A Clinical Trial Testing Two Artificial Pancreas Algorithms

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Clinical Trial Identifier: NCT02438670

Trial name: MPC Versus PID for Closed Loop Insulin Delivery

Diabetes type: Type 1 diabetes.

What it’s testing: The goal of the study is to compare use of two artificial pancreas algorithms: the “PID” (Proportional-Integral-Derivative) algorithm vs. the “MPC” (Model Predictive Control) algorithm. Artificial pancreas systems typically have three main components: a continuous glucose monitor (CGM) that measures glucose levels over time, an insulin pump, and a control algorithm. The algorithm is essentially the “brain” of the artificial pancreas system, taking the CGM data and communicating to the insulin pump when and how much insulin to deliver.

In this study, participants will have their blood glucose levels measured for 24 hours while on “open-loop” therapy (i.e., not on an artificial pancreas system). They will then be randomized to use either the PID or MPC algorithm for a 27.5 hour period.

What the trial is measuring: The amount of time spent in a safe blood glucose range (70-180 mg/dl), extreme glucose levels (below 70 mg/dl or above 180 mg/dl), and the need for “outside interventions” (e.g., insulin injections to correct hyperglycemia, or glucose tablets to correct hypoglycemia).

Why this is new/important: Most artificial pancreas studies examine just one control algorithm; there are very few studies that compare them directly head-to-head. This trial will bring some of the first data on how the algorithms perform against each other, offering new insight into which mathematical approach best manages blood sugar.

Trial Length: 4 months.

Trial Location: The trial is located at the William Sansum Diabetes Center, University of California, Santa Barbra, Santa Barbra, CA

Do you qualify? To qualify, participants must be between 21 to 65 years old, have type 1 diabetes, and have an A1c between 5% and 10%. Those with an active infection, recent history of arrhythmia, coronary artery disease, DKA in the last 6 months, a severe hypoglycemic event leading to seizures or unconsciousness in the last 12 months, among other criteria, are unable to participate in the study. For more details on eligibility criteria, please go the clinicaltrails.gov page.

Where to get more information: For more information, please contact Paige Bradley, BS by phone at 805-682-7640 ext 235 or email at [email protected] at the William Sansum Diabetes Center, or visit the study’s clinicaltrials.gov page.