Savvy Updates, 4/6/20: Insulet Horizon Closed Loop, Living Drug Factories, Inhaled Insulin and Covid-19, Txts and Health, Dry Eye, Handwashing and Men

Insulet’s Omnipod to Join Hybrid Closed Loop Pump Market was reported by Sara Seitz for InsulinNation.com, 31 March 2020. Insulet is joining forces with Dexcom to bring its automated insulin delivery system to Omnipod users in the US

At the time of market release, which is expected in early 2021, the system will work exclusively with the current G6 Dexcom sensor which provides highly accurate glucose readings without the need for fingersticks. But the system will also be fully compatible with Dexcom’s next generations sensor–the G7–which should be released at the end of 2020 with a wider commercial release in early 2021 (see News Release below, date will probably be in 2022).

The Omnipod system will also include a number of advanced and unique features that we haven’t seen in current products on the market, including:

- Customizable blood sugar targets.
- Full control over the system through an optional smartphone app.
- Direct communication between the sensor and pod that does not require a control device or smartphone to be within range for automated insulin delivery.

And of course, this will be the first AID system available on a tubeless pump device.

The system will include a number of features that we have come to expect from newer AID systems, including:

- Automated basal rate adjustment using micro boluses to increase time in range.
- Automatic corrections to avoid hyperglycemia and for missed mealtime boluses.
- Adjustable settings for times of increased activity or when hypoglycemia or hyperglycemia is more likely.

NEW RELEASE, 3/2/2020: ACTON, Mass. (BUSINESS WIRE): Insulet Corporation today announced that it plans to pause the pivotal study of the Omnipod Horizon™ Automated Glucose Control System to correct a software anomaly. The identified anomaly could result in the system using an incorrect glucose value which has the potential to impact insulin delivery. The issue is rare, but because of the potential to affect insulin delivery, the Company will pause the study until the anomaly is corrected. No adverse events have been reported due to this issue.

“Living drug factories” might treat diabetes and other diseases, was written by Anne Trafton for MIT News Office, 30 March 2020. Chemical engineers have developed a way to protect transplanted drug-producing cells from immune system rejection.

MIT researchers have now devised a way to encapsulate therapeutic cells in a flexible protective device that prevents immune rejection while still allowing oxygen and other critical nutrients to reach the cells. Such cells could pump out insulin or other proteins whenever they are needed. Suman Bose, a research scientist at the Koch Institute, is the lead author of the paper, which appears today in Nature Biomedical Engineering.

To protect the transplanted cells from the immune system, the researchers housed them inside a device built out of a silicon-based elastomer (polydimethylsiloxane) and a special porous membrane. “It’s almost the same stiffness as tissue, and you make it thin enough so that it can wrap around organs,” Bose says. They then coated the outer surface of the device with a small-molecule drug called THPT.

The device contains a porous membrane that allows the transplanted cells obtain nutrients and oxygen from the bloodstream. These pores must be large enough to allow nutrients and insulin to pass through, but small enough so that immune cells such as T cells can’t get in and attack the transplanted cells.

This type of “living drug factory” could be useful for treating any kind of chronic disease that requires frequent doses of a protein or hormone, the researchers say. They are currently focusing on diabetes and are working on ways to extend the lifetime of transplanted islet cells.

Is Inhaled Insulin Safe During the COVID-19 Outbreak? was published by Amy Tenderich for DiabetesMine.com, 27 March 2020.

The short answer is that there’s no reason not to use inhalable insulin unless you are ill to the point of experiencing “acute respiratory distress” that requires hospitalization.

Mike Castagna, CEO of MannKind, said about the interplay of colds and flu with using the Afrezza inhaler, “We don’t have any evidence that there’s an issue with absorption, and there’s no evidence that it exacerbates respiratory issues. The powder is not sitting in the lungs, but rather goes through the

John Patton (one of the nation’s premier experts in inhalable medication science, is a veteran of the team that developed the world’s first inhalable insulin, Exubera, from Pfizer. He is a co-founder and now board member of Aerami, a start-up developing a new formulation of inhaled insulin) tells DiabetesMine. “Pfizer actually ran trials where they gave people rhinovirus to do testing. We did not find that episodic lung diseases or infections were cause for concern.”

The people who appear to be at “enormous risk” of developing worst-case-scenario COVID-19 are smokers, whose lungs are filled with high loads of tar, Patton says. Vaping is also suspected to make COVID-19 cases worse, although there is no solid data on this yet.

DiabetesMine also connected with North Carolina-based Aerami Therapuetics (formerly Dance Pharmaceuticals), which is working on a next-generation inhalable insulin product. Theirs is a fine mist aerosol formulation instead of a powder, delivered by their new inhaler device called AFINA. It will have built-in Bluetooth capability to track data and integrate with apps and platforms. The company has completed seven early stage trials to date, and is now looking for a partner for their phase 3 study design with the Food and Drug Administration.

Aerami COO Timm Crowder says: “We’re seeing acute respiratory issues now with this virus which are pretty unique. It’s probably not something people have put a lot of thought into. Is this the new normal…?” But he says their inhalable drug formulation should be perfectly safe and effective for those with “normal” cold and flu symptoms — perhaps even more so than Afrezza. “Ours is a soft liquid, that’s shown no cough, and been very gentle on the lungs in trials. Our high peripheral deposition (HPD) insulin droplets go into the deepest part of the lungs. Even with congestion, you’re not typically going to see mucus in that part of the lung,” Crowder explains.

Daily text messages could help improve diet, lifestyle for patients with CKD was reported on Healio.com/Nephrology, 30 March 2020.

A healthy diet and lifestyle intervention utilizing daily text messages may help improve the behaviors of patients with chronic kidney disease, according to results of a pilot intervention that were presented at the virtual National Kidney Foundation Spring Clinical Meetings.

“We know that our lifestyle and dietary choices have a big impact on our health,” Mustafa Kagalwalla, MD, of the University of Illinois at Chicago, told Healio Nephrology. “Also, we have widespread availability of cellphones now. We wanted to see if we could use this technology to improve the health of patients with chronic kidney disease.”

Patients who received the messages reported reading more than 90% of the texts, 100% found the texts useful and easy to understand, 95% reported that the texts motivated them to change their lifestyle, 90% reported their diet became healthier and 74% reported increased exercise.

Eyelid selfies can warn of elevated glucose levels with dry eye was reported by Healio.com/EndocrinologyToday, 31 March 2020.

With the use of infrared images of the inside of the lower eyelids, researchers determined that higher glucose levels are associated with loss of meibomian glands that are crucial for tear film production, according to study results accepted for presentation at the Endocrine Society Annual Meeting and delivered in a virtual press conference.

The meibomian glands, which appear as vertical striations lining the inside of the eyelid, produce the lipid layer of tear film. This layer, together with a middle aqueous layer produced by the lacrimal gland and a glycoprotein inner layer made by the cornea, is required for the tear film to keep the eye lubricated, according to presenter Gloria Wu, MD, a clinical faculty member in the ophthalmology department at the University of California, San Francisco.

“Seven percent [of people] in the United States have dry eye, 16.8 million people, and 57% of type 1 diabetics and 70% of type of 2 diabetic patients have dry eye and complain of dry eye.” Loss of meibomian glands was greater among the diabetes group, which had a mean of 51.54% of the glands missing, compared with 11.29% among controls (P < .0001). Higher HbA1c was associated with greater meibomian gland loss.

Men wash their hands much less often than women and that matters more than ever was reported by Katie Hunt for CNN.com, 1 April 2020.

Handwashing with soap and warm water for 20 seconds — along with staying home and standing six feet apart from others — is the best weapon we have against the novel coronavirus that has infected almost 800,000 people around the world.

However, there’s one big yet little discussed difference when it comes to this essential personal hygiene habit: Women are hands down better handwashers than men.

Years of surveys, observations and research have found that women are more likely to wash their hands, use soap and scrub for a longer period of time than men after using the restroom. However, there’s still a surprisingly large portion of both sexes who don’t wash their hands at all.

Some 15% of men didn’t wash their hands at all, compared with 7% of women. When they did wash their hands, only 50% of men used soap, compared with 78% of women. Overall, only 5% of people who used the bathroom washed their hands long enough to kill the germs that can cause infections.

There’s been far less research done on why there is such a gap between the sexes when it comes to hand-washing. Susan Michie, health psychology professor and director of the Centre for Behaviour Change at the Department of Clinical, Educational and Health Psychology at University College London. Michie, said it was likely socially programmed behavior, not genetic.”Women are more focused on care than men — childcare, household care, personal care,” she said.

An unidentified Red Cross nurse teaches a class on home hygiene and care for the sick to a group of women of various ages, 1920. (Photo by Library of Congress/Interim Archives/Getty Images)

Similarly, Carl Borchgrevink, director of the School of Hospitality at Michigan State University in East Lansing, said that while his study didn’t look at why men didn’t wash their hands as much as women, he suggested that it could be down to a sense that men were too macho to fear germs.

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