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Closed Loop Pumps vs. Traditional Open Loop Pumps in Managing Blood Glucose Levels in T1DM Patients Fasting in Ramadan.
Sponsor: King Fahad Medical City
Summary
Our proposed study aims to build upon the existing findings by conducting a first-of-its-kind randomized controlled trial (RCT) that directly compares Advanced Hybrid Closed Loop (AHCL) and open-loop insulin delivery (OLID) systems during Ramadan. This comparison is crucial for understanding the nuanced benefits and potential limitations of each system in the context of Ramadan fasting, a topic not yet explored in RCT settings. By undertaking this study, we intend to bridge this gap in research, providing valuable insights into the effectiveness of these contrasting insulin delivery methods. The outcomes of this research could significantly inform clinical recommendations for T1DM management during Ramadan, emphasizing the importance of personalized treatment approaches that are aligned with patient needs and technological advancements.
Official title: Comparative Efficacy of Advanced Hybrid Closed Loop (AHCL) Therapy Versus Open-Loop Insulin Delivery (OLID) System in Type 1 Diabetes Management During Ramadan: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
14 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2024-02-01
Completion Date
2025-03-29
Last Updated
2024-08-14
Healthy Volunteers
No
Conditions
Interventions
Advanced hybrid closed loop insulin pump
All groups will receive comprehensive diabetes education and extensive carbohydrate counting training. Continuous glucose monitoring (CGM) will be conducted using the Guardian 4 sensor or Dexcom G6 for the intervention group depending on the type of pump used. fructosamine levels for all patients will be checked both before and after Ramadan to provide a more immediate assessment of glycemic control.
Open Loop Insulin Delivery system
the control group will continue using their current CGM device. Data on glycemic control, hypoglycemic events, and patient satisfaction will be collected before and throughout Ramadan. Additionally, fructosamine levels for all patients will be checked both before and after Ramadan to provide a more immediate assessment of glycemic control.
Locations (1)
King Fahad Medical City
Riyadh, Riyadh Region, Saudi Arabia