Medtronic announced last week that they’ve launched their MiniMed 670G for type 1 diabetes, which combines an insulin pump with continuous glucose monitoring technology to deliver or withhold insulin based on its measurement of the patient’s blood glucose. Blood glucose is checked every five minutes, and the round-the-clock monitoring and automatic administration of insulin represent a significant improvement over the inherent variability in glucose self-monitoring and administration of insulin injections. Further, the device tracks insulin use to identify a personalized range for each patient, with one of the key outcomes measures in the company’s 670G pivotal trial being the device’s ability to maximize time spent in that range.
In a study published in JAMA last September, the investigators reported that users of the MiniMed 670G “experienced less glycemic variability, more time in the target range, less exposure to hypoglycemia and hyperglycemia and reduced A1c” compared to baseline data using sensor augmented pumps. The study enrolled 124 patients, and the company described it as the “largest and longest at-home closed loop study” performed to date. In additional comments on the study, Medtronic noted that the 24-hour monitoring and glucose administration reduced some of the challenges of diabetes on patients, particularly at night, when glucose levels are more difficult to monitor and control. It does have some technical limitations – the user has to enter carbohydrates consumed at mealtimes and exercise information – but the technology represents a significant step toward less burdensome diabetes management.
This advance comes at a cost. Price estimates on the device range from around $6,000 to $9,000, though the cost to the patient will vary based on insurance coverage. Medtronic, which initially received approval for the device “earlier than expected” (only 104 days after their PMA filing), has spent the months since the approval in late 2016 working to promote payer coverage and perform customer education, among other activities. While it remains to be seen whether the cost and coverage will be an impediment to adoption, the careful rollout does seem to be delivering some early returns on the promise of the system. The company says that a training phase was initiated in March to precede a broader launch, and that program returned “excellent feedback on system performance, clinical outcomes and user experience … including a 94 percent overall satisfaction rate with the training and onboarding.”