Evidence map›Paper›PMID 38086595›Full record

ArticleBMJ open2023

Lisdexamphetamine versus methylphenidate for paediatric patients with attention-deficit hyperactivity disorder and type 1 diabetes (LAMAinDiab): protocol for a multicentre, randomised cross-over clinical trial in an outpatient telemedicine-supported setting.

Arkadiusz Michalak, Jędrzej Chrzanowski, Hanna Kuśmierczyk-Kozieł, Ewa Klejman, Katarzyna Błaziak, Beata Mianowska, Agnieszka Szadkowska, Agata P Chobot, Przemysława Jarosz-Chobot, Małgorzata Myśliwiec and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05957055 (LAMAinDiab - Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes - a Randomized Cross-over Clinical Trial), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.7field-weighted citation impact, top 29% 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.

NCT05957055 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

LAMAinDiab - Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes - a Randomized Cross-over Clinical Trial

TypeinterventionalSponsorMedical University of LodzRan2024 to 2027Enrolled150ConditionsAttention Deficit Disorder with Hyperactivity, Diabetes Mellitus, Type 1Armsparental training in behavior management, Lisdexamfetamine, Methylphenidate
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 3 citations in OpenAlex.

No citing paper in PubMed yet.

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

16 authors at 7 institutions in 3 countries.

Arkadiusz Michalak *Department of Biostatistics and Translational Medicine, Medical University of Lodz, Lodz, Poland.ORCID 0000-0002-6088-9636
Jędrzej Chrzanowski *Department of Biostatistics and Translational Medicine, Medical University of Lodz, Lodz, Poland.
Hanna Kuśmierczyk-KoziełDepartment of Pediatrics, Diabetology, Endocrinology and Nephrology, Medical University of Lodz, Lodz, Poland.
Ewa KlejmanDepartment of Biostatistics and Translational Medicine, Medical University of Lodz, Lodz, Poland.
Katarzyna BłaziakClinical Trials' Unit, Medical University of Lodz, Lodz, Poland.
Beata MianowskaDepartment of Pediatrics, Diabetology, Endocrinology and Nephrology, Medical University of Lodz, Lodz, Poland.
Agnieszka SzadkowskaDepartment of Pediatrics, Diabetology, Endocrinology and Nephrology, Medical University of Lodz, Lodz, Poland.
Agata P ChobotDepartment of Pediatrics, University Clinical Hospital in Opole, Opole, Poland.
Przemysława Jarosz-ChobotDepartment of Children's Diabetology, Medical University of Silesia, Katowice, Poland.
Małgorzata MyśliwiecDepartment of Pediatrics, Diabetology and Endocrinology, Medical University of Gdansk, Gdansk, Poland.
Iwona MakowskaChild and Adolescent Psychiatric Department, Medical University of Lodz, Lodz, Poland.ORCID 0000-0003-4830-6343
Anna KalenikDepartment of Child Psychiatry, Medical University of Warsaw, Warszawa, Poland.
Monika ZamarlikFaculty of Health Sciences, Institute of Public Health, Jagiellonian University, Krakow, Poland.
Tomasz WolańczykDepartment of Child Psychiatry, Medical University of Warsaw, Warszawa, Poland.
Wojciech FendlerDepartment of Biostatistics and Translational Medicine, Medical University of Lodz, Lodz, Poland wojciech.fendler@umed.lodz.pl.ORCID 0000-0002-5083-9168
Agnieszka ButwickaDepartment of Biostatistics and Translational Medicine, Medical University of Lodz, Lodz, Poland.
Medical University of Lodz · PLMedical University of Warsaw · PLGdańsk Medical University · PLJagiellonian University · PLMedical University of Silesia · PLUniversity of Opole · PLUniversity of Oslo · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAttention deficit hyperactivity disorder (ADHD) affects 5%-10% of paediatric population and is reportedly more common in children with type 1 diabetes (T1D), exacerbating its clinical course. Proper treatment of ADHD in such patients may thus provide neurological and metabolic benefits. To test this, we designed a non-commercial second phase clinical trial comparing the impact of different pharmacological interventions for ADHD in children with T1D. METHODS AND ANALYSIS: This is a multicentre, randomised, open-label, cross-over clinical trial in children and adolescents with ADHD and T1D. The trial will be conducted in four reference paediatric diabetes centres in Poland. Over 36 months, eligible patients with both T1D and ADHD (aged 8-16.5 years, T1D duration >1 year) will be offered participation. Patients' guardians will undergo online once-weekly training sessions behaviour management for 10 weeks. Afterward, children will be randomised to methylphenidate (long-release capsule, doses 18-36-54 mg) versus lisdexamphetamine (LDX, 30-50-70 mg). Pharmacotherapy will continue for 6 months before switching to alternative medication. Throughout the trial, the participants will be evaluated every 3 months by their diabetologist and online psychological assessments. The primary endpoint (ADHD symptom severity, Conners 3.0 questionnaire) will be assessed by a blinded investigator. Secondary endpoints will include HbA1c, continuous glucose monitoring indices and quality-of-life (PedsQL). ETHICS AND DISSEMINATION: The trial is approved by Bioethical Committee at Medical University of Lodz and Polish regulatory agency (RNN/142/22/KE, UR/DBL/D/263/2022). The results will be communicated to the research and clinical community, and Polish agencies responsible for healthcare policy. Patient organisations focused on paediatric T1D will be notified by a consortium member. We hope to use the trial's results to promote collaboration between mental health professionals and diabetes teams, evaluate the economic feasibility of using LDX in patients with both diseases and the long run improve ADHD treatment in children with T1D. TRIAL REGISTRATION NUMBERS: EU Clinical Trials Register (EU-CTR, 2022-001906-24) and NCT05957055.

Indexed as

Attention Deficit Disorder with HyperactivityCentral Nervous System StimulantsDiabetes Mellitus, Type 1MethylphenidateAdolescentBlood GlucoseBlood Glucose Self-MonitoringChildHumansLisdexamfetamine DimesylateMulticenter Studies as TopicOutpatientsRandomized Controlled Trials as TopicTreatment OutcomeBlood GlucoseCentral Nervous System StimulantsLisdexamfetamine DimesylateMethylphenidateBehaviorChild & adolescent psychiatryImpulse control disordersPaediatric endocrinologyProtocols & guidelinesRandomized Controlled Trial

Identifiers

PMID38086595
PMCPMC10728970
OpenAlexW4389627797

What OpenQuestion holds

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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.