Natalie Bellini, DNP, FNP-BC, BC-ADM, CDCE

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, discuss a pair of topics making headlines in recent weeks: the US Food and Drug Administration’s 510(k) clearance for the Accu-Chek Solo micropump system and Abbott’s acquisition of Bigfoot Biomedical.

Announced by Roche on August 23, 2023, the FDA’s 510(k) clearance for the Accu-Chek Solo micro pump system indicates the device for use in people with aged 2 years and older with 

. Worn as a patch directly on the body and controlled wirelessly from a touchscreen handheld device, the system consists of a disposable adhesive pump holder, an infusion cannula, a reservoir, a reusable pump base, and a reusable handheld diabetes manager equipped with an integrated Accu-Chek guide glucose meter and bolus calculator.

“We are pleased to see our latest innovative pump system cleared by the FDA”, said Marcel Gmünder, global head of Roche Diabetes Care.

 “We are proud of our teams who have been steadfast in their activities to accomplish this important achievement for our Accu-Chek Solo system and appreciate the close collaboration with the authority.”

On September 5, 2023, Abbott and Bigfoot Biomedical announced a definitive agreement for Abbott to acquire Bigfoot, with the deal expected to close in the third quarter of 2023 and no financial terms disclosed at the time of announcement. Developers of Bigfoot Unity, a system designed to work exclusively with Abbott’s FreeStyle Libre technology, Abbott and Bigfoot have worked together on connected diabetes solutions dating back to 2017.

"The acquisition of Bigfoot Biomedical will combine two leaders in different aspects of diabetes care: continuous glucose monitoring and insulin dosing support," said Jared Watkin, senior vice president of Abbott's Diabetes Care business.

 "Bringing our companies together will allow us to further develop connected solutions for making diabetes management even more personal and precise."

Roche Diabetes Care. The Accu-Chek Solo micropump system received 510(k) clearance. Roche Diabetes Care. August 23, 2023. Accessed September 19, 2023. https://www.rochediabetes.com/media/blogs/accu-chek-solo-micropump-system-received-510k-clearance.

Association of Diabetes Care and Education Specialists. Accu-Chek Solo micropump system received FDA approval. ADCES. August 31, 2023. Accessed September 19, 2023. https://www.diabeteseducator.org/danatech/latest-news/danatech-latest-news/2023/08/31/accu-chek-solo-micropump-system-received-fda-approval.

Abbott. Abbott to Acquire Bigfoot Biomedical, Furthering Efforts to Develop Personalized, Connected Solutions for People with Diabetes. Abbott Media Room. September 5, 2023. Accessed September 19, 2023. https://abbott.mediaroom.com/2023-09-05-Abbott-to-Acquire-Bigfoot-Biomedical,-Furthering-Efforts-to-Develop-Personalized,-Connected-Solutions-for-People-with-Diabetes.

Articles

Diana Isaacs, PharmD, and Natalie Bellini, DNP, provide a breakdown of the latest news in diabetes management, including FDA clearance of a new insulin pump and a major acquisition within the diabetes world. 

Diabetes Dialogue: Accu-Chek Solo and Abbott Acquiring Bigfoot Biomedical

On September 6, 2023, a report published in the New England Journal of Medicine detailed the effects of semaglutide use in patients with newly diagnosed 

, indicating use could eliminate the need for insulin.

A 10-person case series from the State University of New York at Buffalo, the report provided an overview of the effects of semaglutide use in people with newly diagnosed type 1 diabetes, with results suggesting use was associated with a complete elimination of the need for mealtime insulin doses among the entire study cohort, allowed 70% to eliminate basal insulin use within 6 months, and decreased the mean HbA1c from 11.7% at baseline to 5.9% at 6 months and 5.7% at 12 months.

For many, the news comes as a pleasant surprise. However, for some in endocrinology, the news was not much of a surprise at all as many have off-label and this report been not the first research endeavor from Dandona examining use of a GLP-1 receptor agonist in type 1 diabetes. In 2011, Dandona helped lead a study examining use of liraglutide in people with type 1 diabetes. Among the authors of the study examining use of liraglutide in 2011 is Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center.

, Bellini leverages this unique perspective in a discussion around the latest data on semaglutide in newly diagnosed type 1 diabetes in a conversation with cohost 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.

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.

Campbell P. Semaglutide could eliminate need for insulin in type 1 diabetes. HCP Live. September 6, 2023. Accessed September 7, 2023. https://www.hcplive.com/view/semaglutide-could-eliminate-need-for-insulin-in-type-1-diabetes.

Varanasi A, Bellini N, Rawal D, et al. Liraglutide as additional treatment for type 1 diabetes. 

. 2011;165(1):77-84. doi:10.1530/EJE-11-0330

In this episode, hosts sit down for a discussion around a recent NEJM report assessing the effects of semaglutide use in people with type 1 diabetes, including the implications of the findings and their real-world experiences with GLP-1 use in people with type 1 diabetes.

Diabetes Dialogue: Making Sense of Semaglutide in Type 1 Diabetes

During 2023, few fields can lay claim to the same amount of advancement in technology as 

The celebration of new technologies in diabetes continued during Summer 2023, with US FDA’s clearance of the Mobi insulin pump from Tandem Diabetes Care in mid-July and a pair of clearances for the BlueStar diabetes platform from Welldoc in August.

on July 11, 2023, Tandem Diabetes Care announced the FDA clearance of the Tandem Mobi insulin pump for use in people aged 6 years and older with diabetes. billed as the world’s smallest durable automated insulin delivery device, with the device less than half the size of the t:slim X2 pump and able to fit in a coin pocket, be clipped to clothing, or worn on-body with an adhesive sleeve.

Fully controllable from a mobile app or an on-pump button and featuring a 200-unit insulin cartridge, the pump is designed for use as part of an AID system and comes with Control-IQ technology.

The first clearance in August 2023 for BlueStar was announced by Welldoc on August 15, 2023. The 510(k) clearance from the FDA, which marked the 10th such clearance from the FDA for Welldoc, enables the BlueStar platform to use connected insulin dosing data in personalized bolus insulin dosing recommendations. According to Welldoc, this function will be made commercially available in 2024.

Just more than a week later on August 23, 2023, Welldoc announced it had received its 11th 510(k) clearance from the FDA—again, for the BlueStar diabetes platform. Building on the aforementioned August 15, 2023, clearance, the latest clearance allows BlueStar to provide bolus insulin dose recommendations based on the most recent glucose reading and rate of change from a compatible continuous glucose monitoring device.

 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, discuss their experience with the Tandem Mobi pump from the ADCES 2023 meeting and offer perspective on what the Welldoc clearances mean for people with diabetes and care providers.

Campbell P. Tandem Mobi Insulin Pump, billed as World’s smallest insulin pump, receives FDA clearance. HCP Live. July 12, 2023. Accessed September 2, 2023. https://www.hcplive.com/view/tandem-mobi-insulin-pump-billed-as-world-s-smallest-insulin-pump-receives-fda-clearance.

Welldoc. Welldoc receives 10th 510(k) clearance from FDA for award-winning diabetes Platform Bluestar® - Welldoc: Chronic care platform. Welldoc. August 15, 2023. Accessed September 2, 2023. https://www.welldoc.com/news/welldoc-10th-510k-clearance-fda-diabetes-platform/.

Welldoc. Welldoc receives 11th 510(k) clearance from FDA for award-winning diabetes Platform Bluestar® - Welldoc: Chronic care platform. Welldoc. August 23, 2023. Accessed September 2, 2023. https://www.welldoc.com/news/welldoc-11th-510k-clearance-fda-diabetes-platform/.

In this episode, hosts discuss their experience interacting with the Tandem Mobi pump from the ADCES 2023 meeting and offer perspective on what the Welldoc clearances mean for people with diabetes and care providers.

Diabetes Dialogue: Tandem Mobi and Welldoc's BlueStar Platform

Earlier this month, the Association of Diabetes Care and Education Specialists (ADCES) celebrated the organization’s 50th anniversary through their 2023 annual meeting (ADCES 23).

Hosted in-person from August 3-7, 2023, in Houston, TX and on-demand from August 21-October 30, 2023, the meeting featured nearly 200 unique presentations and hundreds of leading experts from across the continuum of the 

. Among these experts was Etty Vider, PharmD, of ambulatory care clinical pharmacist at Zing Health, which is a physician-founded and led provider of Medicare Advantage health plans

During her time at ADCES 2023, Vider led a presentation titled “Address Health Disparities with a CGM Remote Patient Monitoring Program”. During this session, Vider reviewed barriers to technology utilization in underserved populations as well as practical strategies to overcome these barriers and increase technology use. Vider also described the implementation of a continuous glucose monitor remote patient monitoring program for participants enrolled in a Medicare Advantage Plan led by clinical pharmacists and how this program addressed health disparities.

As part of our celebration of the 50th anniversary of the ADCES and ADCES 23, 

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, have recorded multiple special edition episodes with guests and presenters from the meeting, including Vider.


During this episode, hosts Isaacs and Bellini are joined by Vider for a nuanced discussion surrounding leveraging diabetes technology to improve care for people with diabetes. In their conversation with Vider, Isaacs and Bellini explore strategies for improving utilization of diabetes technology, the role of primary care in adoption of these technologies, and outcomes from the aforementioned pharmacist-led program.

During this episode, hosts are joined by Etty Vider, PharmD, for a nuanced discussion surrounding leveraging diabetes technology to improve care for people with diabetes, including exploring strategies for improving the utilization of diabetes technology, the role of primary care in adoption of these technologies, and how improved uptake correlates to improved outcomes.