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

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

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

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 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.

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.

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. 

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

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

Podcasts

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

Evaluating the Medtronic 780G System in Type 2 Diabetes

Advanced hybrid closed-loop (AHCL) therapy use provided safe insulin intensification and demonstrated key improvements in mean hemoglobin A1c (HbA1c) and time-in-range in people with 

The 13-site, single-arm, open-label study assessed the safety and effectiveness of the MiniMed™ 780G system among 95 adults with insulin-requiring T2D, with a 21-day run-in period of open-loop or HCL followed by a 90-day study period of AHCL.

In a recent episode of 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, explored the potential of the MiniMed 780G system for T2D and how they could improve outcomes for this population.

“I think it just adds to all this evidence of these systems working very well in people with T2D and so, the question is why we aren't using these systems more in this population,” Isaacs said.

Across the 90-day study period, the MiniMed™ 780G system decreased mean HbA1c from 7.9% to 7.2% (

 <.001), while the percentage of time-in-range (70–180 mg/dL) reached 80.9% (95% CI, 78.4–83.1) during that time. The total daily insulin needs increased from 77.4 U to 91.8 U over that period, with stability in carbohydrate intake and a decrease in the number of user-initiated boluses.

Safety results revealed no significant changes in participant weight or body mass index (BMI) during the study alongside no reports of severe hypoglycemia, diabetic ketoacidosis, hyperosmolar hyperglycemic state, or serious adverse events.

“These systems are so strong that they can help these people with T2D,” Bellini said. “I'm thrilled that this is another option. One question becomes, where does that FDA indication come from, do we think this will push Medtronic to get a T2D indication?”

Diana Isaacs P, Natalie Bellini D. Diabetes dialogue: Omnipod 5 and Medtronic 780G for Type 2 diabetes. HCP Live. February 15, 2025. Accessed February 25, 2025. 

https://www.hcplive.com/view/diabetes-dialogue-omnipod-5-and-medtronic-780g-for-type-2-diabetes

Bhargava A, Bergenstal RM, Warren ML, et al. Safety and Effectiveness of MiniMed™ 780G Advanced Hybrid Closed-Loop Insulin Intensification in Adults with Insulin-Requiring Type 2 Diabetes. Diabetes Technol Ther. Published online February 6, 2025. doi:10.1089/dia.2024.0586

Videos

In a recent Diabetes Dialogue segment, hosts discussed the efficacy and safety of advanced hybrid closed-loop therapy with the MiniMed 780G system.

Understanding Omnipod 5 AID and SECURE-T2D

A recent nonrandomized clinical trial found the initiation of automated insulin delivery (AID) safe and effective for a population of insulin-requiring adults with 

, particularly for lowering hemoglobin A1c (HbA1c) levels.

The SECURE-T2D trial evaluated the impact of the Omnipod 5 AID system on glycemic control among 305 participants with diverse representation, including 24% Black and 22% Hispanic or Latino. After a 14-day standard therapy phase, the population used the Ompiod 5 AID system for 13 weeks.

In a recent episode of 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, examined the benefit of the diverse trial population on applying these notable data to wider populations

“One of the criticisms of insulin pumps or technology trials is that they include a highly educated population that is tech savvy and it becomes difficult to apply that to the general population, because the average person may not have that education,” Isaacs said. “They were much more diverse in terms of education level, income level, and even when you look at race and ethnicity, 50% were White and the other half came from different ethnicities.”

The US Food and Drug Administration cleared Omnipod 5 Automated Insulin Delivery (AID) System in August 2024, becoming the first AID system to be FDA-cleared for both type 1 (T1D) and T2D management.

Analyses from SECURE-T2D showed the Omnipod 5 AID system led to a decrease in HbA1c from 8.2% at baseline to 7.4% (mean difference, -0.8 percentage points; 95% CI, -1.0 to -0.7; P <.001), while time in range (70-180 mg/dL) increased from 45% to 66% (mean difference, 20 percentage points; 95% CI, 18 to 22; P <.001).

“For them to get that FDA approval, we needed more data and this HbA1c reduction is huge,” Bellini said. “For the time in range, which [we] have been believers in since we first started using CGM, every 5% increase reduces complications and we’re at a 20% increase. That’s incredible and they’re not having to add different medication or taking insulin at every meal.”

Campbell P. FDA clears omnipod 5 aid system for type 2 diabetes. HCP Live. August 26, 2024. Accessed February 25, 2025. https://www.hcplive.com/view/fda-clears-omnipod-5-aid-system-for-type-2-diabetes.

Pasquel FJ, Davis GM, Huffman DM, et al. Automated Insulin Delivery in Adults With Type 2 Diabetes: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025;8(2):e2459348. doi:10.1001/jamanetworkopen.2024.59348

In this Diabetes Dialogue segment, hosts discussed the strengths of trial diversity and HbA1c reductions with automated insulin delivery in type 2 diabetes.

Diabetes Dialogue: Omnipod 5 and Medtronic 780G for Type 2 Diabetes

, 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 recently published studies examining the use of diabetes technology in adults with 

A single-arm prospective study conducted at 21 US clinical centers, SECURE-T2D assessed the impact of automated insulin delivery (AID) on glycemic control in adults with type 2 diabetes using insulin for at least 3 months. The study enrolled 305 participants (mean age, 57 years; 57% female), with a diverse racial and ethnic representation, including 24% Black and 22% Hispanic or Latino.

Following a 14-day standard therapy phase, participants used the Omnipod 5 AID system for 13 weeks. HbA1c decreased from 8.2% (SD, 1.3) at baseline to 7.4% (SD, 0.9) (mean difference, -0.8 percentage points; 95% CI, -1.0 to -0.7; 

 <.001) and time in range (70-180 mg/dL) increased from 45% (SD, 25) to 66% (SD, 17) (mean difference, 20 percentage points; 95% CI, 18 to 22; 

Improvement was observed across subgroups, regardless of concurrent GLP-1 RA or SGLT2 inhibitor use or pretrial insulin regimen. Rates of hypoglycemia remained noninferior to standard therapy, with one severe hypoglycemia event and no cases of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome. Findings suggest AID may be a safe and effective option for insulin-requiring adults with type 2 diabetes.

A 13-site, single-arm, open-label study evaluated the safety and effectiveness of the MiniMed™ 780G advanced hybrid closed-loop (AHCL) system in 95 adults with insulin-requiring type 2 diabetes. Over the 90-day study period, mean HbA1c decreased from 7.9% (SD, 1.0%) to 7.2% (SD, 0.7%) (P < 0.001), and the percentage of time in range of 70 to 180 mg/dL) reached 80.9% (95% CI, 78.4% to 83.1%).

Total daily insulin dose increased from 77.4 U (SD, 38.5) to 91.8 U (SD, 49.3) (

<.0001), while carbohydrate intake remained stable, and user-initiated boluses decreased. Investigators pointed out no significant changes in participant weight or body mass index were observed during the study and there were no reports of severe hypoglycemia, diabetic ketoacidosis, hyperosmolar hyperglycemic state, or serious adverse events.

Pasquel FJ, Davis GM, Huffman DM, et al. Automated Insulin Delivery in Adults With Type 2 Diabetes: A Nonrandomized Clinical Trial. 

 2025;8(2):e2459348. doi:10.1001/jamanetworkopen.2024.59348

Bhargava A, Bergenstal RM, Warren ML, et al. Safety and Effectiveness of MiniMed™ 780G Advanced Hybrid Closed-Loop Insulin Intensification in Adults with Insulin-Requiring Type 2 Diabetes. 

. Published online February 6, 2025. doi:10.1089/dia.2024.0586

In this episode, hosts offer perspective on recent studies assessing insulin delivery systems in adults with type 2 diabetes.

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

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