Comparing Lisdexamphetamine and Methylphenidate for Kids with ADHD and Type 1 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of parental training in behavior management combined with medication for children aged 8-16.5 years who have both Attention Deficit Hyperactivity Disorder (ADHD) and Type 1 Diabetes (T1D). After an initial training period for parents, children will be randomized to receive either lisdexamfetamine or methylphenidate, followed by a crossover to the other medication after a set treatment duration. The study will assess ADHD symptom severity and any adverse events, while also monitoring T1D control and quality of life. Conducted in multiple pediatric diabetes centers in Poland, this trial aims to address the often undiagnosed ADHD in T1D patients.

Why it matters

Who can join: the full rules

Principal inclusion criteria:

* 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-glutamate decarboxylase, islet cell antibody, insulin autoantibody/islet antigen 2 autoantibody, zinc transporter 8 antibody) 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 incidental glycemia ≥200mg/dl and symptoms of hyperglycemia (such as increased thirst, polyuria, weakness) or
  * two times a fasting blood glucose ≥125mg/dl or
  * a blood glucose ≥200mg/dL in the 120th minute of an oral glucose load test or
  * HbA1c ≥6.5%.
* T1D diagnosed at least 12 months before recruitment;
* T1D treated with functional intensive insulin therapy
* a diagnosis of ADHD according to Diagnostic and Statistical Manual 5 (DSM-5) criteria confirmed by a psychiatrist or a diagnosis of ADHD according to other criteria recognized in Poland, confirmed by an authorized person as consistent with DSM-5
* Polish citizenship and Polish health insurance

Principal exclusion criteria:

* Daily insulin dose\<0.3 j/kg and concomitant HbA1c measurement ≤6.5% from the last 3 months (clinical partial remission of T1D);
* Severely unsatisfactory glycemic control - mean HbA1c over the past year ≥12% (not including HbA1c measurement at diagnosis of T1D);
* Diagnosed intellectual or other disability that prevents participation in the trial or adherence to its therapeutic regimen;
* Clinically apparent cardiovascular disease: recognized hemodynamically significant heart defect, advanced vascular atherosclerosis;
* Diagnosis of other mental illness or disorder preventing participation in the trial, e.g. bipolar affective disorder, schizophrenia, other psychotic disorders, psychoactive substance abuse;
* Diagnosed allergy or hypersensitivity to drugs used in pharmacological intervention -methylphenidate and/or lisdexamphetamine;
* Language barrier making it impossible to conduct a full psychological consultation in Polish;
* Lack of permanent residence in Poland;
* Contraindications as reported for investigated drugs: documented hypertension (at least stage 2), positive family history for sudden cardiac deaths and atrial arrythmias in relatives below 40 y.o., clinically evident glaucoma or abnormally elevated intraocular pressure, history of suicide attempts or present suicide intentions, oppositional defiant disorder, chronic motor tics or Tourette syndrome, pregnancy or breastfeeding, short stature, underweight (≤ 3rd percentile for reference percentile charts), epilepsy, pheochromocytoma, substance abuse or positive drug test results, prolonged treatment with sedative drugs (e.g., 1st generation antihistamines);
* Declared by the parents/legal guardians' inability or unwillingness to come to the Center at the time specified by the protocol, in particular - to pick up the Trial drugs at the dose adjustment stage (the need to pick up 4-5 times over 6-8 weeks, each time within 2-3 days of receiving the recommendations);
* Other reasons that, in the opinion of the attending physician, are more likely to result in difficulties in maintaining the continuity of the participant's participation in the trial or harm to the participant's health in case of participation in the trial.

Where it's running

• Pediatric Center of the Central Clinical Hospital of the Medical University of Lodz
  Lodz, Łódź Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Agnieszka Butwicka, A/Prof — Department of Biostatistics and Translational Medicine, Medical University of Lodz
• Study coordinator: Agnieszka Butwicka, A/Prof
• Email: agnieszka.butwicka@umed.lodz.pl
• Phone: +46 72 326 66 31

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predictive CGM with App for people with type 1 or insulin-treated type 2 diabetes

  This study tests whether using the Accu-Chek SmartGuide CGM with its Predict App can reduce fear of hypoglycemia and improve related behaviors and confidence in adults with type 1 or insulin-treated type 2 diabetes.

  Recruiting Fidam Rdc · Bad Mergentheim, Baden-Wurttemberg · NCT07814508

• Tirzepatide for type 1 diabetes patients who are overweight or obese

  This study tests whether tirzepatide can affect stomach emptying in adults with type 1 diabetes and overweight or obesity.

  Recruiting Phase 1 Eli Lilly and Company · Miami, Florida · NCT07803744

• Oral insulin vs. subcutaneous insulin in adults with type 1 diabetes

  This study tests an oral insulin tablet (SCD0503) against subcutaneous insulin and placebo to see how it behaves in the blood and helps control blood sugar in adults with type 1 diabetes.

  Recruiting Phase 1 Sam Chun Dang Pharm. Co. Ltd. · Neuss, North Rhine-Westphalia · NCT07634770

• Genetic risk score and progression to insulin in type 1 diabetes

  This study tests whether a genetic risk score can predict which people with type 1 diabetes will need insulin progression over three years.

  Recruiting Second Xiangya Hospital of Central South University · Changsha, Hunan · NCT07621445

• Home-based use of an advanced hybrid closed-loop insulin pump with telemonitoring for adults with type 1 diabetes

  This study tests whether starting an advanced hybrid closed-loop insulin pump at home, with online education and telemonitoring, is feasible and safe for adults with type 1 diabetes.

  Recruiting Air Liquide Healthcare Spain · Cartagena, Murcia and 2 other locations · NCT07492992

• Diabetes multimorbidity and a voice diary app to help self-manage

  This study tests whether the Fabla-diabetesMM audio diary app is feasible and helpful for older adults with type 1 or type 2 diabetes who also have additional chronic conditions.

  Recruiting Emory University · Atlanta, Georgia · NCT07474376

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.