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Pfutzner A.,Ikfe Institute For Klinische Forschung Und Entwicklung | Hermanns N.,Fidam Institute For Diabetesforschung | Funke K.,IKFE Potsdam | Forst T.,Profil Mainz | And 4 more authors.
Diabetes, Stoffwechsel und Herz | Year: 2013

Temperature changes on the skin surface result in changes in cutaneous and/or subcutaneous microcirculation, a well-known phenomenon addressed in developing the InsuPad device towards improving prandial insulin absorption. Standardized warming cycles applied after insulin injection result in a more rapid increase in insulin plasma concentrations and faster action, and applying a similar dose of short-acting insulin analogues in standardized meal studies showed significantly improved postprandial control using InsuPad. InsuPad use allows for a twenty-percent dose reduction for the same level of control, and injection of insulin after the meal still improves glycaemic control compared to the same dose injected without the device prior to food uptake. This study tested InsuPad use in a controlled randomized parallel study on 145 patients with type 1 and type 2 diabetes in real-world conditions for three months; target HbA1c levels (HbA1c: 6.3 ± 0.5 %) were reached in both treatment groups with and without the device; however, InsuPad patients needed 28 % less prandial insulin compared to the control group (p < 0.001), 12 % less total insulin (p < 0.001), and suffered 46 % fewer hypoglycaemic events (p < 0.05). Treatment satisfaction remained unchanged despite the additional treatment procedure, and the vast majority of patients continued to use the device after study termination. InsuPad is registered and reimbursed as a medical device, so it can also help reduce the burden on the drug budget for prescribing physicians. Source


Musholt P.B.,Ikfe Institute For Klinische Forschung Und Entwicklung | Kaiser P.,Ikfe Institute For Klinische Forschung Und Entwicklung | Maxeiner S.,Ikfe Institute For Klinische Forschung Und Entwicklung | Weise A.,Ikfe Institute For Klinische Forschung Und Entwicklung | And 4 more authors.
Diabetes, Stoffwechsel und Herz | Year: 2011

The resuspension of NPH insulin prior to injection is unpopular with patients and frequently performed inadequately. In order to explore the mixing efficiency of NPH products, we investigated the dose delivery of 12 cartridges, each from the five existing manufacturers in Germany (sanofi-aventis, Lilly, Berlin-Chemie, B. Braun Melsungen and Novo Nordisk). In the first step, a dialed dose of 28IU was delivered after correct mixing (shaking 20 times). Thereafter, the cartridges were emptied over five days (morning and evening) with doses of 28IU in laboratory tubes with different numbers of shaking procedures (3x, 6x, 10x, and 20x). The delivered insulin doses were determined by means of a validated HPLC method. While all products delivered a correct first dose (after 20 x shaking), substantial and clinically relevant differences were seen between the different cartridges with the consecutive inadequate mixing procedures. Mean deviations and maximal individual overdose from the dialed 28IU dose with 3x shaking were: Insuman Basal: 1.1 ± 1.0%/4IU; Huminsulin Basal: 2.6 ± 3.4 %/19IU; Berlinsulin H Basal: 4.4 ± 6.0 %/26IU; Insulin B. Braun Basal: 10.4 ± 8.9 %/38IU; and Protaphane: 4.7 ± 4.1 %/19IU (all p < 0.05 vs. Insuman Basal). Only the Insuman Basal cartridges (containing three metal mixing bullets) showed efficient mixing even with only 3x shaking. If really injected, all other cartridges (with 1-2 glass bullets) would have delivered clinically harmful overdoses. Source

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