NCT05181917|Completed
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Sponsor study identifier
interventional
28
1 country
1
Study Start
May 1, 2023
Actual (reported)Primary Completion
November 30, 2023
Actual (reported)Study Completion
November 30, 2023
Actual (reported)Insulin remains the only approved treatment for type 1 diabetes mellitus patients and is used by many with type 2 diabetes. Carbohydrate counting is the most recommended way to prescribe prandial insulin dose because it is safe and efficacious, and also it allows a more variate diet to patients. Methods to improve carbohydrate counting include automatization of the process, optimizing carbohydrate meal content estimation, and including other nutrients such as fat into the equation. Being an iterative process that patients perfect by practicing and repeating, we believe that using simulations can improve carbohydrate counting. Simulations allow individuals to practice in a safe environment and help build confidence in one's ability to perform a task. In this clinical trial, patients assigned to the intervention group will have installed the STUDIA app, an automatic carbohydrate counter coupled to a mathematical model that simulates glucose excursions at the individual level using the patients' parameters in their smartphone. Time in range will be measured using a continuous glucose monitor.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 20, 2021
Actual (reported)January 10, 2022
Actual (reported)May 1, 2023
Actual (reported)November 30, 2023
Actual (reported)November 30, 2023
Actual (reported)TIme in range
Time in range (TIR) is expressed as the ratio between the number of hours a patient spends in a given glucose range and the total number of hours of monitoring. According to the proposal of the international consensus of time in range (50) for people with usual hypoglycemia risk, it was defined for the study as the time between 70 and 180 mg / dL.
4 weeks
Hyperglycemic crisis:
4 weeks
Hypoglycemia
4 weeks
Prediction capacity of the model of postprandial glucose values
4 weeks
Glycemic variability:
4 weeks
Usability of the application
4 weeks
Actions carried out by participants
4 weeks
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.
STUDIA application 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital Pablo Tobón Uribe
Medellín, Antioquia, Colombia
Carlos E. Builes-Montaño, MD
Hospital Pablo Tobón Uribe
28 participants (actual enrollment reported by the registry).
First Submitted
December 20, 2021
First Posted
January 10, 2022
Study Start
May 1, 2023
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
November 30, 2023
Actual (reported)Study Completion
November 30, 2023
Actual (reported)Last Updated
June 6, 2024
Record last verified: 2024-06
The datasets generated or analyzed during the current study may be available from the sponsor institution on reasonable request.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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