Will ViaCyte’s Encaptra Cell Delivery System ‘Cure’ Type 1 Diabetes? was reported by Ginger Vieira for InsulinNation.com, 10 March 2020. ViaCyte transplants pancreatic beta-cell ‘precursors’ that mature in place as needed into islets.
ViaCyte — based in San Diego, CA — has developed a device that is implanted in a person with Type 1 Diabetes. There are actually two devices — PEC-Encap and PEC-Direct — that work very similarly. Both contain pancreatic beta-cell ‘precursors.’ Beta-cell precursor cells are basically like the newborn baby of a fully functioning beta-cell. These young beta-cells develop into mature islet cells that are able to produce insulin, amylin, and other endocrine hormones.
PEC-Encap is a device that is completely encapsulated which means it doesn’t require suppressing your immune system. Instead, it contains beta-cell precursors that are fully protected from being attacked and destroyed. The device is implanted within the subcutaneous layer of your skin. Over the course of several months, the surface of the device becomes gradually ‘vascularized’. This vascularization triggers beta-cell precursor cells to mature into insulin-producing cells. So, even though your immune system cannot breach the device and destroy the cells, your blood glucose can flow through it and insulin and amylin can be returned to the rest of your body.
Phase II is Still Recruiting: Begun in July 2017 with an estimated end in September 2020 ViaCyte’s Phase II trial is still recruiting additional patients for this research. This is an exciting phase where the technology is demonstrated on humans instead of rodents. Participants must meet all of these details in order to qualify:
- Men and non-pregnant women of non-childbearing potential
- Diagnosis of T1DM for a minimum of five (5) years
- At least one (1) severe hypoglycemic event in the previous 12 months
- Hypoglycemia unawareness or significant glycemic lability
- Stable diabetic treatment
- Willingness to use a continuous glucose meter
- Acceptable candidate for implantation
Patients with any of the following issues cannot participate in the study (however, that doesn’t mean they wouldn’t be able to receive the technology once it’s FDA-approved!):
- History of islet cell, kidney, and/or pancreas transplant
- Six (6) or more severe, unexplained hypoglycemic events within six (6) months of enrollment
- Uncontrolled or untreated thyroid disease or adrenal insufficiency
- Diabetic complications such as severe kidney disease or renal dysfunction, proliferative retinopathy, diabetic foot ulcers, amputations attributable to diabetes, and/or severe peripheral neuropathy
- Non-compliance with the patient’s current anti-diabetic regimen
Read more: ViaCyte’s Encaptra Cell Delivery System
Lilly to Participate in New Model Designed to Make Insulins More Affordable for Seniors in Medicare Part D was reported by SeekingAlpha.com, 11 March 2020.
Eli Lilly and Company is proud to announce its planned participation in the new Part D Senior Savings Model, announced today by the Centers for Medicare & Medicaid Services (CMS), that aims to improve the affordability of insulin for seniors in Medicare Part D. The Model will go into effect January 1, 2021, through the CMS Innovation Center, and Lilly will participate by offering to include all formulations of Lilly’s insulins.
The Part D Senior Savings Model is an especially important addition to the cost-saving options Lilly currently offers. Of the small percentage of people who pay more than $100 per prescription for a Lilly insulin, the majority are in Medicare Part D plans, and current law prohibits manufacturers from providing co-pay assistance to those patients. However, through this new Model, seniors in participating Medicare Part D insurance plans will see out-of-pocket costs for covered Lilly insulins reduced to no more than $35 per 30-day supply during their deductible phase, during initial coverage and while in the coverage gap. Seniors who take insulin and enroll in a plan participating in the Model are expected to save an average of $446 in annual out-of-pocket costs for insulin, with only slightly higher premiums. This means that the insurance plan chosen by seniors will become even more important during open enrollment for 2021, as it will dictate the out-of-pocket costs a person taking insulin may face.
Arden’s Day and The Juicebox Podcast presented “Fox in the Loop House” with Kenny Fox, March 9 and 12, 2020. Kenny Fox is the dad of a 6 year-old T1 who has been “looping” since shortly after her diagnosis just over a year ago. Kenny has been somewhat of a local celebrity in the T1 DIY Looping community, often just reaching out and helping others achieve better results with their closed loop systems. He’s a great and fun guy … certainly worth listening , since closed loop systems will be mainstream within the next 1-2 years. Enjoy!
Endo 2020, the annual meeting of the Endocrine Society, scheduled to be held in San Francisco, CA, March 28-31, 2020, has been cancelled, due to concerns regarding coronovirus.
All ancillary events, including independent certified sessions and non-certified prime-time exhibitor events, run by the Endocrine Society, exhibitors, nonprofits, universities, and others are canceled in San Francisco.
Meetings the size of ENDO 2020 are planned years in advance, with hundreds of faculty members involved in planning sessions and science, as well as careful coordination with cities large enough to accommodate thousands of people at once. As such, rescheduling is not an option.
However, while we might not be able to meet live and in person, we are committed to bringing the education and science directly to our members. Look for more details soon on our virtual plans for delivering elements of the ENDO 2020 program.