Updated to include comments from Abbott medical affairs head Dr. Mahmood Kazemi.
Data from the 328-patient trial was published in the journal Lancet, the company said.
The Impact study looked to assess the differences in levels of hypoglycaemia between patients using the FreeStyle Libre system and those using self-monitored glucose testing.
The FreeStyle Libre is designed to monitor glucose through a sensor worn on the back of the upper arm for 2 weeks, without the need for the finger prick calibration required by continuous glucose monitoring systems, Abbott said.
“Our device is in its own unique category right now, so can be difficult to compare against other products which aren’t using a factory calibrated sensor the way we do and don’t have the advantages that we have with that technology. If you take a look at the reduction in hypoglycaemia that was demonstrated in Impact, and if you look at the reduction from traditional CGM, you will see that the percentage of reduction of hypoglycaemia that we found will meet or exceed, percentage wise, what any one else has to offer,” Abbott medical affairs head Dr. Mahmood Kazemi told MassDevice.
Dr. Kazemi said that the study was a big step for Abbott, and showed that the company is delivering on its promise to improve the lives of diabetes patients it serves.
“At Abbott, our commitment has always been to bring the best tech to people living with diabetes to allow them to live their lives to the fullest. What this particular study does is provide important and groundbreaking data for individuals with type 1 diabetes. It’s shown that individuals with type 1 diabetes, with this technology, are able to reduce their hypoglycaemia levels, which can be quite significant, by using this particular monitoring method and are able to do so safely. It results in improved quality of life for patients, as well as a safer method of care,” Dr. Kazemi said. “From the Abbott perspective, we’ve achieved our aim because we’ve released technology that matters to the patients and allows them to live their lives the way they want to live them without being constrained by current issues with diabetes monitoring.”
Results indicated a 38% reduction in time in hypoglycaemia for patients using the FreeStyle Libre, with no device related hypoglycaemia or safety issues reported.
Also reported was a 40% reduction in the rate of nocturnal hypoglycaemia, a 50% reduction in serious hypoglycaemia and no increase in HbA1c at 6 months.
“Time spent in hypoglycaemia was reduced almost immediately as sensor-based results became visible to participants (ie, before sensor results were reviewed with their clinician at study visits). This finding indicates fast adaptation to the device. Furthermore, it could suggest that real-time and glucose trend data, rather than retrospective analysis of the recordings, were predominantly used for proactive self-adjustments of glycaemic control,” study authors wrote.
A total of 13 adverse events were reported by 10 participants related to the Freestyle Libre, including 4 allergy events, 1 itching event, 1 rash, 4 insertion-site symptoms, 2 erythema and one oedema. Ten serious adverse events, 5 in each group, were reported by participants, though none were related to the device.
“In summary, use of the novel flash glucose sensor system resulted in a significant reduction in time and incidence of hypoglycaemia, without deterioration in HbA1c levels, demonstrating that the system is a safe replacement for self-monitoring of blood glucose and is highly acceptable to individuals with type 1 diabetes. For many individuals, hypoglycaemia is a barrier to optimum glucose control. Novel sensor-based systems to monitor glucose hold great promise as an effective alternative to conventional self-monitoring of blood glucose,” study authors wrote.
“From a medical perspective, it’s a ground breaking study,” Dr. Kazemi said.”The testament to that was that it was published in Lancet. I think this further adds credence that these findings are significant not just from an Abbott perspective, but from a worldwide medical perspective.”