Preference for a new prefilled insulin pen compared with the original pen.
ABSTRACT The prevalence of diabetes is increasing in the United States and worldwide. Insulin injection pens are preferred over vial/syringe methods, and are designed to facilitate use, improve adherence, and provide accurate insulin delivery.
This study compares the efficacy, safety profile, and patient preference of the new prefilled insulin pen FT* versus the original insulin pen FP.
This randomized, multicenter, open-label, crossover study was conducted in insulin-treated pen-naïve patients with type 1 or type 2 diabetes mellitus (n = 242, mean age 58 years, mean body mass index (BMI) 31.4 kg/m(2), baseline glycosylated hemoglobin [HbA(1c)] 7.3%). Patients were randomized 1:1 to either FT or FP for 12 weeks and then switched to the alternate insulin device for 12 weeks, while the insulin regimen was kept the same. All subjects were on either insulin detemir alone or in combination with insulin aspart treatment during the trial. HbA(1c) was assessed at screening, randomization, cross-over period, and end of trial. The safety profile was evaluated based on adverse events (AEs), adverse device effects (ADEs), and hypoglycemic episodes. Patient-reported outcome (PRO) questionnaires assessed at randomization, crossover period, and end of trial were used to investigate the subjects' preference of the two prefilled devices.
A total of 400 subjects were screened, 242 subjects were randomized and exposed to the prefilled pen devices, and 222 subjects completed the trial. Twenty subjects discontinued the study. Four subjects discontinued due to adverse events. Subject default (withdrawal of consent and loss to follow up) was the most common reason for discontinuation (10 subjects), Glycemic control achieved with FT was comparable to that with FP (FT-FP: difference -0.047 [95% CI -0.127; 0.032%]). The majority of subjects (68%) indicated a preference for the FT device over FP. In addition, the majority of subjects found FT easier to use (64% [144/226]), easier to inject the insulin dose (65% [148/227]) and easier to push for injection (69% [155/226]). The Treatment Related Impact Measure-Diabetes (TRIM-D) ratings of FT were significantly higher for diabetes management facilitation (P < 0.001), and treatment burden (P < 0.001). The safety profiles were comparable for FT and FP.
FT was found to be comparable to FP with respect to the efficacy and safety profile. Significantly more subjects favored the FT device in terms of ease of use, insulin injection, diabetes management, and overall preference. A limitation of the present study was its open-label design because the pen devices used to administer the insulin were distinctively different and the use of a double-dummy design was precluded by the absence of placebo pen devices. The questionnaires about treatment were related to the use of the device and therefore a blinded study was not possible.
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ABSTRACT: For people with diabetes treated with insulin, the development of insulin pens has led to important advantages compared with the use of vials and syringes. Insulin pens are associated with improved ease of use, user confidence, treatment satisfaction, and quality of life compared with vials and syringes. Continual improvements to insulin pen designs to further enhance usability and improve patient perceptions may help to lower patients' resistance to initiating insulin therapy and further improve treatment adherence. This article reviews recent developments in prefilled insulin pens that may assist health care professionals when considering insulin-delivery devices to recommend to their patients.Postgraduate Medicine 09/2012; 124(5):110-20. DOI:10.3810/pgm.2012.09.2587 · 1.54 Impact Factor
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ABSTRACT: Objective: Usability of a new prefilled insulin pen, FlexTouch® (FT; Novo Nordisk A/S, Bagsvaerd, Denmark), with no push-button extension and low injection force, was compared with vial and syringe (V&S). Research design and methods: People with diabetes, and healthcare professionals with diabetes management experience conducted test injections and answered questions on preference, ease of use, confidence, ease of learning and teaching. Results: The study involved 30 needle-naïve patients (naïve to any diabetes injection therapy), 30 V&S-experienced patients, 30 physicians and 30 nurses. In the total population, FT was preferred to V&S for teaching or learning to use (both p < 0.001). Nurses (100 vs. 0%) and physicians (87 vs. 7%) preferred FT to V&S for ease of teaching. V&S-experienced (73 vs. 7%) and needle-naïve patients (83 vs. 7%) preferred FT to V&S for ease of learning. The remainder chose "equally easy/difficult." More participants in each group rated FT "very/fairly easy" for ease of depressing the push-button/plunger (FT vs. V&S: physicians, 93 vs. 80%; nurses, 97 vs. 80%; V&S-experienced patients, 93 vs. 90%; needle-naïve patients, 100 vs. 77%), and injecting three doses. More participants were "very/rather confident" in managing daily injections using FT (FT vs. V&S: physicians, 100 vs. 60%; nurses, 100 vs. 70%; V&S-experienced patients, 93 vs. 90%; needle-naïve patients, 90 vs. 40%). Conclusions: FT was rated easier to use, learn to use or teach to use than V&S by patients with or without experience of insulin injection with V&S, and by physicians and nurses with diabetes management experience.Expert Opinion on Drug Delivery 09/2012; 9(10):1181-96. DOI:10.1517/17425247.2012.721774 · 4.12 Impact Factor
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ABSTRACT: Insulin degludec (IDeg) is a new basal insulin in development with a flat, ultra-long action profile that may permit dosing using a simplified titration algorithm with less frequent self-measured blood glucose (SMBG) measurements and more simplified titration steps than currently available basal insulins. This 26-week, multi-center, open-label, randomized, treat-to-target study compared the efficacy and safety of IDeg administered once-daily in combination with metformin in insulin-naïve subjects with type 2 diabetes using two different patient-driven titration algorithms: a "Simple" algorithm, with dose adjustments based on one pre-breakfast SMBG measurement (n = 111) versus a "Step-wise" algorithm, with adjustments based on three consecutive pre-breakfast SMBG values (n = 111). IDeg was administered using the FlexTouch(®) insulin pen (Novo Nordisk A/S, Bagsværd, Denmark), with once-weekly dose titration in both groups. Glycosylated hemoglobin (HbA1c) decreased from baseline to week 26 in both groups (-1.09%, IDegSimple; -0.93%, IDegStep-wise). IDegSimple was non-inferior to IDegStep-wise in lowering HbA1c [estimated treatment difference (IDegSimple - IDegStep-wise): -0.16% points (-0.39; 0.07)95% CI]. Fasting plasma glucose was reduced (-3.27 mmol/L, IDegSimple; -2.68 mmol/L, IDegStep-wise) with no significant difference between groups. Rates of confirmed hypoglycemia [1.60, IDegSimple; 1.17, IDegStep-wise events/patient year of exposure (PYE)] and nocturnal confirmed hypoglycemia (0.21, IDegSimple; 0.10, IDegStep-wise events/PYE) were low, with no significant differences between groups. Daily insulin dose after 26 weeks was 0.61 U/kg (IDegSimple) and 0.50 U/kg (IDegStep-wise). No significant difference in weight change was seen between groups by week 26 (+1.6 kg, IDegSimple; +1.1 kg, IDegStep-wise), and there were no clinically relevant differences in adverse event profiles. IDeg was effective and well tolerated using either the Simple or Step-wise titration algorithm. While selection of an algorithm must be based on individual patient characteristics and goals, the ability to attain good glycemic control using a simplified titration algorithm may enable patient empowerment through self-titration, improved convenience, and reduced costs.Advances in Therapy 06/2013; 30(6). DOI:10.1007/s12325-013-0036-1 · 2.44 Impact Factor