NEJM: Sensor-Augmented Pump Therapy Shows Promise in Diabetes Study

Coinciding with a presentation at the American Diabetes Association, the New England Journal of Medicine published an industry supported study on the effectiveness of Sensor-Augmented Insulin-pumps, concluding that such a technology “resulted in significant improvement in glycated hemoglobin levels, as compared with injection therapy.” This study used the MiniMed Paradigm REAL-Time System from Medtronic. In our recent story on Medtronic, we talked about their interest in closed-loop diabetes management. This system is a few steps removed from a closed loop system. While the continuous glucose monitoring receiver and insulin pump share the same display and housing external to the body on a belt mounted computer, they do not talk to one another, hence Sensor-Augmented and not Sensor-Driven. This device collected glucose levels every few minutes and reported levels and trends to the user who then had to interpret and direct the pump to deliver an appropriate insulin regimen.
From the NEJM abstract:

Results At 1 year, the baseline mean glycated hemoglobin level (8.3% in the two study groups) had decreased to 7.5% in the pump-therapy group, as compared with 8.1% in the injection-therapy group (P<0.001). The proportion of patients who reached the glycated hemoglobin target (<7%) was greater in the pump-therapy group than in the injection-therapy group. The rate of severe hypoglycemia in the pump-therapy group (13.31 cases per 100 person-years) did not differ significantly from that in the injection-therapy group (13.48 per 100 person-years, P=0.58). There was no significant weight gain in either group. Conclusions In both adults and children with inadequately controlled type 1 diabetes, sensor-augmented pump therapy resulted in significant improvement in glycated hemoglobin levels, as compared with injection therapy. A significantly greater proportion of both adults and children in the pump-therapy group than in the injection-therapy group reached the target glycated hemoglobin level. (ClinicalTrials.gov number NCT00417989 [ClinicalTrials.gov].)

Full NEJM article:Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes…
NEJM editorial: Continuous Glucose Monitoring — Coming of Age…
Medtronic press release: STAR 3 Trial Results Confirm Medtronic’s Sensor-Augmented Insulin Pump Therapy Achieves Better Glucose Control Than Daily Insulin Injections in People with Diabetes…