Dataset Information

Injecting without pressing a button: An exploratory study of a shield-triggered injection mechanism.

ABSTRACT: AIMS:To evaluate the injection success and user perception of a shield-triggered pen-injector mechanism. METHODS:The trial (ClinicalTrials.gov NCT02627287) was an exploratory, two-centre, one-visit, open-label, randomized controlled trial conducted in Germany in 150 injection-experienced individuals with type 1 or type 2 diabetes. Participants self-administered subcutaneous injections of a placebo solution using a prototype shield-triggered pen-injector, DV3316 (Novo Nordisk, Bagsvaerd, Denmark), and FlexPen (Novo Nordisk, Bagsvaerd, Denmark). Injection success was evaluated on a yes/no basis by the investigator. Participant confidence, leakage of fluid and pain were evaluated after each injection. Pain and device experience were assessed after completion of all injections with each pen-injector. Overall preference was assessed after completion of all injections with both pen-injectors. RESULTS:Injection success was high with both pen-injectors (97.0%, DV3316 vs 99.7%, FlexPen). Participant confidence in dose delivery was similar for the two devices (88% of injections with DV3316 vs 81% with FlexPen were scored as "extremely confident"). The median injection pain score on a visual analogue scale (0-100) was 3 with DV3316 vs 4 with FlexPen after each injection, and 4 with DV3316 vs 5 with FlexPen after all injections with each device. After all injections were completed, 55% of participants reported an overall preference for DV3316 vs 21% for FlexPen. CONCLUSION:This study demonstrates that injection-experienced individuals can achieve a high injection success rate with a shield-triggered pen-injector, with similar patient confidence and injection pain compared with FlexPen.

SUBMITTER: Zijlstra E

PROVIDER: S-EPMC5947669 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Injecting without pressing a button: An exploratory study of a shield-triggered injection mechanism.

Zijlstra Eric E Coester Hans-Veit HV Heise Tim T Plum-Mörschel Leona L Rasmussen Ole O Rikte Tord T Pedersen Line Kynemund LK Qvist Marianne M Sparre Thomas T

Diabetes, obesity & metabolism 20180125 5

<h4>Aims</h4>To evaluate the injection success and user perception of a shield-triggered pen-injector mechanism.<h4>Methods</h4>The trial (ClinicalTrials.gov NCT02627287) was an exploratory, two-centre, one-visit, open-label, randomized controlled trial conducted in Germany in 150 injection-experienced individuals with type 1 or type 2 diabetes. Participants self-administered subcutaneous injections of a placebo solution using a prototype shield-triggered pen-injector, DV3316 (Novo Nordisk, Bags ...[more]

PMID: 29369493

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Project description:The dataset presented in the article consists of finger forces of participants during a finger pressing task. The finger pressing task involves the production of fingertip forces using Index, Middle, Ring, and Little (I, M, R&L) fingers of the right hand. The participant performed two types of task, namely MVC task and visual occlusion task. The participants completed the Maximum Voluntary Contraction (MVC) task first, where they were instructed to produce maximum possible force from each finger individually and all fingers together. The visually occluded finger pressing task followed the MVC task. In this task, the participant's visual feedback was removed after 8s. There were two conditions in this task, one with post-trial performance feedback (referred to as "epilogue" condition in this manuscript) and another that does not have this post-trial performance feedback (referred to as "no epilogue" condition in this manuscript). The epilogue condition is a particular case of post-trial visual feedback where, at the end of each trial, the performance in that trial is shown to the participant. This was followed by the next trial. Normalization of force levels for visual occlusion tasks was performed for the forces with the participants produced in the MVC task. Fourteen healthy participants were recruited for performing the experiments. For the experiments, they were instructed to produce fingertip forces using four fingers of the right hand with the target line at 15% MVC (15% of the force that they produced in the MVC task). The two visual occlusion conditions had 30 trials each. In both conditions, a single trial lasted 16 s. For the initial 8 s, there is visual feedback, which follows an eight-second visual occlusion period where there is no visual feedback. The dataset consists of three files; the first file has the data of Maximum Voluntary Contraction (MVC) data, the second file has the data for the "without epilogue" condition, and the third file has the data of "epilogue" case.

Project description:IntroductionThe aim of this randomized controlled trial was to assess the impact of providing intensive injection technique (IT) education to patients routinely injecting insulin into sites of lipohypertrophy (LH).MethodsBetween November 2016 and May 2018, insulin-injecting patients with LH treated at Tianjin Metabolism Hospital (a public tertiary medical institution), Tianjin, China, were included in a 6-month prospective randomized controlled trial and randomized into either the intervention (the IT-education group) or the control (control group) arm. The control and IT-education groups were seen by different groups of trained nurses on different clinic days. IT education emphasized moving injections to normal tissue sites, within-and between-site injection rotation, an initial reduction of insulin total daily dose (TDD), and stopping needle reuse. Needles were provided to the IT group, while controls acquired needles in their usual way. Differences in changes in glycated hemoglobin (HbA1c) and insulin TDD were the primary and main secondary endpoints, respectively.ResultsThe control (n = 104) and IT-education (N = 106) groups had similar demographic parameters (97% with type 2 diabetes) and baseline IT behavior. HbA1c reduction was similar in the IT-education and control group in the intention-to-treat (ITT) analysis (6-month between-group difference 0.16% [1.7 mmol/mol], 95% confidence interval [CI] - 0.11, 0.43 [- 1.2, 4.7]; p = 0.239) but was significant by the per-protocol (PP) analysis (difference 0.31% [3.4 mmol/mol], 95% CI 0.02, 0.60 [0.2, 6.6]; p = 0.038). Changes in TDD insulin in the IT-education group were approximately - 7 and - 8 IU by the ITT and PP analyses, respectively, versus - 1 IU (nonsignificant) in the controls (both between-group differences p ≤ 0.05). Despite the study design, IT education "contamination" (unplanned adoption of IT-intervention behaviors) was documented in 63 control patients. By post hoc analyses, HbA1c in "contaminated" controls decreased by 0.70% (7.7 mmol/mol) vs. 0.20% (2.2 mmol/mol) in "non-contaminated' patients (p = 0.019) at 6 months.ConclusionsProper IT, including learning to not inject into sites of LH, proper within- and between site rotation, needle reuse reduction, and the use of 4-mm, 32-G needles in Chinese patients injecting into sites of LH enables a safe reduction of TDD insulin while maintaining overall glycemic control.Trial registrationTrial registration: ChiCTR-IOR-16009270 in the Chinese Clinical Trials Registry.

Dataset Information

Injecting without pressing a button: An exploratory study of a shield-triggered injection mechanism.

Publications

Injecting without pressing a button: An exploratory study of a shield-triggered injection mechanism.

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