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‘Suspend-before-low’ feature reduces hypoglycemia with pump therapy in type 1 diabetes
Adults with long-standing type 1 diabetes and hypoglycemia unawareness using an insulin pump therapy system with an algorithm-driven, insulin-suspension feature experienced fewer hypoglycemic events than those using sensor-augmented pump therapy, according to findings published in The Lancet Diabetes & Endocrinology.
“Automated insulin delivery devices that incorporate Medtronic’s predictive algorithm to suspend and resume insulin delivery, based on real-time glucose sensing, provide an efficient and safe reduction in recurrent and severe hypoglycemia,” Ohad Cohen, MD, medical affairs director of Medtronic Diabetes for Europe, Middle East and Africa (EMEA) and clinical professor of medicine at the Sackler School of Medicine, Tel-Aviv University, told Endocrine Today. “This achievement is accomplished while maintaining overall good glycemic control and an increase in time-in-range in a population prone to hypoglycemia. These patients were usually excluded from previous randomized controlled trials. The protection from hypoglycemia is sustained during the night, when people living with diabetes are more susceptible to the severe consequences of hypoglycemia.”
Cohen and colleagues analyzed data from 153 adults with type 1 diabetes for at least 10 years considered at high risk for hypoglycemia, defined as experiencing recent severe hypoglycemia or hypoglycemia unawareness (mean age, 48 years; 77 men), enrolled in the SMILE study, an open-label, randomized controlled trial. Participants were enrolled from 16 centers in Canada, France, Italy, the Netherlands and the United Kingdom between December 2016 and March 2018 and were using insulin pump therapy at least 6 months. Participants used blinded continuous glucose monitoring during a 2-week run-in phase after which researchers randomly assigned them to the Medtronic MiniMed 640G pump with self-monitoring of blood glucose (n = 77; controls) or to the MiniMed 640G pump with the “suspend-before-low” feature enabled (n = 76) for 6 months. Primary outcome was the mean number of severe hypoglycemic events, defined as a blood glucose level of 55 mg/dL or lower, analyzed on an intention-to-treat basis.
At 6 months, researchers found that participants in the intervention group experienced fewer hypoglycemic events per week compared with controls (mean, 1.1 vs. 4.1), for a model-based treatment effect of –2.9 (95% CI, –3.5 to –2.3). Participants in the intervention group also experienced fewer severe hypoglycemic events overall (mean, 3 vs. 18; P = .0036).
In the intervention group, the mean number of suspend-before-low events was 2.5 per participant per 24-hour period and 1.4 per participant per night, according to researchers.
The most common adverse events during the study were severe hypoglycemia, observed in three participants in the intervention group and 10 participants in the control group, and hyperglycemia, observed in seven participants in each arm, according to researchers.
The researchers did not observe any serious adverse device effects or episodes of diabetic ketoacidosis during the study.
“This large and powered randomized controlled trial provided clear evidence that adults with long-standing type 1 diabetes and hypoglycemia unawareness can benefit from the access to advanced technologies that prevent hypoglycemia’s life-threatening outcomes,” Cohen said. “Research in the field of automated insulin delivery — closed-loop systems — is required to further increase time-in-range and provide more efficient glycemic control while maintaining safety and improving the quality of life of people living with diabetes.”
In a press release announcing the findings, Robert Vigersky, MD, chief medical officer, global medical and clinical affairs for the Diabetes Group at Medtronic, said the new data demonstrate the clinical effectiveness of SmartGuard technology.
“Additionally, these results were achieved with a group of patients that are among the most challenging to treat successfully,” Vigersky said in the release. “Medtronic is committed to continuous technology innovation and expanding access to our therapies. These results further support our focus to deliver improved glycemic control while reducing the burden of people living with diabetes." – by Regina Schaffer
For more information:
Ohad Cohen, MD, can be reached at Medtronic International Trading Sarl, Tolochenaz 1131, Switzerland; email: ohad.cohen@medtronic.com.
Disclosures: Medtronic Canada and Medtronic International Trading Sarl funded this study. Cohen reports he is medical affairs director of Medtronic Diabetes EMEA. Vigersky is chief medical officer, global medical and clinical affairs for the Diabetes Group at Medtronic. Please see the study for all other authors’ relevant financial disclosures.