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

NCT ID: NCT01400659

Last Updated: 2015-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-11-30

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

CSII; prandial insulin requirements; bolus calculation; dual-wave bolus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CARB Counting

For CARB counting, insulin dose will be calculated according to the carbohydrate content of the test meal (1 carb unit = 10 g carbohydrate). The insulin-to-carbohydrate ratio will be applied according to the current individual therapy of the patient.

Group Type: ACTIVE_COMPARATOR

CFP counting

Intervention Type: PROCEDURE

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.

CFP counting

For CFP counting, insulin dose will be calculated according the carbohydrate content (1 carb unit = 10 g carbohydrate) as well as fat/protein content (1 FPU = 100 kcal from fat and protein) of the meal. The insulin-to-carbohydrate ratio will be applied according to the current individual therapy of the patient. The insulin-to-FPU ratio is the same as the insulin to carb ratio.

Group Type: ACTIVE_COMPARATOR

CARB counting

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

CFP algorithm according to Pankowska et al.; CARB algorithm

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Kinderkrankenhaus auf der Bult

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olga Kordonouri, MD

Role: PRINCIPAL_INVESTIGATOR

Kinderkrankenhaus auf der Bult

References

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.

Reference Type: BACKGROUND

PMID: 20513322 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22765260 (View on PubMed)

Other Identifiers

PPS2008

Identifier Type: -

Identifier Source: org_study_id