Diabetes Awareness Month Opens Amid New T1D, T2D Approvals

November marks Diabetes Awareness Month, and this year it arrives after a busy stretch for diabetes therapeutics and technology. Since June, the FDA has approved the first disease-modifying therapy for children recently diagnosed with stage 3 type 1 diabetes (T1D) and a second once-weekly basal insulin for adults with type 2 diabetes (T2D) and has cleared an automated insulin delivery (AID) system for adults with insulin-treated T2D. Each changes how patients take therapy or track their response, and each opens new counseling opportunities for pharmacists.

Teplizumab Moves Into Stage 3 T1D

On June 12, 2026, the FDA granted accelerated approval to teplizumab-mzwv (Tzield; Sanofi) to delay the decline of endogenous insulin production in patients aged 8 to 17 years who were recently diagnosed with stage 3 T1D. The agent was previously approved to delay the onset of stage 3 disease in adults and pediatric patients aged 1 year and older with stage 2 T1D.¹

The approval rests on the phase 3 PROTECT trial (NCT03875729), which randomly assigned 328 participants diagnosed within the preceding 6 weeks 2:1 to teplizumab or placebo. Teplizumab slowed the decline in C-peptide, a marker of residual beta-cell function, versus placebo (difference in least-squares means, 0.13 pmol/mL; 95% CI, 0.09-0.17; P < .001). Because C-peptide is a surrogate end point, continued approval may depend on the confirmatory BETA-PRESERVE trial (NCT07088068).²

In PROTECT, participants received 2 courses of 12 daily infusions, 26 weeks apart. Pharmacists supporting infusion services should know the most common adverse reactions, including lymphopenia, rash, leukopenia, and elevated liver transaminases, as well as serious risks such as cytokine release syndrome and viral reactivation.²

A Second Once-Weekly Basal Insulin

In September, Eli Lilly announced FDA approval of insulin efsitora alfa-gobe (Onswik), used with diet and exercise, for adults with T2D.^3,4 It follows insulin icodec-abae (Awiqli; Novo Nordisk)—which was approved in March 2026—as the second once-weekly basal insulin for this population.³

Approval was based on the 4 phase 3 QWINT trials (NCT05275400), which enrolled more than 3400 adults across insulin-naive, basal-treated, and basal-bolus populations. Efsitora met its primary end point of noninferior hemaglobin A_1c (HbA_1c) reduction versus daily insulin glargine or degludec in each trial, with a safety profile similar to the daily comparators.⁴ It is not recommended for patients with T1D because of a possible increased risk of severe hypoglycemia.³

Lilly said the KwikPen will be available in 500 U/mL and 1000 U/mL concentrations in the coming months.³ With 2 concentrations and a weekly schedule, pharmacists will be central to confirming the right product, setting a consistent dosing day, and reinforcing hypoglycemia recognition as patients transition from daily basal insulin.

AID Expands to T2D

In October 2026, Sequel Med Tech announced 510(k) clearance of its twiist AID system for adults aged 18 years and older with insulin-treated T2D.^5,6 The system, previously cleared for T1D, uses an algorithm based on Tidepool Loop and pairs with the FreeStyle Libre 3 Plus and Eversense 365 continuous glucose monitors.^5,6

In a 13-week pivotal trial of 307 adults at 30 US sites, mean HbA_1c fell 0.7% from a baseline of 8.1%, and time in range (70-180 mg/dL) rose from approximately 57% to 73%, or about 3.8 more hours per day. No severe hypoglycemia occurred. More than half of participants (56%) were also taking a glucagon-like peptide-1 receptor agonist, and 37% an sodium-glucose cotransporter 2 inhibitor, a reminder that AID will often sit alongside complex medication regimens pharmacists already manage.⁶

Turning Glucose Data Into Action

These advances share a common thread: patients have more ways to treat diabetes and more glucose data to interpret. Throughout Diabetes Awareness Month, Pharmacy Times will explore how pharmacists can help patients choose a monitoring approach that fits their therapy and daily life, build consistent routines that produce useful readings, and turn those readings into more productive conversations with their care team.

REFERENCES

1. Halpern L. FDA approves teplizumab-mzwv for children with newly diagnosed stage 3 type 1 diabetes. Pharmacy Times. June 16, 2026. Accessed October 28, 2026. https://www.pharmacytimes.com/view/fda-approves-teplizumab-mzwv-children-newly-diagnosed-stage-3-type-1-diabetes

2. Sanofi's Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes. News release. Sanofi. June 12, 2026. Accessed October 28, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-06-12-22-09-58-3311349

3. FDA approves Onswik, a once-weekly basal insulin, for adults with type 2 diabetes. Healio. September 24, 2026. Accessed October 28, 2026. https://www.healio.com/news/endocrinology/20260924/fda-approves-onswik-a-onceweekly-basal-insulin-for-adults-with-type-2-diabetes

4. McGovern G. FDA approves insulin efsitora, once-weekly basal insulin injection for adults with T2D. September 24, 2026. Accessed October 28, 2026. https://www.pharmacytimes.com/view/fda-approves-insulin-efsitora-once-weekly-basal-insulin-injection-for-adults-with-t2d

5. Taylor NP. FDA clears Sequel's insulin delivery system in type 2 diabetes. MedTech Dive. October 19, 2026. Accessed October 28, 2026. https://www.medtechdive.com/news/fda-clears-sequels-insulin-delivery-system-in-type-2-diabetes/833317/

6. Debbarma S. FDA clears Sequel Med Tech's twiist system for type 2 diabetes. Medical Device Network. October 19, 2026. Accessed October 28, 2026. https://www.medicaldevice-network.com/news/fda-sequel-med-techs-twiist-system/