HL-01: Inhaled Insulin for Children Newly Diagnosed with Type 1 Diabetes: The INHALE-1st Study Prelimi nary Results
G Forlenza, C Berget, L Laffel, D Raghinaru, T Mouse, R BeckAbstract
Introduction
Background
For most children diagnosed with type 1 diabetes (T1D), insulin treatment generally begins with injections of insulin, which include long-acting basal insulin (BI), usually once a day, and rapid-acting analogue (RAA) insulin at meals and for corrections. Having to give multiple insulin injections during the day can be stressful and burdensome for the child and parents.
Objectives
The INHALE-1st study was designed to evaluate the safety, efficacy, and child/parent satisfaction with a regimen of inhaled insulin in combination with BI in youth with newly-diagnosed T1D.
Methods
An initial feasibility study was conducted at 2 U.S. pediatric diabetes centers. Eight participants (age 10 to 16 years) initiated a regimen of BI plus inhaled insulin for meal boluses and corrections within 3 to 10 days following T1D diagnosis. Initially, contacts for dose adjustments were daily and thereafter less frequently. The primary outcome was time-in-range 70-180 mg/dL (TIR) at 13 weeks.
Results
All 8 participants used the inhaled insulin-BI regimen for 13 weeks. At 13 weeks, TIR was ≥67% for 7 (88%) and >80% for 6 (75%). No serious adverse events occurred. At 4 weeks and 13 weeks, both participant and parent scores on a modified version of the Insulin Treatment Satisfaction Questionnaire showed a high degree of satisfaction and strong preference for inhaled insulin for meals and corrections compared with perceived effects if switched to RAA injections. At completion of the 13-week study, 6 participants elected to continue the inhaled insulin-BI regimen, 1 switched to AID and 1 was removed from the study due to smoking. HbA1c was >11% at study entry in 7 (88%) of the 8 participants and <7% at 13 weeks in 5 (63%).
Conclusions
In a sample of newly diagnosed pediatric TID, the inhaled insulin-BI regimen was well tolerated, with no safety concerns and a high degree of participant and parent satisfaction. Efficacy was very favorable with 75% having a TIR >80% at 13 weeks.