Normal Versus Dual Wave Insulin Bolus for High-protein Food

NCT02276859 | Completed Phase 4

• 1 other identifier: Protein Food Insulin Bolus
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

dual-wave bolus; square bolus; normal bolus; standard bolus; high-protein meal; prandial insulin requirement

Outcome Measures

Primary Outcomes (3)

• Postprandial glycemia

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

  60 minutes after the meal

• Postprandial glycemia

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

  120 minutes after the meal

• Postprandial glycemia

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

  180 minutes after the meal

Secondary Outcomes (3)

• Hypoglycemia episodes

  3-hour study period

• Glucose Area Under the Curve (AUC)

  3-hour study period

• Mean amplitude of glycemic excursion

  3-hour study period

Study Arms (2)

Normal/ Dual-wave

EXPERIMENTAL

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

Drug: insulin aspart; Drug: insulin lispro; Drug: insulin glulisine

Dual-wave/Normal

EXPERIMENTAL

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

Drug: insulin aspart; Drug: insulin lispro; Drug: insulin glulisine

Interventions

insulin aspart DRUG

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

Also known as: NovoRapid®

Dual-wave/Normal; Normal/ Dual-wave

insulin lispro DRUG

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

Also known as: Humalog®

Dual-wave/Normal; Normal/ Dual-wave

insulin glulisine DRUG

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

Also known as: Apidra®

Dual-wave/Normal; Normal/ Dual-wave

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Pediatrics, Medical University of Warsaw, Poland

Warsaw, 01-184, Poland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart; Insulin Lispro; insulin glulisine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Agnieszka Szypowska

  University of Alberta

  STUDY CHAIR

• Katarzyna Piechowiak

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 28, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 31, 2018

Record last verified: 2014-09

Locations

PL (1)