Evidence map›Paper›PMID 28840263›Full record

Trial reportDiabetologia2017

Closed-loop glucose control in young people with type 1 diabetes during and after unannounced physical activity: a randomised controlled crossover trial.

Klemen Dovc, Maddalena Macedoni, Natasa Bratina, Dusanka Lepej, Revital Nimri, Eran Atlas, Ido Muller, Olga Kordonouri, Torben Biester, Thomas Danne and 2 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetologia, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02657083 (Prevention of Hypoglycemia After Exercise Using DreaMed Substance Administration Device in Children and Adolescents With Type 1 Diabetes), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
6.7field-weighted citation impact, top 2% 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.

NCT02657083 nacompletednot on this map

Prevention of Hypoglycemia After Exercise Using DreaMed Substance Administration Device in Children and Adolescents With Type 1 Diabetes (The PHYSI-DREAM Study)

TypeinterventionalSponsorUniversity of Ljubljana, Faculty of MedicineRan2016 to 2016Enrolled20ConditionsType 1 Diabetes MellitusArmsDreaMed Substance Administration Device, Sensor Augmented Pump (SAP)
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 82 citations in OpenAlex.

  1. Trial
  2. Review
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  4. Review
  5. Observational
  6. Article
  7. Article
  8. Association of HbA1c with VOMetabolites · 2022
    Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Glycemic Status Assessment by the Latest Glucose Monitoring Technologies.International journal of molecular sciences · 2020
    Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
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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

12 authors at 6 institutions in 4 countries.

Klemen DovcDepartment of Paediatric Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital, University Medical Centre Ljubljana, Bohoriceva 20, SI-1000, Ljubljana, Slovenia.
Maddalena MacedoniDepartment of Paediatrics-Diabetes Service Studies, University of Milan, Ospedale dei Bambini Vittore Buzzi, Milan, Italy.
Natasa BratinaDepartment of Paediatric Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital, University Medical Centre Ljubljana, Bohoriceva 20, SI-1000, Ljubljana, Slovenia.
Dusanka LepejDepartment of Pulmonology, University Children's Hospital, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Revital NimriThe Jesse and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Centre for Childhood Diabetes, Schneider Children's Medical Centre of Israel, Petah Tikva, Israel.
Eran AtlasDreaMed Diabetes Ltd, Petah Tikva, Israel.
Ido MullerDreaMed Diabetes Ltd, Petah Tikva, Israel.
Olga KordonouriDiabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus Auf der Bult, Hannover, Germany.
Torben BiesterDiabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus Auf der Bult, Hannover, Germany.
Thomas DanneDiabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus Auf der Bult, Hannover, Germany.
Moshe PhillipThe Jesse and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Centre for Childhood Diabetes, Schneider Children's Medical Centre of Israel, Petah Tikva, Israel.
Tadej BattelinoDepartment of Paediatric Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital, University Medical Centre Ljubljana, Bohoriceva 20, SI-1000, Ljubljana, Slovenia. tadej.battelino@mf.uni-lj.si.
Kinderkrankenhaus auf der Bult · DELjubljana University Medical Centre · SIOspedale dei Bambini Vittore Buzzi · ITSchneider Children's Medical Center · ILTel Aviv University · ILUniversity of Ljubljana · SI

Funding

Slovenian National Research Agency Grants V3-1505University Medical Centre Ljubljana Research and Development Grant #20110359
6 · The paper itself

Abstract

aims/hypothesisHypoglycaemia during and after exercise remains a challenge. The present study evaluated the safety and efficacy of closed-loop insulin delivery during unannounced (to the closed-loop algorithm) afternoon physical activity and during the following night in young people with type 1 diabetes.

methodsA randomised, two-arm, open-label, in-hospital, crossover clinical trial was performed at a single site in Slovenia. The order was randomly determined using an automated web-based programme with randomly permuted blocks of four. Allocation assignment was not masked. Children and adolescents with type 1 diabetes who were experienced insulin pump users were eligible for the trial. During four separate in-hospital visits, the participants performed two unannounced exercise protocols: moderate intensity (55% of [Formula: see text]) and moderate intensity with integrated high-intensity sprints (55/80% of [Formula: see text]), using the same study device either for closed-loop or open-loop insulin delivery. We investigated glycaemic control during the exercise period and the following night. The closed-loop insulin delivery was applied from 15:00 h on the day of the exercise to 13:00 h on the following day.

resultsBetween 20 January and 16 June 2016, 20 eligible participants (9 female, mean age 14.2 ± 2.0 years, HbA CONCLUSIONS/

interpretationClosed-loop insulin delivery was safe both during and after unannounced exercise protocols in the in-hospital environment, maintaining glucose values mostly within the target range without an increased risk of hypoglycaemia.

trial registrationClinicaltrials.gov NCT02657083

fundingUniversity Medical Centre Ljubljana, Slovenian National Research Agency, and ISPAD Research Fellowship.

Indexed as

AdolescentChildCross-Over StudiesDiabetes Mellitus, Type 1ExerciseFemaleHumansHypoglycemiaMaleClinical scienceDevicesDiabetes in childhoodExerciseHypoglycaemia

Identifiers

PMID28840263
PMCPMC6448906
OpenAlexW2749586080

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

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.