Of 263 patients randomized (HumaPen Memoir/Luxura, 130/133), 261 (130/131) patients started to use the study pen, 257 (129/128) patients with at least one post-baseline HbA1c measurement were included in the primary analysis, and 250 (123/127) patients completed the study. Baseline characteristics were similar in both pen groups (). The majority of patients (87.9%) were adults, with a mean (SD) age of 39.8 (16.5) years and a mean (SD) diabetes duration of 16.0 (11.21) years. The mean (SD) HbA1c at baseline was 9.09% (0.99%), and 40.9% of patients had a baseline HbA1c > 9%. Most patients (83.5%) used the short-acting insulin lispro for mealtime insulin injections. Sixty-three percent needed three mealtime insulin injections per day while 35.0% needed ≥4. The mean (SD) basal insulin dose was 0.39 (0.18) IU/kg per day. The mean (SD) prandial insulin dose was 0.43 (0.24) IU/kg per day. Mean basal and prandial insulin doses remained unchanged during the study.
The least square (LS) mean change of HbA1c from baseline up to week 24 did not significantly differ between the pen groups [group difference, HumaPen Memoir minus HumaPen Luxura, 0.05; 95% confidence interval (CI) -0.17 to +0.26; p= .669; ]. Mean HbA1c decreased with both pens. The LS mean (95% CI) changes from baseline were -0.43% (-0.59% to -0.28%) points with HumaPen Memoir and -0.48% (-0.64% to -0.32%) points with HumaPen Luxura (p= .669). Superiority of the memory function pen could not be concluded (). Four patients (3.1%) in the HumaPen Memoir group and seven patients (5.5%) in the HumaPen Luxura group achieved the HbA1c target of ≤7.0% (p= .355).
Change in HbA1c from baseline to week 24. Data presented are LS means derived from the mixed model repeated measures and the respective 95% CIs. MMRM, mixed model repeated measures.
The proportion of patients reporting hypoglycemic episodes (confirmed or unconfirmed) between baseline and week 24 did not differ significantly between both pen groups. At least one hypoglycemic episode was reported by 81 patients (62.3%; severe 1 patient, 0.8%) in the HumaPen Memoir and by 79 patients (60.8%; severe 2 patients, 1.5%) in the HumaPen Luxura group (p= .799). At least one nocturnal episode was reported by 45 patients (34.6%) with HumaPen Memoir and by 54 patients (41.5%) with HumaPen Luxura (p= .250).
On the IDSQ scale, which ranges from 1–7, with higher scores reflecting a more positive evaluation, the mean (SD) IDSQ scores for insulin delivery were 5.6 (1.20) for the HumaPen Memoir and 5.5 (1.41) for the HumaPen Luxura group, and the respective IDSQ scores on the ease of dosing were 6.1 (0.84) and 6.0 (0.88), respectively. Of those patients using HumaPen Memoir, 76.7% were mostly or definitely willing to continue using the study pen, as were 78.1% of those using HumaPen Luxura. The ANCOVA did not identify any significant difference for the different subscale ratings at week 24 (delivery satisfaction, p = .315; perceived blood sugar control, p = .895; ease of dosing, p = .116; lifestyle impact, p = .889; willingness to continue, p = .907). Pen-related functional complaints were reported by 12 patients (9.2%) in the HumaPen Memoir and by 2 patients (1.5%) in the HumPen Luxura pen group. Eleven of the 12 pen-related functional complaints in the HumaPen Memoir group related to a dysfunction of the electronic display. None of the complaints were associated with an adverse event.
Fifty-two patients (40.0%) in the HumaPen Memoir and 56 patients (42.7%) in the HumaPen Luxura group experienced at least one adverse event. The proportions of patients reporting any adverse event or any serious adverse event did not differ between the two pen groups (p = .652 and p = .779, respectively). Nasopharyngitis was the most frequent adverse event in both groups (HumaPen Memoir 9.2%, HumaPen Luxura 11.5%), followed by urinary tract infection (HumaPen Memoir 1.5%, HumaPen Luxura 2.3%) and diabetic foot (HumaPen Memoir 2.3%, HumaPen Luxura 0.8%).