Type 1 DiabetesPhase 4NCT02276859
Normal Versus Dual Wave Insulin Bolus for High-protein Food
A Phase 4 study testing insulin aspart, insulin lispro and insulin glulisine in people with Type 1 Diabetes, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- insulin aspart, insulin lispro and insulin glulisine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2014to Sep 2015
- 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
- patients must be willing to wear a glucose sensor for two days
- insulin requirement more than 0,5 units/kg/day
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pediatrics, Medical University of Warsaw, Poland
Warsaw, 01-184
About this study
Official title: The Optimal Type of Bolus Following a High-protein Meal in Type 1 Diabetic Children Treated With Insulin Pumps
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- insulin aspart, insulin lispro, insulin glulisine
- Keywords
- dual-wave bolus, square bolus, normal bolus, standard bolus, high-protein meal, prandial insulin requirement
- 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 aspartDrug
Also called NovoRapid®
A kind of study bolus insulin will be insulin aspart if participant used insulin aspart 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
insulin glulisineDrug
Also called Apidra®
A kind of study bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: insulin aspart; Drug: insulin lispro; Drug: insulin glulisine |
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: 60 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose
Measured: 120 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose
Measured: 180 minutes after the meal
Secondary outcomes (3)
Hypoglycemia episodes
Hypoglycemia defined as a plasma glucose concentration below 65 mg/dl with or without symptoms
Measured: 3-hour study period
Glucose Area Under the Curve (AUC)
measurements based on CGMS
Measured: 3-hour study period
Mean amplitude of glycemic excursion
measurements based on CGMS
Measured: 3-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 posted28 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnieszka Szypowska, Study chair, University of AlbertaKatarzyna Piechowiak, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276859
- Sponsor's protocol ID
- Protein Food Insulin Bolus
- Status last verified
- Sep 2014
- First submitted
- 7 Oct 2014
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Type of Bolus Following a High-protein Meal in Type 1 Diabetic Children Treated With Insulin Pumps
- ClinicalTrials.gov ID
- NCT02276859
- Acronym / sponsor ID
- Protein Food Insulin Bolus
- Conditions
- Type 1 Diabetes
- Keywords
- dual-wave bolus, square bolus, normal bolus, standard bolus, high-protein meal, prandial insulin requirement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 28 Oct 2014 (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.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal/ Dual-wave | Experimental | Drug: insulin aspart, Drug: insulin lispro, Drug: insulin glulisineOn 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 |
| Dual-wave/Normal | Experimental | Drug: insulin aspart, Drug: insulin lispro, Drug: insulin glulisineOn 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 |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 aspartAlso: NovoRapid®A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial | Drug | Dual-wave/Normal, Normal/ Dual-wave |
| insulin lisproAlso: Humalog®A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial | Drug | Dual-wave/Normal, Normal/ Dual-wave |
| insulin glulisineAlso: Apidra®A kind of study bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial | Drug | Dual-wave/Normal, Normal/ Dual-wave |
Primary outcome
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: 120 minutes after the meal
Post-prandial blood glucose excursions measured by self monitoring of blood glucose
Postprandial glycemia
Time frame: 180 minutes after the meal
Post-prandial blood glucose excursions measured by self monitoring of blood glucose
3 secondary outcomes
Hypoglycemia episodes
Time frame: 3-hour study period
Glucose Area Under the Curve (AUC)
Time frame: 3-hour study period
Mean amplitude of glycemic excursion
Time frame: 3-hour study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
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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.
Agnieszka Szypowska study chair
University of Alberta
Katarzyna Piechowiak principal investigator
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 aspart, insulin lispro and insulin glulisine in people with Type 1 Diabetes, 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 5 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: finished, as of the sponsor's last update on 31 Jan 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glycemia (time frame: 60 minutes after the meal). The study lists 3 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 31 Jan 2018.