LAMAinDiab
Project data
Project financing: 9 987 887 PLN (including financing for UMED: 7 152 075 PLN), financed by the Medical Research Agency (ABM) - ABM/2021/2
Project description:
The aim of the project is to optimise the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents with coexisting type 1 diabetes. ADHD is the most common neurodevelopmental disorder in the paediatric population, yet it remains undiagnosed in approximately 90% of cases. Undiagnosed or untreated ADHD can measurably worsen the control of type 1 diabetes, which is one of the most debilitating chronic diseases – for both the child and their guardians. In addition, currently there are no dedicated ADHD treatment recommendations for this particular group of patients. The project consists of a screening programme for ADHD in selected paediatric diabetes centres in Poland and a non-commercial clinical trial of medicinal products (lisdexamphetamine and methylphenidate). The clinical trial will begin with an initial educational intervention in the form of workshops for guardians, followed by the introduction of pharmacotherapy with one of the study drugs (lisdexamphetamine or methylphenidate) in randomised manner, the therapy will last 6 months followed by a change to the other study drug.
The primary objective and endpoint of the study is to improve control of ADHD symptoms. The other effects of the drugs will also be verified – on improved quality of life and the change in the schooling outcomes of treated patients, as well as increased motor activity and sleep quality – measured by personal accelerometers. Last but not least, the effect of optimising ADHD treatment on diabetes control will also be assessed.
The project is carried out in consortium with the Independent Public Health Care Institution of the Central Clinical Hospital of the Medical University of Lodz and the All-Poland Federation of Diabetes Care Organisations for Children and Adolescents.
Beneficiary
Consortium composed of:
Medical University of Lodz (Leader)
The Central Teaching Hospital of the Medical University of Lodz (Partner)
National Federation of Organisations Helping Children and Young People with Diabetes (Partner)
Coordinating Principal Investigator
Agnieszka Butwicka, MD, PhD