Type 1 Diabetes (T1D)NCT07037810
Compare Multiple Daily Injections With Carbohydrate Counting or With Simplified Qualitative Meal-Size Estimation in Type 1 Diabetes
A study testing iBolus and Carb counting in people with Type 1 Diabetes (T1D), run by Dasman Diabetes Institute at 1 site in Kuwait.
Trial summary
Type 1 diabetes (T1D) is an autoimmune disease characterized by loss of Beta cells in the pancreas, thus exogenous insulin is the mainstay of the management of it. Currently insulin is taken either in fixed doses for meals or variable doses via carbohydrate counting method. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- iBolus and Carb counting
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteKuwait
- Study dates
- 17 Feb 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 21 years of age.
- Clinical diagnosis of T1D for at least 12 months. The diagnosis of T1D is based on the investigator's judgment; C-peptide level and antibody determinations are not needed.
- On MDI therapy.
- Previously trained to count carbohydrates through a structured education program or known to perform carbohydrate counting by their educator/ dietitian.
- Baseline HbA1c value ≥ 7.5% and < 11% (up to 7 days before or after screening)
Who cannot join
- Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with the study protocol or with team's recommendations.
- Injection of isophane insulin (NPH) or any intermediate-acting insulin.
- More than 1 slow-acting injection and unwilling to switch to once a day for the study
- Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2, GLP-1, Metformin, Acarbose, etc.).
- Pregnancy.
Show all 10Show fewer
- Severe hypoglycemic episode within one month of admission.
- Severe diabetic ketoacidosis episode within one month of admission.
- Clinically significant nephropathy, neuropathy, or retinopathy as judged by the investigator.
- Conditions that may interfere with accurate HbA1c levels: clinically significant anemia, hemoglobinopathy, or a recent blood transfusion as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Non-inferiority Trial to Compare Multiple Daily Injections With Carbohydrate Counting or With Simplified Qualitative Meal-Size Estimation in Type 1 Diabetes: A Randomized Controlled Crossover Design.
Type 1 diabetes (T1D) is an autoimmune disease characterized by loss of Beta cells in the pancreas, thus exogenous insulin is the mainstay of the management of it. Currently insulin is taken either in fixed doses for meals or variable doses via carbohydrate counting method. Fixed insulin dosing regimen may result in hyperglycemia or hypoglycemia if the insulin dose was mismatched with the ingested meal. Carbohydrate counting method was found to be superior to the fixed dosing insulin regimen. However, literature search revealed that there is a tendency to underestimate the amount of carbohydrates in meals when carbohydrate counting method was used.
To assist people with diabetes in making better decisions regarding their diabetes care, new technological tools were introduced. Among those tools a novel learning algorithm (LA) that was created to assist in optimizing carbohydrate ratio for patients with T1D on multiple daily injection (MDI) therapy.
Read more
Therefore, in this study we aim to investigate the non-inferiority of simplified qualitative meal size estimation for insulin dosing compared to carbohydrate counting method through a mobile application that is designed with the purpose of alleviating the burden of carbohydrate counting for people with T1D on multiple daily injection regimen in a randomized controlled trial with cross-over design.
Sub-Study:
Due to the significant changes in participants' diets during the month of Ramadan, none of the two interventions will be conducted during the month of Ramadan (i.e., no intervention will start in the three months preceding the month of Ramadan). However, those participants who wish to fast may enroll in an exploratory sub-study during the month of Ramadan. The sub-study will be a two-arm, crossover study in which each participant will undergo two weeks of conventional therapy and two weeks of using the McGill iBolus mobile application to adjust their basal dose and carbohydrate ratio. The primary hypothesis of this exploratory sub-study that the McGill iBolus mobile application will improve glucose control, as measured by the percentage of time spent in target range (3.9-10 mmol/L), in patients with type 1 diabetes who fast during the month of Ramadan. Note that participants may opt to participate in this sub-study and not the main study, in which case they will not be counted towards the recruitment goal of the main study.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- iBolus, Carb counting
- Keywords
- Type 1 diabetes, carbohydrate counting, clinical trial
- 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.
iBolusDevice
MDI+ FreeStyle Libre 2 +iBolus
Carb countingOther
MDI+FreeStyle Libre 2+ Carbcounting
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Placebo comparator | MDI+FreeStyle Libre 2+ Carb counting Receives: Other: Carb counting |
| Experimental | Experimental | MDI+ FreeStyle Libre 2 +iBolus Receives: Device: iBolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
Time spent in glucose target range 3.9-10 mmol/L (70-180 mg/dl)
Measured: 12 month
Secondary outcomes (7)
Secondary endpoint
Time spent in glucose range will be measured in percentage. Between 3.9 and 7.8 mmol/L; below 3.9 mmol/L; below 3.3 mmol/L; below 2.8 mmol/L; above 7.8 mmol/L; above 10 mmol/L; above 13.9 mmol/L; above 16.7 mmol/L.
Measured: 12 month
Secondary endpoint
HbA1c (%)
Measured: 12 month
Secondary endpoint
Percentage of overnight time (23:00-7:00) of sensor glucose levels. Between 3.9 and 7.8 mmol/L; below 3.9 mmol/L; below 3.3 mmol/L; below 2.8 mmol/L; above 7.8 mmol/L; above 10 mmol/L; above 13.9 mmol/L; above 16.7 mmol/L.
Measured: 12 month
Secondary endpoint
Percentage of daytime (7:00-23:00) of sensor glucose levels. Between 3.9 and 7.8 mmol/L; below 3.9 mmol/L; below 3.3 mmol/L; below 2.8 mmol/L; above 7.8 mmol/L; above 10 mmol/L; above 13.9 mmol/L; above 16.7 mmol/L.
Measured: 12 month
Secondary endpoint
Standard deviation of glucose levels as a measure of glucose variability
Measured: 12 month
Secondary endpoint
Total insulin delivery (Unit/day)
Measured: 12 month
Secondary endpoint
Mean sensor glucose level during, the overall study period, daytime period, overnight period
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start17 Feb 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dasman Diabetes Institute
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University
- Responsible party
- Principal investigator, Dr. Ebaa Al Ozairi, Dasman Diabetes Institute
- Investigators
- Ebaa Al Ozairi, MD, Principal investigator, Dasman Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037810
- Sponsor's protocol ID
- RA HM-2024-14
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Non-inferiority Trial to Compare Multiple Daily Injections With Carbohydrate Counting or With Simplified Qualitative Meal-Size Estimation in Type 1 Diabetes: A Randomized Controlled Crossover Design.
- ClinicalTrials.gov ID
- NCT07037810
- Acronym / sponsor ID
- RA HM-2024-14
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- Type 1 diabetes, carbohydrate counting, clinical trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Dasman Diabetes InstituteUniversity, hospital or other
- Collaborators
- McGill University
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Jun 2025 (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.
Type 1 diabetes (T1D) is an autoimmune disease characterized by loss of Beta cells in the pancreas, thus exogenous insulin is the mainstay of the management of it. Currently insulin is taken either in fixed doses for meals or variable doses via carbohydrate counting method. Fixed insulin dosing regimen may result in hyperglycemia or hypoglycemia if the insulin dose was mismatched with the ingested meal. Carbohydrate counting method was found to be superior to the fixed dosing insulin regimen. However, literature search revealed that there is a tendency to underestimate the amount of carbohydrates in meals when carbohydrate counting method was used.
To assist people with diabetes in making better decisions regarding their diabetes care, new technological tools were introduced. Among those tools a novel learning algorithm (LA) that was created to assist in optimizing carbohydrate ratio for patients with T1D on multiple daily injection (MDI) therapy.
Therefore, in this study we aim to investigate the non-inferiority of simplified qualitative meal size estimation for insulin dosing compared to carbohydrate counting method through a mobile application that is designed with the purpose of alleviating the burden of carbohydrate counting for people with T1D on multiple daily injection regimen in a randomized controlled trial with cross-over design.
Sub-Study:
Due to the significant changes in participants' diets during the month of Ramadan, none of the two interventions will be conducted during the month of Ramadan (i.e., no intervention will start in the three months preceding the month of Ramadan). However, those participants who wish to fast may enroll in an exploratory sub-study during the month of Ramadan. The sub-study will be a two-arm, crossover study in which each participant will undergo two weeks of conventional therapy and two weeks of using the McGill iBolus mobile application to adjust their basal dose and carbohydrate ratio. The primary hypothesis of this exploratory sub-study that the McGill iBolus mobile application will improve glucose control, as measured by the percentage of time spent in target range (3.9-10 mmol/L), in patients with type 1 diabetes who fast during the month of Ramadan. Note that participants may opt to participate in this sub-study and not the main study, in which case they will not be counted towards the recruitment goal of the main study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Placebo comparator | Other: Carb countingMDI+FreeStyle Libre 2+ Carb counting |
| Experimental | Experimental | Device: iBolusMDI+ FreeStyle Libre 2 +iBolus |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females ≥ 21 years of age.
- Clinical diagnosis of T1D for at least 12 months. The diagnosis of T1D is based on the investigator's judgment; C-peptide level and antibody determinations are not needed.
- On MDI therapy.
- Previously trained to count carbohydrates through a structured education program or known to perform carbohydrate counting by their educator/ dietitian.
- Baseline HbA1c value ≥ 7.5% and < 11% (up to 7 days before or after screening)
Key exclusion criteria (10 listed)
- Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with the study protocol or with team's recommendations.
- Injection of isophane insulin (NPH) or any intermediate-acting insulin.
- More than 1 slow-acting injection and unwilling to switch to once a day for the study
- Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2, GLP-1, Metformin, Acarbose, etc.).
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 |
|---|---|---|
| iBolusMDI+ FreeStyle Libre 2 +iBolus | Device | Experimental |
| Carb countingMDI+FreeStyle Libre 2+ Carbcounting | Other | Usual care |
Primary outcome
Primary endpoint
Time frame: 12 month
Time spent in glucose target range 3.9-10 mmol/L (70-180 mg/dl)
7 secondary outcomes
Secondary endpoint
Time frame: 12 month
Secondary endpoint
Time frame: 12 month
Secondary endpoint
Time frame: 12 month
Secondary endpoint
Time frame: 12 month
Secondary endpoint
Time frame: 12 month
Secondary endpoint
Time frame: 12 month
Secondary endpoint
Time frame: 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- 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.
Ebaa Al Ozairi, MD principal investigator
Dasman Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iBolus and Carb counting in people with Type 1 Diabetes (T1D), run by Dasman Diabetes Institute at 1 site in Kuwait.
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 10 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: enrolling by invitation, as of the sponsor's last update on 26 Jun 2025. 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 Kuwait. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Primary endpoint (time frame: 12 month). 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 26 Jun 2025.