Parents’ perceptions of microneedle-mediated monitoring as an alternative to blood sampling in the monitoring of their infants

Mooney, Karen; McElnay, James; Donnelly, Ryan F.

doi:10.1111/ijpp.12195

Cited by 10 publications

(7 citation statements)

References 25 publications

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“…Microneedle sampling is another novel approach to collecting PK samples while reducing sample volume requirements and procedural discomfort. Microneedles (typically 50‐900 μm), superficially penetrate the skin to sample interstitial fluid (IF) or blood while they avoid deeper (painful) structures such as nerves . For example, a microneedle system was used to sample IF glucose in adult participants; this study showed a strong correlation between IF glucose area under the curve and plasma glucose area under the curve and could potentially be used to monitor postprandial glucose in diabetes mellitus .…”

Section: Clinical Trial Optimizationmentioning

confidence: 91%

“…Microneedles (typically 50–900 um), superficially penetrate the skin to sample interstitial fluid (IF) or blood while avoiding deeper (painful) structures such as nerves. 43,44 For example, a microneedle system was used to sample IF glucose in adult participants; this study showed a strong correlation between IF glucose area under the curve (AUC) and plasma glucose AUC and could potentially be used to monitor postprandial glucose in diabetes. 45 In addition, the vast majority of respondents in the study did not report pain during microneedle sampling.…”

Section: Clinical Trial Optimizationmentioning

confidence: 93%

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Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children

Balevic

Cohen‐Wolkowiez

2018

The Journal of Clinical Pharma

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Almost half of recent pediatric trials failed to achieve labeling indications, due in large part to inadequate study design. Therefore, innovative study methods are crucial to optimize trial design while also reducing the potential harms inherent with drug investigation. Several methods exist to optimize the amount of pharmacokinetic (PK) data collected from the smallest possible volume and with the fewest number of procedures, including the use of opportunistic and sparse sampling, alternative and non-invasive matrices, and micro-volume assays. In addition, large research networks using master protocols promote collaboration, reduce regulatory burden, and increase trial efficiency for both early- and late-phase trials. Large pragmatic trials that leverage electronic health records can capitalize on central management strategies to reduce costs, enroll patients with rare diseases on a large scale, and augment study generalizability. Further, trial efficiency and safety can be optimized through Bayesian adaptive techniques that permit planned protocol changes based on analyses of prior and accumulated data. In addition to these trial design features, advances in modeling and simulation have paved the way for systems-based and physiologically-based models that individualize pediatric dosing recommendations and support drug approval. Lastly, given the low prevalence of many pediatric diseases, collecting de-identified genetic and clinical data on a large scale is a potentially transformative way to augment clinical pharmacology research in children.

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Section: Clinical Trial Optimizationmentioning

confidence: 91%

Section: Clinical Trial Optimizationmentioning

confidence: 93%

Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children

Balevic

Cohen‐Wolkowiez

2018

The Journal of Clinical Pharma

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“…The group interaction promotes discussion, thus leading to a greater appreciation of older people’s views than one-to-one questioning [ 18 ]. A topic guide for focus group discussion was developed according to previous studies investigating MNs using qualitative methodologies [ 11 – 13 , 15 ], and then piloted to refine content and ensure validity. Each focus group began with simple introductory questions relating to medication use and common issues encountered, before progressing to the concept of MNs and discussion points on the use of such a technology by older people, as summarised in Fig.…”

Section: Methodsmentioning

confidence: 99%

In vivo and qualitative studies investigating the translational potential of microneedles for use in the older population

Quinn

Hughes

Donnelly

2017

Drug Deliv. and Transl. Res.

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Microneedles (MNs) are a novel transdermal drug delivery platform, rapidly progressing from a substantive evidence base, towards commercialisation. As part of this transition, it is important to consider the future use of MNs by older people in order to ensure optimal therapeutic outcomes for this unique and increasing population group. This paper, therefore, considers the use of MNs by those aged over 65 years, investigating insertion parameters in ageing skin, alongside the feasibility and acceptability of the technology. Hydrogel-forming MN arrays were applied to seven subjects aged over 65 years, with breach of the stratum corneum confirmed using optical coherence tomography. Insertion depths recorded in each case were similar to a comparative group, aged 20–30 years. Skin recovery was, however, demonstrated to occur at a slower rate in the older subjects, as measured using transepidermal water loss. Qualitative methods, including focus groups and semi-structured interviews, were employed to collect the views and opinions of older people and community pharmacists respectively. The overall consensus was positive, with a number of benefits to MN-mediated drug delivery identified, such as reduced dosing frequency, improved adherence and an alternative delivery route where oral or injectable medication was precluded. Concerns centred on practical issues associated with age-related functional decline, including, for example, reduced dexterity and skin changes. The presentation of this work collectively provides the first convincing report of the importance of further translational research in this area to support future MN use in older people, ensuring an age-appropriate delivery platform.

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“…Due to their small size and short depth of penetration, MNs provide a painless, simple, and minimally invasive way to sample skin ISF. To evaluate patient compliance with MN‐based diagnostics, Mooney et al interviewed 16 parents with experience of premature birth and the interviewees preferred MN‐mediated monitoring over traditional blood sampling in neonates 24. Based on MNs‐mediated fluid extraction strategy, Chang et al achieved offline analysis of metabolites such as glucose and cholesterol 25.…”

Section: Figurementioning

confidence: 99%

Gelatin Methacryloyl Microneedle Patches for Minimally Invasive Extraction of Skin Interstitial Fluid

Zhu

Zhou

Kim

et al. 2020

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141

130

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The extraction of interstitial fluid (ISF) from skin using microneedles (MNs) has attracted growing interest in recent years due to its potential for minimally invasive diagnostics and biosensors. ISF collection by absorption into a hydrogel MN patch is a promising way that requires the materials to have outstanding swelling ability. Here, a gelatin methacryloyl (GelMA) patch is developed with an 11 × 11 array of MNs for minimally invasive sampling of ISF. The properties of the patch can be tuned by altering the concentration of the GelMA prepolymer and the crosslinking time; patches are created with swelling ratios between 293% and 423% and compressive moduli between 3.34 MPa and 7.23 MPa. The optimized GelMA MN patch demonstrates efficient extraction of ISF. Furthermore, it efficiently and quantitatively detects glucose and vancomycin in ISF in an in vivo study. This minimally invasive approach of extracting ISF with a GelMA MN patch has the potential to complement blood sampling for the monitoring of target molecules from patients.

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Parents’ perceptions of microneedle-mediated monitoring as an alternative to blood sampling in the monitoring of their infants

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Cited by 10 publications

References 25 publications

Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children

Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children

In vivo and qualitative studies investigating the translational potential of microneedles for use in the older population

Gelatin Methacryloyl Microneedle Patches for Minimally Invasive Extraction of Skin Interstitial Fluid

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