This trial will evaluate the safety and effectiveness of the Hybrid Closed Loop (HCL) system in adult and pediatric patients with type 1 diabetes.
The primary outcome of this study will be a change in HbA1c levels (average blood glucose over 3 months).
The details
HCL systems are a diabetes management strategy. They are composed of a continuous blood glucose monitor (CGM) and an insulin pump that together act as an artificial pancreas. The safety and effectiveness of these systems in the home setting is still under investigation.
This study will evaluate if a HCL system is effective at managing blood sugar levels in a diverse group of patients with type 1 diabetes. The safety and effectivness will be measured through changes in HbA1c, time spent in the target range for blood glucose, and time spent in hypoglycemia (very low blood glucose).
Who are they looking for?
This trial will recruit approximately 1500 patients (aged 2-80 years) with type 1 diabetes and requiring a minimum daily insulin dose of 8 units. Patients currently using multiple daily insulin injections (MDI), subcutaneous insulin infusions (CSII) or sensor-augmented pump (SAP) therapy as part of their diabetes regimen will be included. Patients with any type of cardiovascular disorder must have the consent of their cardiologist before taking part.
Patients cannot take part if they are receiving MDI treatment along with CGM. Patients that are pregnant or plan to become pregnant cannot take part in the study. Other exclusion criteria include: hyperthyrodism, chronic kidney diease, eating disorders, history of visual impairment and alcohol or drug abuse.
How will it work
Patients will be randomly assigned to two groups. One group will receive the HCL system and the other group will maintain their current diabetes regimen. The groups will be further divided into three arms within each treatment group to reflect the previous diabetes regimen used – MDI, CSII, and SAP.
During the trial, patients in the HCL treatment group must wear the system for a minimum of 80% of the time and upload data from the system on a weekly basis. The initial treatment phase will last 6 months. Following this, the trial will continue for a further 6 months and all patients will use the HCL system during this period.
