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Jerome E. Thurman - One of the best experts on this subject based on the ideXlab platform.

  • Original article Usability and preference evaluation of a prefilled Insulin Pen with a novel injection mechanism by people with diabetes and healthcare professionals
    2020
    Co-Authors: T. Bailey, Jerome E. Thurman, Marcus Niemeyer
    Abstract:

    Objective: This cross-over usability study assessed the perceptions of, and preference for, FT (FlexTouch*), a new prefilled Insulin Pen, compared with KP (KwikPeny) another widely available prefilled Insulin Pen, among people with diabetes and healthcare professionals (physicians and nurses).

  • healthcare professional and patient perceptions of a new prefilled Insulin Pen versus vial and syringe
    Expert Opinion on Drug Delivery, 2012
    Co-Authors: Rosemarie Lajara, German Guerrero, Jerome E. Thurman
    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-naive patients (naive 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-naive 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 ...

  • usability and preference evaluation of a prefilled Insulin Pen with a novel injection mechanism by people with diabetes and healthcare professionals
    Current Medical Research and Opinion, 2011
    Co-Authors: T. Bailey, Jerome E. Thurman, Marcus Niemeyer, G Schmeisl
    Abstract:

    AbstractObjective:This cross-over usability study assessed the perceptions of, and preference for, FT (FlexTouch), a new prefilled Insulin Pen, compared with KP (KwikPen) another widely available prefilled Insulin Pen, among people with diabetes and healthcare professionals (physicians and nurses). *FlexTouch (FT) is a registered trade name of Novo Nordisk A/S, Bagsvaerd, Denmark. †KwikPen (KP) is a registered trade name of Eli Lilly & Co., Indianapolis, IN, USA.Research design and methods:Participants were randomly assigned to start with either FT or KP. Following instruction on how to operate the Pen, the participant performed several injections at different doses into a foam cushion and then answered written questions on ease of use, confidence and preference.Results:Seventy-nine people with diabetes and 81 healthcare professionals (40 physicians and 41 nurses) took part. Overall, most respondents preferred using FT (86%) to KP (7%; p < 0.001), found FT (85%) the easier Pen to use versus KP (4%; p < 0....

  • Analysis of Insulin Pen Devices for the Treatment of Diabetes Mellitus
    Journal of diabetes science and technology, 2008
    Co-Authors: Jerome E. Thurman
    Abstract:

    Insulin Pen devices allow for accurate, flexible, and less complicated delivery of Insulin for the treatment of diabetes mellitus. These devices permit small dose administration, and can be used by patients with limited dexterity and visual impairment. These characteristics may prove beneficial when considering their usefulness. The article by Hanel et al. in this issue of Journal of Diabetes Science and Technology clearly points out that the OptiClik® reusable Pen may underdose Insulin early after cartridge replacement unless properly primed. Insulin Pens clearly offer several advantages over traditional vials and syringes. However, patients must be well educated in their use, with continued communication between them and their health care provider to enable good glycemic control.

  • Insulin Pen injection devices for management of patients with type 2 diabetes considerations based on an endocrinologist s practical experience in the united states
    Endocrine Practice, 2007
    Co-Authors: Jerome E. Thurman
    Abstract:

    Objective: To review the features of several Insulin Pens currently available in the United States, discuss the validity of concerns about certain Pen devices, and provide specific training information for clinicians to increase the accuracy of Insulin administration and patient satisfaction with the use of Insulin Pens.Methods: The published literature on Insulin Pens and Internet-available, product-specific information are reviewed. In addition, special practical considerations regarding Insulin Pen selection based on personal experience in a high-volume endocrinology practice are high-lighted by presentation of case vignettes.Results: For some patients with diabetes, the need for performance of self-injection can be a barrier to acceptance of Insulin therapy. Insulin Pen devices provide a delivery option that may be more acceptable and more convenient to use in comparison with traditional vials and syringes and thus may promote patient compliance, which can enhance the ability to achieve and maintain g...

Marcus Niemeyer - One of the best experts on this subject based on the ideXlab platform.

  • Original article Usability and preference evaluation of a prefilled Insulin Pen with a novel injection mechanism by people with diabetes and healthcare professionals
    2020
    Co-Authors: T. Bailey, Jerome E. Thurman, Marcus Niemeyer
    Abstract:

    Objective: This cross-over usability study assessed the perceptions of, and preference for, FT (FlexTouch*), a new prefilled Insulin Pen, compared with KP (KwikPeny) another widely available prefilled Insulin Pen, among people with diabetes and healthcare professionals (physicians and nurses).

  • assessment for ease of use and preference of a new prefilled Insulin Pen flextouch degludec u100 u200 versus the solostar Insulin Pen by patients with diabetes and healthcare professionals
    Expert Opinion on Drug Delivery, 2014
    Co-Authors: Andreas Pfutzner, Marcus Niemeyer, T Forst, Timothy L. Bailey
    Abstract:

    Objective: FlexTouch® (FT) is a new prefilled Insulin Pen with no push-button extension and a low injection force used to deliver several basal Insulins, including Insulin degludec across a wide dose range (1 – 80 units with FT 100 IU/ml [FT100] and 2 – 160 units with 200 IU/ml [FT200]). This study was carried out to evaluate whether the novel features of FT affect the preferences of the device among patients with diabetes and healthcare professionals compared with the widely used SoloSTAR® Pen.Research design and methods: A multicenter, randomized, oPen-label, crossover study compared FT100 and FT200 with SoloSTAR. The study included patients with either type 1 (n = 22) or type 2 diabetes (n = 42), nurses (n = 32) and physicians (n = 32). Subjects were randomized to test each of the FT100, FT200 and SoloSTAR Pens in a crossover set up. Subjects performed injections into a foam cushion at 4 – 6 different doses per device (2, 20, 40, 80, 120 and 160 IU).Results: Overall, a significantly higher proportion o...

  • accuracy and preference assessment of prefilled Insulin Pen versus vial and syringe with diabetes patients caregivers and healthcare professionals
    Current Medical Research and Opinion, 2013
    Co-Authors: Andreas Pfutzner, David C. Klonoff, Marcus Niemeyer, Timothy L. Bailey, Carlos Campos, German Guerrero, Douglas Kahn, Ellen Ambers, Irina Nayberg
    Abstract:

    AbstractObjectives:The primary objective of this study was to investigate the dosing accuracy of the new prefilled FlexTouch Insulin Pen (FT) in comparison to conventional vial and syringe (V&S) when used by patients (Pts), caregivers (CG) and healthcare professionals (HCPs).Methods:A total of 120 subjects participated in the trial (40 diabetes patients aged 61 ± 11 [mean ± SD] yrs, 20 caregivers [parents and other relatives], 20 physicians, and 40 nurses/certified diabetes educators). The participants were introduced to the devices in randomized order and were asked to perform injections of 5, 25, 43 and 79 IU doses into laboratory tubes. Dosing accuracy was analyzed by weighing the tubes on a pharmaceutical balance and calculating the mean absolute deviation (MAD) from the intended doses. After completing a device assessment questionnaire, Patient Perception Questionnaire (PPQ), with questions regarding device design and performance, the procedure was repeated for the other device, and the patients were...

  • healthcare professional and patient assessment of a new prefilled Insulin Pen versus two widely available prefilled Insulin Pens for ease of use teaching and learning
    Current Medical Research and Opinion, 2012
    Co-Authors: Daniel A Nadeau, Marcus Niemeyer, Carlos Campos, Timothy L. Bailey
    Abstract:

    AbstractObjective:FlexTouch (FT) is a new prefilled Insulin Pen with no push-button extension at any set dose and a low activation force that is designed to improve ease of use and Insulin administration. This paper reports the results of two usability studies assessing perceptions of FT compared with KwikPen (KP)and SoloStar (SS) among healthcare professionals (HCPs; both physicians and nurses) and people with diabetes (both Insulin Pen-experienced and Insulin Pen-naive). *FlexTouch is a registered trade name of Novo Nordisk A/S, Bagsvaerd, Denmark. †KwikPen is a registered trade name of Eli Lilly & Co., Indianapolis, IN, USA. ‡SoloStar is a registered trade name of Sanofi, Paris, France. Research design and methods:Participants were randomly assigned to start with FT or KP in one study and FT or SS in the other. Participants performed injections at different doses (20, 40 and 60 International Units [IU] in the FT vs. KP study or 20, 40 and 80 IU in the FT vs. SS study) into a foam cushion before answeri...

  • a prefilled Insulin Pen with a novel injection mechanism and a lower injection force than other prefilled Insulin Pens
    Diabetes Technology & Therapeutics, 2011
    Co-Authors: Hans Hemmingsen, Marcus Niemeyer, Marianne Rye Hansen, Ditlef Bucher, Niels Bjerrum Thomsen
    Abstract:

    Abstract Background: FlexTouch® (Novo Nordisk A/S, Bagsvaerd, Denmark) is a new prefilled Insulin Pen for people with diabetes, with a novel injection mechanism and no push-button extension at any dose setting. This study compared the injection force of FlexTouch with that of SoloStar® (sanofi-aventis, Paris, France) and KwikPen® (Eli Lilly & Co., Indianapolis, IN). Methods: Injection force was measured with the manufacturers' recommended needle attached to each Pen (NovoFine® [Novo Nordisk] 32-gauge tip extra thin wall 6 mm needle for FlexTouch and BD [Franklin Lakes, NJ] MicroFine™ 31-gauge 5 mm needle for SoloStar and KwikPen) during injection of the maximum dose (60 IU for KwikPen and 80 IU for FlexTouch and SoloStar). Injection was performed at three different constant push-button speeds. Results: FlexTouch had a significantly (P<0.0001) lower injection force than SoloStar and KwikPen at all injection speeds. The mean±SD injection force of FlexTouch was 5.1±0.5 N. At 4, 6, and 8 mm/s push-button spee...

Irina Nayberg - One of the best experts on this subject based on the ideXlab platform.

  • Functional Evaluation of the Reusable JuniorSTAR® Half-Unit Insulin Pen:
    Journal of diabetes science and technology, 2015
    Co-Authors: David C. Klonoff, Irina Nayberg, Ivana Rabbone, Catherine Domenger, Udo Stauder, Hamid Oualali, Thomas Danne
    Abstract:

    Background: The functional performance of the JuniorSTAR® (Sanofi, Paris, France) half-unit Insulin Pen was evaluated through a series of specific objective tests to assess the dose accuracy, Pen w...

  • Evaluation of the JuniorSTAR® Half-unit Insulin Pen in Young People with Type 1 Diabetes - User Perspectives.
    European Endocrinology, 2013
    Co-Authors: David C. Klonoff, Irina Nayberg, Ivana Rabbone, Catherine Domenger, Wolfgang Landgraf, Thomas Danne
    Abstract:

    : This paper discusses the results of a survey on the usability of a new half-unit Insulin Pen, JuniorSTAR® (CE mark Pending, under the responsibility of Haselmeier), in children with type 1 diabetes. Insulin Pen devices have advantages over the traditional vial-and-syringe method of Insulin delivery, including improved patient satisfaction and adherence, greater ease of use and superior accuracy, especially when delivering small doses of Insulin. The accuracy and design of Insulin Pens is particularly important in the paediatric population. Young children often require half-unit adjustments. As the incidence of type 1 diabetes is expected to increase in the coming years in children less than 5 years old, a higher use of half-unit dosing Pens may be anticipated. A survey with JuniorSTAR half-unit Insulin Pen has shown that it is easy to use, read, carry and dial back. This was confirmed by patients and also by nurses. In conclusion, the JuniorSTAR half-unit Pen is well suited to the lifestyle of young people with type 1 diabetes and could help them to gain autonomy to self-inject.

  • accuracy and preference assessment of prefilled Insulin Pen versus vial and syringe with diabetes patients caregivers and healthcare professionals
    Current Medical Research and Opinion, 2013
    Co-Authors: Andreas Pfutzner, David C. Klonoff, Marcus Niemeyer, Timothy L. Bailey, Carlos Campos, German Guerrero, Douglas Kahn, Ellen Ambers, Irina Nayberg
    Abstract:

    AbstractObjectives:The primary objective of this study was to investigate the dosing accuracy of the new prefilled FlexTouch Insulin Pen (FT) in comparison to conventional vial and syringe (V&S) when used by patients (Pts), caregivers (CG) and healthcare professionals (HCPs).Methods:A total of 120 subjects participated in the trial (40 diabetes patients aged 61 ± 11 [mean ± SD] yrs, 20 caregivers [parents and other relatives], 20 physicians, and 40 nurses/certified diabetes educators). The participants were introduced to the devices in randomized order and were asked to perform injections of 5, 25, 43 and 79 IU doses into laboratory tubes. Dosing accuracy was analyzed by weighing the tubes on a pharmaceutical balance and calculating the mean absolute deviation (MAD) from the intended doses. After completing a device assessment questionnaire, Patient Perception Questionnaire (PPQ), with questions regarding device design and performance, the procedure was repeated for the other device, and the patients were...

Timothy L. Bailey - One of the best experts on this subject based on the ideXlab platform.

  • Original article Preference for a new prefilled Insulin Pen compared with the original Pen
    2020
    Co-Authors: Satish K. Garg, Timothy L. Bailey, Tony Deluzio, D. Pollom
    Abstract:

    Background: 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. Objective: This study compares the efficacy, safety profile, and patient preference of the new prefilled Insulin Pen FT* versus the original Insulin Pen FP.y Methods: This randomized, multicenter, oPen-label, crossover study was conducted in Insulin-treated Pen-nao¨ve patients with type 1 or type 2 diabetes mellitus (n ¼ 242, mean age 58 years, mean body mass index (BMI) 31.4 kg/m 2 , baseline glycosylated hemoglobin [HbA1c] 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. HbA1c 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. Results: 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 (P50.001), and treatment burden (P50.001). The safety profiles were comparable for FT and FP. Conclusions: 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.

  • assessment for ease of use and preference of a new prefilled Insulin Pen flextouch degludec u100 u200 versus the solostar Insulin Pen by patients with diabetes and healthcare professionals
    Expert Opinion on Drug Delivery, 2014
    Co-Authors: Andreas Pfutzner, Marcus Niemeyer, T Forst, Timothy L. Bailey
    Abstract:

    Objective: FlexTouch® (FT) is a new prefilled Insulin Pen with no push-button extension and a low injection force used to deliver several basal Insulins, including Insulin degludec across a wide dose range (1 – 80 units with FT 100 IU/ml [FT100] and 2 – 160 units with 200 IU/ml [FT200]). This study was carried out to evaluate whether the novel features of FT affect the preferences of the device among patients with diabetes and healthcare professionals compared with the widely used SoloSTAR® Pen.Research design and methods: A multicenter, randomized, oPen-label, crossover study compared FT100 and FT200 with SoloSTAR. The study included patients with either type 1 (n = 22) or type 2 diabetes (n = 42), nurses (n = 32) and physicians (n = 32). Subjects were randomized to test each of the FT100, FT200 and SoloSTAR Pens in a crossover set up. Subjects performed injections into a foam cushion at 4 – 6 different doses per device (2, 20, 40, 80, 120 and 160 IU).Results: Overall, a significantly higher proportion o...

  • accuracy and preference assessment of prefilled Insulin Pen versus vial and syringe with diabetes patients caregivers and healthcare professionals
    Current Medical Research and Opinion, 2013
    Co-Authors: Andreas Pfutzner, David C. Klonoff, Marcus Niemeyer, Timothy L. Bailey, Carlos Campos, German Guerrero, Douglas Kahn, Ellen Ambers, Irina Nayberg
    Abstract:

    AbstractObjectives:The primary objective of this study was to investigate the dosing accuracy of the new prefilled FlexTouch Insulin Pen (FT) in comparison to conventional vial and syringe (V&S) when used by patients (Pts), caregivers (CG) and healthcare professionals (HCPs).Methods:A total of 120 subjects participated in the trial (40 diabetes patients aged 61 ± 11 [mean ± SD] yrs, 20 caregivers [parents and other relatives], 20 physicians, and 40 nurses/certified diabetes educators). The participants were introduced to the devices in randomized order and were asked to perform injections of 5, 25, 43 and 79 IU doses into laboratory tubes. Dosing accuracy was analyzed by weighing the tubes on a pharmaceutical balance and calculating the mean absolute deviation (MAD) from the intended doses. After completing a device assessment questionnaire, Patient Perception Questionnaire (PPQ), with questions regarding device design and performance, the procedure was repeated for the other device, and the patients were...

  • healthcare professional and patient assessment of a new prefilled Insulin Pen versus two widely available prefilled Insulin Pens for ease of use teaching and learning
    Current Medical Research and Opinion, 2012
    Co-Authors: Daniel A Nadeau, Marcus Niemeyer, Carlos Campos, Timothy L. Bailey
    Abstract:

    AbstractObjective:FlexTouch (FT) is a new prefilled Insulin Pen with no push-button extension at any set dose and a low activation force that is designed to improve ease of use and Insulin administration. This paper reports the results of two usability studies assessing perceptions of FT compared with KwikPen (KP)and SoloStar (SS) among healthcare professionals (HCPs; both physicians and nurses) and people with diabetes (both Insulin Pen-experienced and Insulin Pen-naive). *FlexTouch is a registered trade name of Novo Nordisk A/S, Bagsvaerd, Denmark. †KwikPen is a registered trade name of Eli Lilly & Co., Indianapolis, IN, USA. ‡SoloStar is a registered trade name of Sanofi, Paris, France. Research design and methods:Participants were randomly assigned to start with FT or KP in one study and FT or SS in the other. Participants performed injections at different doses (20, 40 and 60 International Units [IU] in the FT vs. KP study or 20, 40 and 80 IU in the FT vs. SS study) into a foam cushion before answeri...

  • Preference for a new prefilled Insulin Pen compared with the original Pen
    Current Medical Research and Opinion, 2011
    Co-Authors: Satish K. Garg, Timothy L. Bailey, Tony Deluzio, D. Pollom
    Abstract:

    AbstractBackground: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.Objective:This study compares the efficacy, safety profile, and patient preference of the new prefilled Insulin Pen FT *FlexTouch is a registered trade name of Novo Nordisk A/S, Bagsvaerd, Denmark. versus the original Insulin Pen FP. †FlexPen is a registered trade name of Novo Nordisk A/S, Bagsvaerd, Denmark.Methods:This randomized, multicenter, oPen-label, crossover study was conducted in Insulin-treated Pen-naive patients with type 1 or type 2 diabetes mellitus (n = 242, mean age 58 years, mean body mass index (BMI) 31.4 kg/m2, baseline glycosylated hemoglobin [HbA1c] 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 ...

Tom Elliott - One of the best experts on this subject based on the ideXlab platform.

  • evaluation of a new reusable Insulin Pen clikstar in canadian patients with type 1 and type 2 diabetes mellitus receiving Insulin glargine
    Diabetes Technology & Therapeutics, 2012
    Co-Authors: Irving I Gottesman, Patrice Perron, Lori Berard, John Stewart, Nils Basso, Kim Mettimano, Tom Elliott
    Abstract:

    Abstract Background: The objective of this Canadian observational study was to assess the safety and patient satisfaction with the ClikSTAR® (sanofi-aventis, Frankfurt am Main, Germany) reusable Insulin Pen in clinical practice. Subjects and Methods: Patients with diabetes (n=2,517) were recruited from 103 sites, provided with the ClikSTAR Pen, and instructed to report product technical complaints (PTCs), product technical failures (PTFs), and adverse events (AEs) over 6–12 weeks of use. A patient subgroup (n=301) completed a Pen use questionnaire at 12 weeks. The risk acceptance criterion was that no validated PTF led to a serious AE (SAE). PTFs were PTCs having a confirmed technical deficiency. Results: Patients (68.5% with type 2 diabetes) had a mean age of 56.2 years, and 92.5% were Insulin Pen users. In total, 84 PTCs were reported by 79 (3.1%) patients. Most PTCs were due to Pen handling errors. PTCs from 12 patients were possibly related to AEs, three of which were SAEs; none was confirmed to be du...