Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES

Diabetes Dialogue: Stelo OTC Availability and Omnipod 5 for Type 2 Diabetes

Diabetes Dialogue: Stelo OTC Availability and Omnipod 5 for T2D

August 26, 2024 will be remembered as the start of a new era in glucose monitoring and management. A day beginning with Dexcom’s announcement of availability and pricing for the first OTC glucose sensor in the Dexcom Stelo and ending with the FDA’s announcement of clearance for the Omnipod 5 Automated Insulin Delivery System (AID) for adults with type 2 diabetes—the first AID to receive FDA clearance for 

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives

, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, provide an overview of important facts surrounding the Dexcom Stelo, including price, personal experience, and outlook on future competitors, as well as a breakdown of the Omnipod 5 clearance and how SECURE-T2D informs use of the AID system in type 2 diabetes.

Dexcom announced the Dexcom Stelo would be available beginning on August 26, 2024 via the 

 website at a price as low as $89.99 for a 2-pack of sensors. Cleared by the FDA on March 05, 2024, the Stelo is indicated for use by anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels.

According to Dexcom, the Stelo will be HSA/FSA eligible, available to pay-as-you-go customers for $99 for a single pack of 2 sensors for a total wear time of up to 30 days, and available to subscribers at a 10% savings by paying $89 per month for an ongoing subscription of the same 2-sensor pack delivered every 30 days.

The Stelo was the first of 3 OTC glucose monitors to receive FDA clearance through August 2024. In June 2024, On June 10, 2024, Abbott announced the FDA clearance of the Lingo and Libre Rio, which are intended for people 18 years and older looking to improve their overall health and those with type 2 diabetes not using insulin, respectively.

For more on the Stelo: check out this interview with Jake Leach, executive vice president and chief operating officer at Dexcom, from March 2024!

Less than 12 hours after Dexcom made their announcement of availability and pricing, the FDA and Insulet announced expanded indications for the company’s SmartAdjust technology, which now means the Omnipod 5 AID system becomes the first FDA-cleared AID system for both type 1 and type 2 diabetes. According to Insulet Corporation, the FDA’s clearance is based, in part, on the results of the SECURE-T2D trial, which the company debuted at the 84th American Diabetes Association Scientific Sessions.

Results of the trial showed that, at 13 weeks, the mean HbA1c among the cohort decreased from 8.2% (SD, 1.3) at baseline to 7.4% (SD, 0.9) (treatment effect= -0.8%; 95% CI, -1.0 to -0.7; 

 <.001). When assessing secondary glycemic metrics, results indicated use was associated with a 20% increase in time in range of 70 to 180 mg/dL (4.8 hours per day) and a 20% decrease in time above 180 mg/dL (4.8 hours per day) (

Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

Dexcom Inc. STELO BY DEXCOM, THE FIRST OVER-THE-COUNTER GLUCOSE BIOSENSOR IN THE U.S., IS NOW AVAILABLE. Dexcom Inc. August 26, 2024. Accessed August 26, 2024.

Campbell P. FDA clears Dexcom Stelo sensor, first OTC glucose sensor in agency history. HCP Live. March 5, 2024. Accessed August 65, 2024. https://www.hcplive.com/view/fda-clears-dexcom-stelo-sensor-first-otc-glucose-sensor-in-agency-history.

Office of the Commissioner. FDA clears first device to enable automated insulin dosing for individuals with type 2 diabetes. U.S. Food and Drug Administration. August 26, 2024. Accessed August 26, 2024. https://www.fda.gov/news-events/press-announcements/fda-clears-first-device-enable-automated-insulin-dosing-individuals-type-2-diabetes.

Insulet Corporation. Omnipod® 5 Automated Insulin Delivery System is now FDA-cleared for People with Type 2 Diabetes. Insulet Corporation. August 26, 2024. Accessed August 26, 2024. https://investors.insulet.com/news/news-details/2024/Omnipod-5-Automated-Insulin-Delivery-System-is-now-FDA-cleared-for-People-with-Type-2-Diabetes/default.aspx.

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In this episode, hosts discuss the implications of Dexcom announcing availability of their Stelo sensor and the FDA clearance of the Omnipod 5 for type 2 diabetes. 

Diabetes Dialogue: ADCES 2024 Part 2

our second related to the Association of Diabetes Care and Education Specialists (ADCES) 2024 annual meeting, spotlights new data and perspectives from the meeting brought forth by pharmaceutical and diabetes technology companies.

Check out our first episode related to ADCES 2024.

A large theme of the episode is discussion around data and interactions with Lexicon, which announced the resubmission of a New Drug Application for sotagliflozin (Zynquista) as an adjunct to insulin therapy for glycemic control among adults with type 1 diabetes and chronic kidney disease. According to the FDA, the agency considers the resubmission a complete response to its 2019 letter regarding sotagliflozin for type 1 diabetes.

For this application, the FDA has assigned a Prescription Drug User Fee Act review date of December 20, 2024. On August 21, 2024, Lexicon Pharmaceuticals announced the FDA’s intention to host an advisory board meeting regarding this application.

Of note, sotagliflozin (Inpefa) has received approval in heart failure for reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors in May 2023.

Following this, the conversation between hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, shifts to a discussion on Medtronic's collaboration with Abbott, with the hosts praising this partnership as a strategic move to improve sensor technology for patients.

The episode then highlights the innovative educational approach to learning about the Sequel Twiist, with Sequel hosting a jeopardy-style game to engage attendees in learning about their upcoming pump product. Finally, the hosts explore the Diabetotech certificate program, which offers in-depth education on various diabetes technologies, and emphasize the importance of continuous learning and unbiased educational resources in the rapidly evolving field of diabetes management.

Lexicon Pharmaceuticals. Lexicon Pharmaceuticals Resubmits Sotagliflozin NDA for Type 1 Diabetes. Lexicon Pharmaceuticals Media Center. June 21, 2024. Accessed August 21, 2024. https://www.lexpharma.com/media-center/news/2024-06-21-lexicon-pharmaceuticals-resubmits-sotagliflozin-nda-for-type-1-diabetes.

Lexicon Pharmaceuticals. Lexicon Pharmaceuticals Announces FDA Advisory Committee Meeting for Zynquista. Lexicon Pharmaceuticals Media Center. August 21, 2024. Accessed August 21, 2024. https://www.lexpharma.com/media-center/news/2024-08-21-lexicon-pharmaceuticals-announces-fda-advisory-committee-meeting-for-zynquista.

Campbell P. FDA approves Sotagliflozin for treatment of heart failure. HCP Live. May 26, 2023. Accessed August 21, 2024. https://www.hcplive.com/view/fda-approves-sotagliflozin-for-treatment-of-heart-failure.

This episode focuses on sotagliflozin in type 1 diabetes and other highlights from the ADCES 2024 annual meeting. 

Diabetes Dialogue: Sotagliflozin for T1D and Other ADCES 2024 Highlights

Diabetes Dialogue: CMS Price List Announcements

On August 15, 2024, the Biden-Harris Administration announced the price list for the first 10 drugs selected as part of the Medicare price negotiations between the United States Department of Health and Human Services (HHS) and pharmaceutical manufacturers.

“Americans pay too much for their prescription drugs. That makes today’s announcement historic. For the first time ever, Medicare negotiated directly with drug companies and the American people are better off for it,” said HHS Secretary Xavier Becerra.

Part of the Inflation Reduction Act, the announcement of intended pricing for these agents comes nearly a year after the Centers for Medicare and Medicaid Services (CMS) announced the list of the first 10 agents included in the negotiations. The list, which consists of the 10 drugs with the highest gross annual spending total, accounts for $50.5 billion in total Part D gross covered prescription costs per year and more than $3.4 billion in out-of-pocket costs

Among the first 10 agents chosen, 4 have specific indications for 

: empagliflozin, sitagliptin, dapagliflozin, and Novo Nordisk-specific insulin aspart products. According to CMS statistics, these 4 agents accounted for more than $16 billion in total Part D spending from June 1, 2022 through May 31, 2023.

CMS Projected Price Changes

These prices will come into effect starting January 1, 2026. As part of the Inflation Reduction Act, CMS will select up to 15 more drugs covered under Part D for negotiation in 2027, up to 15 more drugs in 2028, including drugs covered under Part B and Part D, and up to 20 more drugs for each year after.

A follow-up to their reaction episode earlier this year, this episode of 

 examines the price changes and what this could translate to for those with diabetes or members of the care team. In the episode, hosts discuss how significant reductions in the prices of SGLT2 inhibitors and insulin products will benefit people with diabetes, but point out the absence of long-acting insulin and GLP-1 agonists from the initial list is notable and will require continued negotiations.

Relevant disclosures for Dr. Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Dr. Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

ASPA Press Office. Negotiating for lower drug prices works, saves billions. HHS.gov. August 15, 2024. Accessed August 19, 2024. https://www.hhs.gov/about/news/2024/08/15/historic-first-biden-harris-administration-successfully-negotiates-medicare-drug-prices-delivers-promise-lower-prescription-drug-costs-american-seniors.html.

Fact sheet: Biden-Harris Administration announces new, lower prices for first ten drugs selected for Medicare price negotiation to lower costs for millions of Americans. The White House. August 15, 2024. Accessed August 19, 2024. https://www.whitehouse.gov/briefing-room/statements-releases/2024/08/15/fact-sheet-biden-harris-administration-announces-new-lower-prices-for-first-ten-drugs-selected-for-medicare-price-negotiation-to-lower-costs-for-millions-of-americans/.

In this episode, hosts react to the announced CMS list prices for the first 10 drugs chosen for negotiation as part of the Inflation Reduction Act.

Diabetes Dialogue: First 10 Prices Announced from CMS Price Negotiations

Diabetes Dialogue: Navigating ADCES 2024

The Association of Diabetes Care and Education Specialists (ADCES) is an organization ahead of its time in the world of healthcare. Often, those in medicine find the field to be reactionary instead of proactive in addressing the rising burden of chronic disease. The ADCES, formerly the American Association of Diabetes Educators, was founded in 1973 to support and educate clinicians, care providers, and patients of the latest advancements to improve care and quality of life for people with 

This mission, while important in the 1970s, has become crucial if health systems hope to combat a burgeoning diabetes crisis. In this episode of 

, we celebrate the ADCES 2024 annual meeting through the perspective of hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center. The first of 2 scheduled episodes related to the meeting, this episode focuses on presentations and sessions Isaacs and Bellini were directly involved in from the meeting.

Key topics include the challenges of using insulin pumps for type 2 diabetes, the role of DME companies in accessing CGM for people with Medicare, and the latest research on automated insulin delivery systems during pregnancy. The hosts also discuss interpreting ambulatory glucose profiles and time-in-range targets. Throughout the conversation, Isaacs and Bellini share their enthusiasm for the advancements in diabetes technology and the importance of effective patient education and counseling.

Association of Diabetes Care and Education Specialists. ADCES24. Accessed August 16, 2024. https://www.adcesmeeting.org/.

Hossain MJ, Al-Mamun M, Islam MR. Diabetes mellitus, the fastest growing global public health concern: Early detection should be focused. 

. 2024;7(3):e2004. Published 2024 Mar 22. doi:10.1002/hsr2.2004

The first of 2 episodes on ADCES 2024, this episode focuses on sessions and presentations hosts Isaacs and Bellini participated in during the meeting. 

Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES

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