Carbohydrate Count Aided by a Simulation in People With Type 1 Diabetes Mellitus. A Protocol for a Clinical Trial

NCT05181917 | Completed

• 1 other identifier: 2021.004
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Hyperglycemic crisis:

  4 weeks

• Hypoglycemia

  4 weeks

• Prediction capacity of the model of postprandial glucose values

  4 weeks

Other Outcomes (3)

• Glycemic variability:

  4 weeks

• Usability of the application

  4 weeks

• Actions carried out by participants

  4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: STUDIA app

Control

ACTIVE COMPARATOR

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.

Behavioral: STUDIA app

Interventions

STUDIA app BEHAVIORAL

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.

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Pablo Tobón Uribe: lead
• Universidad de Antioquia: collaborator

Study Sites (1)

Hospital Pablo Tobón Uribe

Medellín, Antioquia, Colombia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Carlos E. Builes-Montaño, MD

  Hospital Pablo Tobón Uribe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: May 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)