Evidence mapPaperPMID 30849076Full record

Trial reportPloS one2019

Lower plasma insulin levels during overnight closed-loop in school children with type 1 diabetes: Potential advantage? A randomized cross-over trial.

Ulrike Schierloh, Malgorzata E Wilinska, Ineke M Pit-Ten Cate, Petra Baumann, Roman Hovorka, Carine De Beaufort, Spidiman Study Group: Single Port Insulin Infusion for Improved Diabetes Management

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 21% 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

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Recent advances in closed-loop insulin delivery.Metabolism: clinical and experimental · 2022
    Review
  2. Exposure to Closed Loop Barriers Using Virtual Reality.Journal of diabetes science and technology · 2020
    Article
  3. Insulin-delivery methods for children and adolescents with type 1 diabetes.Therapeutic advances in endocrinology and metabolism · 2020
    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

7 authors at 4 institutions in 3 countries.

Ulrike SchierlohPediatric Clinic, Centre Hospitalier de Luxembourg, Luxembourg, GD de Luxembourg.ORCID 0000-0002-7644-4818
Malgorzata E WilinskaDepartment of Paediatrics, University of Cambridge, Cambridge, United Kingdom.
Ineke M Pit-Ten CateFaculty of Language and Literature, Humanities, Arts and Education, University of Luxembourg, Luxembourg, GD de Luxembourg.ORCID 0000-0002-9847-9683
Petra BaumannJoanneum Research Forschungsgesellschaft, Graz, Austria.
Roman HovorkaDepartment of Paediatrics, University of Cambridge, Cambridge, United Kingdom.
Carine De BeaufortPediatric Clinic, Centre Hospitalier de Luxembourg, Luxembourg, GD de Luxembourg.
Spidiman Study Group: Single Port Insulin Infusion for Improved Diabetes Management
Centre Hospitalier de Luxembourg · LUUniversity of Cambridge · GBJoanneum Research · ATUniversity of Luxembourg · LU

Funding

Wellcome Trust
6 · The paper itself

Abstract

backgroundStudies have shown that overnight closed-loop insulin delivery can improve glucose control and reduce the risk of hypoglycemia and hence may improve metabolic outcomes and reduce burden for children with type 1 diabetes and their families. However, research so far has not reported insulin levels while comparing closed-loop to open-loop insulin delivery in children. Therefore, in this study we obtained glucose levels as well as plasma insulin levels in children with type 1 diabetes to evaluate the efficacy of a model-based closed-loop algorithm compared to an open-loop administration.

methodsFifteen children with type 1 diabetes, 6-12 years, participated in this open-label single center study. We used a randomized cross over design in which we compared overnight closed-loop insulin delivery with sensor augmented pump therapy for two nights in both the hospital and at home (i.e., 1 night in-patient stay and at home per treatment condition). Only during the in-patient stay, hourly plasma insulin and blood glucose levels were assessed and are reported in this paper.

resultsResults of paired sample t-tests revealed that although plasma insulin levels were significantly lower during the closed-loop than in the open-loop (Mean difference 36.51 pmol/l; t(13) = 2.13, p = .03, effect size d = 0.57), blood glucose levels did not vary between conditions (mean difference 0.76 mmol/l; t(13) = 1.24, p = .12, d = 0.37). The administered dose of insulin was significantly lower during the closed-loop compared with the open-loop (mean difference 0.10 UI; t(12) = 2.45, p = .02, d = 0.68).

conclusionsLower insulin doses were delivered in the closed-loop, resulting in lower plasma insulin levels, whereby glucose levels were not affected negatively. This suggests that the closed-loop administration is better targeted and hence could be more effective.

Indexed as

Blood GlucoseChildCross-Over StudiesDiabetes Mellitus, Type 1FemaleHumansHypoglycemiaHypoglycemic AgentsInsulinInsulin Infusion SystemsMaleTreatment OutcomeBlood GlucoseHypoglycemic AgentsInsulin

Identifiers

PMID30849076
PMCPMC6408001
OpenAlexW2921922020

What Socratic holds

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LicenceCC BY
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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 Socratic graph.