Evaluating advanced hybrid closed-loop systems for managing Type 1 Diabetes
Clinical Effectiveness of Advanced Hybrid Closed-loop Systems (AHCL) for Achieving Time in Tight Range (TiTR) of Interstitial Glucose Among Adult Type 1 Diabetes (T1D) Patients
This study is testing three different advanced insulin delivery systems to see which one helps adults with Type 1 Diabetes keep their blood sugar levels in a healthy range.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 189 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Castilla-La Mancha Health Service Academic / other |
| Locations | 3 sites (Terrassa, Barcelona and 2 other locations) |
| Trial ID | NCT06834334 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the effectiveness of three different advanced hybrid closed-loop (AHCL) systems in improving time in tight range (TiTR) for adults with Type 1 Diabetes (T1D). Participants will have been using these systems for at least three months and will have continuous glucose monitoring data available from the last 14 days. The study will compare the performance of Medtronic Minimed 780G, Tandem T Slim X2, and Ypsopump CamAPS in maintaining blood glucose levels within the target range of 70-140 mg/dL. The findings could provide insights into the best practices for glycemic control in T1D patients using AHCL technology.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Type 1 Diabetes who have been using an advanced hybrid closed-loop system for at least three months.
Not a fit: Patients with other types of diabetes or those not using advanced hybrid closed-loop systems will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved glycemic control and quality of life for patients with Type 1 Diabetes.
How similar studies have performed: Previous studies have shown that advanced hybrid closed-loop systems significantly improve glycemic control, indicating a strong potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with type 1 diabetes. * Age greater than or equal to 18 years. * Treated with advanced hybrid closed-loop systems (AHCL) for at least 3 months * Actived continuous glucose monitoring data in the last 14 days. Exclusion Criteria: * Other types of diabetes. * Receiving treatment with insulin regimens other than AHCL. * Having received AHCL treatment for less than 3 months in a row prior to inclusion in the study with the same system. * No data on use of the AHCL system during the previous 14 days. * Severe or uncontrolled psychiatric disorder. * Pregnancy or end of pregnancy less than 3 months ago or preparation for pregnancy.
Where this trial is running
Terrassa, Barcelona and 2 other locations
- Hospital Universitario Mutua de Tarrasa — Terrassa, Barcelona, Spain (Recruiting)
- Badajoz University Hospital — Badajoz, Spain (Recruiting)
- Ciudad Real General University Hospital — Ciudad Real, Spain (Recruiting)
Study contacts
- Principal investigator: Jesus Moreno Fernandez, PhD — Castilla-La Mancha Health Public Service
- Study coordinator: Jesus Moreno, PhD
- Email: jmorenof@sescam.jccm.es
- Phone: 926278000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.