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

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

Diabetes Dialogue: Bionic Pancreas Brings AID to Primary Care & Telehealth

New research underlines the feasibility of telehealth- and primary care-led initiation of automated insulin delivery (AID) among patients with 

A multisite, random-order crossover trial of 40 adults with type 1 diabetes, study results suggest 97% of participants achieved a mean glucose less than 8% (183 mg/dL) and 64% achieved a mean glucose less than 7% (154 mg/dL) when using the iLet Bionic Pancreas.

“These findings suggest that this device, with its uniquely simplified initialization and use, may expand access to AID technology to more patients who otherwise may be limited by geography and/or access limitations to subspecialty care," wrote investigators. 

A clinical trial led by Sean Oser, MD, MPH, and Tamara Oser, MD,  and conducted between March 2022 and May 2023, the study was designed to evaluate the use of the iLet Bionic Pancreas for insulin delivery in individuals with type 1 diabetes across primary care and endocrinology settings, including both in-person and telehealth subgroups.

Per trial protocol, participants completed 2, 14-day study arms in randomized order. One study arm involved use of the iLet Bionic Pancreas and the other required patients to their usual care insulin regimen, which was defined as multiple daily injections with or without continuous glucose monitoring for primary care and automated insulin delivery or insulin pump with or without continuous glucose monitoring for endocrinology.

The primary outcome was the percentage of participants achieving a mean glucose level of less than 183 mg/dL, which is representative of a glucose management indicator of less than 8.0%. The trial’s key secondary outcome included achievement of a mean glucose level of less than 154 mg/dL, which is representative of a glucose management indicator of less than 7.0%).

The 40-patient study cohort had a mean age of 44.8 (SD, 14.0) years, 43% were female, and 85% were White). At baseline, the primary care group had a mean a HbA1c of 6.9% (SD, 0.8%) and the endocrinology group had a mean HbA1c of 7.2% (SD, 0.8%). Of note, a single patient was lost to follow-up as the result of a seizure unrelated to study procedures during the usual care portion and never participated in the intervention arm.

Results of the study suggested 97% of participants achieved a mean glucose level less than 183 mg/dL and 64% reached less than 154 mg/dL. Further analysis of study data revealed no differences in glucose levels among those attending primary care and endocrinology nor were any differences observed between initiation with telehealth and in-person settings (

Additionally, investigators pointed out the iLet Bionic Pancreas demonstrated consistent performance across mean glucose levels, time in range, time above 180 mg/dL, time above 250 mg/dL, time below 54 mg/dL, and glucose variability.

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, take a deep dive into this study and discuss the role of primary care in diabetes technology uptake in type 1 diabetes.

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.

Oser SM, Putman MS, Russell SJ, et al. Assessing the iLet Bionic Pancreas Deployed in Primary Care and via Telehealth: A Randomized Clinical Trial. 

. Published online February 24, 2025. doi:10.2337/cd24-0104

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In this episode, hosts discuss a study assessing the benefit and feasibility of AID for type 1 diabetes with the iLet Bionic Pancreas in different settings.

Diabetes Dialogue: Understanding Control-IQ+ AID Algorithm with Laurel Messer, PhD, RN | Image Credit: HCPLive

In this episode of Diabetes Dialogue, 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 speak with Laurel Messer, PhD, RN, senior director of medical affairs at Tandem Diabetes Care, about the latest advancements in Control-IQ+, the company’s next-generation automated insulin delivery (AID) technology.

With clearance received from the US Food and Drug Administration (FDA) in February 2025, Tandem announced on March 18, 2025, that the Control-IQ+ hybrid closed-loop algorithm is now available for use in adults with type 2 diabetes (T2D) aged ≥18 years alongside people with type 1 diabetes (T1D) aged ≥2 years.

“These new features allow for even greater levels of personalization and flexibility within our algorithm, while still receiving high marks for ease of use across a diverse population of users,” said John Sheridan, president and chief executive officer of Tandem Diabetes.

 “We are proud to offer this life-changing technology to millions more people living with diabetes.”

Enhancements to the algorithm included a broader weight range (20–440 lbs) and insulin dosing parameters (5–200 units), representing a more inclusive algorithm. In this episode, Messer highlighted other new features in the updated algorithm, such as temp basal rate adjustments for exercise or illness and an extended bolus option of up to eight hours, which enhances flexibility in insulin management during meals. 

“In addition to optimizing the algorithm for expanded access, these new features, including temp basal rates and extended bolus, we hear over and over that these were important to users, so we want to make sure we meet the needs as people are telling them to us,” Messer said.

Messer also emphasized that Control-IQ+ offers a unique advantage: the ability to fine-tune correction factors, allowing providers to tailor insulin delivery for improved glycemic control. With the AutoBolus feature, Control-IQ+ predicts and corrects hyperglycemia every hour, significantly benefiting individuals who struggle with consistent mealtime bolusing.

The conversation also shifted to practical aspects of access, with current Tandem pump users eligible for a software update to enable the new features. Additionally, new functionalities such as Spanish-language support and an automatic profile-setting calculator aim to improve usability and provider confidence in initiating insulin pump therapy.

Messer highlighted clinical data supporting Control-IQ+ from a randomized trial of 102 children aged 2 to 6, demonstrating a 12.4% increase in time in range (TIR), without an increase in hypoglycemia. Parents reported substantial improvements in children’s outcomes, including quality of life and sleep, and confidence in managing their child's diabetes.

Overall, Messer emphasized how Control-IQ+ represents an essential evolution in AID, offering greater personalization, expanded access, and improved quality of life for both T1D and T2D populations.

“I would say we are the best algorithm out there, but because it’s been out for 4 years, it’s time for a refresh. I’m really about passionate about being able to have labeling that expands who can use Control-IQ, as a nurse and scientist, and as someone who wants to make lives better for people living with diabetes,” Messer added.

Important Safety Information: RX ONLY. Indicated for patients with type 1 diabetes, 2 years and older and for patients with type 2 diabetes, 18 years and older. BOXED WARNING: Control-IQ+ technology should not be used in anyone under the age of 2 years old with type 1 diabetes or under the age of 18 years old with type 2 diabetes. It should also not be used in patients who require less than a total daily insulin dose of 5 units of insulin per day or who weigh less than 20 pounds, as those are the required minimum values needed for Control-IQ+ to operate safely. Safety info: tandemdiabetes.com/safetyinfo.

Tandem Diabetes Care announces FDA clearance of Control-IQ+ automated insulin delivery technology for people with type 2 diabetes. Tandem Diabetes Care. February 25, 2025. Accessed March 19, 2025. 

https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-fda-clearance-control-iq?_gl=1%2A74fjn4%2A_gcl_au%2AMTA5MTAyNTMwNS4xNzQyMzAzNDM3

Tandem Diabetes Care launches new control-IQ+ automated insulin delivery technology in the United States. Tandem Diabetes Care. March 18, 2025. Accessed March 18, 2025. 

https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-launches-new-control-iq-automated-insulin?_gl=1%2A6x86ih%2A_gcl_au%2AMTA5MTAyNTMwNS4xNzQyMzAzNDM3

In this episode, hosts discuss the launch of the Control-IQ+ AID algorithm with Laurel Messer, PhD, RN of Tandem Diabetes Care.

Diabetes Dialogue: Understanding Control-IQ+ AID Algorithm with Laurel Messer, PhD, RN

Diabetes Dialogue: Impact of NovoCare Pharmacy, LillyDirect Self Pay on GLP-1 RA Access

In the post-shortage era of GLP-1 receptor agonists (GLP-1 RAs), companies involved in the competitive landscape find themselves digging in for an extended battle—either with each other or against recent regulation changes.

While compounding pharmacies are fighting for their right to continue producing compounded versions of semaglutide, tirzepatide, and other GLP-1 RAs, the rightful developers of these agents, Novo Nordisk and Eli Lilly and Company, find themselves engaging in a price war with one another.

In 2024, Eli Lilly and Company launched LillyDirect Self Pay Pharmacy Solutions to improve access by allowing patients to access savings outside of insurance. In late February 2025, the launch of a new Zepbound Self Pay Journey Program was announced, which includes 7.5 mg and 10 mg single-dose vials for $499 as well as reduced pricing for the 2.5 mg and 5 mg doses.

"Every major medical organization and establishment recognizes obesity as a chronic disease, yet insurance and federal programs do not systematically cover people living with obesity for medical care — this needs to change," said Patrik Jonsson, executive vice president and president of Lilly Cardiometabolic Health and Lilly USA.

On March 05, 2025, Novo Nordisk announced the launch of the NovoCare Pharmacy, a direct-to-patient delivery option that offers cash-paying patients all dose strengths of Wegovy at a reduced cost of $499 per month. According to the release from Novo Nordisk, the company plans to update the overall savings offer for semaglutide so that cash-paying patients who use traditional retail pharmacies will also benefit from this lower price.

"With NovoCarePharmacy, patients and prescribers alike have another option that provides convenient access to all doses of real, FDA-approved Wegovy

 at a reduced cost in our high-quality pen,” said Dave Moore, executive vice president of US Operations and Global Business Development and president of Novo Nordisk.

, 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, breakdown what the latest developments in the GLP-1 RA affordability and accessibility battles mean for providers and patients.

Eli Lilly and Company. Lilly launches additional Zepbound vial doses and offers new savings for self-pay patients. Eli Lilly and Company. February 25, 2025. Accessed March 16, 2025. 

https://investor.lilly.com/news-releases/news-release-details/lilly-launches-additional-zepbound-vial-doses-and-offers-new

Novo Nordisk. Novo Nordisk introduces NovoCare® Pharmacy, lowering cost of all doses of FDA-approved Wegovy® (semaglutide) to $499 per month and offering easy home delivery for cash-paying patients. Novo Nordisk. March 5, 2025. Accessed March 16, 2025. 

https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915288

In this episode, hosts discuss the impact of recently launched direct, cash pay options for people using semaglutide and tirzepatide.

Diabetes Dialogue: News and Updates in Diabetes Care from February 2025

, 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 the changing landscape of GLP-1 receptor agonist-based therapies in light of Eli Lilly and Company’s announcement of new tirzepatide (Zepbound) single-dose vials and reduced pricing as well as the FDA 

decision to remove semaglutide from the drug shortage list

. Later in the episode, hosts focus on updates in diabetes technology from the month of February, with a particular focus on the FDA’s historic clearance of the Tandem Control-IQ automated insulin delivery (AID) for 

On February 25, 2025, Eli Lilly and Company announced the launch of 7.5 mg and 10 mg tirzepatide (Zepbound) single-dose vials, available for $499 with the new Zepbound Self Pay Journey Program as well as a price reduction for their 2.5 mg and 5 mg vials through LillyDirect Self Pay Pharmacy Solutions. While hosts express excitement over this and the removal of semaglutide (Ozempic, Wegovy) from the drug shortage list, they express concern over the impact discontinued access through compounding pharmacies may have on both access and patient health.

On February 25, 2025, Tandem announced its Control-IQ+ technology (Control-IQ+) was cleared by the FDA for people with type 2 diabetes ages 18 and older. Already cleared for use by people with type 1 diabetes, the latest clearance is based on a trial of more than 300 people with type 2 diabetes, which Tandem bills as the first large-scale, randomized, controlled study of an automated insulin delivery system completed in this patient population.

Eli Lilly and Company. Lilly launches additional Zepbound vial doses and offers new savings for self-pay patients. Eli Lilly and Company. February 25, 2025. Accessed March 2, 2025. 

Novo Nordisk. FDA declares Wegovy® and Ozempic® shortage is over and that Novo Nordisk is fully meeting or exceeding nationwide demand for all doses. PR Newswire: press release distribution, targeting, monitoring and marketing. February 21, 2025. Accessed March 2, 2025. https://www.prnewswire.com/news-releases/fda-declares-wegovy-and-ozempic-shortage-is-over-and-that-novo-nordisk-is-fully-meeting-or-exceeding-nationwide-demand-for-all-doses-302382370.html

Tandem Diabetes Care. Tandem Diabetes Care announces FDA clearance of Control-IQ+ automated insulin delivery technology for people with type 2 diabetes. Tandem Diabetes Care. February 25, 2025. Accessed March 2, 2025. 

https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-fda-clearance-control-iq

In this episode, hosts discuss the implications of recent changes in GLP-1 RA availability as well as diabetes technology updates.

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

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