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.

INTRODUCTION: Attention 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.

Assessment of Selected Aspects of the Quality of Life of Children with Type 1 Diabetes Mellitus in Poland.

Type 1 diabetes mellitus (T1D) is, next to obesity and asthma, the most common chronic disease in children in Poland. T1D is not only a medical challenge, but it also affects all areas of a sick child's life and family functionality. New forms of therapy facilitate the daily management of the disease, but their availability is limited and partly dependent on socioeconomic status. This study aimed to assess the incidence and interrelationships between the child's health condition and the applied therapy model, and selected aspects of the child's family functionality and access to health and care services. The survey involved 206 child and youth caregivers with T1D who are members of Facebook support groups. The analysis of the obtained results revealed the existence of links between family income level and the type of insulin therapy applied. Children from families with a better financial situation (subjective and objective) were more likely to have additional medical consultations and make more frequent control visits. In families with a higher level of income, the T1D-induced restriction of child activity was less frequent. Living outside of urban centers was associated with a reduced availability of care or educational facilities adapted to take care of a child with T1D. No statistically significant correlations were observed between demographic and economic factors and the child's health status expressed by the occurrence of complications. The incidence of the latter, however, affected the child's family situation.

Providing care for children with type 1 diabetes in kindergartens and schools.

INTRODUCTION: Type 1 diabetes in the paediatric population is becoming a serious social problem affecting an increasing number of families with small, dependent children. Polish educational institutions are not prepared to provide care for students with diabetes. There are no nurses who, by law, are responsible for taking care for diabetic children. Teachers are not trained to provide care for pupils with diabetes and there is no system of obligatory, standardized training in this field. AIM: The aim of the study was to examine parents' opinions of the quality of care for diabetic students in educational institutions and compare the results obtained in 2013 and 2020. MATERIAL AND METHODS: The research, in the form of a questionnaire containing closed and open questions, was conducted in 2013 (n = 602) and 2020 (n = 604). RESULTS: There has been a slight positive change in providing the right care for children with type 1 diabetes in school facilities. In 2013 parents rated the quality of diabetic care as: bad - 13%, insufficient - 68%, sufficient - 14%, good - 5%, and in 2020 as: bad - 11%, insufficient - 54%, sufficient - 25.5%, good - 10.5%. However, the problem of the lack of appropriate legal regulations and absence of nurses in educational institutions has deepened. Systematic training of staff financed from public funds has still not been provided. CONCLUSIONS: It is necessary to solve the problem systematically, introduce mandatory, standardized training, clarify the responsibilities of teachers taking care of children with diabetes, introduce appropriate legislative changes and regulate the currently omitted preschool children.

The degree of fathers' involvement in taking care of children with diabetesand its implications in family functioning in the assessment of diabetic children's mothers.

INTRODUCTION: Children's type 1 diabetes is one of the most mentally aggravating chronic diseases for the patient and his/her parents. The disease disturbs relationships in the family, disrupts communication, and enforces a change in the organisation of daily life. THE AIM OF THE STUDY: The aim of the study was to gather opinions about fathers' involvement in taking care of children with type 1 diabetes. Opinions were stated by mothers of sick children regarding managing of diabetes and its impact on the functioning and relationships of the family. MATERIAL AND METHODS: The survey (conducted in 2017) was in the form of a questionnaire, which was filled in by 459 mothers. The average duration of the child's illness was 3.8 years, (SD 2.95, Me 3), the average age of the child was about 8.9 years (SD 3.96, Me 8.5). RESULTS: 83% of the respondents indicated that the child's disease was a huge psychological burden for them and that it was the mother who mostly took care of the sick child. 38.8% of mothers could count on the support of other family members. Because of the need to take care of the child, 58.8% of them were not professionally active, and 24.2%, despite their professional activity, were the only ones in the family who controlled the diabetes. In 15.3% of families, the father did not perform any activities related to the child's diabetes. 33.8% estimated that the child's disease worsened the situation of the family, and in 4.4% it caused its disintegration. Only 18.1% of mothers declared that the father was able to look after the child with diabetes by himself. CONCLUSIONS: It is necessary to support families affected by diabetes. Their personal and social skills should be developed so that they can cope with chronic disease and the duties related to managing diabetes. The responsibility should be shared by both parents.