Evidence map›Paper›PMID 28728559›Full record

Trial reportTrials2017

Effect of insulin therapy and dietary adjustments on safety and performance during simulated soccer tests in people with type 1 diabetes: study protocol for a randomized controlled trial.

Javier Calvo-Marín, Gabriel Torrealba-Acosta, Matthew Campbell, Jesse Gaboury, Ajmol Ali, Chih Hao Chen-Ku

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. 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
0.8field-weighted citation impact, top 23% 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

1 citing paper in PubMed, 3 citations in OpenAlex.

  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

6 authors at 5 institutions in 4 countries.

Javier Calvo-MarínDivision of Endocrinology, Hospital San Vicente de Paul, Heredia, Costa Rica. javier.calvo@ucr.ac.cr.
Gabriel Torrealba-AcostaNeuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA.
Matthew CampbellSchool of Sport, Leeds Beckett University, Leeds, West Yorkshire, UK.
Jesse GabouryNeuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA.
Ajmol AliSchool of Sport and Exercise, College of Health, Massey University, Albany, New Zealand.
Chih Hao Chen-KuDepartment of Pharmacology and Clinic Toxicology, University of Costa Rica - Division of Endocrinology, Hospital San Juan de Dios, San José, Costa Rica.
Harvard University · USLeeds Beckett University · GBMassey University · NZSpaulding Rehabilitation Hospital · USUniversidad de Costa Rica · CR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite the reduction in glycemic derangement in patients with type 1 diabetes mellitus (T1D) through dietary and therapeutic adjustments implemented before, during and after continuous exercise, evidence for its effectiveness with intermittent forms of exercise, such as soccer, is still lacking. METHODS/

designWe designed a study protocol for a randomized, crossover, double-blinded, controlled trial, for the evaluation of the effect that a strategy of dietary and therapeutic modifications may have on safety and performance of persons with T1D in soccer training sessions and cognitive testing. Inclusion criteria comprise: age older than 18 years, more than 2 years since T1D diagnosis, low C-peptide level, a stable insulin regimen, HbA1c less than 9.0% and regular participation in soccer activities. Our primary outcome evaluates safety regarding hypoglycemia events in patients using dietary and therapeutic adjustments, compared with the performance under the implementation of current American Diabetes Association (ADA) usual recommendations for nutritional and pharmacological adjustments for exercise. Additionally, we will evaluate as secondary outcomes: soccer performance, indexed by performance in well-established soccer skill tests, cognitive functions (indexed by Stroop, digital vigilance test (DVT), Corsi block-tapping task (CBP), and rapid visual information processing (RVIP) tests), and glycemic control measured with a continuous glucose monitor (CGM). DISCUSSION: Dietary and insulin adjustments standardized under a 4-step method strategy have never been tested in a clinical trial setting with intermittent forms of exercise, such as soccer. We hypothesize that through this strategy we will observe better performance by persons with T1D in soccer and cognitive evaluations, and more stable control of glycemic parameters before, during and after exercise execution, indexed by CGM measurements.

trial registrationISRCTN, ISRCTN17447843. Registered on 5 January 2017.

Indexed as

ExerciseSoccerBiomarkersBlood GlucoseClinical ProtocolsCosta RicaCross-Over StudiesDiabetes Mellitus, Type 1Double-Blind MethodExercise TestGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulinMonitoring, AmbulatoryBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinContinuous glucose monitoringExerciseHypoglycemiaInsulinType 1 diabetes

Identifiers

PMID28728559
PMCPMC5520333
OpenAlexW2739470599

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.