Literature DB >> 26002837

Usability of the Gla-300 Injection Device Compared With Three Other Commercialized Disposable Insulin Pens: Results of an Interview-Based Survey.

David Klonoff1, Irina Nayberg2, Frank Erbstein3, Anna Cali4, Claire Brulle-Wohlhueter4, Thomas Haak5.   

Abstract

Entities:  

Keywords:  Gla-300 SoloSTAR; insulin pen; interview-based survey; usability

Mesh:

Substances:

Year:  2015        PMID: 26002837      PMCID: PMC4525641          DOI: 10.1177/1932296815586219

Source DB:  PubMed          Journal:  J Diabetes Sci Technol        ISSN: 1932-2968


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New insulin glargine 300 U/mL (Gla-300; Toujeo®), recently approved for use in the United States and in Europe, has more stable and prolonged pharmacokinetic and pharmacodynamic profiles compared with glargine 100 U/mL (Gla-100; Lantus®).[1] In clinical practice this translates into a comparable glucose-lowering effect and reduced risk of hypoglycemia.[2-4] To deliver Gla-300, the well-known and widely used SoloSTAR® pen has been adapted, allowing accurate delivery of insulin units in one-third of the volume compared with Gla-100. To evaluate the perceptions of people with diabetes (users; 26 with type 1 and 228 with type 2 diabetes) and health care professionals with experience in prescribing insulin pens and training insulin pen users (trainers; n = 190) about the usability of the Gla-300 SoloSTAR, we conducted an interview-based survey in France, Germany, Spain, the United Kingdom, the United States, and Japan, comparing this device with three other commercialized disposable insulin pens: Gla-100 SoloSTAR (Sanofi, Paris, France), FlexPen® (Novo Nordisk A/S Bagsværd, Denmark), and KwikPen™ (Eli Lilly & Co, Indianapolis, IN). Each 75-minute face-to-face interview was conducted by an independent moderator. First, participants ranked a predefined list of features in order of importance to them, before the moderator demonstrated how to use each pen. Participants then tested each pen and ranked them (first, second, third or fourth) for each predefined feature (Figure 1). Only the identity of Gla-300 SoloSTAR was masked as the survey included pen-experienced users; to avoid bias caused by familiarity with other insulin pens, ≤16% of users were experienced with any one device. Participants were not informed of the survey sponsor.
Figure 1.

Percentage of users (n = 254) (A) and trainers (n = 190) (B) ranking each pen device in first place for each pen feature, in order of importance of pen features to the surveyed population (top is most important and bottom is least important). *P < .05 vs Gla-300 SoloSTAR. **P < .01 vs Gla-300 SoloSTAR. ***P < .001 vs Gla-300 SoloSTAR. Statistical significance estimated using two-tailed one-sample t test. Only trainers were asked to rank devices against the feature “Least time required to train in using the device.”

Percentage of users (n = 254) (A) and trainers (n = 190) (B) ranking each pen device in first place for each pen feature, in order of importance of pen features to the surveyed population (top is most important and bottom is least important). *P < .05 vs Gla-300 SoloSTAR. **P < .01 vs Gla-300 SoloSTAR. ***P < .001 vs Gla-300 SoloSTAR. Statistical significance estimated using two-tailed one-sample t test. Only trainers were asked to rank devices against the feature “Least time required to train in using the device.” Both users and trainers selected the same three features as being most important (Figure 1). Of these, users and trainers ranked Gla-300 SoloSTAR first for “Easiest to inject yourself” and “Easiest to use overall” significantly more often than other pens. In addition, the percentage of users and trainers ranking Gla-300 SoloSTAR in first place for “Easiest to dial the right dose” was numerically higher than for any other pen, although these differences did not always reach statistical significance. Gla-300 SoloSTAR was also ranked first significantly more often than the other pens when considering the feature “Least effort required to push plunger” (Figure 1). This suggests that Gla-300 SoloSTAR may benefit people with reduced hand strength, although supporting data from a laboratory-based injection-force study would be of interest. Of note, Gla-100 SoloSTAR was perceived to perform significantly better than Gla-300 SoloSTAR for “Easiest to see how much insulin is left in the pen,” as was FlexPen for “Easiest to feel and hear the dial turning.” This interview-based survey has limitations that should be considered when interpreting the results, including the use of only a single personal interview, the unmasked nature of the survey with regards to three of the tested pens, and the use of newly developed questionnaires that have not been validated or undergone psychometric testing. Further investigation of the use of Gla-300 SoloSTAR in clinical practice, ideally by insulin-naïve people with diabetes who may be reluctant to initiate insulin therapy, would therefore be of interest. In conclusion, these survey results are promising because an insulin device that is easy to use and inject may contribute to increased adherence to insulin therapy,[5] and therefore improve glycemic management.
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Authors:  Reinhard H A Becker; Raphael Dahmen; Karin Bergmann; Anne Lehmann; Thomas Jax; Tim Heise
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3.  New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2).

Authors:  Hannele Yki-Järvinen; Richard Bergenstal; Monika Ziemen; Marek Wardecki; Isabel Muehlen-Bartmer; Emmanuelle Boelle; Matthew C Riddle
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4.  New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1).

Authors:  Matthew C Riddle; Geremia B Bolli; Monika Ziemen; Isabel Muehlen-Bartmer; Florence Bizet; Philip D Home
Journal:  Diabetes Care       Date:  2014-07-30       Impact factor: 19.112

5.  New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naïve people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3).

Authors:  G B Bolli; M C Riddle; R M Bergenstal; M Ziemen; K Sestakauskas; H Goyeau; P D Home
Journal:  Diabetes Obes Metab       Date:  2015-02-12       Impact factor: 6.577

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1.  Patients' Preferences for Insulin Injection Devices.

Authors:  Andreas Pfützner
Journal:  J Diabetes Sci Technol       Date:  2017-01-09

Review 2.  Clinical Pharmacokinetics and Pharmacodynamics of Insulin Glargine 300 U/mL.

Authors:  Jennifer N Clements; Tiffaney Threatt; Eileen Ward; Kayce M Shealy
Journal:  Clin Pharmacokinet       Date:  2017-05       Impact factor: 6.447

Review 3.  Insulin Glargine 300 U/mL: A Review in Diabetes Mellitus.

Authors:  Hannah A Blair; Gillian M Keating
Journal:  Drugs       Date:  2016-03       Impact factor: 9.546

4.  Accuracy and Injection Force of the Gla-300 Injection Device Compared With Other Commercialized Disposable Insulin Pens.

Authors:  David Klonoff; Irina Nayberg; Marissa Thonius; Florian See; Mona Abdel-Tawab; Frank Erbstein; Thomas Haak
Journal:  J Diabetes Sci Technol       Date:  2015-08-26

Review 5.  rDNA insulin glargine U300 - a critical appraisal.

Authors:  Fei Wang; Stefanie Zassman; Philip A Goldberg
Journal:  Diabetes Metab Syndr Obes       Date:  2016-12-02       Impact factor: 3.168

Review 6.  Challenges and unmet needs in basal insulin therapy: lessons from the Asian experience.

Authors:  Wing Bun Chan; Jung Fu Chen; Su-Yen Goh; Thi Thanh Huyen Vu; Iris Thiele Isip-Tan; Sony Wibisono Mudjanarko; Shailendra Bajpai; Maria Aileen Mabunay; Pongamorn Bunnag
Journal:  Diabetes Metab Syndr Obes       Date:  2017-12-15       Impact factor: 3.168

7.  Ease of Use of the Insulin Glargine 300 U/mL Pen Injector in Insulin-Naïve People With Type 2 Diabetes.

Authors:  Harald Pohlmeier; Lori Berard; Claire Brulle-Wohlhueter; Junlong Wu; Raphael Dahmen; Irene Nowotny; David Klonoff
Journal:  J Diabetes Sci Technol       Date:  2016-09-25

Review 8.  Insulin glargine 300 U/mL for basal insulin therapy in type 1 and type 2 diabetes mellitus.

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9.  Efficacy and Safety of Switching from Insulin Glargine 100 U/mL to the Same Dose of Glargine 300 U/mL in Japanese Type 1 and 2 Diabetes Patients: A Retrospective Analysis.

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10.  Efficacy and Safety of Switching Patients Inadequately Controlled on Basal Insulin to Insulin Glargine 300 U/mL: The TRANSITION 2 Study.

Authors:  Pierre Gourdy; Amar Bahloul; Zahra Boultif; Didier Gouet; Bruno Guerci
Journal:  Diabetes Ther       Date:  2019-11-28       Impact factor: 2.945

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