Evaluating advanced hybrid closed-loop systems for managing Type 1 Diabetes
Clinical Utility of a Tight Glucose Objectives Through Advanced Hybrid Closed-loop Systems in Adult Patients With Type 1 Diabetes and Poor Glycemic Control
Castilla-La Mancha Health Service · NCT06466967
This study is testing if using a new advanced hybrid closed-loop system can help adults with Type 1 Diabetes better manage their blood sugar levels when they aim for stricter glucose targets.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Castilla-La Mancha Health Service (other) |
| Locations | 1 site (Ciudad Real) |
| Trial ID | NCT06466967 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the effects of tighter glucose objectives on time in range (TIR) for adult patients with Type 1 Diabetes (T1D) who switch to an advanced hybrid closed-loop (AHCL) system after previously being treated with multiple dose insulin injections or other AHCL systems. The study focuses on patients with poor glycemic control, specifically those with an HbA1c greater than 7%. By utilizing the new CamAPS FX system, the research seeks to determine if stricter glycemic targets can lead to improved glucose management and reduced complications associated with T1D. The study will collect interstitial glucose data to assess the impact of these interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Type 1 Diabetes and an HbA1c greater than 7%.
Not a fit: Patients with other types of diabetes, uncontrolled psychiatric diseases, or those who have previously used the CamAPS-Ypsopump may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved glycemic control and reduced complications for patients with Type 1 Diabetes.
How similar studies have performed: Previous studies have shown that advanced hybrid closed-loop systems can improve glycemic control, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with type 1 diabetes. * Age greater than or equal to 18 years. * HbA1c \> 7% (previous poor glycemic control condition). * Prior treatment with MDI or aHCL. Exclusion Criteria: * Other types of diabetes. * Pregnancy or pre-conception control. * Uncontrolled psychiatric disease. * Current or previous treatment with CamAPS-Ypsopump. * No glucometric data available during the periods under study. * History of severe hypoglycemia.
Where this trial is running
Ciudad Real
- Ciudad Real General University Hospital — Ciudad Real, Spain (RECRUITING)
Study contacts
- Study coordinator: Ignacio González Maroto
- Email: igmaroto@sescam.jccm.es
- Phone: 0034-926278000
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.
Conditions: Type 1 Diabetes, advanced hybrid closed-loop, tight time in range, artificial pancreas