NCT05181917Completed
Carbohydrate Count Aided by a Simulation in People With Type 1 Diabetes Mellitus. A Protocol for a Clinical Trial
Carbohydrate Count Aided by a Simulation of Postprandial Glucose Dynamics Generated by a Mathematical Model in People With Type 1 Diabetes Mellitus. A Protocol for a Clinical Trial
Source: ClinicalTrials.gov · Last updated 6 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 20 Dec 2021
- Start date
- 1 May 2023
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- Hospital Pablo Tobón Uribe
- Diseases
- Type 1 diabetes
- NCT number
- NCT05181917
What you commit to
- Study type: Interventional
- Participants enrolled: 28
- From 1 May 2023 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients been treated with any other form of medication different from insulin for DM.
Other illness
- 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.
Other
- A confirmation or possible diabetic gastroparesia.
- Pregnant women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Pablo Tobón Uribe Coordinator of this site? Confirm its status | Medellín | Colombia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.