Review
Endocrinology & Metabolism
John S. Pemberton, Emma G. Wilmot, Katharine Barnard-Kelly, Lalantha Leelarathna, Nick Oliver, Tabitha Randell, Craig E. Taplin, Pratik Choudhary, Peter Adolfsson
Summary: In 2022, the National Institute for Clinical Excellence updated guidance for continuous glucose monitoring (CGM), recommending its availability for all people with type 1 diabetes. CGM manufacturers can trade in the UK with CE marking without national assessment, unlike FDA and TGA processes. Clinical accuracy studies submitted for CE marking by UK manufacturers showed wide-ranging indications, unlike FDA and TGA approvals that require comprehensive clinical data evaluation. FDA- and TGA-approved indications match available clinical data, while CE marking indications can have discrepancies. UK Conformity Assessed marking can strengthen regulation from January 2025.
DIABETES OBESITY & METABOLISM
(2023)
Article
Endocrinology & Metabolism
Satish K. Garg, Mark Kipnes, Kristin Castorino, Timothy S. Bailey, Halis Kaan Akturk, John B. Welsh, Mark P. Christiansen, Andrew K. Balo, Sue A. Brown, Jennifer L. Reid, Stayce E. Beck
Summary: The study evaluated the accuracy and safety of a seventh generation Dexcom CGM in adults with diabetes. Results showed single-digit MARD values with sensors placed on the arm or abdomen, indicating high accuracy.
DIABETES TECHNOLOGY & THERAPEUTICS
(2022)
Article
Pharmacology & Pharmacy
Tiecheng Zhong, Zonggui Wang, Sayeman Islam Niloy, Yue Shen, Stephen T. O'Rourke, Chengwen Sun
Summary: Cardiac hypertrophy is initially an adaptive response to cardiac overload, but can progress to decompensation, leading to heart failure and sudden cardiac death. This study found that both PI3KC1 and PI3KC3 are involved in Ang II-induced cardiac hypertrophy, with PI3KC1 inhibiting autophagy activity leading to ROS accumulation and hypertrophy, while PI3KC3 activation improving autophagy activity, reducing ROS production, and providing a protective effect against Ang II-induced cardiac hypertrophy.
FRONTIERS IN PHARMACOLOGY
(2021)
Article
Engineering, Electrical & Electronic
Shinji Matsuo, Takuma Aihara, Tatsurou Hiraki, Yoshiho Maeda, Toshiki Kishi, Takuro Fujii, Koji Takeda, Takaaki Kakitsuka
Summary: Silicon photonics is a crucial technology for large-scale photonic integrated circuits due to its capability of high uniformity and quality wafer processes. This paper focuses on the heterogeneous integration of membrane III-V compound semiconductor photonic devices, which offer optical gain and high modulation efficiency. The use of a simple taper waveguide structure enables efficient optical coupling with a Si waveguide. Furthermore, the micro-transfer-printing technology allows for device selection and integration on Si substrates, facilitating the development of transmission modules with low power consumption.
IEEE JOURNAL OF SELECTED TOPICS IN QUANTUM ELECTRONICS
(2023)
Article
Endocrinology & Metabolism
Martin Gariepy, Niyoosha Yoosefi, Carolina Silva, Jean-Pierre Chanoine, Fatema S. Abdulhussein
Summary: This study aimed to evaluate the glycemic pattern of children with HI on stable therapy and determine the frequency of undetected hypoglycemia using CGM. The results showed that CGM can help detect hypoglycemia and guide medical management.
JOURNAL OF PEDIATRIC ENDOCRINOLOGY & METABOLISM
(2023)
Article
Health Care Sciences & Services
Victor Ravelo, Gabriela Olate, Marcio de Moraes, Claudio Huentequeo, Roberto Sacco, Sergio Olate
Summary: The aim of this study was to determine changes in the mandibular condyle 6 months after orthognathic surgery. The study found that orthognathic surgery caused significant changes in the anterior, superior, and posterior joint spaces of the mandibular condyle, but no significant changes in the position of the condyle in the articular fossa.
JOURNAL OF PERSONALIZED MEDICINE
(2023)
Article
Green & Sustainable Science & Technology
Kun Ge, Jiaxing Liu, Jiaqi Wang, Zhen Long, Xinyu Zhang, Haoqi Wei, Wei Yu
Summary: This study developed a hydrate decomposition model to investigate the gas generation behaviors in different hydrate reservoirs with various horizontal well-spacing strategies. The results showed that the placement of the production well had significant effects on gas and water production, gas-water ratio, and temperature in hydrate reservoirs, depending on the type of hydrate reservoir.
JOURNAL OF CLEANER PRODUCTION
(2023)
Review
Medicine, General & Internal
Jonathan J. Darrow, Jerry Avorn, Aaron S. Kesselheim
Summary: Medical device regulation in the US has become more complex over the past 45 years, with various regulatory pathways and evolving evidence requirements. Increased FDA support from industry and concerns about flexible authorization requirements highlight the ongoing tension between efficient access and ensuring patient safety.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
(2021)
Article
Engineering, Electrical & Electronic
Hongying Yang, Yumeng Luo, Gaofei Lu, Yang Chai, Zhiqin Chu, Kwai Hei Li
Summary: In this letter, a miniature viscosity sensor based on GaN-on-sapphire optical device integrated with an inclined flow channel is demonstrated. The monolithic device, consisting of a pair of GaN diodes responsible for light emission and detection, can monitor droplet sliding. The proposed elegant design of a few centimeters in size is capable of distinguishing the liquid viscosities from 2 to 600 mPa center dot s in tens of seconds. The proposed optical sensor exhibits attractive features, such as compactness, low cost, ease of operation, and small liquid volume required, making it suitable for practical applications in liquid viscosity measurement.
IEEE ELECTRON DEVICE LETTERS
(2022)
Article
Endocrinology & Metabolism
Kiran Kumar Golla, Yashdeep Gupta, Alpesh Goyal, Mani Kalaivani, Garima Kachhawa, Vidushi Kulshrestha, Aparna. K. K. Sharma, Jyoti Meena, Juhi Bharti, Jai. B. B. Sharma, Vatsla Dadhwal, Neena Malhotra, Neerja Bhatla, Nikhil Tandon
Summary: This study compared the performance of Freestyle Libre Pro (FSL-Pro) and blinded Medtronic iPro2 continuous glucose monitoring system in pregnancy. The study found that iPro2 was more accurate, but both sensors showed lower accuracy in the hypoglycemic range, highlighting the need for improvements in current sensors to address this issue.
DIABETES TECHNOLOGY & THERAPEUTICS
(2023)
Article
Chemistry, Analytical
Daniel A. Hochfellner, Amra Simic, Marlene T. Taucher, Lea S. Sailer, Julia Kopanz, Tina Poettler, Julia K. Mader
Summary: This study evaluated the accuracy and usability of a novel continuous glucose monitoring (CGM) system and found that it met the clinical requirements. The needle-free insertion technology of the system was well tolerated by users and reduced medical waste.
Article
Endocrinology & Metabolism
Chris Worth, Mark J. Dunne, Maria Salomon-Estebanez, Simon Harper, Paul W. Nutter, Antonia Dastamani, Senthil Senniappan, Indraneel Banerjee
Summary: This study developed a Hypoglycaemia Error Grid (HEG) for CGM assessment in CHI patients and found that CGM accuracy is inadequate to recommend it as a standalone tool for routine clinical use. However, CGM still has value in other aspects for CHI patients.
FRONTIERS IN ENDOCRINOLOGY
(2022)
Article
Chemistry, Multidisciplinary
Alessio Danilo Inchingolo, Sabino Ceci, Assunta Patano, Angelo Michele Inchingolo, Valentina Montenegro, Chiara Di Pede, Giuseppina Malcangi, Grazia Marinelli, Giovanni Coloccia, Mariagrazia Garibaldi, Zamira Kruti, Giulia Palmieri, Nicole De Leonardis, Biagio Rapone, Antonio Mancini, Alexandra Semjonova, Ludovica Nucci, Ioana Roxana Bordea, Antonio Scarano, Felice Lorusso, Elisabetta Ferrara, Marco Farronato, Gianluca Martino Tartaglia, Daniela Di Venere, Filippo Cardarelli, Francesco Inchingolo, Gianna Dipalma
Summary: This study analyzed the effectiveness of elastodontic therapy with AMCOP (R) devices in treating children with hyperdivergent class II malocclusion, and found that this treatment method can effectively correct malocclusion and improve upper airway space in a short period of time.
APPLIED SCIENCES-BASEL
(2022)
Article
Biology
Khalid H. Zawawi, Fahad F. Alsulaimani, Ayman A. Al-Dharrab, Ahmed R. Afify, Mohammad S. Al-Zahrani, Hosam A. Baeshen
Summary: This study compared and contrasted the morphological characteristics of Class I, II, and III malocclusions in adolescent Saudis, revealing significant differences between gender and malocclusions, especially in Class III malocclusions. Additionally, skeletal differences were observed among the groups with different malocclusions.
SAUDI JOURNAL OF BIOLOGICAL SCIENCES
(2021)
Article
Astronomy & Astrophysics
Pradip Gatkine, Sylvain Veilleux, Daniel Perley, Joseph Durbak, Simone Dichiara, S. Bradley Cenko, Eleonora Troja
Summary: We investigate the outflows in host galaxies of gamma-ray bursts (GRBs) at redshift z = 2-6 and find clear correlations between high-ion-traced outflows and the star formation rate (SFR). The mass outflow rate and momentum flux of high-ion outflows are supported by the momentum imparted by star formation. However, low-ion outflows show weaker correlations with SFR. We also observe a trend of normalized velocity decreasing with halo mass and increasing with specific SFR.
ASTROPHYSICAL JOURNAL
(2022)
Article
Endocrinology & Metabolism
Tadej Battelino, Ramin Tehranchi, Timothy Bailey, Klemen Dovc, Anita Melgaard, Jenine Yager Stone, Stephanie Woerner, Thekla von Dem Berge, Linda DiMeglio, Thomas Danne
Summary: In a trial involving pediatric individuals with type 1 diabetes experiencing insulin-induced hypoglycemia, dasiglucagon proved to be more effective in restoring blood glucose levels compared to placebo, with a safety profile similar to glucagon.
PEDIATRIC DIABETES
(2021)
Article
Endocrinology & Metabolism
Timothy S. Bailey, Julie Willard, Leslie J. Klaff, Jenine Yager Stone, Anita Melgaard, Ramin Tehranchi
Summary: Dasiglucagon administered via an autoinjector device provided rapid reversal of hypoglycaemia in adults with type 1 diabetes, with no serious adverse events reported. The aqueous formulation of dasiglucagon in a ready-to-use autoinjector device may offer a reliable treatment option for severe hypoglycaemia.
DIABETES OBESITY & METABOLISM
(2021)
Article
Endocrinology & Metabolism
Satish K. Garg, David Liljenquist, Bruce Bode, Mark P. Christiansen, Timothy S. Bailey, Ronald L. Brazg, Douglas S. Denham, Anna R. Chang, Halis Akturk, Andrew Dehennis, Katherine S. Tweden, Francine R. Kaufman
Summary: The PROMISE study evaluated the accuracy and safety of the next-generation implantable Eversense CGM system for up to 180 days. The results showed sustained accuracy and safety of the system, with improved calibration scheme and sensor survival, using either primary or SBA sensors.
DIABETES TECHNOLOGY & THERAPEUTICS
(2022)
Article
Endocrinology & Metabolism
Satish K. Garg, Mark Kipnes, Kristin Castorino, Timothy S. Bailey, Halis Kaan Akturk, John B. Welsh, Mark P. Christiansen, Andrew K. Balo, Sue A. Brown, Jennifer L. Reid, Stayce E. Beck
Summary: The study evaluated the accuracy and safety of a seventh generation Dexcom CGM in adults with diabetes. Results showed single-digit MARD values with sensors placed on the arm or abdomen, indicating high accuracy.
DIABETES TECHNOLOGY & THERAPEUTICS
(2022)
Article
Endocrinology & Metabolism
Naila Celeste Bailey, Jeannett Dimsits, Mette Hammer, David M. Kendall, Timothy S. Bailey
Summary: In the study, it was found that trained caregivers and untrained bystanders were able to administer the dasiglucagon autoinjector more rapidly and with greater ease compared to the Eli Lilly GEK, resulting in higher user satisfaction.
DIABETES TECHNOLOGY & THERAPEUTICS
(2022)
Article
Endocrinology & Metabolism
Timothy S. Bailey, Jasvinder Gill, Merwyn S. Jones, Laxmi Shenoy, Charlie Nicholls, Jukka Westerbacka
Summary: Adding insulin glargine 300 U/mL (Gla-300) to GLP-1RA therapy significantly improved glycemic control without increasing the risk of hypoglycemia in patients with type 2 diabetes.
DIABETES OBESITY & METABOLISM
(2022)
Article
Endocrinology & Metabolism
Ron Brazg, Satish K. Garg, Anuj Bhargava, James R. Thrasher, Kashif Latif, Bruce W. Bode, Timothy S. Bailey, Barry S. Horowitz, Arvind Cavale, Yogish C. Kudva, Kevin B. Kaiserman, George Grunberger, John Chip Reed, Sarnath Chattaraj, Gina Zhang, John Shin, Vivian Chen, Scott W. Lee, Toni L. Cordero, Andrew S. Rhinehart, Robert A. Vigersky, Bruce A. Buckingham
Summary: This trial evaluated the safety and performance of a new extended-wear infusion set when used for 7 days by adults with type 1 diabetes. The results showed that the extended-wear infusion set was safe and rated with high satisfaction by patients, without adversely affecting glycemic control.
DIABETES TECHNOLOGY & THERAPEUTICS
(2022)
Article
Endocrinology & Metabolism
Lori M. Laffel, Timothy S. Bailey, Mark P. Christiansen, Jennifer L. Reid, Stayce E. Beck
Summary: The accuracy of the G7 continuous glucose monitoring system was evaluated in children and adolescents with type 1 diabetes. The results showed that the system was accurate in various age groups and situations, whether the sensor was placed on the arm or abdomen.
JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY
(2023)
Review
Endocrinology & Metabolism
John Walsh, Ruth Roberts, Timothy S. Bailey, Lutz Heinemann
Summary: This study proposes the establishment of an Insulin Advisory Committee to develop insulin titration guidelines 100 years after its discovery. Despite significant advances in diabetes technology, glucose control metrics remain poor. The lack of clear insulin titration guidelines has led to inefficiencies in reaching recommended glycemic goals, with healthcare providers and patients managing insulin titrations as they see fit. This review details the widespread problems in current insulin delivery devices and presents a method for optimized total daily doses of insulin to address hyperglycemia.
JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY
(2023)
Editorial Material
Biochemistry & Molecular Biology
Jeremy Pettus, Schafer C. Boeder, Mark P. Christiansen, Douglas S. Denham, Timothy S. Bailey, Halis K. Akturk, Leslie J. Klaff, Julio Rosenstock, Mickie H. M. Cheng, Bruce W. Bode, Edgar D. Bautista, Ren Xu, Hai Yan, Thai Dung, Satish K. Garg, Samuel Klein
Summary: This study evaluated the safety and efficacy of volagidemab, an antagonistic monoclonal glucagon receptor antibody, as an adjunct to insulin therapy in patients with type 1 diabetes. The results showed that volagidemab reduced daily insulin use and decreased HbA1c levels. However, further research is needed to confirm the long-term efficacy and safety of volagidemab.
Article
Endocrinology & Metabolism
Simon Heller, Tadej Battelino, Timothy S. Bailey, Thomas R. Pieber, Ulrike Hoevelmann, Leona Plum-Moerschel, Anita E. Melgaard, Ronnie Aronson, Linda A. DiMeglio, Thue Johansen, Thomas Danne
Summary: This study analyzed the safety and efficacy of dasiglucagon, a glucagon analogue, in treating severe hypoglycemia in patients with type 1 diabetes. The results showed that dasiglucagon had a similar safety profile as reconstituted glucagon and was more effective in glucose recovery compared to placebo.
DIABETES OBESITY & METABOLISM
(2023)
Article
Endocrinology & Metabolism
Jasmin R. Kastner, Timothy S. Bailey, Poul Strange, Leon Shi, Keith A. Oberg, Paul J. Strasma, Jeffrey I. Joseph, Douglas B. Muchmore
Summary: Insulin exposure varies over the course of insulin infusion set (IIS) wear, posing challenges for insulin dosing in people with diabetes. This study extends previous observations by examining 7 days of IIS wear and reports insulin pharmacodynamic and pharmacokinetic data. The results show progressive decreases in insulin t(max), C-max, and mean residence time, as well as a decline in the area under the insulin concentration curve (AUC(0-300)). These findings have implications for individuals with diabetes and the development of closed-loop algorithms, although further research is needed to confirm these findings. The study was registered in clinicaltrials.gov (NCT04398030).
DIABETES TECHNOLOGY & THERAPEUTICS
(2023)
Correction
Biochemistry & Molecular Biology
Jeremy Pettus, Schafer C. Boeder, Mark P. Christiansen, Douglas S. Denham, Timothy S. Bailey, Halis K. Akturk, Leslie J. Klaff, Julio Rosenstock, Mickie H. M. Cheng, Bruce W. Bode, Edgar D. Bautista, Ren Xu, Hai Yan, Dung Thai, Satish K. Garg, Samuel Klein
Article
Endocrinology & Metabolism
Shridhara Alva, Ronald Brazg, Kristin Castorino, Mark Kipnes, David R. Liljenquist, Hanqing Liu
Summary: This study evaluated the performance of the FreeStyle Libre (R) 3 continuous glucose monitoring system (FSL3) and compared it to different reference glucose values. The results showed that the FSL3 demonstrated accurate performance during the 14-day sensor wear period.
Article
Endocrinology & Metabolism
Shridhara Alva, Timothy Bailey, Ronald Brazg, Erwin S. Budiman, Kristin Castorino, Mark P. Christiansen, Gregory Forlenza, Mark Kipnes, David R. Liljenquist, Hanqing Liu
Summary: This study evaluated the analytical performance of the second-generation factory-calibrated FreeStyle Libre 2 system compared to the YSI reference. The results showed that the system performed well in terms of accuracy and bias during the 14-day sensor wear period. It demonstrated excellent performance in the hypoglycemic range.
JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY
(2022)
