Medtronic has begun enrolling patients in an investigational device exemption (IDE) study of its new and innovative Predictive Low Glucose Management (PLGM) technology. The start of this study marks a critical step toward development of an artificial pancreas in the U.S. market. PLGM technology builds upon Medtronic’s already available Threshold Suspend feature, the only technology available in the U.S. that can automatically stop insulin delivery when sensor glucose values reach a preset level and when the patient doesn’t respond to the Threshold Suspend alarm. PLGM takes the interaction with the insulin pump a step further by automatically stopping insulin delivery when the sensor glucose level is predicted to approach a low limit, and then resuming insulin delivery after those glucose levels recover.
The trial will evaluate the safety of its next-generation integrated insulin pump and continuous glucose monitoring (CGM) system, which automatically stops insulin delivery when the sensor measures a glucose level predicted to approach the lowest tolerable limit, and then resumes insulin delivery after those glucose levels recover. The technology is designed to help people with diabetes better manage the challenges of hypoglycemia (low blood sugar) and rebound hyperglycemia (high blood sugar) inherent in external insulin therapy use.
A total of up to 84 subjects will be enrolled at up to eight investigational centers across the United States. The Medtronic system being studied includes a fourth generation sensor with new intelligent sensor diagnostics, which is 80% smaller than the Enlite sensor currently available in the U.S. market, and a new MiniMed insulin pump design. The objective of the study is to evaluate the safety of the PLGM algorithm with the new sensor as well as the algorithm’s ability to prevent hypoglycemia. Hypoglycemia is a common occurrence and concern in diabetes management and can result in confusion, unresponsiveness and – in severe cases – even death.
For more details, including enrollment information, please visit clinicaltrials.gov.
Ever since I heard they were talking about a Predictive Low Glucose Suspend feature, I’ve been (manually) trying to do it myself — I set my CGM thresholds to alert me to a predicted low at a ridiculously high level so that I can suspend it manually and hopefully avoid the low. For me, it hasn’t worked too well most of the time, but that’s probably because my basal is so low in proportion to my bolus (I’m at about a 33%:66% basal:bolus ratio rather than the recommended 50:50). But I do think this holds promise and can’t wait to… Read more »
Ever since I heard they were talking about a Predictive Low Glucose Suspend feature, I’ve been (manually) trying to do it myself — I set my CGM thresholds to alert me to a predicted low at a ridiculously high level so that I can suspend it manually and hopefully avoid the low. For me, it hasn’t worked too well most of the time, but that’s probably because my basal is so low in proportion to my bolus (I’m at about a 33%:66% basal:bolus ratio rather than the recommended 50:50). But I do think this holds promise and can’t wait to… Read more »