Insulin Treatment Satisfaction Questionnaire (ITSQ) Results for PRONTO-Pump-2 Study

Background In PRONTO-Pump-2, a Phase-3, 16-week, randomized, double-blind clinical trial in patients with type 1 diabetes (T1D) on continuous subcutaneous insulin infusion (CSII), ultra rapid lispro (URLi), showed superior postprandial glucose control and noninferior HbA1c reduction, with less hypoglycemia compared to Lispro. Treatment satisfaction was assessed using the ITSQ.

Methods Patients (URLi, N=215; lispro, N=217) completed the ITSQ at baseline and endpoint (week 16 or early discontinuation). The 5 domains assessed were glycemic control, hypoglycemic control, insulin delivery device, inconvenience of regimen, and lifestyle flexibility. Domain scores were transformed to a scale of 0-100 for analysis, with higher scores indicating better treatment satisfaction. The change in each domain-specific and overall transformed score from baseline to endpoint (last observation carried forward) was analyzed using an ANCOVA model.

Results At endpoint, glycemic control scores had increased from a baseline of 66.9 by + 7.0 (standard error [SE] 1.59; p<0.001), in URLi-treated patients and scores for all other domains, except hypoglycemic control, had numerically increased. For lispro-treated patients, glycemic control scores increased from a baseline of 61.3 by + 3.9(SE 1.51;p=0.010) while inconvenience of regimen scores decreased from a baseline of 80.0 by -2.5(SE 1.13;p=0.029). At endpoint, the inconvenience of regimen score was significantly higher with URLi compared to lispro (between-treatment difference: 2.9[95% CI 0.2, 5.6];p=0.034). No significant differences were observed in the overall ITSQ score between treatments.

Conclusion Patients with T1D treated with URLi using CSII reported satisfaction with glycemic control they experienced and perceived URLi treatment to be more convenient than lispro.

Conflict of Interest

Disclosure: This study was initially presented at American Diabetes Association - 81st Annual Scientific Sessions (ADA 2021).

COI of the authors: All authors are employees and minor stake/shareholders of Eli Lilly and Company.

Publication History

Article published online:
26 May 2022