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Improved Insulin Absorption by Means of Standardized Injection Site Modulation Results in a Safer and More Efficient Prandial Insulin TreatmentA Review of the Existing Clinical Data
Authors:Andreas Pfützner  Itamar Raz  Gabriel Bitton  David Klonoff  Ron Nagar  Norbert Hermanns  Thomas Haak
Institution:1Pfützner Science & Health Institute, Diabetes Center and Practice, Mainz, Germany;2Hadassah School of Medicine, Jerusalem, Israel;3Insuline Medical Ltd, Petach-Tikva, Israel;4Diabetes Center, Mills Peninsula Health Services, San Mateo, CA, USA;5FIDAM—Institute for Diabetes Research, Bad Mergentheim, Germany
Abstract:Temperature changes on the surface of the skin lead to modifications of subcutaneous microcirculation. This phenomenon is employed in a standardized way by the InsuPad device to stabilize skin conditions before injections, which is associated with enhanced prandial insulin absorption. Three programmed warming cycles to 40°C within 50 minutes are resulting in faster insulin appearance in the plasma. Early standardized meal tolerance studies indicated a substantial improvement in postprandial glucose control when the same short-acting insulin analog dose was applied using InsuPad, and a dose reduction by 20% resulted in comparable glucose excursions. Similar results were obtained when patients applied the device under real-world conditions for 1 month. The InsuPad device was also tested in a prospective, controlled, parallel 3-month real-world study with 145 well-controlled but insulin-resistant patients with type 1 or type 2 diabetes. Patients were treated to target in both treatment arms (6.2 ± 0.5% in each group), with or without the device. However, patients with InsuPad needed 28% less prandial insulin, needed 12.5% less total insulin, and had 46% less confirmed hypoglycemic events (blood glucose < 63 mg/dL) as compared to the control group. Except for very few inflammatory or allergic skin reactions, there were no device-specific adverse events reported from these studies. In conclusion, use of InsuPad when applying prandial insulin doses may result in a safer and more efficient treatment of type 1 or type 2 diabetes.
Keywords:insulin treatment  InsuPad  injection site modulation  prandial insulin dose  hypoglycemia
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