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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- TIme in range
研究概览
简要总结
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.
详细描述
Study setting Patients with T1DM trained in carbohydrate counting whose follow-up is considered feasible will be recruited from university hospitals and clinics dedicated to treating people with DM in the city of Medellín, Colombia.
Cointerventions Since only patients with T1DM will be recruited, patients in both groups are expected to be treated with insulin, either with a multiple injection scheme or an insulin pump. There are no other approved interventions for the treatment of T1DM. Researchers will be instructed to avoid the use of unapproved drugs for T1DM.
Protocol discontinuation
The protocol will be discontinued if any of the following conditions are met:
The patient does not wish to continue participating in the study. The patient's treating physician decides that she should not continue in the study due to the need for additional therapies that could affect the patient's ability to interact with the application or substantially modify glucose behavior and require other interventions, such as treatment with high doses of glucocorticoids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
TIme in range
时间窗: 4 weeks
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.
次要结局
- Hyperglycemic crisis:(4 weeks)
- Prediction capacity of the model of postprandial glucose values(4 weeks)
- Hypoglycemia(4 weeks)