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Completed

NCT Number: NCT02276859

Normal Versus Dual Wave Insulin Bolus for High-protein Food

Patients receive a standardized high-protein test meal at breakfast time. Insulin is given as bolus (normal or dual-wave (normal plus square) and basal rate using an insulin pump. The 3h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG) (every 1 hour) and continuous glucose monitoring system (CGMS). The intervention is taking part under in-patient clinical conditions.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Pediatrics, Medical University of Warsaw, Poland

Warsaw, 01-184, Poland

About this study

The dual-wave bolus delivers an immediate normal pre-meal insulin bolus followed by square-wave bolus that is evenly delivered over several hours as programmed by the patient. The aim of this study is to compare post-prandial glycaemic excursions following a high-protein meal after administration of insulin by normal vs dual-wave bolus. During this prospective, cross-over, repeated measures study, pediatric patients with type 1 diabetes, treated with insulin pump therapy will be evaluated using the self-blood glucose measurements following standardized high-protein meal and two types of boluses (normal or dual-wave). The required insulin dose will be calculated based on patient's insulin-exchange ratio. A high-protein meal will be given on two subsequent breakfasts and comparisons will be made between normal and dual-wave insulin bolus delivery. Prolonged post-prandial glycaemic excursions will be identified using the CGMS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • patients must be willing to wear a glucose sensor for two days
  • insulin requirement more than 0,5 units/kg/day

Exclusion criteria

  • concomitant dietary restrictions (e.g. celiac disease or food allergy)
  • diabetes related complications (e.g. nephropathy)
  • any disease judged by the investigator to affect the trial
  • withdrawal of consent to participate in the study

Treatment and study plan

insulin aspart

Drug

A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial

Other names: NovoRapid®

Insulin Lispro

Drug

A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial

Other names: Humalog®

insulin glulisine

Drug

A kind of study bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial

Other names: Apidra®

Primary outcomes

  1. Postprandial glycemia

    Time frame: 60 minutes after the meal

    Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)

  2. Postprandial glycemia

    Time frame: 120 minutes after the meal

    Post-prandial blood glucose excursions measured by self monitoring of blood glucose

  3. Postprandial glycemia

    Time frame: 180 minutes after the meal

    Post-prandial blood glucose excursions measured by self monitoring of blood glucose

Secondary outcomes

  1. Hypoglycemia episodes

    Time frame: 3-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: 3-hour study period

    measurements based on CGMS

  3. Mean amplitude of glycemic excursion

    Time frame: 3-hour study period

    measurements based on CGMS

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

The Optimal Type of Bolus Following a High-protein Meal in Type 1 Diabetic Children Treated With Insulin Pumps

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 28, 2014
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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