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

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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.