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No association between nocturnal hypoglycemia, improved glycemic control
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SAN FRANCISCO — Data from the ASPIRE In-Home study indicate that beneficial reductions in nocturnal hypoglycemia occurred with the use of the threshold suspend feature of a sensor-augmented pump therapy, independent of changes to HbA1c. These findings suggest that improved glycemic control is not necessarily linked to an increased risk for nocturnal hypoglycemia, according to researchers here.
Timothy S. Bailey, MD, FACE, CPI, clinical associate professor at the University of California, San Diego, and director of the AMCR Institute, and colleagues randomly assigned 247 patients with type 1 diabetes to sensor-augmented pump therapy with (n=121) or without (n=126) the threshold suspend feature as part of the Automation to Simulate Pancreatic Insulin Response (ASPIRE) In-Home Study, according to data.
The researchers stratified HbA1c changes, categorized as: less than –0.3% for ‘decreased,’ –0.3% to 0.3% inclusive for ‘stable,’ and greater than 0.3% for ‘increased’ for both the threshold suspend and control group, from baseline over the 3-month study period, according to data.
At the conclusion of the study, HbA1c values were 7.1% for patients in the ‘decreased’ category (25 threshold, 28 control), 7.1% for patients in the ‘stable’ category (65 threshold, 77 control), and 7.7% for patients in the ‘increased’ category (26 threshold, 19 control), according to data.
The nocturnal hypoglycemia event rate was 1.5 per week in all three categories of the threshold suspend group — a finding that was lower compared with rates found in the ‘decreased’ and ‘stable’ control groups, according to data.
“In this study there were no serious adverse events related to the study device or study procedures. Four severe hypoglycemic episodes did occur in four subjects. There were no episodes of [diabetic ketoacidosis],” Bailey said.
Additional data demonstrated that the area under the curve of nocturnal hypoglycemia events was significantly lower (P<.001) in the threshold suspend group in all three HbA1c categories, according to Bailey.
“We speculate that predictive algorithms may help to further reduce the rate of nocturnal hypoglycemia in our patients with type 2 diabetes,” Bailey said. – by Samantha Costa
Disclosure: Bailey reports financial ties with consultancy, research support, and/or speaker’s bureau with: Abbott Diabetes Care, ACON Laboratories, Alee, Animas Corp., Bayer Health Care, BD Medical Diabetes Care, Bristol-Myers Squibb, Cebix, Dexcom, Eli Lilly and Company, GlaxoSmithKline, Halozyme, Insulet Corp., Lifescan Animas, MannKind, Medtronic, Merck, Novo Nordisk, Orexigen, Sanofi, and Tandem Diabetes Care.
For more information: Bailey TS. Abstract 231-OR. Presented at: American Diabetes Association’s 74th Scientific Sessions; June 13-17, 2014; San Francisco.