Pizza-Salami Study in Children and Adolescents With Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400659
• Other study ID #: PPS2008
• Status: Completed
• Phase: Phase 4
• First received: July 20, 2011
• Last updated: December 17, 2015
• Start date: March 2009
• Est. completion date: November 2009

Study information

• Verified date: December 2015
• Source: Kinderkrankenhaus auf der Bult
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 21 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Procedure:
• CFP counting
Patients receive a standardized test meal at lunch time. The required insulin dose is calculated by CFP counting. Insulin is given as bolus and basal rate using an insulin pump. Continuous glucose monitoring is performed by sensor-augmented pump system for 6 hours after the meal. The intervention is taking part under in-patient clinical conditions.
• CARB counting
Patients receive a standardized test meal at lunch time. The required insulin dose is calculated by CARB counting. Insulin is given as bolus and basal rate using an insulin pump. Continuous glucose monitoring is performed by sensor-augmented pump system for 6 hours after the meal. The intervention is taking part under in-patient clinical conditions.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kinderkrankenhaus auf der Bult	Medtronic

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CGM-Glucose Area Under the Curve	CGM = Continuous Glucose Monitoring	6 hours after the test meal	No
Secondary	Time of glucose nadir		6 hours after the test meal	No
Secondary	hyperglycemia (6h-AUC >180 mg/dl)	AUC = Area Under the Curve	6 h after the test meal	No
Secondary	frequency and amount of interventional hypoglycemic therapy	i.e. g of glucose required to treat hypoglycemia	6 h after the test meal	Yes
Secondary	frequency of adverse events (incl. SAE)	Hospital stay was from 2h before until 6h after teast meal. SAE = Severe Adverse Event	during hospitalization period of the study	Yes