Technosphere insulin and Degludec non-inferior to usual care for postprandial hyperglycemia in T1 Diabetics: Study
A recent study published in the journal Diabetes Care found that the combination of Technosphere insulin (TI) plus insulin degludec is non-inferior to the usual care of an automated insulin delivery (AID) system or multiple daily insulin injections (MDI) for controlling postprandial diabetes in individuals with Type 1 diabetes.
Only a limited proportion of adults with type 1 diabetes meet the Glycemic targets set by the American Diabetes Association. The delayed onset of rapid-acting analog (RAA) insulin makes it difficult for Automated insulin delivery (AID) systems to prevent hyperglycemia. Inhaled Technosphere insulin (TI) is better at offering faster onset and dissipation, reducing post-meal hyperglycemia and hypoglycemia risk. Despite the drug's limited use, despite FDA approval, trials comparing TI with traditional insulin regimens were done. Researchers from the U.S.A. conducted a study to evaluate a regimen of inhaled Technosphere insulin (TI) plus insulin degludec in adults with type 1 diabetes, who were predominately using either an automated insulin delivery (AID) system or multiple daily insulin injections (MDI) with continuous glucose monitoring before participating in the study.
A randomized trial was conducted at 19 endocrinology practices in the U.S., including individuals aged ≥18 years old with type 1 diabetes for at least 6 months. Inclusion criteria were adhering to the same treatment regimen for at least 3 months, like the AID nonautomated pump, or MDI, and having an HbA1c level < 11.0%. Eligible participants were randomly assigned (1:1) with the use of a block design separately for each site to either the TI-degludec regimen or the usual care (UC) group. HbA1c was measured at baseline and after 17 weeks, along with forced expiratory volume in 1 s, continuous glucose monitoring (CGM), and a patient-reported outcome survey.
Findings:
- AID was used by 48% and MDI by 45% before the study.
- Mean ± SD HbA1c was 7.57% ± 0.97% at baseline and 7.62% ± 1.06% at 17 weeks in the TI group.
- Mean ± SD HbA1c was 7.59% ± 0.80% at baseline and 7.54% ± 0.77% at 17 weeks in the UC group.
- In the TI group, HbA1c improved by >0.5% from baseline to 17 weeks in 21 % of the participants and 5% of them in the UC group.
- In the UC group, HbA1c worsened by >0.5% from baseline to 17 weeks in 26% of the TI group and 3% of the UC group.
- The most common TI side effect was a brief cough.
- About eight participants discontinued TI due to side effects.
Thus, the study concluded that TI and degludec were non-inferior to UC. A similar number of participants showed improvements and worsening of glycemic control, so self-management of TI with degludec is necessary with free frequent TI inhalation during the day and evening. The researchers also suggested that TI with degludec can be used as a viable option for patients with type 1 diabetes. Hence, clinicians should carefully select the patients while prescribing this combination for optimal glycemic control.
Further reading: A Randomized Trial Comparing Inhaled Insulin Plus Basal Insulin Versus Usual Care in Adults With Type 1 Diabetes. Doi: https://doi.org/10.2337/dc24-1832.
