Normal Versus Dual Wave Insulin Bolus for High-protein Food

NCT ID: NCT02276859

Last Updated: 2018-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-09-30

Brief 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.

Detailed 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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Normal/ Dual-wave

On the first study day, pre-breakfast insulin was given as a normal bolus 15 minutes before a standardized high-protein meal. On the second day, pre-breakfast insulin was given as a dual-wave bolus before the same high-protein meal.

The carbo-insulin and 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

Group Type: EXPERIMENTAL

insulin aspart

Intervention Type: DRUG

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

insulin lispro

Intervention Type: DRUG

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

insulin glulisine

Intervention Type: DRUG

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

Dual-wave/Normal

On the first study day, pre-breakfast insulin was given as a dual-wave bolus 15 minutes before a standardized high-protein meal. On the second day, pre-breakfast insulin was given as a normal bolus before the same high-protein meal.

The carbo-insulin and 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

Group Type: EXPERIMENTAL

insulin aspart

Intervention Type: DRUG

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

insulin lispro

Intervention Type: DRUG

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

insulin glulisine

Intervention Type: DRUG

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

Interventions

insulin aspart

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

Intervention Type: DRUG

insulin lispro

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

Intervention Type: DRUG

insulin glulisine

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

Intervention Type: DRUG

Other Intervention Names

NovoRapid®; Humalog®; Apidra®

Eligibility 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
• 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agnieszka Szypowska

Role: STUDY_CHAIR

University of Alberta

Katarzyna Piechowiak

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Department of Pediatrics, Medical University of Warsaw, Poland

Warsaw, , Poland

Countries

Poland

Other Identifiers

Protein Food Insulin Bolus

Identifier Type: -

Identifier Source: org_study_id