FDA Approval of Omnipod 5 Looks More Promising with Impressive Trial Results was reported by Andrew Briskin for diaTribe.org, 4 October 2021.  The recent release of clinical trial results shows that Omnipod 5, an automated insulin delivery (AID) system, can significantly increase Time in Range and reduce stress around managing diabetes.

At the European Association for the Study of Diabetes (EASD) 2021 conference, experts discussed the positive impacts of using Omnipod 5, highlighted by encouraging results from the latest clinical trial data published in Diabetes Care.

Omnipod 5 is a new automated insulin delivery (AID) system that integrates the Omnipod patch pump with the Dexcom G6 continuous glucose monitor. Using the smart algorithm built into the patch pump, these devices are linked and can be controlled directly from the smartphone app, unlike the previous version, which required an external Personal Diabetes Manager (PDM) – a small smartphone-like device that gives you control over the insulin pump pod.

This new device can predict changes in glucose levels and then automatically adjust the users’ insulin doses. The app will only be available for Android users initially, but Insulet is working on an iPhone version – though no timelines have been announced for when this version will be available.

Improvements in A1C, Time in Range, and hypoglycemia reduction were all observed over a 12-month period while using Omnipod 5,” said Dr. Trang Ly, one of the researchers on this study and the senior vice president and medical director at Insulet, which makes the Omnipod.  New data also demonstrates that use of the Omnipod 5 can improve quality of life for people with diabetes.

“We see a significant reduction in diabetes distress [in Omnipod 5 users] in terms of stress overeating, hypoglycemia, general diabetes management, and interacting with a physician,” said Dr. William Polonsky, founder of the Behavioral Diabetes Institute, a nonprofit organization in San Diego, focused on the social, emotional, and psychological barriers in diabetes. “What was particularly impressive was that these people were already starting at a low level of diabetes distress, so the impact that [Omnipod 5] can have on those with higher distress levels can be even more significant.”

Read more:  FDA Approval of Omnipod 5 Looks More Promising

Back-to-Back Recalls for Medtronic Insulin Pumps was written by Kristen Monaco for MedPageToday.com, 6 October 2021.  

The FDA announced that Medtronic expanded two recalls relating to the MiniMed 600 series of insulin pumps and MiniMed 508 remote controllers. Both were designated by the agency as Class I, the most serious type of recall, due to the risk of death or serious injury.

For the 600 series, the recall now includes models 630G and 670G, which contain a clear retainer ring that can become damaged and lead to incorrect dosing — the recall affects 463,464 devices in the U.S. The recall announcement warned patients to immediately stop using the pump, switch to manual injections in the interim, and request a replacement if this clear retainer ring is loose, damaged, or missing, or if the reservoir does not lock into the pump. If the insulin cartridge is not properly locked into place, the pump may deliver more or less insulin than needed, resulting in hyperglycemia or hypoglycemia.  “DO NOT insert the reservoir back into your pump while connected because you could mistakenly give yourself a rapid, and possibly large, insulin bolus,” the statement reads in bold text.

In a separate update, the FDA announced a recall expansion of the MiniMed 508 and Paradigm remote controllers due to cybersecurity risks.  This Class I recall applies to all MiniMed remote controllers — including models MMT-500 and MMT-503 — that are used with a Medtronic MiniMed 508 insulin pump or the MiniMed Paradigm family of pumps.  Initiated back in August 2018, this recall applies to 31,310 devices in the U.S., which were distributed from August 1999 to July 2018.  These devices, which use older technology, could allow unauthorized persons to hack into the device and instruct the pump to either over-deliver or stop insulin delivery.

Read more:  Back-to-Back Recalls for Medtronic Insulin Pumps

MannKind Announces First Patient Enrolled In Inhale-1 Study Of Afrezza® In Pediatric Population was released by MannKind Corporation 4 October 2021.  A multi-center study has been launched to assess the efficacy and safety of Afrezza in patients aged 4-17 living with type 1 or type 2 diabetes.

MannKind Corporation, a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today the enrollment of the first pediatric patient in the INHALE-1 study. The multi-center study will evaluate the efficacy and safety of Afrezza® (Technosphere Insulin) in combination with basal insulin vs. multiple daily injections of insulin in children and adolescents aged 4-17 who are living with type 1 or type 2 diabetes.

“We are pleased to announce enrollment has begun for the INHALE-1 Phase 3 study, which is designed to assess the safety and efficacy of Afrezza in young people living with type 1 or type 2 diabetes,” said Dr. Kevin Kaiserman, Vice President, Medical Affairs and Safety of MannKind Corporation. “MannKind is pleased to sponsor this study with the goal of bringing Afrezza to a younger generation.”

INHALE-1 is a 26-week open-label, randomized clinical trial with a 26-week extension. The primary endpoint is change in HbA1c level after 26 weeks. Secondary endpoints include change in fasting plasma glucose after 26 weeks and rate of hypoglycemic events.

Enrollment is underway at several sites, including AM Diabetes & Endocrinology Center in Bartlett, Tenn., where the first patient was enrolled. In all, approximately 260 patients are planned to be enrolled at more than 30 sites across the United States. Details of the study and sites can be found at: https://clinicaltrials.gov/ct2/show/NCT04974528.

Read more:  MannKind Announces First Patient Enrolled In Inhale-1 Study Of Afrezza® In Pediatric Population

Non-Invasive CGMs are COMING!!!

GraphWear tallies up $20M VC funding for needle-free wearable glucose monitor was published by Andrea Park for FierceBiotech.com, 5 October 2021.  The GraphWear continuous glucose monitor, which can be either worn on the wrist or attached to the torso, is powered by graphene sheets that conduct electricity to attract molecules through the skin and measure the amount of glucose. 

GraphWear, with a nanotechnology-powered sensor that it says can measure glucose with the best of them—without ever breaking the skin. The technology is powered by graphene, a one-atom-thick sheet of carbon atoms that is extremely strong and a powerful conductor of electricity. When activated, the electrical field surrounding GraphWear’s sensor attracts molecules near the surface of the skin, which it can then analyze to measure blood sugar levels.

The readings, which the company says can come from as few as 100 to 200 molecules, are then sent via Bluetooth to a connected app, where users can track their glucose over time and receive real-time alerts if they hit specified levels.  The sensor technically measures the amount of glucose in the interstitial fluid among the wearer’s cells, rather than in the blood itself. Though not interchangeable, studies have found that the two values correlate to one another, according to the American Diabetes Association.  GraphWear’s sensor can be embedded into either a smartwatch-like wearable device strapped to the wrist or an adhesive patch attached to the torso.

Rajatesh Gudibande, co-founder of GraphWear, told TechCrunch that the first feasibility study proved the sensor’s ability to generate glucose readings “comparable” to those of traditional CGMs. Once that ability has been further proven in clinical studies and, eventually, regulatory clearances, he said, the sensor could ultimately be adapted to analyze molecules for more than just glucose levels.

Read more:  GraphWear tallies up $20M VC funding for needle-free wearable glucose monitor


Know Labs unveils pocket-sized glucose monitor that swaps fingersticks for radiofrequency sensors was reported by Andrea Park for FierceBiotech.com, 22 September 2021.  Know Labs’ devices—including the KnowU on-demand glucose monitor and UBand wearable CGM—use radiofrequency sensors and spectroscopy to measure glucose levels in the blood through the skin, without requiring regular fingersticks for calibration.

Know Labs debuted its second device that can measure glucose levels from outside the body, without requiring lancets, test strips, implants or any other additional components besides an accompanying smartphone app.  The KnowU device, small enough to fit easily in the user’s pocket, is designed for on-demand use. It consists of a battery-powered, sensor-equipped monitor to perform the measurements and a base that charges the monitor and displays its calculated readings.  The hand-held device joins the previously unveiled UBand, which is worn around the wrist for continuous glucose monitoring. Both devices connect wirelessly via Bluetooth to the Know Labs smartphone app, which will track and store glucose readings.

Know Labs’ glucose monitors are both powered by its Body-Radio Frequency Identification, or Bio-RFID, technology. The Bio-RFID sensors emit radio waves to measure specific molecular signatures in the blood through the skin, calculated using spectroscopy.

“We know that not all people with diabetes are looking for a wearable continuous glucose monitoring device to manage their diabetes. Some simply want to replace the painful, inconvenient and expensive fingersticks they currently rely on,” said CEO Phil Bosua, who invented the Bio-RFID technology. “The Bio-RFID sensor we currently use for our internal product testing fits in your pocket and is ready for final use, so we decided to create the KnowU as a portable, affordable and convenient alternative requiring no disposable items, such as test strips and lancets.”

Read more:  Know Labs unveils pocket-sized glucose monitor that swaps fingersticks for radiofrequency sensors

Ban on negotiating Medicare drug prices under pressure was written by Ricardo Alonso-Zalfivar for APNews.com, 6 October 2021.  

Negotiating Medicare drug prices is the linchpin of President Joe Biden’s ambitious health care agenda. Not only would consumers see lower costs, but savings would be plowed into other priorities such as dental coverage for retirees and lower premiums for people with plans under the Obama-era health law.  To do that, Congress would have to change an unusual arrangement that’s written into law.

When lawmakers created Medicare’s Part D outpatient prescription drug program in 2003, they barred Medicare from negotiating prices. Republicans who controlled Congress at the time wanted insurers that administer drug plans to do the haggling. Medicare was sidelined, despite decades of experience setting prices for hospitals, doctors and nursing homes.

“I don’t know of any other situation where the government has one hand tied behind its back when dealing with people like big pharma,” said Sen. Ron Wyden, D-Ore., who is leading efforts to draft the Democratic plan in the Senate.

Known as the “noninterference clause,” the ban has been unbendable. That’s the way the pharmaceutical industry wants to keep it.  Former Medicare administrator Andy Slavitt recalls proposing a “modest experiment” on pricing. “You would have thought we had pressed the nuclear button and the country was going to blow up,” he said.

Read more:  Ban on negotiating Medicare drug prices under pressure

Nephrology experts develop roadmap to advance kidney disease research was published by the National Kidney Foundation, 7 October 2021.  

The National Kidney Foundation (NKF) released today a research roadmap that, if funded by Congress, would quickly accelerate innovations in treatment and increase understanding of kidney disease. 

Kidney disease is growing in the United States so much so that now 1 in 3 adults are at risk, yet the pace of funding, research, and innovation in therapies is not sufficient to tackle the illness and lags far behind research for other diseases. In fact, many treatment options for those with the most advanced stage of chronic kidney disease (CKD) haven’t changed in 40 years.

Today’s report maps a strategy to accelerate scientific discovery and address the most vexing challenges in kidney disease, especially the challenges posed by healthcare inequity. The report calls on Congress to fully fund research in preclinical science, genetics, health equity, implementation science, and other priorities.

“We urge Congress and the Administration to significantly increase its investment in CKD research,” said Holly Kramer, MD, MPH, co-author, NKF Board member and immediate past President, and Professor of Public Health Sciences and Medicine, Division of Nephrology and Hypertension Loyola University Chicago. “Investment in research saves lives as demonstrated by the decrease in mortality for heart disease and cancer over the past 20 years due to research. Research can advance knowledge on how and why kidney disease starts and progresses and can identify better treatments. Dialysis should not be the only solution to a disease that affects so many people, especially those from under-represented groups.”

Read more:  Nephrology experts develop roadmap to advance kidney disease research

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