Compare Multiple Daily Injections With Carbohydrate Counting or With Simplified Qualitative Meal-Size Estimation in Type 1 Diabetes

Launched by DASMAN DIABETES INSTITUTE · Jun 17, 2025

Keywords

ClinConnect Summary

This study is testing a new, easier way to dose insulin for adults with Type 1 diabetes who use multiple daily injections. Researchers want to see if using a simplified, qualitative estimate of meal size (instead of counting exact carbohydrates) is not worse than traditional carbohydrate counting when helping people stay in a healthy glucose range. The trial uses an app called iBolus and a continuous glucose monitor (FreeStyle Libre 2) to guide insulin dosing. It’s a randomized crossover study, so each participant tries both approaches at different times. The main goal is to measure how much time participants’ blood glucose stays in the target range of about 70–180 mg/dL (3.9–10 mmol/L) over 12 months. Secondary goals include HbA1c (average glucose over 2–3 months), and various measures of glucose control, variability, and insulin use. The study is led by Dasman Diabetes Institute in Kuwait with McGill University, and results are not yet available.

Who can join and what to expect: Eligible adults are 21 or older, have Type 1 diabetes for at least 1 year, are on multiple daily injections, and have training in carbohydrate counting. They must have a baseline HbA1c between 7.5% and 11% within about a week of screening. Exclusions include pregnancy, recent serious low or high blood sugar events, significant kidney, nerve, or eye disease, use of certain other diabetes medicines, and conditions that could affect study participation or accurate measurements. Participants will wear the CGM, be randomly assigned to start with either carb counting (usual care) or the iBolus method (experimental), and then cross over to the other method later. There is also a Ramadan sub-study for those who fast during Ramadan, comparing two weeks of each method, but the main study avoids Ramadan changes. The trial is open in Kuwait, aims to enroll about 34 people, and results are not yet published.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Males and females ≥ 21 years of age.
• • 2. 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.
• • 3. On MDI therapy.
• • 4. Previously trained to count carbohydrates through a structured education program or known to perform carbohydrate counting by their educator/ dietitian.
• • 5. Baseline HbA1c value ≥ 7.5% and \< 11% (up to 7 days before or after screening)
• Exclusion Criteria:
• • 1. Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
• • 2. Failure to comply with the study protocol or with team's recommendations.
• • 3. Injection of isophane insulin (NPH) or any intermediate-acting insulin.
• • 4. More than 1 slow-acting injection and unwilling to switch to once a day for the study
• • 5. Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2, GLP-1, Metformin, Acarbose, etc.).
• • 6. Pregnancy.
• • 7. Severe hypoglycemic episode within one month of admission.
• • 8. Severe diabetic ketoacidosis episode within one month of admission.
• • 9. Clinically significant nephropathy, neuropathy, or retinopathy as judged by the investigator.
• • 10. Conditions that may interfere with accurate HbA1c levels: clinically significant anemia, hemoglobinopathy, or a recent blood transfusion as judged by the investigator.