Insulet drops 10% as CEO indicates launch of Omnipod insulin product likely delayed was reported by Jonathan M. Block for SeekingAlpha.com, 3 December 2021.
Insulet CEO Shacey Petrovic said that the FDA will likely not complete its review of the company’s Omnipod 5 insulin delivery system before the end of the year, delaying launch until Q1 2022. She made the comments at the Nasdaq Investor Conference.
J.P. Morgan analyst Robbie Marcus noted that a timely approach and launch is important and the product is critical for the company’s growth. And Piper Sandler analyst Matthew O’Brien said that the development “likely puts other clearances across med teach (and the diabetes category) at risk of delays.”
He added that the delay could help rival Tandem Diabetes Care.
Abbott sues DexCom over glucose-monitoring patent settlement, license was reported by Blake Brittain for Reuters.com, 2 December 2021.
An Abbott Laboratories subsidiary focused on diabetes care sued rival DexCom in Delaware federal court for allegedly violating a 2014 settlement agreement and asked the court to declare that Abbott doesn’t infringe its patents. The lawsuit filed Wednesday is sealed, and the motion to seal says it relates to Abbott’s Freestyle Libre continuous glucose monitoring system.
Chicago-based Abbott made more than $2.6 billion from worldwide sales of Freestyle Libre products last year, according to a filing with the U.S. Securities and Exchange Commission. DexCom’s flagship G6 system is a rival to the Freestyle Libre. The settlement gave the companies cross-licenses to patents related to glucose monitoring, and included agreements lasting through March 2021 not to sue each other for patent infringement or challenge the patents’ validity.
San Diego-based DexCom sued Abbott in Waco, Texas, in June alleging the Freestyle Libre system infringed its patents. Abbott countered with its own lawsuit against DexCom in Delaware the next day, alleging DexCom’s G6 products infringed its Freestyle Libre patents.
Device recalls jumped 36% in Q3, first quarterly increase since 2020 was reported by Ricky Zipp for MedTechDive.com, 3 December 2021. The primary reason for recalls in the quarter was software issues, which has been the leading cause in 21 of the last 22 quarters, according to Sedgwick’s November U.S. product recall index.
Medical device recalls climbed nearly 36% in the third quarter compared to the previous quarter, marking the first quarter-over-quarter jump in recalls in the past year, according to Sedgwick’s most recent U.S. product recall index. There were 235 medical device recall events last quarter, up from 173 in the second quarter, according to the report, which was released Nov. 19. The rise in recalls is the first quarterly increase since the second quarter of 2020 and signifies “a return to pre-pandemic levels.” The leading reasons for recalls were software issues, mislabeling, parts issues, as well as product quality and safety concerns. According to the report, software issues have been the primary cause of recalls in 21 of the last 22 quarters.
The medical device recall process has been a contentious issue for years, with industry experts claiming that the FDA’s system is outdated, lacks accountability for device manufacturers and leaves patients vulnerable to health risks, including being implanted with devices that have already been recalled.
New study examines differences in children diagnosed with type 1 diabetes was published by Diabetes.co.uk, 17 November 2021. The characteristics of children diagnosed with type 1 diabetes before and after the age of six have been investigated in a new study.
Studies by The Environmental Determinants of Diabetes in the Young (TEDDY) are adding to an increasing body of evidence suggesting that type 1 diabetes is not a single disease. They suggest that autoimmune diabetes varies amongst children who are at high risk due to their genetic makeup.
These studies advance what is known about autoantibodies relating to type 1 diabetes and can aid in foreseeing which genetically high-risk children are most likely to develop type 1 diabetes as they grow. For people with type 1 diabetes, a misdirected immune response attacks and wipes out beta cells in the pancreas that produce insulin. The four autoantibodies that are associated with attacking these beta cells (GADA, IA, IA2-2A, and ZnT8A) are the most reliable in indicating that the person may develop type 1 diabetes. Nevertheless, not all children with any of these indicators are guaranteed to get type 1 diabetes.
A TEDDY study evaluated the features of type 1 diabetes in children who were diagnosed before six-years-old, compared to those diagnosed after six years old. Lead author Dr. Jeffrey Krischer, a Distinguished University Health Professor and co-chair for the National Institutes of Health-funded TEDDY consortium, said: “Our results underscore the importance of taking into account the age at development of multiple autoantibodies when evaluating risk factors for progression to a diabetes diagnosis. When the changing picture of autoantibody presentation is considered, it appears that type 1 diabetes at an early age is a more aggressive form of the disease.”
Poor sleep quality, later bedtime influence glucose level after breakfast was reported by Regina Schaffer for Healio.com/Endocrinology, 1 December 2021.
“While there have been numerous large prospective cohort studies focused on the relationship between self-reported sleep, disease and well-being, objective data on sleep and postprandial glucose metabolism typically comes from small studies conducted in tightly controlled settings and in specific population subgroups, such as those suffering sleep disturbances owing to pregnancy, sleep apnea, depression, obesity or diabetes,” Paul W. Franks, PhD, professor of genetic epidemiology at Lund University Diabetes Centre in Malmö, Sweden, and colleagues said in a press release. “Because of this, there is a need for greater evidence of the effects of sleep on glucose metabolism in healthy individuals.”
For nearly 45 years, doctors have relied on well-known cardiovascular risk factors to determine how patients should be treated to ward off a heart attack or stroke. These factors include high blood pressure, elevated cholesterol, diabetes, a history of smoking, obesity and a family history of premature heart disease. When a patient has either no risk factors or many of them, treatment decisions are usually straightforward. Doctors typically tell patients with no risk factors to keep doing what they’re doing, while those at high or moderately high risk are often advised to start medications along with adopting lifestyle measures, like a heart-healthy diet and regular exercise.
But when patients are in the middle-ground of risk, or are known to be at elevated risk but resist advice to take medication or change their habits, there’s a test that can help to clarify the best course of treatment and help convince reluctant patients to follow it.
The test is a coronary calcium scan, which takes 10 to 15 minutes and usually costs about $100 to $400, though it is often not covered by insurance. The test uses specialized CT X-rays to assess the presence and amount of calcium (actually bony deposits of plaque that signal atherosclerosis, or “hardening of the arteries”) in the blood vessels that feed the heart.
Two diabetes drug classes can increase, maintain beta-cell function was written by Regina Schaffer for Healio.com/endocrinology, 3 December 2021. The thiazolidinedione pioglitazone and GLP-1 receptor agonists are the only two diabetes drugs proved to increase and maintain beta-cell function, and both should be first-line therapies for patients, according to a speaker.
Overt diabetes does not occur in the absence of progressive beta-cell failure, Ralph A. DeFronzo, MD, professor of medicine and chief of the diabetes division at the University of Texas Health Science Center at San Antonio, said during a presentation at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. Several sophisticated methods can measure beta-cell function; however, HbA1c can serve as a relatively simple measure for the clinician to assess for persistently elevated glucose concentrations and ultimately decide whether a person is on the right therapy regimen.
“If the HbA1c is rising, you have the patient on the wrong drug,” DeFronzo said. “Furthermore, it means you have the patient on drugs that are not preserving beta-cell function. There are not many options in terms of choosing drugs that preserve that function.”
Data from the San Antonio metabolism study, published in Diabetologia in 2004, demonstrated a progressive decline in beta-cell function that begins even among patients with seemingly “normal” glucose tolerance, DeFronzo said. When insulin secretion is related to the underlying insulin resistance, beta-cell function in adults with obesity and normal glucose tolerance, impaired glucose tolerance and type 2 diabetes is superimposable on that of lean individuals with the same category of glucose tolerance, he said.
“Clearly, this disease starts much earlier, and we use these arbitrary cut points that are based on glucose or HbA1c, but we have forgotten about pathophysiology,” DeFronzo said. “There are only two drugs that will increase beta-cell function and preserve the increase on a long-term basis,” DeFronzo said. “They are pioglitazone and the GLP-1 receptor agonist.
Wonder if/how this might apply to the development and management of Type 1 diabetes?
Another Diabetes Complication? High Blood Sugar & Tooth Loss was reported by Ross Wollen for DiabetesDaily.com, 26 November 2021.
The study, which was published recently in examined the health records of over 200,000 patients, making it the largest look yet at the topic of diabetes and tooth loss. The research was organized by Sunstar, a Japanese conglomerate that manufactures oral healthcare products (among many other things). The Sunstar press release is the best place to view the data.
Health experts don’t put a ton of emphasis on the oral health of people with diabetes, but it is a real issue. Researchers already knew that people with diabetes are at an increased risk of periodontal (gum) disease and other mouth issues, such as thrush. Issues may be caused both by a higher percentage of sugar in the saliva and by microvascular dysfunction affecting the gums and bones.
Patients with high blood sugars who also smoked had by far the highest likelihood of losing teeth. These patients were over 3.5 times more likely to have fewer than 24 teeth than nonsmoking adults with normal blood sugars.