nanoparticle tracking analysis (NTA), micro-flow imaging (MFI) and second derivative ultraviolet (UV) spectroscopy. RESULTS: Ten out of twenty-one stressed product samples (47.6%) showed increased particle numbers in the submicron and micron size range when compared to controls. For each product, DLS, MFI and NTA detected an increase in particle level in at least one stressed syringe (both continuous freezing and freeze-thaw), whereas HP-SEC and UV spectroscopy showed no differences between stressed and non-stressed products. CONCLUSION: TNF-α inhibitors are relatively resistant to freezing temperatures similar to storage conditions previously observed in patients' homes. However, almost half of the stressed product samples showed formation of particles in the submicron and micron size range

The Impact of Inadequate Temperature Storage Conditions on Aggregate and Particle Formation in Drugs Containing Tumor Necrosis Factor-Alpha Inhibitors

Purpose: To measure aggregate and particle formation in tumor necrosis factor-alpha (TNF-α) inhibitors etanercept, adalimumab and certolizumab pegol product samples after exposure to freezing temperature conditions similar to storage conditions previously observed in patients’ homes. Methods: TNF-α inhibitors in their original primary and secondary packaging were exposed to 32 freeze-thaw cycles (−10°C for 120min/5°C for 60 min) or continuous low storage temperature (−20°C for 96 h) before thawing at 2–8°C. Non-stressed products were used as controls. The products were analyzed by high pressure size exclusion chromatography (HP-SEC), dynamic light scattering (DLS), nanoparticle tracking analysis (NTA), micro-flow imaging (MFI) and second derivative ultraviolet (UV) spectroscopy. Results: Ten out of twenty-one stressed product samples (47.6%) showed increased particle numbers in the submicron and micron size range when compared to controls. For each product, DLS, MFI and NTA detected an increase in particle level in at least one stressed syringe (both continuous freezing and freeze-thaw), whereas HP-SEC and UV spectroscopy showed no differences between stressed and non-stressed products. Conclusion: TNF-α inhibitors are relatively resistant to freezing temperatures similar to storage conditions previously observed in patients’ homes. However, almost half of the stressed product samples showed formation of particles in the submicron and micron size range

Label-Free, Flow-Imaging Methods for Determination of Cell Concentration and Viability

Personalised Therapeutic

Determination of the Porosity of PLGA Microparticles by Tracking Their Sedimentation Velocity Using a Flow Imaging Microscope (FlowCAM)

PURPOSE: To investigate whether particle sedimentation velocity tracking using a flow imaging microscope (FlowCAM) can be used to determine microparticle porosity. METHODS: Two different methods were explored. In the first method the sedimentation rate of microparticles was tracked in suspending media with different densities. The porosity was calculated from the average apparent density of the particles derived by inter- or extrapolation to the density of a suspending medium in which the sedimentation velocity was zero. In the second method, the microparticle size and sedimentation velocity in one suspending fluid were used to calculate the density and porosity of individual particles by using the Stokes’ law of sedimentation. RESULTS: Polystyrene beads of different sizes were used for the development, optimization and validation of the methods. For both methods we found porosity values that were in excellent agreement with the expected values. Both methods were applied to determine the porosity of three PLGA microparticle batches with different porosities (between about 4 and 52%). With both methods we obtained microparticle porosity values similar to those obtained by mercury intrusion porosimetry. CONCLUSIONS: We developed two methods to determine average microparticle density and porosity by sedimentation velocity tracking, using only a few milligrams of powder. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s11095-017-2120-8) contains supplementary material, which is available to authorized users