Mark Peyrot1, Richard R Rubin. 1. Department of Sociology, Loyola University Maryland, Baltimore, Maryland, USA. mpeyrot@loyola.edu
Abstract
AIMS: This randomized controlled trial assessed the impact of Technosphere insulin (MannKind Corp., Valencia, CA) delivered via the MedTone inhaler (MannKind Corp.) on quality of life and treatment satisfaction in adults with type 2 diabetes. METHODS:Subjects were 119 insulin-naive subjects with starting hemoglobin A1c >6.5%: 58 in the active inhaled insulin arm and 61 in the inhaled placebo arm (67% male; mean age 55 years; mean duration of diagnosed diabetes 7 years). Subjects completed a measure of health-related quality of life (the SF-36) and a measure of treatment satisfaction (the Insulin Treatment Questionnaire [ITQ]) before starting insulin treatment and approximately 12 weeks later. The ITQ assesses Diabetes Worries, Perceptions of Insulin Therapy, and Inhaler Performance. RESULTS: There was no significant change in any SF-36 factor or Diabetes Worries during the trial in either arm, and there were no significant between-arm differences in change on any of these measures. Perceptions of Insulin Therapy improved significantly during the trial in the active medication arm (effect size for composite measure = 0.56, P = 0.002) but not in the placebo arm; there were no significant between-arm differences in change. The majority of subjects gave positive ratings of Inhaler Performance on all items (median = 93% positive ratings). CONCLUSIONS: In this study treatment with inhaled Technosphere insulin was well tolerated, clinically efficacious, and associated with positive patient-reported outcomes, including improved attitudes toward insulin therapy and high treatment satisfaction. This treatment strategy was implemented without a negative impact on health-related quality of life or worries about diabetes.
RCT Entities:
AIMS: This randomized controlled trial assessed the impact of Technosphere insulin (MannKind Corp., Valencia, CA) delivered via the MedTone inhaler (MannKind Corp.) on quality of life and treatment satisfaction in adults with type 2 diabetes. METHODS: Subjects were 119 insulin-naive subjects with starting hemoglobin A1c >6.5%: 58 in the active inhaled insulin arm and 61 in the inhaled placebo arm (67% male; mean age 55 years; mean duration of diagnosed diabetes 7 years). Subjects completed a measure of health-related quality of life (the SF-36) and a measure of treatment satisfaction (the Insulin Treatment Questionnaire [ITQ]) before starting insulin treatment and approximately 12 weeks later. The ITQ assesses Diabetes Worries, Perceptions of Insulin Therapy, and Inhaler Performance. RESULTS: There was no significant change in any SF-36 factor or Diabetes Worries during the trial in either arm, and there were no significant between-arm differences in change on any of these measures. Perceptions of Insulin Therapy improved significantly during the trial in the active medication arm (effect size for composite measure = 0.56, P = 0.002) but not in the placebo arm; there were no significant between-arm differences in change. The majority of subjects gave positive ratings of Inhaler Performance on all items (median = 93% positive ratings). CONCLUSIONS: In this study treatment with inhaled Technosphere insulin was well tolerated, clinically efficacious, and associated with positive patient-reported outcomes, including improved attitudes toward insulin therapy and high treatment satisfaction. This treatment strategy was implemented without a negative impact on health-related quality of life or worries about diabetes.
Authors: David T Eton; Tarig A Elraiyah; Kathleen J Yost; Jennifer L Ridgeway; Anna Johnson; Jason S Egginton; Rebecca J Mullan; Mohammad Hassan Murad; Patricia J Erwin; Victor M Montori Journal: Patient Relat Outcome Meas Date: 2013-06-05