Evidence map›Paper›PMID 27352278›Full record

ReviewAnnals of biomedical engineering2016

A Review of Safety and Design Requirements of the Artificial Pancreas.

Helga Blauw, Patrick Keith-Hynes, Robin Koops, J Hans DeVries

Open access · hybridAbstract readReview
In one paragraph

Review in Annals of biomedical engineering, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
6.2field-weighted citation impact, top 3% of its field
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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 63 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Automated Insulin Delivery Systems: Today, Tomorrow and User Requirements.Journal of diabetes science and technology · 2021
    Article
  8. Review
  9. Observational
  10. Article
  11. Article
  12. Article
  13. Development of glucose-responsive 'smart' insulin systems.Current opinion in endocrinology, diabetes, and obesity · 2017
    Review
  14. Review
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

4 authors at 3 institutions in 3 countries.

Helga BlauwDepartment of Endocrinology, Academic Medical Center, University of Amsterdam, P.O Box 22660, 1100 DD, Amsterdam, The Netherlands. h.blauw@amc.uva.nl.ORCID http://orcid.org/0000-0002-4074-478X
Patrick Keith-HynesTypeZero Technologies, LLC, Charlottesville, VA, USA.
Robin KoopsInreda Diabetic BV, Goor, The Netherlands.
J Hans DeVriesDepartment of Endocrinology, Academic Medical Center, University of Amsterdam, P.O Box 22660, 1100 DD, Amsterdam, The Netherlands.
Amsterdam UMC Location University of Amsterdam · NLFidal · FRUniversity of Virginia · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

As clinical studies with artificial pancreas systems for automated blood glucose control in patients with type 1 diabetes move to unsupervised real-life settings, product development will be a focus of companies over the coming years. Directions or requirements regarding safety in the design of an artificial pancreas are, however, lacking. This review aims to provide an overview and discussion of safety and design requirements of the artificial pancreas. We performed a structured literature search based on three search components-type 1 diabetes, artificial pancreas, and safety or design-and extended the discussion with our own experiences in developing artificial pancreas systems. The main hazards of the artificial pancreas are over- and under-dosing of insulin and, in case of a bi-hormonal system, of glucagon or other hormones. For each component of an artificial pancreas and for the complete system we identified safety issues related to these hazards and proposed control measures. Prerequisites that enable the control algorithms to provide safe closed-loop control are accurate and reliable input of glucose values, assured hormone delivery and an efficient user interface. In addition, the system configuration has important implications for safety, as close cooperation and data exchange between the different components is essential.

Indexed as

AlgorithmsDiabetes Mellitus, Type 1Pancreas, ArtificialSafetyAnimalsGlucagonHumansInsulinInsulin SecretionGlucagonInsulinClosed loop systemDiabetesMedical device developmentRisk analysisSensors

Identifiers

PMID27352278
PMCPMC5093196
OpenAlexW2463970543

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.