Clinical trial NCT01400659: Pizza-Salami Study in Children and Adolescents With Type 1 Diabetes
Official title: The PIZZA-Salami Trial: Monocentric Randomised Cross-over Study of Carb Counting vs. Carb Plus Fat/Protein Counting Based Insulin Bolus Used for Sensor-augmented Continuous Subcutaneous Insulin Infusion (CSII) in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Keywords: CSII
prandial insulin requirements
bolus calculation
dual-wave bolus
Lead sponsor: Kinderkrankenhaus auf der Bult
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2011-07-22
Enrollment: 42
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The Pizza-Salami-Study aims to investigate the efficacy of carbohydrate plus fat/protein (CFP) counting compared with carbohydrate (CARB) counting using normal and dual-wave bolus in sensor-augmented pump therapy in children and adolescents with type 1 diabetes. For fat/protein counting the model used by Pankowska et al. will be applied.

Detailed description: This is a prospective, international multi-centre, open randomized clinical trial to assess whether the use of Paradigm REAL-Time System from the onset of Type 1 Diabetes (T1D) leads to a better glycaemic control after 12 months of T1D compared with the use of Paradigm 515/715 insulin pump combined with conventional Self-Monitoring Blood Glucose finger-sticks in paediatric patients. Total randomized treatment duration of the study for a patient will be 12 months with an optional phase of follow-up of 3 months.Patients eligible according to inclusion and exclusion criteria will be randomized to one of the two treatment groups. A total of 160 patients will be recruited. Each subject will participate in the study for 15 months, which includes 12 months of treatment and 3 months of follow-up. Each patient is asked to use either the Paradigm REAL-Time System that provides a combination of insulin pump and the Real-Time continuous glucose monitoring or Paradigm 515/715 insulin pump combined to conventional SMBG finger-sticks. Main time-points of assessments are at baseline (within one month after T1D onset) and 12 months thereafter. In total, there will be 6 study visits at the local site. During study, patients will regularly attend the outpatient clinic according to local Standard care, i.e. every 8±2 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with type 1 diabetes
* Age 6 - 21 years
* Diabetes duration \> 1 year
* Treatment with pump therapy (CSII) \> 3 months
* Written informed consent by patients and parents
* Patients must be willing to wear a glucose sensor for two days and to perform capillary blood glucose measurement twice a day
* Patients must be willing to performed all study procedures

Exclusion Criteria:

* Language barriers
* Eating disorders
* Pregnancy
* Drug abuse
* Patient refutes participation or study procedures

Primary outcomes:
measure: CGM-Glucose Area Under the Curve
timeFrame: 6 hours after the test meal
Secondary outcomes:
measure: Time of glucose nadir
timeFrame: 6 hours after the test meal
measure: hyperglycemia (6h-AUC >180 mg/dl)
timeFrame: 6 h after the test meal
measure: frequency and amount of interventional hypoglycemic therapy
timeFrame: 6 h after the test meal
measure: frequency of adverse events (incl. SAE)
timeFrame: during hospitalization period of the study
Other outcomes:
Locations:
Study officials:
affiliation: Kinderkrankenhaus auf der Bult
name: Olga Kordonouri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pankowska E, Blazik M. Bolus calculator with nutrition database software, a new concept of prandial insulin programming for pump users. J Diabetes Sci Technol. 2010 May 1;4(3):571-6. doi: 10.1177/193229681000400310.
citation: Kordonouri O, Hartmann R, Remus K, Blasig S, Sadeghian E, Danne T. Benefit of supplementary fat plus protein counting as compared with conventional carbohydrate counting for insulin bolus calculation in children with pump therapy. Pediatr Diabetes. 2012 Nov;13(7):540-4. doi: 10.1111/j.1399-5448.2012.00880.x. Epub 2012 Jul 6.