Diabetes Mellitus, Type 1Phase 4NCT04019821
Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal
A Phase 4 study testing Insulin Glulisine, Insulin Aspart and Insulin Lispro in people with Diabetes Mellitus, Type 1, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of this study is to determine whether Super-Bolus is more effective in postprandial glycemic control than Normal-Bolus after the high glycemic index (H-GI) meal in children with type 1 diabetes (T1DM) treated with insulin pump (continuous subcutaneous insulin infusion, CSII). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Insulin Glulisine, Insulin Aspart and Insulin Lispro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2020to 1 Apr 2023
- 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 12months,
- insulin pump therapy longer than 3 months,
- written informed consent to participate in the study signed by parents (and patient older than 16 years).
Who cannot join
- celiac disease,
- diabetes related complications (e.g. nephropathy),
- BMI at or above the 95th percentile and at or below 3rd percentiles for children and teenagers of the same age and sex,
- withdrawal of consent to participate in the study,
- comorbid conditions and treatment which could significantly affect glycemic values in the researchers' opinion.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital
Warsaw
About this study
Official title: Effects of Super-Bolus on Postprandial Glycemia After High Glycemic Index Meal in Children With Type 1 Diabetes Mellitus- Randomized Study
The aim of this study is to determine whether Super-Bolus is more effective in postprandial glycemic control than Normal-Bolus after the high glycemic index (H-GI) meal in children with type 1 diabetes (T1DM) treated with insulin pump (continuous subcutaneous insulin infusion, CSII).
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin Glulisine, Insulin Aspart, Insulin Lispro
- Keywords
- super bolus, diabetes type 1, insulin bolus, high glycemic index meal, prandial insulin requirement, postprandial glycemia, insulin pump therapy
- 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 type of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.
Insulin AspartDrug
Also called NovoRapid
A type of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.
Insulin LisproDrug
Also called Humalog, Liprolog
A type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.
| Study group | Role | What they receive |
|---|---|---|
| Normal Bolus | Active comparator | Pre-breakfast insulin will be given as a Normal Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Normal Bolus will be calculated based on individual insulin-to-carbohydrate ratio (ICR). Receives: Drug: Insulin Glulisine; Drug: Insulin Aspart; Drug: Insulin Lispro |
| Super Bolus | Experimental | Pre-breakfast insulin will be given as a Super Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Super Bolus will be calculated based on individual ICR increased to 150% and basal insulin will be suspended for 2 hours at the same time. 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
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)
Measured: 90 minutes after the prandial bolus
Secondary outcomes (8)
Hypoglycemia Episodes
Hypoglycemia defined as a plasma glucose concentration below or equal 70mg/dl with or without symptoms
Measured: 3-hours after the prandial bolus
Glucose Area Under the Curve (AUC)
Measurements based on Continuous Glucose Monitoring System (CGMS)
Measured: 3-hours after the prandial bolus
Mean amplitude of glycaemic excursion (MAGE)
MAGE will be defined as a standard deviation of blood glucose (SDBG) obtained from all blood glucose concentrations
Measured: 3-hours after the prandial bolus
Capillary blood glucose level 30,60,120,150,180 min after administration of the prandial bolus
measured by SMBG
Measured: 3-hours after the prandial bolus
Glycemic rise (GR)
a difference between baseline and the maximum glucose value based on CGMS
Measured: 3-hours after the prandial bolus
Peak glucose level (PG)
the maximum value of glycemia during 3 hours of postmeal time based on CGMS
Measured: 3-hours after the prandial bolus
Time to glucose peak
based on CGMS
Measured: 3-hours after the prandial bolus
Time in postprandial glucose range between 70 to 180 mg/dl (4.0-10.0 mmol/L)
based on CGMS
Measured: 3-hours after the prandial bolus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start1 Jan 2020
- Primary completion1 Jan 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnieszka Szypowska, Prof., Study chair, Department of Pediatrics, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019821
- Sponsor's protocol ID
- SuperBolus
- Status last verified
- Nov 2023
- First submitted
- 11 Jul 2019
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kowalczyk-Korcz E, Dyminska M, Szypowska A. Super Bolus-A Remedy for a High Glycemic Index Meal in Children with Type 1 Diabetes on Insulin Pump Therapy?-A Randomized, Double-Blind, Controlled Trial. Nutrients. 2024 Jan 16;16(2):263. doi: 10.3390/nu16020263.
PubMed 38257156Kowalczyk E, Dzygalo K, Szypowska A. Super Bolus: a remedy for a high glycemic index meal in children with type 1 diabetes on insulin pump therapy?-study protocol for a randomized controlled trial. Trials. 2022 Mar 29;23(1):240. doi: 10.1186/s13063-022-06173-4.
PubMed 35351180
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Super-Bolus on Postprandial Glycemia After High Glycemic Index Meal in Children With Type 1 Diabetes Mellitus- Randomized Study
- ClinicalTrials.gov ID
- NCT04019821
- Acronym / sponsor ID
- SuperBolus
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- super bolus, diabetes type 1, insulin bolus, high glycemic index meal, prandial insulin requirement, postprandial glycemia, insulin pump therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 15 Jul 2019 (actual)
- 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.
The aim of this study is to determine whether Super-Bolus is more effective in postprandial glycemic control than Normal-Bolus after the high glycemic index (H-GI) meal in children with type 1 diabetes (T1DM) treated with insulin pump (continuous subcutaneous insulin infusion, CSII).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Bolus | Active comparator | Drug: Insulin Glulisine, Drug: Insulin Aspart, Drug: Insulin LisproPre-breakfast insulin will be given as a Normal Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Normal Bolus will be calculated based on individual insulin-to-carbohydrate ratio (ICR). |
| Super Bolus | Experimental | Drug: Insulin Glulisine, Drug: Insulin Aspart, Drug: Insulin LisproPre-breakfast insulin will be given as a Super Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Super Bolus will be calculated based on individual ICR increased to 150% and basal insulin will be suspended for 2 hours at the same time. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- duration of type 1 diabetes longer than 12months,
- insulin pump therapy longer than 3 months,
- written informed consent to participate in the study signed by parents (and patient older than 16 years).
Key exclusion criteria (5 listed)
- celiac disease,
- diabetes related complications (e.g. nephropathy),
- BMI at or above the 95th percentile and at or below 3rd percentiles for children and teenagers of the same age and sex,
- withdrawal of consent to participate in the study,
- comorbid conditions and treatment which could significantly affect glycemic values in the researchers' opinion.
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: ApidraA type of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial. | Drug | Normal Bolus, Super Bolus |
| Insulin AspartAlso: NovoRapidA type of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial. | Drug | Normal Bolus, Super Bolus |
| Insulin LisproAlso: Humalog, LiprologA type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial. | Drug | Normal Bolus, Super Bolus |
Primary outcome
Postprandial Glycemia
Time frame: 90 minutes after the prandial bolus
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)
8 secondary outcomes
Hypoglycemia Episodes
Time frame: 3-hours after the prandial bolus
Glucose Area Under the Curve (AUC)
Time frame: 3-hours after the prandial bolus
Mean amplitude of glycaemic excursion (MAGE)
Time frame: 3-hours after the prandial bolus
Capillary blood glucose level 30,60,120,150,180 min after administration of the prandial bolus
Time frame: 3-hours after the prandial bolus
Glycemic rise (GR)
Time frame: 3-hours after the prandial bolus
Peak glucose level (PG)
Time frame: 3-hours after the prandial bolus
Time to glucose peak
Time frame: 3-hours after the prandial bolus
Time in postprandial glucose range between 70 to 180 mg/dl (4.0-10.0 mmol/L)
Time frame: 3-hours after the prandial bolus
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 30 Nov 2023.
- Derived from this study: PubMed 38257156Kowalczyk-Korcz E, Dyminska M, Szypowska A. Super Bolus-A Remedy for a High Glycemic Index Meal in Children with Type 1 Diabetes on Insulin Pump Therapy?-A Randomized, Double-Blind, Controlled Trial. Nutrients. 2024 Jan 16;16(2):263. doi: 10.3390/nu16020263.
- Derived from this study: PubMed 35351180Kowalczyk E, Dzygalo K, Szypowska A. Super Bolus: a remedy for a high glycemic index meal in children with type 1 diabetes on insulin pump therapy?-study protocol for a randomized controlled trial. Trials. 2022 Mar 29;23(1):240. doi: 10.1186/s13063-022-06173-4.
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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, Prof. study chair
Department of Pediatrics, Medical University of Warsaw
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 Mellitus, Type 1, 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 3 inclusion and 5 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 30 Nov 2023. 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: 90 minutes after the prandial bolus). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04019821, which also lists 2 linked publications.
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 30 Nov 2023.