NCT02685449

Brief Summary

This is a randomized, cross-over study. The aim of this study is to compare the post-prandial glycaemic variability after pure protein meal following with an administration of square-wave bolus of meal-insulin or without any meal-insulin bolus on the other day. Prolonged post-prandial glycaemic variability will be identified using the self-monitoring of blood glucose (10-point curve) and CGMS.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

July 29, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

February 12, 2016

Last Update Submit

July 28, 2016

Conditions

Diabetes type1

Keywords

diabetes type 1insulin pumpprandial insulin requirementpure protein mealhigh protein mealsquare bolussquare-wave bolusinsulin bolusdietary protein

Outcome Measures

Primary Outcomes (10)

  • Postprandial glycemia

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

    30 minutes after the meal

  • 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 (SMBG)

    90 minutes after the meal

  • Postprandial glycemia

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

    120 minutes after the meal

  • Postprandial glycemia

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

    150 minutes after the meal

  • Postprandial glycemia

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

    180 minutes after the meal

  • Postprandial glycemia

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

    210 minutes after the meal

  • Postprandial glycemia

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

    240 minutes after the meal

  • Postprandial glycemia

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

    270 minutes after the meal

  • Postprandial glycemia

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

    300 minutes after the meal

Secondary Outcomes (4)

  • Hypoglycemia episodes

    5-hour study period

  • Glucose Area Under the Curve (AUC)

    5-hour study period

  • Mean amplitude of glycemic excursion

    5-hour study period

  • The difference between the maximum and baseline glucose level

    5-hour study period

Study Arms (2)

group A

PLACEBO COMPARATOR

On the first study day, insulin bolus was not given before a standardized pure protein meal. On the second day, pre-breakfast insulin was given as a square-wave bolus before the same standardized pure protein meal. The 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 glulisineDrug: Insulin aspartDrug: Insulin lispro

group B

ACTIVE COMPARATOR

On the first study day, pre-breakfast insulin was given as a square-wave bolus before a standardized pure protein meal. On the second day, insulin bolus was not given before the same standardized pure protein meal. The 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 glulisineDrug: Insulin aspartDrug: Insulin lispro

Interventions

Insulin glulisineDRUG

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

Also known as: Apidra®
group Agroup B
Insulin aspartDRUG

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

Also known as: NovoRapid®
group Agroup B
Insulin lisproDRUG

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

Also known as: Humalog®
group Agroup B

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (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
  • insulin requirement more than 0,5 units/kg/day

You may not qualify if:

  • diabetes related complications (e.g. nephropathy)
  • chronic kidney diseases
  • any disease judged by the investigator to affect the trial
  • withdrawal of consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University

Warsaw, 02- 091, Poland

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin glulisineInsulin AspartInsulin Lispro

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Katarzyna Dżygało

    Department of Pediatrics, Warsaw Medical University

    PRINCIPAL INVESTIGATOR

  • Kamila Indulska

    University of Alberta

    STUDY DIRECTOR

  • Agnieszka Szypowska

    University of Alberta

    STUDY CHAIR

Central Study Contacts

Kamila Indulska

CONTACT

48223179421

Katarzyna Dżygało

CONTACT

48223179538k.dzygalo@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2016

First Posted

February 18, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2018

Study Completion

August 1, 2018

Last Updated

July 29, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)