In 2019, there were over 140 publication on the topic of artificial pancreas (AP) – the highest number on record, according to PubMed. This presentation offers a brief review of recent and ongoing AP studies in type 1 diabetes (T1D), and then focuses in more detail on the three largest randomized controlled trials to date.
Data from three NIH/NIDDK-funded clinical trials: (1) iDCL Protocol 1 (NCT02985866) of the International Diabetes Closed-Loop Trial, which randomized 126 participants for 3 months to establish that mobile AP using a smart phone as a computational hub running the control algorithm is a viable treatment for T1D; (2) iDCL Protocol 3 (NCT03563313) of the International Diabetes Closed-Loop Trial, which randomized 168 participants with T1D for 6 months in a pivotal trial aiming regulatory clearance of the new Control-IQ system, and (3) Project Nightlight (NCT02679287) – a 10-month study which randomized 80 participants with T1D to compare two different treatment modalities – evening/night vs 24/7 closed loop.
All three studies used sensor-augmented pump (SAP) as their control condition, and all used the same AP algorithm, originally developed at the University of Virginia for the DiAs research platform and then translated to industry as inControl (TypeZero Technologies) used in iDCL Protocol 1 and Project Nightlight, and Control-IQ (Tandem Diabetes Care) used in Project Nightlight and iDCL Protocol 3. Because in all three studies the control groups received the same treatment (SAP) and all studies shared the same AP algorithm, cross-study meta-analyses are justified and are used to compare glycemic and technology-acceptance outcomes across different technology implementations, e.g. mobile AP vs. AP embedded in the pump.
Large-scale artificial pancreas studies have established the current capabilities of automated closed-loop control. First-generation systems are now transitioning to routine use by people with type 1 diabetes.