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Hypoglycemia awareness increased with use of sensor-augmented pump therapy
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Using the Paradigm Veo system from Medtronic, accompanied by education sessions and patient-led assistance, patients with type 1 diabetes developed awareness of hypoglycemia, according to preliminary findings from a cohort study in Australia.
Patients with type 1 diabetes on insulin pump therapy with little awareness about hypoglycemia participated in a 6-month trial comparing their standard pump therapy with the Veo, which allows insulin to automatically suspend up to 2 hours when the sensor glucose levels fall to less than 60 mg/dL.
Trang T. Ly, MBBS, DCh, FRACP, a pediatric endocrinologist and research fellow at Princess Margaret Hospital in Australia, and colleagues designed the study that consisted of 24 patients aged 4 to 50 years.
Patients received a questionnaire, followed by random assignment to 3-hour face-to-face education sessions, and patient-led assistance via phone or email. For 6 months, patients also used the Veo system to determine low-glucose suspend events.
When glucose levels fell to less than the threshold of 60 mg/dL, an alarm was signaled by the pump. In a situation where a patient did not respond to the alarm, insulin would be suspended up to 2 hours after standard basal insulin, the researchers said. Patients could intervene, but if no intervention occurred, the pump cycled on a 6-hour continuous cycle of 2 hours of insulin followed by 4 hours of basal insulin.
There were 45.8 severe hypoglycemic events per 100 patient-years before use of the Veo system, and the HbA1c level improved from 7.8% at baseline, to 7.4% at 6 months. However, the HbA1c level increased from months 3 to 6 in the study (P=.517). Throughout the entire study, the sensor was worn 2,493 of 4,218 patient-days, with 1.3 low-glucose suspend events occurring per day, 40% of which occurred overnight.
After the Veo system intervention, 79% of patients continued to wear the system for another 6 months.
There were no serious adverse outcomes during this study, and hypoglycemia awareness scores improved after the completion of the study. Final results have yet to be reported.
Disclosure: Dr. Ly is supported by a Juvenile Diabetes Research Foundation postdoctoral fellowship and received travel reimbursement from Medtronic. Timothy W. Jones, MD, received honoraria for scientific lectures and travel reimbursement from Eli Lilly, Medtronic, Novo Nordisk and Sanofi-Aventis. No other researchers reported relevant financial disclosures.
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