Carbohydrate Count Aided by a Simulation in People With Type 1 Diabetes Mellitus. A Protocol for a Clinical Trial
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- Age: Adults 18 years old or older.
- T1DM with at least one year since diagnosis.
- Treatment with a multiple daily injection scheme or insulin pump.
- Trained in advance CHOC.
- Have an HbA1c above 7.5% and below 10% in the three months before the randomization.
- Be able to use a Smartphone app for carbohydrate counting.
Exclusion Criteria:
- A confirmation or possible diabetic gastroparesia.
- With a chronic renal disease and an estimated filtration rate of 65 ml/min/1.73m2 or less using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.
- Patients been treated with any other form of medication different from insulin for DM.
- Pregnant women.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intervention
Control
Patients assigned to the intervention group will receive the STUDIA application on their mobile device, which has two functions, an insulin bolus calculator that estimates the amount of insulin according to the amount of carbohydrates that the patients compute, the insulin sensitivity factor, and the insulin/carbohydrate ratio provide by their treating physician. The application has a graphical interface that shows a glucose curve four hours after the meal. This graph is built using the estimations made by an MSBF based on some characteristics of the patient previously recorded in the same application, the amount of carbohydrates entered to calculate the insulin bolus, and an estimate of the fat and protein content of the meal.
The patients assigned to the control group will also receive the STUDIA application on their mobile devices. The insulin dose calculation process is the same as that described for the intervention group. However, the simulation results will be kept hidden from the patient.