Normal Versus Dual Wave Insulin Bolus for High-protein Food

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02276859
• Other study ID #: Protein Food Insulin Bolus
• Status: Completed
• Phase: Phase 4
• First received: October 7, 2014
• Last updated: January 29, 2018
• Start date: October 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2014
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• 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

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
Poland	Department of Pediatrics, Medical University of Warsaw, Poland	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)	60 minutes after the meal
Primary	Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose	120 minutes after the meal
Primary	Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose	180 minutes after the meal
Secondary	Hypoglycemia episodes	Hypoglycemia defined as a plasma glucose concentration below 65 mg/dl with or without symptoms	3-hour study period
Secondary	Glucose Area Under the Curve (AUC)	measurements based on CGMS	3-hour study period
Secondary	Mean amplitude of glycemic excursion	measurements based on CGMS	3-hour study period