Using a hybrid closed loop insulin delivery system to improve blood sugar control in type 1 diabetes patients
Effect of an Artificial Pancreas System on Glycemic Control in Patients With Type 1 Diabetes
This study is testing if a new insulin delivery system can help people with type 1 diabetes better control their blood sugar levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Masaryk Hospital Usti nad Labem Academic / other |
| Locations | 1 site (Usti Nad Labem) |
| Trial ID | NCT05924932 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of a hybrid closed loop insulin delivery system on glycemic control in patients with type 1 diabetes (T1D) who have varying initial levels of glycated hemoglobin. The study will compare the impact of this advanced insulin dosing method on reducing glycemic variability among participants. By including a diverse group of T1D patients, the research seeks to provide insights into the real-world application of this technology in managing diabetes effectively.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of type 1 diabetes for more than one year.
Not a fit: Patients with severe noncompliance, significant diabetic retinopathy, or those who are pregnant or planning to become pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved blood sugar management and reduced complications for patients with type 1 diabetes.
How similar studies have performed: Other studies have shown promising results with hybrid closed loop systems in managing type 1 diabetes, indicating that this approach is gaining traction in clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with T1D * Type 1 diabetes for \> 1 years * ≥ 18 years old * CSII (without HCL) or MDI Exclusion Criteria: * Severe noncompliance * Known severe diabetic retinopathy and/or macular edema, * Lactation, pregnancy, or intending to become pregnant during the study; * A condition likely to require MRI. Use of acetaminophen-containing medication; * Unwillingness to use the study device for \>70% of time. * Conditions that affect red blood cell turnover (hemolytic and other anemias, glucose-6-phosphate dehydrogenase deficiency, recent blood transfusion, use of drugs that stimulate erythropoesis, end-stage kidney disease).
Where this trial is running
Usti Nad Labem
- Lucie Radovnická — Usti Nad Labem, Czechia (Recruiting)
Study contacts
- Study coordinator: Lucie Radovnická
- Email: radovnickal@gmail.com
- Phone: +420777624793
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.