About this trial

This clinical trial aims to evaluate the safety and effectiveness of an intervention involving parental training in behaviour management and medication in children with both Type 1 Diabetes (T1D) and Attention Deficit Disorder with Hyperactivity (ADHD). ADHD is a neurodevelopmental disorder that affects around 5% of school-age children and adolescents, while T1D is a chronic disease requiring strict management.

After initial parental training provided for parents/legal guardians, the children will be randomized to one of two cross-over groups, and treated with either lisdexamfetamine or methylphenidate first. After dose optimization for first 5-7 weeks, patients will be treated for 6 months total, after which they will be switched to the other drug.

Researchers will then compare the ADHD symptom severity as measured by Conners 3 questionnaire, and compare the frequency of any adverse events associated with the therapy. As secondary outcomes, patient's T1D control and quality of life will be compared between the two drugs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 8-16.5 years at study entry;

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

Disqualifiers

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;

Trial design

Design model

Crossover

Treatments tested in this trial

parental training in behavior management
Behavioral
Parental training in behavior management - online group sessions (4-6 families within group) with trained specialist, 10 once-weekly sessions. To continue to pharmacotherapy, the parents/legal guardians are required to participate in at least 8 out of 10 sessions.
Lisdexamfetamine
Drug
Once-daily pharmacotherapy with lisdexamfetamine (608137-32-2, SUB32146), administered orally, for a duration of 6 months with initial dose of 30mg and dose optimization for 5-7 weeks (visits after 1st, 3rd and 5th week of therapy to adjust dose, in 20mg steps).
Methylphenidate
Drug
Once-daily pharmacotherapy with methylphenidate (prolonged-release tablet, 298-59-9, SUB03254MIG), administered orally, for a duration of 6 months with initial of 18mg dose optimization for 5-7 weeks (visits after 1st, 3rd and 5th week of therapy to adjust dose, in 18mg steps).

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Methylphenidate first, lisdexamfetamine secondActive comparator 2 interventions

Group B: Lisdexamfetamine first, methylphenidate secondActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in ADHD symptom scores on the "inattention" scale of the Conners 3 questionnaire

Change of ADHD symptom severity, measured as the difference in ADHD symptom score on the "inattention" scale of the Conners 3 questionnaire (completed by patient and parent/legal guardian), assessed by the investigator blinded to patient allocation.

Time frame

Before pharmacotherapy (after completion of PT training) and the end of the 6-month course of pharmacotherapy with LDX or MPH; similar difference (before pharmacotherapy and after 6 months of therapy) for the other drug

2

Change in ADHD symptom scores on the "hyperactivity/impulsivity" scale of the Conners 3 questionnaire

Change of ADHD symptom severity, measured as the difference in ADHD symptom score on the "hyperactivity/impulsivity" scale of the Conners 3 questionnaire (completed by patient and parent/legal guardian), assessed by the investigator blinded to patient allocation.

Time frame

Before pharmacotherapy (after completion of PT training) and the end of the 6-month course of pharmacotherapy with LDX or MPH; similar difference (before pharmacotherapy and after 6 months of therapy) for the other drug

3

The number of adverse events - methylphenidate arm

The number of adverse events coded following the MedDRA dictionary.

Time frame

Events recorded throughout treatment with MPH for 6 months after randomization or cross-over

4

The frequency of adverse events - methylphenidate arm

The frequency of adverse events per patient-month coded following the MedDRA dictionary.

Time frame

Events recorded throughout treatment with MPH for 6 months after randomization or cross-over.

Secondary outcomes

1

Change in Type 1 Diabetes Mellitus metabolic control - glycated haemoglobin

Change of metabolic control of Type 1 Diabetes Mellitus, quantified as the difference in glycated haemoglobin (HbA1c).

Time frame

Measured after 6 months of MPH or LDX treatment and compared to the measurement before pharmacotherapy (after PT training, week 10th/22nd depending on PT duration)

2

Change in Type 1 Diabetes Mellitus metabolic control - CGM-derived percentage percentage time in target range 70-180mg/dL

Change of metabolic control of Type 1 Diabetes Mellitus, quantified as the difference in the continuous glucose monitoring derived parameters: percentage of time patient's sensor glucose values were in the target range (70-180mg/dl).

Time frame

Measured after 6 months of MPH or LDX treatment (using last 14 days before visit) and compared to the measurement before pharmacotherapy (after PT training, week 10th/22nd depending on PT duration, using data from 14 preceding days)

3

Change in Type 1 Diabetes Mellitus metabolic control - CGM-derived percentage percentage time below target range <70mg/dL (hypoglycemia)

Change of metabolic control of Type 1 Diabetes Mellitus, quantified as the difference in the continuous glucose monitoring derived parameters: percentage of time patient's sensor glucose values were in the hypoglycemia range (\<70mg/dl).

Time frame

MMeasured after 6 months of MPH or LDX treatment (using last 14 days before visit) and compared to the measurement before pharmacotherapy (after PT training, week 10th/22nd depending on PT duration, using data from 14 preceding days)

4

Change in Type 1 Diabetes Mellitus metabolic control - CGM-derived percentage percentage time below target range <54mg/dL (clinically significant hypoglycemia)

Change of metabolic control of Type 1 Diabetes Mellitus, quantified as the difference in the continuous glucose monitoring derived parameters: percentage of time patient's sensor glucose values were in the clinically significant hypoglycemia range (\<54mg/dl).

Time frame

Measured after 6 months of MPH or LDX treatment (using last 14 days before visit) and compared to the measurement before pharmacotherapy (after PT training, week 10th/22nd depending on PT duration, using data from 14 preceding days)

Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

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