Updating Preventive and Treatment Guidelines for Hypoglycemia in Individuals Living With Type 1 Diabetes

Официальное название

Updating pReventive and Treatment guidelinEs for Mild hypOglycemia in Individuals Living With Type 1 Diabetes During the erA of Continuous gLucose Monitoring: The REMODAL Trial

Обзор

The REMODAL trial is a randomized crossover study aiming to update treatment guidelines for mild hypoglycemia in people with Type 1 diabetes using continuous glucose monitoring (CGM) technology. The study will assess whether treating mild hypoglycemia proactively (at a glucose threshold of 5.0 mmol/L) with lower doses of carbohydrate (CHO) is more effective than the traditional reactive approach (treatment at \< 4.0 mmol/L). The goal is to reduce hypoglycemia frequency and improve quality of life, while minimizing caloric intake and rebound hyperglycemia.

Подробное описание

The REMODAL trial explores an individualized, proactive approach to treat mild hypoglycemia in individuals with Type 1 diabetes (T1D) who use CGM. Traditional guidelines, established in the 1980s, recommend the "15g/15min rule" - consuming 15g of CHO every 15 minutes for glucose levels below 4.0 mmol/L. However, these guidelines may no longer be optimal with the advancements in insulin therapies and CGM, which provide real-time glucose data and predict glucose trends.

In this study, 32 adult participants with T1D will receive three interventions to test different amounts and timing of CHO intake under real-life conditions. These are as follows:

1. 8g of CHO at a threshold of 5.0 mmol/L (proactive approach). 2. 16g of CHO at a threshold of 5.0 mmol/L (proactive approach). 3. 16g of CHO at a threshold of \< 4.0 mmol/L (traditional reactive approach).

The primary outcome is the prevention rate of hypoglycemic episodes under each intervention, with additional measures on glucose levels, time spent in hypoglycemia, and rebound hyperglycemia. The study also considers differences in glucose management between multiple daily injections, continuous subcutaneous insulin infusion, and automated insulin delivery systems, which may affect CHO needs. This study hopes to redefine effective hypoglycemia management in the modern era of diabetes care, providing personalized recommendations to improve glycemic control and overall quality of life.

Вмешательства

• Поведенческое Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and Treatment
  The intervention in the REMODAL trial involves administering specific amounts of oral carbohydrates (CHO) at different glucose thresholds to evaluate the effectiveness of proactive versus reactive hypoglycemia management strategies in adults with Type 1 diabetes using continuous glucose monitoring (CGM). Participants will undergo three distinct interventions, each designed to test a different amount and timing of CHO intake.

Первичные конечные точки

• Percentage of Hypoglycemia Prevention with 16g CHO at 5.0 mmol/L [Срок оценки: 60 minutes]

Вторичные конечные точки (8)

• CGM Interstitial Glucose Levels Post-CHO Intake [Срок оценки: 10, 15, 20, 30, and 60 minutes]
• Lowest CGM Glucose Value Post-CHO Intake [Срок оценки: 60 minutes]
• Time Spent in Hypoglycemia Following CHO Intake [Срок оценки: 60 minutes]
• Percentage of Episodes Corrected by CHO at Specific Time Intervals [Срок оценки: 10, 15, 20, and 30 minutes]
• Number of Episodes Requiring Additional CHO Treatment [Срок оценки: 60 minutes]
• Incidence of Rebound Hyperglycemia (≥ 10.0 mmol/L) [Срок оценки: 60 minutes]
• Total CHO Consumption per Intervention [Срок оценки: 60 minutes]
• Safety Endpoint - Plasma Glucose and CGM Lag-Time Analysis [Срок оценки: 5, 10, 15, 20, and 30 minutes]

Критерии участия

Критерии включения

• Adults aged 18 years and older
• Clinical diagnosis of Type 1 diabetes for at least 1 year
• Currently treated with multiple daily insulin injections (MDI), continuous subcutaneous insulin infusion (CSII), or automated insulin delivery (AID) systems
• HbA1c level below 9.0%
• Equal distribution of male and female participants, as well as MDI/CSII and AID users

Критерии исключения

• Gastroparesis
• Significant cardiac rhythm abnormalities
• Clinically significant microvascular complications such as nephropathy (eGFR < 40 ml/min) or severe proliferative retinopathy
• Diagnosis of epilepsy
• Pregnancy or currently breastfeeding
• Severe hypoglycemic episode within 1 month prior to inclusion
• Macrovascular events or uncorrected hypokalemia (K+ < 3.5 mmol/L) within 3 months prior to inclusion
• Anticipated treatment changes during the trial period
• Inability to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

• Institut de recherches cliniques de Montréal — Montreal
• Montreal Clinical Research Institute — Montreal

Идентификаторы

NCT: NCT06683391 · 2025-1295

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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