Pizza-Salami Study in Children and Adolescents With Type 1 Diabetes
This study has been completed.
Sponsor:
Kinderkrankenhaus auf der Bult
Collaborator:
Medtronic
Information provided by:
Kinderkrankenhaus auf der Bult
ClinicalTrials.gov Identifier:
NCT01400659
First received: July 20, 2011
Last updated: July 21, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Mellitus |
Procedure: CFP algorithm |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Insulin human
U.S. FDA Resources
Further study details as provided by Kinderkrankenhaus auf der Bult:
Primary Outcome Measures:
- CGM-Glucose Area Under the Curve [ Time Frame: 6 hours after the test meal ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time of glucose nadir [ Time Frame: 6 hours after the test meal ] [ Designated as safety issue: No ]
- hyperglycemia (6h-AUC >180 mg/dl) [ Time Frame: 6 h after the test meal ] [ Designated as safety issue: No ]
- frequency and amount of interventional hypoglycemic therapy [ Time Frame: 6 h after the test meal ] [ Designated as safety issue: Yes ]i.e. g of glucose required to treat hypoglycemia
- frequency of adverse events (incl. SAE) [ Time Frame: during hospitalization period of the study ] [ Designated as safety issue: Yes ]Hospital stay was from 2h before until 6h after teast meal.
| Enrollment: | 42 |
| Study Start Date: | March 2009 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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.
|
Procedure: CFP algorithm
Patients receive a standardized test meal at lunch time. The required insulin dose is calculated either by CARB or 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.
Other Name: CFP algorithm according to Pankowska et al.
|
|
Active Comparator: 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.
|
Procedure: CFP algorithm
Patients receive a standardized test meal at lunch time. The required insulin dose is calculated either by CARB or 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.
Other Name: CFP algorithm according to Pankowska et al.
|
Eligibility| Ages Eligible for Study: | 6 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. Dr. Olga Kordonouri, MD, Kinderkrankenhaus auf der Bult |
| ClinicalTrials.gov Identifier: | NCT01400659 History of Changes |
| Other Study ID Numbers: | PPS2008 |
| Study First Received: | July 20, 2011 |
| Last Updated: | July 21, 2011 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Kinderkrankenhaus auf der Bult:
|
CSII prandial insulin requirements bolus calculation dual-wave bolus |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013