CHARLOTTE, N.C.--(BUSINESS WIRE)--Monarch Medical Technologies, the leader in precision insulin dosing for optimized inpatient glucose management, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of an additional feature of Monarch EndoTool SubQ, an insulin-on-board (IOB) algorithm.
Monarch’s precision electronic glycemic management system, EndoTool SubQ, recommends a personalized therapy regime for basal-bolus-correction subcutaneous insulin. The company, which first received FDA clearance for EndoTool SubQ in 2015, recently obtained an additional clearance for an optional IOB calculation to mitigate the risk of low glucose values as a result of residual rapid-acting insulin.
Insulin-on-board or residual insulin refers to the accumulation of insulin activity from previous subcutaneous insulin injections that have the potential of future insulin activity. The accumulation of insulin activity will affect blood glucose levels and is often associated with a hypoglycemia event.1
With the optional IOB algorithm, the calculation estimates the sum of the remaining insulin activity from previously administered subcutaneous insulin(s), and if appropriate reduces the prescribed correction dose. The algorithm can also recommend a supplemental carbohydrate dose if appropriate.
“Hypoglycemia is a frequent and costly occurrence in the acute-care setting. Monarch’s solutions have been proven to substantially reduce hypoglycemia while keeping patient’s blood glucose in target range safely,” said Laurel Fuqua, RN, MSN, Executive VP and Chief Clinical Officer of Monarch Medical Technologies “The addition of the IOB feature is an enhancement that will further mitigate the risk of hypoglycemia and improve both clinical outcomes for patients with diabetes or stress-induced hyperglycemia, as well as lower costs for hospitals that use the software solution.”
The solution with the additional algorithm is anticipated to be available in late 2019.
1. Heise T, Luigi F. Meneghini LF. Insulin Stacking Versus Therapeutic Accumulation: Understanding The Differences. Endocrine Practice. 2014; 20: 75-78.
About Monarch Medical Technologies
Monarch Medical Technologies is the leading provider of electronic systems for inpatient glycemic management. Monarch’s EndoTool® Glucose Management System offers personalized dosing recommendations for intravenous and subcutaneous insulin therapy. As a Class II FDA-cleared, patented software suite, EndoTool has been chosen by more than 300 hospitals to provide unsurpassed patient-specific glycemic control across a broad population of patients, and ultimately deliver better, safer care. For more information, please visit monarchmedtech.com.