An interventional study of iBolus and Carb counting in Type 1 Diabetes (T1D), sponsored by Dasman Diabetes Institute. Enrolling by invitation at 1 site in Kuwait. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by Dasman Diabetes Institute · Not applicable, Interventional, and Supportive care
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 34 is below the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Dasman Diabetes Institute is the lead sponsor of 31 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MDI+FreeStyle Libre 2+ Carb counting
Other: Carb counting
MDI+ FreeStyle Libre 2 +iBolus
Device: iBolus
MDI+ FreeStyle Libre 2 +iBolus
MDI+FreeStyle Libre 2+ Carbcounting
Primary endpoint
Time spent in glucose target range 3.9-10 mmol/L (70-180 mg/dl)
Time frame: 12 month
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.
Time frame: 12 month
Secondary endpoint
HbA1c (%)
Time frame: 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.
Time frame: 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.
Time frame: 12 month
Secondary endpoint
Standard deviation of glucose levels as a measure of glucose variability
Time frame: 12 month
Secondary endpoint
Total insulin delivery (Unit/day)
Time frame: 12 month
Secondary endpoint
Mean sensor glucose level during, the overall study period, daytime period, overnight period
Time frame: 12 month
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Jun 2026, 16 months after the start.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 16 months is below that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
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Dasman Diabetes Institute