Treatment satisfaction with inhaled insulin in patients with type 1 diabetes: a randomized controlled trial.
OBJECTIVE
In patients with type 1 diabetes, glycemic control can be achieved as effectively with an inhaled insulin regimen, comprising preprandial inhaled intrapulmonary insulin plus a bedtime ultralente injection, as with a conventional subcutaneous insulin regimen involving two to three injections per day. Our objective was to compare patient satisfaction between inhaled insulin and subcutaneous insulin.


METHODS
Subjects with type 1 diabetes participated in a 12-week open-label trial and were randomized to either an inhaled insulin regimen or a subcutaneous insulin regimen. Subjects (n = 69) were asked to complete a 15-item self-administered satisfaction questionnaire, the Patient Satisfaction with Insulin Therapy (PSIT) Questionnaire, at baseline and week 12. Outcomes included mean percentage changes in global (overall) satisfaction and two subscales: convenience/ease of use and social comfort.


RESULTS
The mean percentage improvement in overall satisfaction with inhaled insulin (35.1%, 95% CI 18.0-52.2) was greater than with subcutaneous insulin (10.6%, 4.7-16.5) (P < 0.01), as was the improvement in convenience/ease of use: inhaled insulin 41.3% (22.9-59.6) versus subcutaneous insulin 11.2% (4.1-18.3; P < 0.01). Improvement in social comfort was greater with inhaled insulin but was not statistically significant. The 12-week change in HbA(1c) was associated with improved overall satisfaction (r = -0.27, P = 0.04).


CONCLUSIONS
Inhaled insulin may offer the first practical, noninvasive alternative to insulin injections. For patients with type 1 diabetes, inhaled insulin maintains glycemic control and provides greater overall satisfaction and convenience/ease of use than subcutaneous insulin.
Gerber
R A
RA
Pfizer Inc., Global Research and Development, Eastern Point Road, Groton, CT 06340, USA. robert_a_gerber@groton.pfizer.com
Cappelleri
J C
JC
Kourides
I A
IA
Gelfand
R A
RA
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy* / Q000523:psychology*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011795:Surveys and Questionnaires
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007328:Insulin