The research from the STAR 3 Study Group (Sensor-Augmented Pump Therapy for A1C Reduction) was released early by The New England Journal of Medicine to coincide with the annual meeting of the American Diabetes Association in Orlando that ends today.
The researchers compared treatment with multiple daily injections to treatment with an insulin pump that also monitored glucose levels in 485 patients with poorly controlled type 1 diabetes. The results showed that the patients with the sensor-augmented pump achieved better glucose control, and specifically had a greater reduction in A1C (glycated hemoglobin), without an increase in episodes of hypoglycemia (low blood glucose).
A1C is a measure of how much glucose has been sticking to hemoglobin, the substance in the red blood cells that carries oxygen to cells, and reflects the degree of blood glucose control over the preceding two to three months.
Previous research has shown that patients who use insulin pumps have on average slightly better glucose control than those using multiple insulin injections (by syringe or insulin pen). Regular blood glucose monitoring (three or more times daily) has also been shown to be important in improving blood glucose levels.
The sensor-augmented pumps used in the study are the first to test two systems together — continuous insulin infusion and continuous glucose monitoring — to manage type 1 diabetes. Through the use of this dual technology patients can access continuous glucose data from their sensing device and use that information to make frequent adjustments to their insulin infusions via their pumps. In addition, patients can upload data to a secure website and enable health care providers to periodically access this information remotely through Internet-based software to monitor treatment and response.
“This trial clearly demonstrates that supplementing insulin therapy with continuous glucose monitoring improves the ability of patients with type 1 diabetes to safely achieve lower blood glucose targets, which should translate into long-term reductions of vascular injury and short-term prevention of clinically significant hypoglycemia,” said Luigi Meneghini, M.D., professor of clinical medicine and principal investigator for the study at the Miller School. “I believe this is an important step toward achieving an integrated system of insulin delivery, eventually combining continuous subcutaneous insulin infusion automatically delivered based on continuous glucose sensing and appropriately tested insulin adjustment algorithms.”
Patients in the study received educational support at the Diabetes Research Institute from certified diabetes educators under the direction of Jane Sparrow-Bodenmiller, who served as the lead study coordinator and was instrumental in the successful completion of this trial.