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Normal Versus Dual Wave Insulin Bolus for High-protein Food

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

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.

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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

Resource links provided by the National Library of Medicine


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®




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276859


Locations
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Poland
Department of Pediatrics, Medical University of Warsaw, Poland
Warsaw, Poland, 01-184
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Study Chair: Agnieszka Szypowska University of Alberta
Principal Investigator: Katarzyna Piechowiak University of Alberta
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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02276859    
Other Study ID Numbers: Protein Food Insulin Bolus
First Posted: October 28, 2014    Key Record Dates
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:
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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