Predictive low-glucose monitoring reduces hypoglycemia in children with type 1 diabetes

A predictive low-glucose management system programmed onto an electronic device significantly reduced the number of hypoglycemic events in children with type 1 diabetes, according to findings from a randomized controlled trial.

“Continuous subcutaneous insulin infusion combined with continuous glucose monitoring is already a well-established therapeutic option for the management of type 1 diabetes in different patient populations,” Tadej Battelino, MD, PhD, of the department of pediatric endocrinology at the University Medical Centre and University Children’s Hospital, Ljubljana, Slovenia, and colleagues wrote. “The MiniMed 640G system (Medtronic) offers the SmartGuard technology with predictive low-glucose management. The ‘suspend before low’ feature of this technology stops insulin delivery when the sensor glucose value is predicted to reach or fall below a preset low glucose limit within 30 minutes and automatically resumes basal insulin delivery after recovery from hypoglycemia.”

Battelino and colleagues performed a randomized, two-arm, open-label study with 100 children and adolescents with type 1 diabetes and HbA1c up to 10% who were using continuous subcutaneous insulin infusion. The researchers randomly assigned patients to a control group (MiniMed system with predictive low-glucose monitoring turned off) or a group with predictive features enabled. The primary endpoint was the number of hypoglycemic events (< 65 mg/dL) during a 14-day study treatment period.

Patients assigned to the predictive monitoring group had significantly fewer hypoglycemic events compared with controls, the researchers reported (mean, 4.4 events vs. 7.4; P = .008). This held true when the researchers calculated the differences in events during daytime (P = .022) and at night (P = .025). Battelino and colleagues reported no hypoglycemic events; however, they did report that patients in the predictive monitoring group experienced a significantly increased amount of time with glucose level above 140 mg/dL (P = .0165).

Researchers wrote that the study was limited by the fact that patients had previous experience with subcutaneous insulin infusion and well-managed diabetes, as well as the fact that the trial was fairly short.

“In the current study, the use of the predictive low-glucose monitoring feature was safe and associated with a significantly reduced number and duration of hypoglycemic events below 65 mg/dL,” Battelino and colleagues wrote. “Although this was achieved at the expense of increased time spent in moderate hyperglycemia, there was no change in mean blood glucose levels in young patients with type 1 diabetes.” – by Andy Polhamus

Disclosure: Medtronic funded the study by offering an unrestricted grant. Battelino reports advisory roles with Bayer Health Care, Boehringer, Eli Lilly, Medtronic, Novo Nordisk and Sanofi. Please see the full study for a complete list of all other authors’ relevant financial disclosures.