Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

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

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

Automated insulin delivery (AID) systems still rely on meal and exercise announcements, and a new consensus framework sets the bar fully closed-loop (FCL) systems must clear in 

In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, spoke with Brynn Marks, MD, MSHPEd, of Breakthrough T1D, first author of the new roadmap.

On this episode of Diabetes Dialogue, Diana Isaacs, PharmD, and Natalie Bellini, DNP, talk with Brynn Marks, MD, MSHPEd, of Breakthrough T1D about where automated insulin delivery is headed. They discuss how next-generation systems might be evaluated and what the shift could mean for people with diabetes and the clinicians who support them.  HCPLive delivers clinical news, expert perspectives, and conference coverage for healthcare professionals across specialties.

Diabetes Dialogue:  A Consensus Definition for Fully Closed-Loop Systems

The framework updates a Breakthrough T1D, formerly known as JDRF, roadmap first issued in 2009 and revised in 2015.

 Rather than prescribing a technology, it holds systems built on artificial intelligence, multi-hormone delivery, multi-analyte sensing, or adjunctive therapy to uniform outcome standards.

 Every FCL system must perform without mandatory meal or activity announcements.

Classification rests on time in tight range (TITR) of 70 to 140 mg/dL, time below 54 mg/dL under 1%, and validated person-reported outcomes.

 Class 3 systems must exceed 50% TITR, roughly equivalent to 70% time in range, while Class 2 and Class 1 systems must exceed 70% and 90%, respectively.

 Class 1a adds a 30-minute standardized moderate exercise test with no time below 54 mg/dL.

The authors chose TITR because emerging evidence ties it more closely than time in range to microvascular complications and glycemic variability. The exercise test starts with glucose in tight range and no carbohydrate intake in the prior 2 hours, limiting insulin on board.

Person-reported outcomes carry equal weight. Trials must enroll representative populations and show meaningful gains in diabetes distress and quality of life among participants with low baseline scores, without deterioration among those already doing well. The requirement guards against trials enrolling only highly engaged participants on low-carbohydrate diets.

Neural network systems now in phase 3 trials need no second hormone or adjunctive drug, though their speed of adapting to day-to-day activity shifts remains uncertain. Glucagon-like peptide-1 (GLP-1) receptor agonists blunt postprandial excursions but carry gastrointestinal adverse effects. Dual glucose-ketone sensing may also renew interest in sodium-glucose cotransporter 2 (SGLT2) inhibitors as adjuncts.

Education needs will shift rather than disappear. Clinicians will still match people to systems, teach recognition of infusion site failure, and support transitions such as the move from pediatric to adult care. Less visit time spent on glucose may free room for lipids, blood pressure, and other complication risks.

Collectively, the framework gives developers, researchers, and clinicians a shared benchmark for FCL performance. It positions reduced self-management burden alongside near-normoglycemia as the defining goals of next-generation AID.

Editors’ Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.

Marks BE, Hilliard ME, Kovatchev B, et al. Roadmap to fully closing the loop to optimize health in type 1 diabetes. 

Kowalski A. Pathway to artificial pancreas systems revisited: moving downstream. 

Podcasts

Brynn Marks, MD, MSHPEd, joins Diana Isaacs, PharmD, and Natalie Bellini, DNP, to discuss a new framework defining fully closed loop insulin delivery.

Diabetes Dialogue: Building A Consensus Definition for Fully Closed-Loop Systems

Automated insulin delivery (AID) is moving toward systems demanding less from users, and new feasibility data suggest a next-generation algorithm may hold glycemic targets in 

On a recent episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, reviewed first-in-human results for the MiniMed Vivera algorithm and the new type 2 diabetes clearance for the twiist AID system.

On this episode of Diabetes Dialogue, Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss where automated insulin delivery is heading and what recent developments could mean for clinicians managing patients on pump therapy. The conversation covers new algorithm research and a recent regulatory update affecting people with type 2 diabetes. 

Diabetes Dialogue: MiniMed Vivera Data and Twiist Type 2 Clearance

The feasibility trial enrolled 24 adults with type 1 diabetes across 3 consecutive 3-week phases: full meal announcement, no meal announcement, and announcement at will.

 Mean time in range (70 to 180 mg/dL) was 82.3%, 73.8%, and 76.7% across the respective phases, with no device-related serious adverse events.

 Time below 54 mg/dL stayed between 0.2% and 0.3% in every phase.

The algorithm also permits a glucose target as low as 90 mg/dL and starts automated mode from total daily dose alone, without the manual-mode run-in required by the MiniMed 780G system. Most participants nonetheless kept a 100 mg/dL target, and a few selected a higher one.

Participants entered with tightly managed disease, with a mean baseline HbA1c of 6.9% and a run-in time-in-range of about 83% on the 780G system. Full-announcement results therefore matched the existing algorithm, placing the advance in performance without announcements. Outcomes in people with higher HbA1c, and the patient-reported burden of each announcement strategy, remain untested.

The FDA cleared the twiist system from Sequel Med Tech for adults with insulin-treated type 2 diabetes in October 2026. In the 13-week pivotal trial of 307 adults, HbA1c fell 0.7% (95% CI, -0.9 to -0.6), and time in range rose from 57% to 73% with no severe hypoglycemia.

 Labeling may ease payer coverage and support prescribing among clinicians less experienced with pump therapy.

The twiist algorithm draws on programmed basal rates and insulin sensitivity factors, a design closer to Control-IQ+ than to MiniMed or Beta Bionics systems. Clinicians familiar with the system report raising the maximum basal limit allows rapid correction of hyperglycemia, even among users who rarely bolus.

Collectively, the developments point toward AID systems requiring less user input across diabetes types. Pivotal trials in broader populations will determine whether reduced burden comes without meaningful glycemic tradeoffs.

Tirosh A, Wheeler BJ, Laron Hirsh M, et al. Efficacy and safety of the MiniMed Vivera algorithm: results from a first-in-human feasibility trial. 

Levy CJ, Kanapka L, Graham TE, et al. A multicenter 13-week evaluation of the twiist automated insulin delivery in insulin-treated type 2 diabetes: the twiist-T2D pivotal trial. 

Articles

Diana Isaacs, PharmD, and Natalie Bellini, DNP, review early MiniMed Vivera data on optional meal announcements and twiist's new type 2 diabetes clearance.

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


Automated insulin delivery (AID) is becoming the standard approach for insulin-requiring 

, and new pivotal data suggest a fourth system may soon join the 3 already cleared for this population.

Diabetes Dialogue: Twiist AID Data and the New ADA/EASD Type 2 Algorithm

On a recent episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, reviewed 2 updates in T2D care. The discussion covered the Twiist AID trial and the new joint management algorithm from the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD).

The single-arm, multicenter trial, published in Diabetes Care, enrolled 307 adults aged 19 to 85 years with insulin-treated T2D who used the system for 13 weeks. Mean HbA1c fell 0.7%, from 8.1% to 7.4%, while continuous glucose monitoring time in range rose from 57% to 73%. Because every 5% gain in time in range carries clinical weight, a 16-point increase represents a substantial shift.

Similar benefits appeared in adults older than 65 years, those using >100 units of insulin daily, and those taking glucagon-like peptide-1 (GLP-1) receptor agonists or sodium-glucose cotransporter 2 (SGLT2) inhibitors. Participants kept background therapy, and few counted carbohydrates at baseline. Fixed meal announcements, such as 45 g per meal with carbohydrate ratios adjusted behind them, and an extended-absorption bolus for gastroparesis or grazing patterns may simplify use.

The ADA/EASD algorithm now integrates comorbidity assessment with glycemic and weight goals rather than splitting them into parallel pathways. Medical nutrition therapy, 24-hour physical activity behaviors, self-management education, and social determinants of health sit at the top. Directly below, the algorithm calls for early SGLT2 inhibitor and/or GLP-1-based therapy to modify disease and complication risk, a position metformin once held.

 recommendation to dual glucose-dependent insulinotropic polypeptide/GLP-1 receptor agonists such as tirzepatide (Mounjaro), reflecting SURPASS-CVOT. Metabolic dysfunction-associated steatotic liver disease and steatohepatitis now sit beside chronic kidney disease and heart failure, with GLP-1-based therapy, low-dose pioglitazone, or SGLT2 inhibitors as options. An evidence graphic also links each additional 500 to 1,000 daily steps with lower all-cause and cardiovascular mortality.

Collectively, the updates mark a move away from stepwise treat-to-fail escalation toward earlier organ-protective therapy and, once insulin is needed, automated delivery as the default.

Levy CJ, Kanapka L, Graham TE, et al. A Multicenter 13-Week Evaluation of the twiist Automated Insulin Delivery in Insulin-Treated Type 2 Diabetes: The twiist-T2D Pivotal Trial. 

Davies MJ, Aroda VR, Bajaj M, et al. Management of type 2 diabetes, 2026. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). 

Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss a major breakthrough with the Twiist insulin pump and the recent ADA/EASD T2D guidelines.

 is moving into clinical practice, raising questions about who to screen, how to stage results, and how to deliver disease-modifying therapy at scale.

Diabetes Dialogue: Screening, Cell Therapy, and Adjunctive Agents at Breakthrough-T1D

On a recent episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, recapped the inaugural Breakthrough T1D Clinical and Research Congress in Philadelphia.

First-degree relatives carry up to a 15-fold increased risk, and screening children at ages two, six, and 10 years identifies roughly 80% of those who will develop the disease. Evidence guiding adult screening and staging remains limited. One health system estimated up to 45,000 candidates after counting relatives and people with 

Placebo-controlled designs, such as the 14-day intravenous infusion regimen in the teplizumab (Tzield) TN10 trial, burden participants. An ongoing comparison of antithymocyte globulin with teplizumab gives every participant active therapy, and involving people with T1D in protocol development may improve enrollment. Eli Lilly is also investigating the Janus kinase inhibitor baricitinib (Olumiant) to delay progression from stage two to stage three disease.

Stem cell-derived islet programs from Vertex aim to overcome donor scarcity, with gene editing intended to reduce immunosuppression requirements. Reports of insulin independence with tegoprubart, an anti-CD40 ligand antibody from Eledon, involve few patients receiving infusions every three weeks, and long-term toxicity of agents such as tacrolimus remains a concern. Long-term Edmonton protocol data show many recipients sustain time in range above 90% despite resuming insulin.

Adjunctive agents layered on automated insulin delivery address residual cardiorenal risk. Dipeptidyl peptidase-4 inhibitors improve time in range without added hypoglycemia, while generic dapagliflozin lowers mean glucose but requires ketone monitoring given euglycemic diabetic ketoacidosis risk. Glucagon-like peptide-1 (GLP-1) and dual GIP/GLP-1 receptor agonists improve time in range, often at low doses such as tirzepatide (Mounjaro) 2.5 mg weekly.

Finerenone (Kerendia) recently gained approval for chronic kidney disease associated with T1D. The 2026 American Diabetes Association Standards of Care also recognize coexisting type 1 and type 2 diabetes, supporting coverage for patients with insulin resistance.

Supply policy compounds the clinical burden. Continuous glucose monitoring sensors frequently fail before their labeled wear time, leaving patients on standard monthly allotments without a sensor for meaningful stretches.

Collectively, these developments point toward individualized T1D care matched to disease stage and residual beta-cell function, with screening infrastructure, trial access, and supply policy shaping how quickly patients benefit.

Breakthrough T1D. Breakthrough T1D Concludes Inaugural Clinical & Research Congress, Highlighting Global Advances in Type 1 Diabetes Research. October 12, 2026. Accessed October 15, 2026. 

https://www.breakthrought1d.org/for-the-media/press-releases/breakthrough-t1d-concludes-inaugural-clinical-research-congress-highlighting-global-advances-in-type-1-diabetes-research/

Diana Isaacs, PharmD, and Natalie Bellini, DNP, recap the first-ever Breakthrough T1D Clinical and Research Congress.