Type 1 Diabetes MellitusPhase 4NCT04783376
Effect of Splitting Mealtime Insulin Doses After Mixed Meals High in Fat and Protein
A Phase 4 study testing : Insulin, lispro and regular insulin in people with Type 1 Diabetes Mellitus, run by Sohag University at 1 site in Egypt.
Trial summary
The current management of type 1 diabetes mellitus (T1DM) depends on the use of intensive insulin therapy - either by insulin pump therapy or multiple daily injection (MDI) therapy - and the use of carbohydrate counting to determine the mealtime bolus insulin dose according the carbohydrate contents of each meal or… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- : Insulin, lispro and regular insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2021to 3 Mar 2022
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and adolescents aged 6 - 18 years
- diagnosed with T1DM for at least 1 year
- using MDI regimen with advanced carbohydrate counting for at least 6 months
Who cannot join
- Subjects with associated
- diabetic autonomic neuropathy
- hypothyroidism
- celiac disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Splitting Mealtime Insulin Doses Used for Mixed Meals High in Fat and Protein on Postprandial Blood Glucose Levels in Children and Adolescents With Type 1 Diabetes Mellitus Using Multiple Daily Injection Regimen
The current management of type 1 diabetes mellitus (T1DM) depends on the use of intensive insulin therapy - either by insulin pump therapy or multiple daily injection (MDI) therapy - and the use of carbohydrate counting to determine the mealtime bolus insulin dose according the carbohydrate contents of each meal or snack. However, several studies reported that the fat and protein contents of the meals can also affect the postprandial blood glucose levels and result in delayed postprandial hyperglycemia especially after high fat and protein meals.
There is no widely accepted regimen to calculate insulin required for the fat and protein contents of meals especially for patients using multiple daily injection regimen. This study aims to find a better method to cover the increased insulin requirements following mixed fat and protein meals. The study will compare the effect of splitting mealtime bolus insulin doses into pre-meal and post-meal portions to the standard regimen which involve giving bolus dose depending on carbohydrate content only with additional correction doses 2 to 3 hours after the meal to compensate for the postprandial hyperglycemia induced by fat and protein content of the meals.
Read the detailed description
The study will include children and adolescents aged 6 - 18 years, diagnosed with T1DM for at least 1 year, using multiple daily injection regimen and carbohydrate counting. The study participants will be admitted at the pediatric department, Sohag University Hospital for 1 week to adjust insulin doses. adjustments will be made to basal doses, insulin to carbohydrate ratio (ICR), insulin sensitivity factor (ISF) if required.
The study participants will have three test lunch meals on 3 consecutive days consumed at the pediatric department, Sohag university hospital at 12 PM. The test meals will consist of two slices of a deep pan pizza base topped with tomato sauce, mozzarella full fat soft cheese, and minced beef. (weight: 150 g, carb. 40 g, fat: 15 g, protein: 20 g, total calories 360 kcal). The meal will be consumed within 20 minutes.
Blood glucose level before the meal should be between 80 to 150 mg/dl. Correction doses can be given 3 hours before the test if needed to bring the blood glucose level to the desired target range before the test meals.
The participant will be assigned to use each one of the following interventions on a separate day in a random sequence.
- Intervention A: the participant will have a mealtime bolus dose of fast-acting insulin 10 minutes before the meal representing 100% of the dose calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio (ICR). If hyperglycemia (blood glucose level >180 mg/dl) developed after 3 hours, the participant will receive an additional correction dose of fast-acting insulin calculated according to the individual insulin sensitivity factor (ISF).
- Intervention B: the bolus insulin dose for the meal will be calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio (ICR) and additional 30% of the calculated dose will added to cover the fat and protein content of the meal. This total dose will be divided into 2 portions. A premeal portion (60% of the total dose) will be given 10 minutes before the meal. The remaining 40% of the total dose will be given 30 minutes after the premeal dose. Both doses will be given as fast-acting insulin.
- Intervention C: the bolus insulin dose for the meal will be calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio (ICR) and additional 30% of the calculated dose will added to cover the fat and protein content of the meal. This total dose will be divided into 2 portions. A premeal portion (60% of the total dose) will be given 10 minutes before the meal as fast-acting insulin. The remaining 40% of the total dose will be given 30 minutes after the premeal dose as regular insulin.
Types of insulin: insulin lispro (Humalog 100 IU/mL) as fast-acting insulin and regular insulin (Humulin R) as regular insulin (Eli Lilly and Company, Indianapolis, IN, USA). Insulin doses will be calculated, splitted, approximated to the nearest 0.5 unit and given using Humapen Luxura half- unit increments insulin pens.
Capillary blood glucose level will be measured by a calibrated finger-prick blood glucose meter before the meals and every hour for the next 6 hours after the test meals. Moreover, venous blood glucose and serum cholesterol and triglycerides levels will be measured 3 hours after the test meals.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- : Insulin, lispro and regular insulin
- 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, lispro and regular insulinDrug
- A: the participant will have a mealtime bolus dose of fast-acting insulin 10 minutes before the meal representing 100% of the dose calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio
- B: the bolus insulin dose for the meal will be calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio and additional 30% of the calculated dose will added to cover the fat and protein content of the meal. This total dose will be divided into 2 portions. A premeal portion (60%) will be given 10 minutes before the meal and (40%) will be given 30 minutes after the premeal dose. Both doses will be given as fast-acting insulin.
- C: the same as intervention B but the 40% of the total dose will be given as regular insulin.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (usual treatment) | Active comparator | intervention A Receives: Drug: : Insulin, lispro and regular insulin |
| Arm 2(splitted bolus dose, fast-acting insulin only) | Active comparator | intervention B Receives: Drug: : Insulin, lispro and regular insulin |
| Arm 3 (splitted bolus dose, fast acting insulin before the meal and regular insulin after the meal) | Active comparator | intervention C Receives: Drug: : Insulin, lispro and regular insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary blood glucose levels before the test meals.
Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter before the test meals
Measured: before the test meals.
Capillary blood glucose levels one hour after the test meals.
Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter one hour after the test meals
Measured: one hour after the test meal
Capillary blood glucose levels two hours after the test meals.
Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter two hours after the test meals
Measured: two hours after the test meal
Capillary blood glucose levels three hours after the test meals.
Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter three hours after the test meals
Measured: three hours after the test meal
Capillary blood glucose levels four hours after the test meals.
Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter four hours after the test meals
Measured: four hours after the test meal
Capillary blood glucose levels five hours after the test meals.
Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter five hours after the test meals
Measured: five hours after the test meal
Capillary blood glucose levels six hours after the test meals.
Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter six hours after the test meals
Measured: six hours after the test meal
Secondary outcomes (2)
assessment of serum cholesterol level three hours after the test meal following each intervention
serum cholesterol levels measured 3 hours after the test meals.
Measured: 3 hours after test meal
assessment of serum triglyceride level three hours after the test meal following each intervention
serum triglycerides levels measured 3 hours after the test meals.
Measured: 3 hours after test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start12 Apr 2021
- Primary completion25 Nov 2021
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sawsana Ewieda, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783376
- Sponsor's protocol ID
- Soh-Med-21-01-02
- Status last verified
- Mar 2022
- First submitted
- 24 Feb 2021
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hegab AM, Hasaballah SE, Mohamed MM. Splitting Mealtime Insulin Doses for Mixed Fat and Protein Meals in Children and Adolescents with Type 1 Diabetes Using Multiple Daily Injection Regimen: A Randomized Cross-Over Trial. Pediatr Diabetes. 2023 Oct 27;2023:7467652. doi: 10.1155/2023/7467652. eCollection 2023.
PubMed 40303273
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Splitting Mealtime Insulin Doses Used for Mixed Meals High in Fat and Protein on Postprandial Blood Glucose Levels in Children and Adolescents With Type 1 Diabetes Mellitus Using Multiple Daily Injection Regimen
- ClinicalTrials.gov ID
- NCT04783376
- Acronym / sponsor ID
- Soh-Med-21-01-02
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 5 Mar 2021 (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 current management of type 1 diabetes mellitus (T1DM) depends on the use of intensive insulin therapy - either by insulin pump therapy or multiple daily injection (MDI) therapy - and the use of carbohydrate counting to determine the mealtime bolus insulin dose according the carbohydrate contents of each meal or snack. However, several studies reported that the fat and protein contents of the meals can also affect the postprandial blood glucose levels and result in delayed postprandial hyperglycemia especially after high fat and protein meals.
There is no widely accepted regimen to calculate insulin required for the fat and protein contents of meals especially for patients using multiple daily injection regimen. This study aims to find a better method to cover the increased insulin requirements following mixed fat and protein meals. The study will compare the effect of splitting mealtime bolus insulin doses into pre-meal and post-meal portions to the standard regimen which involve giving bolus dose depending on carbohydrate content only with additional correction doses 2 to 3 hours after the meal to compensate for the postprandial hyperglycemia induced by fat and protein content of the meals.
Detailed description
The study will include children and adolescents aged 6 - 18 years, diagnosed with T1DM for at least 1 year, using multiple daily injection regimen and carbohydrate counting. The study participants will be admitted at the pediatric department, Sohag University Hospital for 1 week to adjust insulin doses. adjustments will be made to basal doses, insulin to carbohydrate ratio (ICR), insulin sensitivity factor (ISF) if required.
The study participants will have three test lunch meals on 3 consecutive days consumed at the pediatric department, Sohag university hospital at 12 PM. The test meals will consist of two slices of a deep pan pizza base topped with tomato sauce, mozzarella full fat soft cheese, and minced beef. (weight: 150 g, carb. 40 g, fat: 15 g, protein: 20 g, total calories 360 kcal). The meal will be consumed within 20 minutes.
Blood glucose level before the meal should be between 80 to 150 mg/dl. Correction doses can be given 3 hours before the test if needed to bring the blood glucose level to the desired target range before the test meals.
The participant will be assigned to use each one of the following interventions on a separate day in a random sequence.
- Intervention A: the participant will have a mealtime bolus dose of fast-acting insulin 10 minutes before the meal representing 100% of the dose calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio (ICR). If hyperglycemia (blood glucose level >180 mg/dl) developed after 3 hours, the participant will receive an additional correction dose of fast-acting insulin calculated according to the individual insulin sensitivity factor (ISF).
- Intervention B: the bolus insulin dose for the meal will be calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio (ICR) and additional 30% of the calculated dose will added to cover the fat and protein content of the meal. This total dose will be divided into 2 portions. A premeal portion (60% of the total dose) will be given 10 minutes before the meal. The remaining 40% of the total dose will be given 30 minutes after the premeal dose. Both doses will be given as fast-acting insulin.
- Intervention C: the bolus insulin dose for the meal will be calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio (ICR) and additional 30% of the calculated dose will added to cover the fat and protein content of the meal. This total dose will be divided into 2 portions. A premeal portion (60% of the total dose) will be given 10 minutes before the meal as fast-acting insulin. The remaining 40% of the total dose will be given 30 minutes after the premeal dose as regular insulin.
Types of insulin: insulin lispro (Humalog 100 IU/mL) as fast-acting insulin and regular insulin (Humulin R) as regular insulin (Eli Lilly and Company, Indianapolis, IN, USA). Insulin doses will be calculated, splitted, approximated to the nearest 0.5 unit and given using Humapen Luxura half- unit increments insulin pens.
Capillary blood glucose level will be measured by a calibrated finger-prick blood glucose meter before the meals and every hour for the next 6 hours after the test meals. Moreover, venous blood glucose and serum cholesterol and triglycerides levels will be measured 3 hours after the test meals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (usual treatment) | Active comparator | Drug: : Insulin, lispro and regular insulinintervention A |
| Arm 2(splitted bolus dose, fast-acting insulin only) | Active comparator | Drug: : Insulin, lispro and regular insulinintervention B |
| Arm 3 (splitted bolus dose, fast acting insulin before the meal and regular insulin after the meal) | Active comparator | Drug: : Insulin, lispro and regular insulinintervention C |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children and adolescents aged 6 - 18 years
- diagnosed with T1DM for at least 1 year
- using MDI regimen with advanced carbohydrate counting for at least 6 months
Key exclusion criteria (4 listed)
- Subjects with associated
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, lispro and regular insulin* A: the participant will have a mealtime bolus dose of fast-acting insulin 10 minutes before the meal representing 100% of the dose calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio * B: the bolus insulin dose for the meal will be calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio and additional 30% of the calculated dose will added to cover the fat and protein content of the meal. This total dose will be divided into 2 portions. A premeal portion (60%) will be given 10 minutes before the meal and (40%) will be given 30 minutes after the premeal dose. Both doses will be given as fast-acting insulin. * C: the same as intervention B but the 40% of the total dose will be given as regular insulin. | Drug | Arm 1 (usual treatment), Arm 2(splitted bolus dose, fast-acting insulin only), Arm 3 (splitted bolus dose, fast acting insulin before the meal and regular insulin after the meal) |
Primary outcome
Capillary blood glucose levels before the test meals.
Time frame: before the test meals.
Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter before the test meals
Capillary blood glucose levels one hour after the test meals.
Time frame: one hour after the test meal
Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter one hour after the test meals
Capillary blood glucose levels two hours after the test meals.
Time frame: two hours after the test meal
Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter two hours after the test meals
Capillary blood glucose levels three hours after the test meals.
Time frame: three hours after the test meal
Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter three hours after the test meals
Capillary blood glucose levels four hours after the test meals.
Time frame: four hours after the test meal
Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter four hours after the test meals
Capillary blood glucose levels five hours after the test meals.
Time frame: five hours after the test meal
Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter five hours after the test meals
Capillary blood glucose levels six hours after the test meals.
Time frame: six hours after the test meal
Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter six hours after the test meals
2 secondary outcomes
assessment of serum cholesterol level three hours after the test meal following each intervention
Time frame: 3 hours after test meal
assessment of serum triglyceride level three hours after the test meal following each intervention
Time frame: 3 hours after test meal
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 8 Mar 2022.
- Derived from this study: PubMed 40303273Hegab AM, Hasaballah SE, Mohamed MM. Splitting Mealtime Insulin Doses for Mixed Fat and Protein Meals in Children and Adolescents with Type 1 Diabetes Using Multiple Daily Injection Regimen: A Randomized Cross-Over Trial. Pediatr Diabetes. 2023 Oct 27;2023:7467652. doi: 10.1155/2023/7467652. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, lispro and regular insulin in people with Type 1 Diabetes Mellitus, run by Sohag University at 1 site in Egypt.
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 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 8 Mar 2022. 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 Egypt. 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?
Capillary blood glucose levels before the test meals. (time frame: before the test meals.). The study lists 7 primary outcomes in all. 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 NCT04783376, which also lists 1 linked publication.
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 8 Mar 2022.