Integrated Approaches to Close the Loop in Type 1 Diabetes: Role of Gastric Motility

An abnormal rate of gastric emptying, as is observed in approximately 40 percent of often-asymptomatic individuals with type 1 diabetes mellitus (T1DM), has a far-reaching impact on post-meal glucose metabolism and glucose excursions. This can lead to hyperglycemia or hypoglycemia.

Using the triple-tracer method and closed-loop control algorithm, we will study T1DM subjects with normal gastric emptying on three occasions, in random order.

  • On one occasion, gastric emptying will not be manipulated.
  • On another occasion, gastric emptying will be manipulated by pramlintide administration.
  • On the third occasion, both gastric emptying and closed-loop algorithm will be manipulated by pramlintide and incorporation of pramlintide pharmacodynamics in the algorithm.

This study will be conducted with approval from the Food and Drug Administration. We expect to start these studies in July-August 2012. To fine-tune our closed-loop algorithm and understand scientific concepts in more detail, we are conducting a study of normal research volunteers at this time. We expect this study to be completed by late 2012.