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Insulin Requirement for Pure-protein Meal in Children With Type 1 Diabetes on Insulin Pumps.

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ClinicalTrials.gov Identifier: NCT02685449
Recruitment Status : Unknown
Verified January 2016 by Medical University of Warsaw.
Recruitment status was:  Recruiting
First Posted : February 18, 2016
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

Brief Summary:

This is a randomized, cross-over study. The aim of this study is to compare the post-prandial glycaemic variability after pure protein meal following with an administration of square-wave bolus of meal-insulin or without any meal-insulin bolus on the other day.

Prolonged post-prandial glycaemic variability will be identified using the self-monitoring of blood glucose (10-point curve) and CGMS.


Condition or disease Intervention/treatment Phase
Diabetes type1 Drug: Insulin glulisine Drug: Insulin aspart Drug: Insulin lispro Phase 4

Detailed Description:

The square-wave bolus (for meals rich in fat and/or protein) is evenly delivered over several hours as programmed by the patient. The required insulin dose will be calculated based on patient's insulin-exchange ratio. Pure protein meal will be given 3 hours after a first breakfast.

To provide the minimal impact of the previous breakfast, all patients will receive up to 120 kcal of carbohydrates and <100 kcal from protein and fat for the first breakfast (without any extended bolus) Patients receive a standardized pure protein meal at a second breakfast time. Meal insulin will be given as a square bolus or no meal -insulin will be given at all. The 5h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG) (every 30 minutes) and continuous glucose monitoring system (CGMS). The intervention is taking part under in-patient clinical conditions.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Insulin Requirement for Pure- Protein Meal in Children With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion - a Cross-over, Randomized Trial.
Study Start Date : February 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Placebo Comparator: group A

On the first study day, insulin bolus was not given before a standardized pure protein meal. On the second day, pre-breakfast insulin was given as a square-wave bolus before the same standardized pure protein meal.

The fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial.

Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine

Drug: Insulin glulisine
A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial
Other Name: Apidra®

Drug: Insulin aspart
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
Other Name: NovoRapid®

Drug: Insulin lispro
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
Other Name: Humalog®

Active Comparator: group B

On the first study day, pre-breakfast insulin was given as a square-wave bolus before a standardized pure protein meal. On the second day, insulin bolus was not given before the same standardized pure protein meal.

The fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial.

Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine

Drug: Insulin glulisine
A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial
Other Name: Apidra®

Drug: Insulin aspart
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
Other Name: NovoRapid®

Drug: Insulin lispro
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
Other Name: Humalog®




Primary Outcome Measures :
  1. Postprandial glycemia [ Time Frame: 30 minutes after the meal ]
    Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)

  2. Postprandial glycemia [ Time Frame: 60 minutes after the meal ]
    Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)

  3. Postprandial glycemia [ Time Frame: 90 minutes after the meal ]
    Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)

  4. Postprandial glycemia [ Time Frame: 120 minutes after the meal ]
    Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)

  5. Postprandial glycemia [ Time Frame: 150 minutes after the meal ]
    Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)

  6. Postprandial glycemia [ Time Frame: 180 minutes after the meal ]
    Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)

  7. Postprandial glycemia [ Time Frame: 210 minutes after the meal ]
    Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)

  8. Postprandial glycemia [ Time Frame: 240 minutes after the meal ]
    Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)

  9. Postprandial glycemia [ Time Frame: 270 minutes after the meal ]
    Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)

  10. Postprandial glycemia [ Time Frame: 300 minutes after the meal ]
    Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)


Secondary Outcome Measures :
  1. Hypoglycemia episodes [ Time Frame: 5-hour study period ]
    Hypoglycemia defined as a plasma glucose concentration below 65 mg/dl with or without symptoms

  2. Glucose Area Under the Curve (AUC) [ Time Frame: 5-hour study period ]
    Measurements based on CGMS

  3. Mean amplitude of glycemic excursion [ Time Frame: 5-hour study period ]
    measurements based on SMBG

  4. The difference between the maximum and baseline glucose level [ Time Frame: 5-hour study period ]
    Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • duration of type 1 diabetes longer than 12 months
  • insulin pump therapy longer than 3 months
  • written informed consent by patients and parents
  • insulin requirement more than 0,5 units/kg/day

Exclusion Criteria:

  • diabetes related complications (e.g. nephropathy)
  • chronic kidney diseases
  • any disease judged by the investigator to affect the trial
  • withdrawal of consent to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685449


Contacts
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Contact: Kamila Indulska 48223179421
Contact: Katarzyna Dżygało 48223179538 k.dzygalo@gmail.com

Locations
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Poland
Medical University Recruiting
Warsaw, Poland, 02- 091
Contact: Agnieszka Szypowska, MD, PhD    +48223179421      
Sub-Investigator: Kamila Indulska         
Principal Investigator: Katarzyna Dżygało         
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Katarzyna Dżygało Department of Pediatrics, Warsaw Medical University
Study Director: Kamila Indulska University of Alberta
Study Chair: Agnieszka Szypowska University of Alberta

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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02685449     History of Changes
Other Study ID Numbers: Białko_5h
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Medical University of Warsaw:
diabetes type 1
insulin pump
prandial insulin requirement
pure protein meal
high protein meal
square bolus
square-wave bolus
insulin bolus
dietary protein

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Insulin Lispro
Insulin glulisine
Hypoglycemic Agents
Physiological Effects of Drugs