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.
"Two patient-reported outcome (PRO) questionnaires (Device-Specific questionnaires I and II) were self-completed at Visits 14 and 28 to assess subject satisfaction with the FlexTouch pen as an additional trial endpoint. The PRO questionnaire utilized here to assess patient satisfaction with FlexTouch had previously been used in other trials to assess satisfaction with the FlexPen® device (Novo Nordisk A/S, Bagsværd, Denmark) [24, 25]. "
[Show abstract][Hide abstract] 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 · 2.27 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Insulin injection pens have improved the ease and convenience of administering insulin for people with diabetes. This article reviews the data on a new prefilled insulin pen, FlexTouch®. FlexTouch has a novel injection mechanism with no push-button extension and a lower injection force than other prefilled pens, and other features including an end-of-dose click; a large dose display; color-coded pens to distinguish different insulin types; an ergonomic design; and compatibility with both NovoTwist® needles and most screw-thread needles. FlexTouch has been demonstrated to deliver insulin consistently and accurately at minimum, half-maximum and maximum doses. In usability studies recruiting patients and healthcare professionals, FlexTouch was easier to use and instilled more confidence than other prefilled pens, and was preferred to other prefilled pens. FlexTouch was also found to be easier to use and was preferred for learning and teaching to use.
Expert Review of Medical Devices 04/2012; 9(3):209-17. DOI:10.1586/erd.12.13 · 1.68 Impact Factor
[Show abstract][Hide abstract] 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 · 1.70 Impact Factor
Data provided are for informational purposes only. Although carefully collected, accuracy cannot be guaranteed. The impact factor represents a rough estimation of the journal's impact factor and does not reflect the actual current impact factor. Publisher conditions are provided by RoMEO. Differing provisions from the publisher's actual policy or licence agreement may be applicable.