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

Diabetes type1 Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02685449
• Other study ID #: Bialko_5h
• Status: Recruiting
• Phase: Phase 4
• First received: February 12, 2016
• Last updated: July 28, 2016
• Start date: February 2016
• Est. completion date: August 2018

Study information

• Verified date: January 2016
• Source: Medical University of Warsaw
• Contact: Kamila Indulska
• Phone: 48223179421
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes type1

Intervention

Drug:
• Insulin glulisine
A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial
• Insulin aspart
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
• Insulin lispro
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial

Locations

Country	Name	City	State
Poland	Medical University	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	30 minutes after the meal	Yes
Primary	Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	60 minutes after the meal	Yes
Primary	Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	90 minutes after the meal	Yes
Primary	Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	120 minutes after the meal	Yes
Primary	Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	150 minutes after the meal	Yes
Primary	Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	180 minutes after the meal	Yes
Primary	Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	210 minutes after the meal	Yes
Primary	Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	240 minutes after the meal	Yes
Primary	Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	270 minutes after the meal	Yes
Primary	Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	300 minutes after the meal	Yes
Secondary	Hypoglycemia episodes	Hypoglycemia defined as a plasma glucose concentration below 65 mg/dl with or without symptoms	5-hour study period	Yes
Secondary	Glucose Area Under the Curve (AUC)	Measurements based on CGMS	5-hour study period	Yes
Secondary	Mean amplitude of glycemic excursion	measurements based on SMBG	5-hour study period	Yes
Secondary	The difference between the maximum and baseline glucose level	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	5-hour study period	Yes