Normal Versus Dual Wave Insulin Bolus for High-protein Food

• ClinicalTrials.gov Identifier: NCT02276859
• Recruitment Status: Completed
• First Posted: October 28, 2014
• Last Update Posted: January 31, 2018
• Sponsor: Medical University of Warsaw
• Information provided by (Responsible Party): Medical University of Warsaw

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes	Drug: insulin aspart; Drug: insulin lispro; Drug: insulin glulisine	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: The Optimal Type of Bolus Following a High-protein Meal in Type 1 Diabetic Children Treated With Insulin Pumps
• Actual Study Start Date: October 2014
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: September 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Drug: insulin aspart; A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial; Other Name: NovoRapid®; Drug: insulin lispro; A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial; Other Name: Humalog®; Drug: insulin glulisine; A kind of study bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial; Other Name: Apidra®
Experimental: 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	Drug: insulin aspart; A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial; Other Name: NovoRapid®; Drug: insulin lispro; A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial; Other Name: Humalog®; Drug: insulin glulisine; A kind of study bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial; Other Name: Apidra®

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Poland

Department of Pediatrics, Medical University of Warsaw, Poland

Warsaw, Poland, 01-184

Sponsors and Collaborators

Medical University of Warsaw

Investigators

• Study Chair: Agnieszka Szypowska; University of Alberta
• Principal Investigator: Katarzyna Piechowiak; University of Alberta

More Information

• Responsible Party: Medical University of Warsaw
• ClinicalTrials.gov Identifier: NCT02276859
• Other Study ID Numbers: Protein Food Insulin Bolus
• First Posted: October 28, 2014
• Last Update Posted: January 31, 2018
• Last Verified: September 2014

Keywords provided by Medical University of Warsaw:

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

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Lispro; Insulin glulisine; Hypoglycemic Agents; Physiological Effects of Drugs