An inhaled form of rapid-acting insulin is a safe and effective alternative to injected insulin for children and adolescents with diabetes, according to study results presented at the American Diabetes Association’s 85th Scientific Sessions.
The INHALE-1 trial found that technosphere insulin was noninferior to rapid-acting analog insulin in managing HbA1c levels, and participants who used technosphere insulin experienced less weight gain and higher satisfaction with treatment.
Dr Michael Haller said: “The take-home message is that inhaled insulin is safe and effective in children with diabetes.
“Inhaled insulin performed as well as injected rapid acting insulin on average and, for some patients, inhaled insulin proved to provide superior glycaemic control with improved satisfaction scores and reduced weight gain.”
A total of 230 children and adolescents with type 1 or type 2 diabetes were recruited for the INHALE-1 trial, all of whom were receiving multiple daily insulin injections at baseline.
For 26 weeks, each participant either received technosphere insulin or rapid-acting analog insulin. They all used basal insulin and a real-time continuous glucose monitor (Dexcom G6).
Participants in the technosphere insulin group saw their HbA1c rise from 8.22 per cent at baseline to 8.41 per cent at 26 weeks, the study has reported.
Meanwhile, those in the rapid-acting analog group had a HbA1c of 8.21 per cent at baseline and at 26 weeks, the findings have shown.
Roughly 10 per cent of those in the technosphere insulin group had a HbA1c less than seven per cent at 26 weeks, the research has revealed.
According to the study, HbA1c improved by 0.5 percentage points for 15 per cent of youths assigned technosphere insulin and worsened by 0.5 percentage points or more for 29 per cent of those in that group.
Dr Haller said: “Technosphere insulin is more rapid-acting than injectable insulins and using the product requires some adjustments by the patient.
“The patients who do really well have to know they are going to use technosphere insulin multiple times a day and even multiple times following a single meal.
“It requires tune-ups fairly frequently, because while it is the most rapid insulin available, it also clears from the body quickly.
“We realise this approach is not for everyone. In the spirit of giving people with a lifelong diagnosis a broad range of tools to manage their diabetes, inhaled insulin is an important addition to the toolbox.”
Technosphere insulin is not currently FDA-approved for use in children and adolescents. However, Dr Haller said the data from INHALE-1 should be strong enough for the FDA to consider an expanded indication.
He said: “I think there are going to be opportunities to offer this to newly diagnosed kids who are experiencing the life-changing event of a diabetes diagnosis.
“Being able to say you can have one injection a day and manage the rest of your diabetes with an inhaled product is very attractive as you’re transitioning to this new lifelong diagnosis.”
He concluded: “Technosphere insulin could eventually be used with automated insulin delivery systems and can also be beneficial for people who don’t want to use diabetes technology.
“I think these data open up a number of possibilities for the use of inhaled insulin in youths with type 1 diabetes.”
