Roy W. Beck

Inhaled insulin provides a unique prandial insulin option, offering an alternative, with a more rapid onset of effect, to subcutaneous rapid-acting analog insulin. Clinical studies with inhaled insulin have demonstrated its efficacy and safety, with glycemic outcomes comparable to or in some cases better than those of contemporary insulin delivery approaches. However, the use of inhaled insulin for diabetes therapy in daily life remains limited due to payer restrictions, prior authorization requirements, formulary exclusions, clinician knowledge gaps, clinician time constraints, persistent misconceptions regarding safety, and inadequate patient awareness. A panel of clinical experts in diabetes management met in June 2026 to review the safety and efficacy of Technosphere ^® inhaled (TI) insulin, discuss the current obstacles that limit access for people with diabetes (PwD) to TI, identify practical strategies to overcome these obstacles, and issue a call-to-action for payers, clinicians, policymakers, professional organizations, and patient advocacy groups. This article summarizes those discussions and proposes strategies to increase access and choice for PwD.

OBJECTIVE: To evaluate the efficacy, safety, and user satisfaction of the twiist automated insulin delivery (AID) system in adults with type 2 diabetes. RESEARCH DESIGN AND METHODS: In a single-arm, multicenter trial, 307 adults with insulin-treated type 2 diabetes, 19–85 years old, initiated use of the twiist AID system for 13 weeks after collection of baseline continuous glucose monitoring (CGM) data. The primary outcome was change in HbA1c from baseline to 13 weeks. RESULTS: Mean HbA1c decreased by 0.7% (95% CI −0.9 to −0.6) from 8.1% ± 1.5% at baseline to 7.4% ± 0.9% after using twiist for 13 weeks (P < 0.001 for both noninferiority and superiority). The treatment effect was greatest in participants with baseline HbA1c ≥9.0%. A substantial HbA1c reduction was observed when AID was added to prestudy use of a glucagon-like peptide 1 receptor agonist or sodium-glucose cotransporter 2 inhibitor drug, which was continued during the trial. Mean CGM-measured time-in-range 70–180 mg/dL increased from 57% ± 26% to 73% ± 17% (mean change 16% [95% CI 14–18]; P < 0.001). All other multiplicity-controlled CGM outcomes reflective of hyperglycemia showed significant improvement from baseline. The frequency of CGM-measured hypoglycemia was low at baseline and remained low during follow-up. Diabetic ketoacidosis occurred in one participant; no severe hypoglycemia events occurred. Using twiist, participant satisfaction was higher than with their prestudy insulin delivery method (P < 0.001) and sleep quality improved (P < 0.001). CONCLUSIONS: In this single-arm, 13-week trial in adults with insulin-treated type 2 diabetes, AID with the twiist system was safe and associated with substantially improved glycemia.

Objective: To evaluate the relationship between continuous glucose monitoring (CGM)-measured % time T < 54) and level 2 hypoglycemic events (L2 events; ≥15 min T < 54 and L2 events from eight clinical trials over 3–6 months in participants with T1D. Results: Data from 1532 participants with T1D were analyzed (mean age 37 ± 21 years; 72% adults): 43% using automated insulin delivery (AID), 43% CGM users not using AID (34% multiple daily injections [MDI]; 66% standard pump), and 14% self-monitoring blood glucose (SMBG) users not using CGM (58% MDI; 42% standard pump). There was a strong correlation between % T < 54 and L2 event rate ( r = 0.97), but the relationship differed by the average duration of L2 events. For those with 1% T < 54, the predicted L2 event rate per week was 2.4 events for those with short L2 events (average 60 min). Those meeting hypoglycemic targets (T < 54) had on average 0.6 L2 events per week, irrespective of technology use. Those not meeting targets (≥1% T < 54) had on average 2.9 L2 events per week, but this differed based on technology use and observed % T < 54. Conclusions: L2 event frequency and % T < 54 are strongly correlated, but the relationship differs by L2 event duration. Therefore, both frequency and duration of L2 events should be reported together. Time-below-range metrics incorporate both aspects and are core CGM endpoints that summarize overall amount of hypoglycemia exposure.

OBJECTIVE: To assess the effect of automated insulin delivery (AID) on glycemic and insulin outcomes in adults with insulin-treated type 2 diabetes using a glucagon-like peptide-1 receptor agonist (GLP-1 RA). RESEARCH DESIGN AND METHODS: In a randomized trial comparing Control-IQ+ AID versus continuation of prestudy insulin delivery method plus continuous glucose monitoring (CGM group), 143 (45%) of the 319 participants were using a GLP-1 RA at baseline, which was continued during the trial. RESULTS: Among GLP-1 RA users, mean HbA1c decreased by 0.8% from a baseline of 8.0 ± 1.2% with AID, which represented a mean improvement of −0.5% (95% CI −0.8 to −0.3, P < 0.001) compared with the CGM group. Time-in-range 70–180 mg/dL and other CGM metrics reflective of hyperglycemia also showed comparable statistically significant improvements using AID when added to GLP-1 RA use. For GLP-1 RA users, there was no significant difference in weight after 13 weeks with AID compared with the CGM group (0.9 kg, 95% CI −0.2 to 2.1, P = 0.10), whereas, in GLP-1 RA nonusers, there was a mean weight gain of 1.9 kg with AID compared with CGM (95% CI 0.5 to 3.2, P = 0.007). CONCLUSIONS: The benefits of AID appear to be substantial for a broad spectrum of insulin-treated patients with type 2 diabetes, including those already receiving contemporary and guideline-directed therapy, such as a GLP-1 RA medication. These additive benefits of AID in GLP-1 RA users included significant reductions in HbA1c levels with simultaneous reduction in insulin use, along with no statistical increase in weight despite very significant improvements in glycemic control.

OBJECTIVE: To evaluate inhaled technosphere insulin (TI) in children with diabetes. RESEARCH DESIGN AND METHODS: A total of 230 youth 4–17 years old with type 1 (98%) or type 2 (2%) diabetes treated with multiple daily injections of insulin were randomly assigned 1:1 to TI or rapid-acting analog (RAA) insulin plus continuation of long-acting basal insulin and continuous glucose monitoring (CGM) for 26 weeks. The primary outcome was change in HbA1c, tested for noninferiority with margin of 0.4%. RESULTS: In intent-to-treat analysis, mean HbA1c (% ± SD) was 8.22 ± 0.87 at baseline and 8.41 ± 1.38 at 26 weeks with TI and 8.21 ± 0.96 and 8.21 ± 1.10, respectively, with RAA (adjusted difference = 0.18; 95% CI −0.07, 0.43; noninferiority P = 0.091). CGM-measured time in range 70–180 mg/dL was not significantly different between groups (adjusted difference −2.2%; 95% CI −7.0, 2.7; P = 0.38). Two severe hypoglycemic events occurred in the TI group and one in the RAA group. Change in forced expiration volume in 1 s from baseline to 26 weeks did not differ comparing TI and RAA (P = 0.53). The TI group reported greater treatment satisfaction (P = 0.004) and had less gain in weight and BMI percentile (P = 0.009) than did the RAA group. CONCLUSIONS: The primary analysis did not meet the prespecified criteria for HbA1c noninferiority. However, TI use was safe over 26 weeks without affecting pulmonary function and was associated with greater treatment satisfaction and less weight gain compared with RAA, supporting TI as a treatment option for some pediatric patients with type 1 diabetes.

Introduction: This analysis investigated whether use of real-time continuous glucose monitoring (CGM) compared with blood glucose monitoring (BGM) results in rapidly improved glycemic management in adults with type 2 diabetes (T2D) treated with basal insulin. Research design and methods: Using data from the MOBILE study where adults (n=175) with T2D treated with basal insulin without prandial insulin were randomized (2:1) to either CGM (n=116) or BGM (n=59), the treatment effect on glycemic management was determined over 3 months. The main outcome was a between-group difference in hemoglobin A _1c (HbA _1c ) at 3 months adjusted for baseline value. Other outcomes included changes in CGM-derived glucose metrics and hypoglycemic events. Results: After 3 months, there was a greater reduction from baseline in mean HbA _1c in the CGM group compared with the BGM group, from 9.1±1.0% (76±11 mmol/mol) to 8.0±1.2% (64±13 mmol/mol) in the CGM group and from 9.0±0.9% (75±10 mmol/mol) to 8.5±1.5% (69±16 mmol/mol) in the BGM group (adjusted difference, −0.6% (95% CI –0.9% to −0.3%); −6.6 mmol/mol (95% CI –10.2 to –2.9), p13.9 mmol/L) with CGM (adjusted difference, −5.8% (95% CI −10.4% to −1.2%), p1c over 3 months. Trial registration number: NCT03566693 .