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LAMAinDiab - comparison of 2 pharmacological therapies (lisdexamphetamine vs methylphenidate) for pediatric patients with ADHD and type 1 diabetes - a randomized crossover clinical trial
EU CTIS ID: 2023-506862-30-00
What this study is testing
Patients with ADHD and type I diabetes.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 8-16.5 years at study entry
- T1D diagnosed on the basis of clinical features, presence of autoantibodies typical for type 1 diabetes (at least one of the following: anti-GAD, ICA, IAA/IA2, ZnT8) and/or low C-peptide levels (according to the laboratory standard appropriate for the assay method) and criteria for the diagnosis of diabetes according to the criteria of the Polish Diabetes Association and international societies: - an incident glycemia ≥200mg/dl and symptoms of hyperglycemia (such as increased thirst, polyuria, weakness) or - two times a fasting blood glucose ≥126mg/dl or - A blood glucose ≥200mg/dL in the 120th minute of an oral glucose load test or - HbA1c ≥6.5%.
- T1D treated with functional intensive insulin therapy
- T1D lasting at least 12 months at the time of study inclusion
- a diagnosis of ADHD according to DSM-5 criteria confirmed by a psychiatrist or a diagnosis of ADHD according to other criteria recognized in Poland, confirmed by a delegated investigator as consistent with DSM-5
- Polish citizenship and Polish health insurance
You likely can't join if
- Daily insulin dose<0.3 j/kg and concomitant HbA1c measurement ≤6.5% from the last 3 months (clinical partial remission of T1D);
- Extremely abnormal diabetes compensation - mean HbA1c before signing informed consent ≥12% (not including HbA1c measurement at diagnosis of T1D)
- Diagnosis of intellectual disability or other disability, preventing participation in the study or adaptation to its therapeutic regime (in the case of autism, the decision is made by the Investigator)
- Short stature (height ≤ 3pc according to Center for Child Health centile grids Children's Health OLA and OLAF studies);
- Underweight (body weight ≤ 3pc according to the center's centile grids Children's Health OLA and OLAF studies).
- A diagnosed mental illness or disorder that prevents Participation in the trial, e.g., bipolar affective disorder, schizophrenia, other psychotic disorders
See the full eligibility criteria
Who can join
- Age 8-16.5 years at study entry
- T1D diagnosed on the basis of clinical features, presence of autoantibodies typical for type 1 diabetes (at least one of the following: anti-GAD, ICA, IAA/IA2, ZnT8) and/or low C-peptide levels (according to the laboratory standard appropriate for the assay method) and criteria for the diagnosis of diabetes according to the criteria of the Polish Diabetes Association and international societies: - an incident glycemia ≥200mg/dl and symptoms of hyperglycemia (such as increased thirst, polyuria, weakness) or - two times a fasting blood glucose ≥126mg/dl or - A blood glucose ≥200mg/dL in the 120th minute of an oral glucose load test or - HbA1c ≥6.5%.
- T1D treated with functional intensive insulin therapy
- T1D lasting at least 12 months at the time of study inclusion
- a diagnosis of ADHD according to DSM-5 criteria confirmed by a psychiatrist or a diagnosis of ADHD according to other criteria recognized in Poland, confirmed by a delegated investigator as consistent with DSM-5
- Polish citizenship and Polish health insurance
- For patients capable of becoming pregnant who have begun cohabitation, the use of effective contraception for the entire period of participation in the study, and for patients who have not begun cohabitation, the maintenance of sexual abstinence.
What rules you out
- Daily insulin dose<0.3 j/kg and concomitant HbA1c measurement ≤6.5% from the last 3 months (clinical partial remission of T1D);
- Extremely abnormal diabetes compensation - mean HbA1c before signing informed consent ≥12% (not including HbA1c measurement at diagnosis of T1D)
- Diagnosis of intellectual disability or other disability, preventing participation in the study or adaptation to its therapeutic regime (in the case of autism, the decision is made by the Investigator)
- Short stature (height ≤ 3pc according to Center for Child Health centile grids Children's Health OLA and OLAF studies);
- Underweight (body weight ≤ 3pc according to the center's centile grids Children's Health OLA and OLAF studies).
- A diagnosed mental illness or disorder that prevents Participation in the trial, e.g., bipolar affective disorder, schizophrenia, other psychotic disorders
- Diagnosed hemodynamically significant heart defect, advanced vascular atherosclerosis
- Use of unauthorized drugs (described in Section 6.4) at the time of signing informed consent or initiation of therapy with these drugs during study participation (according to the time criteria described in Section 6.4).
- Hypertension confirmed by 24-hour blood pressure measurement (ABPM) of at least grade II (values of office blood pressure measurements above 99pc for sex, age and height +5mmHg for children <=16 years of age, 160/100mmHg for children >=16 years of age), regardless of pharmacological control. In the case of stage I hypertension (existing before or diagnosed during the study - blood pressure values between 95 and 99pc+5mmHg for children <16 years of age, 140-159/90-99mmHg for children >=16 years of age), participation in the study is allowed under the condition of adequate blood pressure control, including the use of pharmacotherapy.
- Epilepsy without optimal seizure control without optimal seizure control (optimal control defined as at least 3 years of stable treatment or no treatment during which there were no confirmed seizures).
- Diagnosed hyperthyroidism requiring treatment.
- The presence of newly diagnosed diseases at the time of signing the informed consent (diagnosed less than one month before signing the consent), which may affect the evaluation of the effectiveness of the study drugs or the safety of the subject: hypertension, hypothyroidism, celiac disease, anemia, others at the discretion of the Investigator. It is possible to include the child in the clinical trial after the inclusion of appropriate treatment and stabilization of the clinical condition at the discretion of the Investigator. In this case, diabetes visit 1 and subsequent visits should be postponed accordingly (maximum 3 months)
- Lack of permanent residence in the Republic of Poland.
- Pregnancy confirmed by a positive urine pregnancy test performed at an enrollment visit or breastfeeding.
- Declared by parents/legal guardians lack of the ability or willingness to come to the Site at the time specified by the protocol, in particular - to receive the investigational medicinal product at the dosage adjustment stage (need to pick up 4-5 times over 6-8 weeks, each time within 2-3 days of receipt of recommendations).
- Other reasons that, in the opinion of the investigator, are more likely than not to result in difficulties in maintaining the continuity of the participant's participation in the trial or harm to the participant's health if he or she participates in the trial.
- Recognized allergy or hypersensitivity to drugs used in drug intervention pharmacological intervention methylphenidate and/or lisdexamphetamine.
- Language barrier preventing full psychological consultation in Polish.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.