Real-Time Pump and CGMS Technology Given the Go-Ahead by the FDA
The FDA has informed Medtronic, Inc., that it was approving its MiniMed Paradigm Real-Time Insulin Pump and Continuous Glucose Monitoring System.
“For the first time in the history of diabetes management, an insulin pump integrates with realtime continuous glucose monitoring (CGM),” says Medtronic.
The Real-Time CGM System relays glucose readings every five minutes from a glucose sensor to the insulin pump, which displays up to 288 readings a day.
“Real-time glucose information displayed on the insulin pump allows patients to take immediate action to improve their glucose control after taking a confirmatory finger stick.”
Medtronic adds that integrating an insulin pump with the Real-Time CGM is a major step toward the development of a “closed-loop” insulin delivery system that may one day mimic some functions of the human pancreas.
“Medtronic is testing future systems that would employ advanced scientific algorithms to proactively recommend insulin dosages to patients. Through this process, Medtronic anticipates developing an external, closed-loop system designed to simplify and improve patient diabetes management.”
The Real-Time CGM System is indicated for patients 18 years of age or older. For more information, call (800) 646-6433.
CoZmonitor Convenient for Treating Type 1 Kids
Colorado researchers say that use of the CoZmonitor blood glucose module is convenient for treating youths with type 1.
The CoZmonitor, manufactured by Smiths Medical, attaches to the back of the Deltec Cozmo pump and uses FreeStyle technology by Abbot Diabetes Care to perform blood glucose tests that read directly on the pump. A total of 34 study participants, aged 11 to 21 years, using the Deltec Cozmo pump were randomized to use (experimental group) or to not use (control group) the CoZmonitor Blood Glucose Module. Thirty of the participants completed their three-month visit (15 experimental, 15 control).
The average A1C level decreased 0.14 percent in the 15 experimental group subjects and increased 0.26 percent in the 15 control subjects.
“At three months, the experimental group did an average of 3.2 BG tests per day and 3.73 boluses per day, while the control group did 4.3 BG tests per day and 3.44 boluses per day,” write the researchers. “The percent of blood glucose readings ‘in target’ remained similar in the experimental group at baseline (32.5) and at three months (33.9) and decreased in the control group from baseline (36.7) to three months (30.6).”
They add that, after three months, the number of missed meal boluses per week remained similar in the experimental group at baseline (3.5) and at three months (3.8) and increased in the control group from baseline (3.3) to three months (4.4).
Dexcom Sensor ‘Safe, Accurate and Stable’
Seven-day use of Dexcom’s transcutaneous glucose sensor (STS System) was found by researchers to be “safe, accurate and stable.”
A1C was measured within 30 days of enrollment for 86 participants who take insulin. Patients wore the STS System for 21 days in three consecutive seven-day periods during normal activities.
The researchers found that patients with an A1C greater than 9% experienced an average increase of 94.6 percent in normal blood glucose (defined as a range of 81 mg/dl to 140 mg/dl) without an increase in hypoglycemia.
Patients with an A1C of less than 7% maintained normal blood glucose.
The researchers say that “patients with poorly controlled diabetes can use the added information from a continuous sensor to significantly improve glycemic profiles without increased risk of hypoglycemia. The well-controlled patient can also maintain glycemic control while using a continuous sensor, but with reduced exposure to hypoglycemia.”