An APDS consists of separate components that must be functionally compatible as a medical device—an insulin pump and a continuous glucose monitoring system—when combined with a controlling algorithm. The purpose of combining these devices is to improve the ability of patients to manage their diabetes with the help of their health care providers.
The complexity of diabetes management and known limitations of the current devices that are used as components in the artificial pancreas require that investigators show that when they put the components together as a closed loop system, the artificial pancreas can help patients with diabetes manage the disease.
A great deal can be learned about how a device may work through laboratory studies, animal studies, or in silico (computer) modeling. However, clinical studies are needed to understand whether or not the device works as intended in the “real world” and determine if there are any safety issues related to that use.
In a clinical study, the device is tested on human beings according to a research plan (called a protocol) designed to answer specific research questions and protect the safety of people participating in the study.
To appropriately evaluate the effectiveness and the risks and benefits of the APDS, different kinds of clinical studies may be needed.
Studies in Clinical Research Settings and Transitional Settings
Studies might be conducted in clinical research centers (CRCs) (hospitals or hospital-like facilities) in which doctors and nurses have access to blood tests used to assess the device’s accuracy and to equipment needed to monitor the patient. This enables them to quickly intervene to keep the patient safe if the device does not work correctly. Patients might need to follow strict instructions regarding what they eat or their level of activity during the study period.
Transitional settings are similar to clinical research settings because they provide ready access to health care providers and monitoring equipment, but patients have more control over daily activities during the study period.
Both kinds of studies can assess how well a device works, identify the risks associated with using the device, or help identify needed device changes or improvements.
Studies in Outpatient Settings
To gain FDA approval to market an APDS, investigators will generally perform an outpatient study. In many cases, patients in the study will use the devices in their homes while under the care of a doctor or nurse. These studies provide information on the overall risks and benefits of an APDS, as well as information that can help in developing the labeling and instructions for health care providers and patients.