Evidence map›Paper›PMID 39090697›Full record

ArticleBMC endocrine disorders2024

Single-arm, first-in-human feasibility study results for an ultra-low-cost insulin pump.

Matthew Payne, Francis Pooke, Tom M Wilkinson, Lui Holder-Pearson, Bronté Chamberlain, Martin de Bock, J Geoffrey Chase

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC endocrine disorders, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Matthew PayneDepartment of Mechanical Engineering, Centre for Bioengineering, University of Canterbury, 20 Kirkwood Avenue, Christchurch, 8041, New Zealand. matt.payne@pg.canterbury.ac.nz.
Francis PookeDepartment of Mechanical Engineering, Centre for Bioengineering, University of Canterbury, 20 Kirkwood Avenue, Christchurch, 8041, New Zealand.
Tom M WilkinsonDepartment of Paediatrics, University of Otago, Christchurch, New Zealand.
Lui Holder-PearsonDepartment of Mechanical Engineering, Centre for Bioengineering, University of Canterbury, 20 Kirkwood Avenue, Christchurch, 8041, New Zealand.
Bronté ChamberlainDepartment of Paediatrics, University of Otago, Christchurch, New Zealand.
Martin de BockDepartment of Paediatrics, University of Otago, Christchurch, New Zealand.
J Geoffrey ChaseDepartment of Mechanical Engineering, Centre for Bioengineering, University of Canterbury, 20 Kirkwood Avenue, Christchurch, 8041, New Zealand.

Funding

NZ National Science Challenge 7, Science for Technology, and Innovation 2019-S3-CRSUniversity of Canterbury Doctoral Scholarship
6 · The paper itself

Abstract

backgroundUse of Continuous Subcutaneous Insulin Infusion (CSII) has been shown to improve glycemic outcomes in Type 1 Diabetes (T1D), but high costs limit accessibility. To address this issue, an inter-operable, open-source Ultra-Low-Cost Insulin Pump (ULCIP) was developed and previously shown to demonstrate comparable delivery accuracy to commercial models in standardised laboratory tests. This study aims to evaluate the updated ULCIP in-vivo, assessing its viability as an affordable alternative for those who cannot afford commercially available devices.

methodsThis first-in-human feasibility study recruited six participants with T1D. During a nine-hour inpatient stay, participants used the ULCIP under clinical supervision. Venous glucose, insulin, and β-Hydroxybutyrate were monitored to assess device performance.

resultsParticipants displayed expected blood glucose and blood insulin levels in response to programmed basal and bolus insulin dosing. One participant developed mild ketosis, which was treated and did not recur when a new pump reservoir was placed. All other participants maintained β-Hydroxybutyrate < 0.6 mmol/L throughout.

conclusionThe ULCIP safely delivered insulin therapy to users in a supervised inpatient environment. Future work should focus on correcting a pump hardware issue identified in this trial and extending device capabilities for use in closed loop control. Longer-term outpatient studies are warranted.

trial registrationThe trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623001288617) on the 11 December 2023.

Indexed as

Blood GlucoseDiabetes Mellitus, Type 1Feasibility StudiesHypoglycemic AgentsInsulinInsulin Infusion SystemsAdultFemaleHumansMaleMiddle AgedBlood GlucoseHypoglycemic AgentsInsulinClinical trialInsulin pumpLow-costOpen-source

Identifiers

PMID39090697
PMCPMC11292867

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.