NCT01400659

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

4 months

First QC Date

July 20, 2011

Last Update Submit

December 17, 2015

Conditions

Type 1 Diabetes Mellitus

Keywords

CSIIprandial insulin requirementsbolus calculationdual-wave bolus

Outcome Measures

Primary Outcomes (1)

  • CGM-Glucose Area Under the Curve

    CGM = Continuous Glucose Monitoring

    6 hours after the test meal

Secondary Outcomes (4)

  • Time of glucose nadir

    6 hours after the test meal

  • hyperglycemia (6h-AUC >180 mg/dl)

    6 h after the test meal

  • frequency and amount of interventional hypoglycemic therapy

    6 h after the test meal

  • frequency of adverse events (incl. SAE)

    during hospitalization period of the study

Study Arms (2)

CARB Counting

ACTIVE COMPARATOR

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 counting

CFP counting

ACTIVE COMPARATOR

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: CARB counting

Interventions

CFP countingPROCEDURE

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.

Also known as: CFP algorithm according to Pankowska et al.
CARB Counting
CARB countingPROCEDURE

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.

Also known as: CARB algorithm
CFP counting

Eligibility Criteria

Age6 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 20513322BACKGROUND

  • 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.

    PMID: 22765260DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Olga Kordonouri, MD

    Kinderkrankenhaus auf der Bult

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2011

First Posted

July 22, 2011

Study Start

March 1, 2009

Primary Completion

July 1, 2009

Study Completion

November 1, 2009

Last Updated

December 18, 2015

Record last verified: 2015-12