Effect of Technosphere Inhaled Insulin on Quality of Life and Treatment Satisfaction

Peyrot, Mark; Rubin, Richard R.

doi:10.1089/dia.2009.0115

Cited by 29 publications

(23 citation statements)

References 26 publications

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“…6 Our finding of greater between-treatment arm differences in improvement for treatment satisfaction and diabetesspecific quality of life (fear of hypoglycemia) than for generic HRQOL is consistent with previous reports of other diabetes treatments. 20,21 We know of no other study comparing SAPT and MDI + SMBG that assessed HRQOL, but there have been studies of pump therapy and of CGM that assessed HRQOL. A recently published article by the Juvenile Diabetes Research Foundation CGM Study Group of children using insulin pump or MDI therapy reported findings similar to those of the current study; after 26 weeks SF-12 PCS and MCS scores (in adults) and PedsQL total scores (in children and caregivers) were largely unchanged in both CGM and SMBG treatment groups, with no significant difference between treatment groups except for a greater improvement in adult CGM patients in SF-12 PCS scores.…”

Section: Discussionmentioning

confidence: 99%

Health-Related Quality of Life and Treatment Satisfaction in the Sensor-Augmented Pump Therapy for A1C Reduction 3 (STAR 3) Trial

Rubin

Peyrot

2012

Diabetes Technology & Therapeutics

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Objective: This study assessed health-related quality of life (HRQOL) and treatment satisfaction in sensoraugmented pump therapy (SAPT) compared with optimal conventional therapy-multiple daily injection (MDI) therapy with self-monitoring of blood glucose (SMBG)-in adults and children with type 1 diabetes and children's caregivers. Patient acceptance of new therapies is essential to their adoption and effective use. Research Design and Methods: STAR 3, a randomized 12-month clinical trial, compared SAPT with MDI + SMBG in 485 adult and pediatric patients. Within-and between-treatment arm changes in generic HRQOL, diabetesspecific HRQOL (fear of hypoglycemia), and treatment satisfaction were assessed (significance criterion P < 0.01). Results: In adults, children, and caregivers, there were no significant between-arm changes in generic HRQOL: SF-36 Physical Component Summary and Mental Component Summary scores in adults and the PedsQL Physical Health Summary and Psychosocial Health Summary scores in children or caregivers. Diabetes-specific HRQOL (Hypoglycemia Fear Survey Worry and Behavior subscale scores) improved more in SAPT than in MDI adults. Hypoglycemia Behavior scores improved more in SAPT caregivers. Key treatment satisfaction measures (Insulin Delivery System Rating Questionnaire measures of Convenience, Efficacy, and Overall Preference) improved more in SAPT adults, children, and caregivers (all P < 0.001); all exceeded the criterion for minimal detectable difference. Conclusions: In the first-ever large-scale study of SAPT compared with optimal conventional therapy, SAPT had significant advantages for hypoglycemia fear in adults and caregivers and for treatment satisfaction in adults, children, and caregivers.

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Section: Discussionmentioning

confidence: 99%

Health-Related Quality of Life and Treatment Satisfaction in the Sensor-Augmented Pump Therapy for A1C Reduction 3 (STAR 3) Trial

Rubin

Peyrot

2012

Diabetes Technology & Therapeutics

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“…Treatment with TI was associated with high treatment satisfaction and improved attitudes toward insulin treatment [20], without a negative effect on health-related quality of life (HR-QOL) [8]. In trial 102 (Sect.…”

Section: Patient-reported Outcomesmentioning

confidence: 99%

“…These barriers are seen to contribute to clinical inertia, a failure to start or intensify treatment in a timely manner [23]. Inhaled insulin may help to overcome these barriers [20]. TI (Afrezza Ò ) is currently the only inhaled insulin approved and marketed in the USA, and evaluations are ongoing for commercialization globally [10,11,24].…”

Section: Current Status Of Insulin Human Inhalation Powder In Type 1 mentioning

confidence: 99%

AFREZZA® (insulin human) Inhalation Powder: A Review in Diabetes Mellitus

Kim

Plosker

2015

Drugs

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Afrezza® (insulin human) inhalation powder is a rapid-acting Technosphere® insulin (TI) administered via a breath-powered oral inhaler to patients with diabetes requiring prandial insulin. TI, a dry powdered formulation of recombinant human insulin adsorbed onto a proprietary carrier, is designed to deliver insulin to the deep lung, at the level of the alveoli, where it is absorbed into the systemic circulation. In a randomized, open-label, multinational, phase III trial (trial 171) in type 1 diabetes (T1DM) patients, prandial TI via the Gen2 inhaler provided noninferior glycated haemoglobin (HbA1c) lowering compared with prandial subcutaneous insulin aspart. Although TI was associated with less HbA1c lowering, it provided significantly lower fasting plasma glucose levels and significantly less hypoglycaemia and bodyweight gain compared with insulin aspart. In a randomized, double-blind, placebo-controlled, multinational, phase III trial (trial 175) in type 2 diabetes (T2DM) patients, prandial TI via the Gen2 inhaler provided superior HbA1c lowering compared with inhaled placebo. Cough was the most commonly occurring non-hypoglycaemia adverse event across both studies. In a pooled analysis of tolerability data from phase II and III studies, the most commonly occurring non-hypoglycaemia adverse events in T1DM and T2DM patients were cough and throat pain/irritation. However, cough was generally mild, dry and decreased over time. In addition, treatment with TI was associated with positive patient-reported outcomes. Insulin human inhalation powder is an effective and generally well-tolerated agent for the prandial treatment of hyperglycaemia in T1DM and T2DM patients and may provide a solution to insulin initiation barriers such as injection phobia, concerns of bodyweight gain and concerns of hypoglycaemia.

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“…Considering the issues associated with Exubera in the past, patient satisfaction and acceptance has been evaluated with the new inhaled insulin product. Overall, significant improvements in attitudes toward insulin therapy, treatment satisfaction, and treatment preference were reported with Technosphere™ insulin (105,116). The therapeutical approach using the new inhaled insulin was implemented without a negative impact on health-related quality of life (116).…”

Section: Current Ultrafast Insulin Formulationsmentioning

confidence: 99%

“…Overall, significant improvements in attitudes toward insulin therapy, treatment satisfaction, and treatment preference were reported with Technosphere™ insulin (105,116). The therapeutical approach using the new inhaled insulin was implemented without a negative impact on health-related quality of life (116). To date, Technosphere™ insulin has demonstrated a favorable safety and tolerability profile in clinical studies that collected data in healthy volunteers and patients with diabetes (105).…”

Section: Current Ultrafast Insulin Formulationsmentioning

confidence: 99%