title: Improved insulin absorption by means of standardized injection site modulation results in a safer and more efficient prandial insulin treatment. A review of the existing clinical data.
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.
authors.affiliation: Pfützner Science & Health Institute, Diabetes Center and Practice, Mainz, Germany andreas.pfuetzner@pfuetzner-mainz.com.
authors.forename: Andreas
authors.initials: A
authors.lastname: Pfützner
authors.affiliation: Hadassah School of Medicine, Jerusalem, Israel.
authors.forename: Itamar
authors.initials: I
authors.lastname: Raz
authors.affiliation: Insuline Medical Ltd, Petach-Tikva, Israel.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Bitton
authors.affiliation: Diabetes Center, Mills Peninsula Health Services, San Mateo, CA, USA.
authors.forename: David
authors.initials: D
authors.lastname: Klonoff
authors.affiliation: Insuline Medical Ltd, Petach-Tikva, Israel.
authors.forename: Ron
authors.initials: R
authors.lastname: Nagar
authors.affiliation: FIDAM-Institute for Diabetes Research, Bad Mergentheim, Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Hermanns
authors.affiliation: FIDAM-Institute for Diabetes Research, Bad Mergentheim, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Haak
mesh_terms: D001786:Blood Glucose / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology / Q000378:metabolism*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology / Q000378:metabolism*; D006801:Humans; D007279:Injections, Subcutaneous / Q000592:standards; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D062407:Meals; D019518:Postprandial Period; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D065566:Subcutaneous Absorption; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D007328:Insulin
keywords: InsuPad; hypoglycemia; injection site modulation; insulin treatment; prandial insulin dose