Insulin Pump Therapy Clinical Trial
— HybridRamOfficial 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
Verified date | June 2024 |
Source | King Fahad Medical City |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 75 |
Est. completion date | June 29, 2024 |
Est. primary completion date | March 11, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 70 Years |
Eligibility | Inclusion Criteria: - Type 1 diabetes as per the American Diabetes Association classification for at least 1 year. - Age 14 to 70. - OLID therapy for at least 6 months. - Willingness and ability to adhere to the study protocol. Exclusion Criteria: - Pregnancy. - Using medications that affect blood glucose like steroids. - Patients who are not able to fast for the entire month of Ramadan due to medical or non-medical reasons. |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King Fahad Medical City | Riyadh | Riyadh Province |
Lead Sponsor | Collaborator |
---|---|
King Fahad Medical City |
Saudi Arabia,
Al Awadi FF, Echtay A, Al Arouj M, Sabir Ali S, Shehadeh N, Al Shaikh A, Djaballah K, Dessapt-Baradez C, Omar Abu-Hijleh M, Bennakhi A, El Hassan Gharbi M, El Sayed El Hadidy K, Abdul Kareem Khazaal F, Hassanein MM. Patterns of Diabetes Care Among People with Type 1 Diabetes During Ramadan: An International Prospective Study (DAR-MENA T1DM). Adv Ther. 2020 Apr;37(4):1550-1563. doi: 10.1007/s12325-020-01267-4. Epub 2020 Mar 6. — View Citation
Alamoudi R, Alsubaiee M, Alqarni A, Saleh Y, Aljaser S, Salam A, Eledrisi M. Comparison of Insulin Pump Therapy and Multiple Daily Injections Insulin Regimen in Patients with Type 1 Diabetes During Ramadan Fasting. Diabetes Technol Ther. 2017 Jun;19(6):349-354. doi: 10.1089/dia.2016.0418. Epub 2017 Mar 15. — View Citation
Elbarbary NS, Ismail EAR. Glycemic control during Ramadan fasting in adolescents and young adults with type 1 diabetes on MiniMed 780G advanced hybrid closed-loop system: A randomized controlled trial. Diabetes Res Clin Pract. 2022 Sep;191:110045. doi: 10.1016/j.diabres.2022.110045. Epub 2022 Aug 17. — View Citation
Wannes S, Gamal GM, Fredj MB, Al Qusayer D, El Abed S, Sedky Y, Khalil M. Glucose control during Ramadan in a pediatric cohort with type 1 diabetes on MiniMed standard and advanced hybrid closed-loop systems: A pilot study. Diabetes Res Clin Pract. 2023 Sep;203:110867. doi: 10.1016/j.diabres.2023.110867. Epub 2023 Aug 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time in Range difference between AHCL and OLID during the 30 days of the month of Ramadan | Time in range on CGM (70-180mg/dL) | 30 days (the month of Ramadan) |
Status | Clinical Trial | Phase | |
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