Diabetes type1Phase 4NCT02685449
Insulin Requirement for Pure-protein Meal in Children With Type 1 Diabetes on Insulin Pumps.
A Phase 4 study testing Insulin glulisine, Insulin aspart and Insulin lispro in people with Diabetes type1, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Diabetes type1
- What is being tested?
- Insulin glulisine, Insulin aspart and Insulin lispro
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2016to Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Kamila Indulska contact
Poland1 site, 1 recruiting
- Recruiting
Medical University
Warsaw, 02- 091
Agnieszka Szypowska, MD, PhD, +48223179421
Kamila Indulska
About this study
Official title: Insulin Requirement for Pure- Protein Meal in Children With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion - a Cross-over, Randomized Trial.
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.
Read the detailed description
The square-wave bolus (for meals rich in fat and/or protein) is evenly delivered over several hours as programmed by the patient. The required insulin dose will be calculated based on patient's insulin-exchange ratio. Pure protein meal will be given 3 hours after a first breakfast.
To provide the minimal impact of the previous breakfast, all patients will receive up to 120 kcal of carbohydrates and <100 kcal from protein and fat for the first breakfast (without any extended bolus) Patients receive a standardized pure protein meal at a second breakfast time. Meal insulin will be given as a square bolus or no meal -insulin will be given at all. The 5h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG) (every 30 minutes) and continuous glucose monitoring system (CGMS). The intervention is taking part under in-patient clinical conditions.
- Conditions
- Diabetes type1
- Being tested
- Insulin glulisine, Insulin aspart, Insulin lispro
- Keywords
- diabetes type 1, insulin pump, prandial insulin requirement, pure protein meal, high protein meal, square bolus, square-wave bolus, insulin bolus, dietary protein
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glulisineDrug
Also called Apidra®
A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial
Insulin aspartDrug
Also called NovoRapid®
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
Insulin lisproDrug
Also called Humalog®
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Insulin glulisine; Drug: Insulin aspart; Drug: 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 Receives: Drug: Insulin glulisine; Drug: Insulin aspart; Drug: Insulin lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Measured: 30 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Measured: 60 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Measured: 90 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Measured: 120 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Measured: 150 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Measured: 180 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Measured: 210 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Measured: 240 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Measured: 270 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Measured: 300 minutes after the meal
Secondary outcomes (4)
Hypoglycemia episodes
Hypoglycemia defined as a plasma glucose concentration below 65 mg/dl with or without symptoms
Measured: 5-hour study period
Glucose Area Under the Curve (AUC)
Measurements based on CGMS
Measured: 5-hour study period
Mean amplitude of glycemic excursion
measurements based on SMBG
Measured: 5-hour study period
The difference between the maximum and baseline glucose level
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Measured: 5-hour study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes type1Studies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katarzyna Dżygało, Principal investigator, Department of Pediatrics, Warsaw Medical UniversityKamila Indulska, Study director, University of AlbertaAgnieszka Szypowska, Study chair, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685449
- Sponsor's protocol ID
- Białko_5h
- Status last verified
- Jan 2016
- First submitted
- 12 Feb 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Requirement for Pure- Protein Meal in Children With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion - a Cross-over, Randomized Trial.
- ClinicalTrials.gov ID
- NCT02685449
- Acronym / sponsor ID
- Białko_5h
- Conditions
- Diabetes type1
- Keywords
- diabetes type 1, insulin pump, prandial insulin requirement, pure protein meal, high protein meal, square bolus, square-wave bolus, insulin bolus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The square-wave bolus (for meals rich in fat and/or protein) is evenly delivered over several hours as programmed by the patient. The required insulin dose will be calculated based on patient's insulin-exchange ratio. Pure protein meal will be given 3 hours after a first breakfast.
To provide the minimal impact of the previous breakfast, all patients will receive up to 120 kcal of carbohydrates and <100 kcal from protein and fat for the first breakfast (without any extended bolus) Patients receive a standardized pure protein meal at a second breakfast time. Meal insulin will be given as a square bolus or no meal -insulin will be given at all. The 5h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG) (every 30 minutes) and continuous glucose monitoring system (CGMS). The intervention is taking part under in-patient clinical conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Placebo comparator | Drug: Insulin glulisine, Drug: Insulin aspart, Drug: Insulin lisproOn 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 |
| group B | Active comparator | Drug: Insulin glulisine, Drug: Insulin aspart, Drug: Insulin lisproOn 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 |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin glulisineAlso: Apidra®A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial | Drug | group A, group B |
| Insulin aspartAlso: NovoRapid®A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial | Drug | group A, group B |
| Insulin lisproAlso: Humalog®A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial | Drug | group A, group B |
Primary outcome
Postprandial glycemia
Time frame: 30 minutes after the meal
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Postprandial glycemia
Time frame: 60 minutes after the meal
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Postprandial glycemia
Time frame: 90 minutes after the meal
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Postprandial glycemia
Time frame: 120 minutes after the meal
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Postprandial glycemia
Time frame: 150 minutes after the meal
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Postprandial glycemia
Time frame: 180 minutes after the meal
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Postprandial glycemia
Time frame: 210 minutes after the meal
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Postprandial glycemia
Time frame: 240 minutes after the meal
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Postprandial glycemia
Time frame: 270 minutes after the meal
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Postprandial glycemia
Time frame: 300 minutes after the meal
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
4 secondary outcomes
Hypoglycemia episodes
Time frame: 5-hour study period
Glucose Area Under the Curve (AUC)
Time frame: 5-hour study period
Mean amplitude of glycemic excursion
Time frame: 5-hour study period
The difference between the maximum and baseline glucose level
Time frame: 5-hour study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamila Indulska contact
Katarzyna Dżygało principal investigator
Department of Pediatrics, Warsaw Medical University
Kamila Indulska study director
University of Alberta
Agnieszka Szypowska study chair
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin glulisine, Insulin aspart and Insulin lispro in people with Diabetes type1, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kamila Indulska (48223179421), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glycemia (time frame: 30 minutes after the meal). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.