InsuPad®’s clinical efficacy and safety has been evaluated in
multiple clinical studies with over 200 Type 1 & Type 2 diabetes patients.
- 50 patients from one of the Barmer study sites were included in the long term follow up survey (25 from the test group and 25 from the control group)
- Average follow up length: 14.8 months
- The reported insulin dose for the control group patients at the start of the follow up period is after one week of Insupad use and dose adjusment.
Study Design (MTT Study): Open-label, randomized, two-period, one-way crossover study to assess the effect of InsuPad® device on post meal glucose excursions during meal tolerance tests. 17 diabetes Type II patients underwent meal tolerance tests with a standardized liquid meal after an overnight fast on two study days. Subjects injected 0.2 U/kg of insulin Aspart or Lispro s.c. into the abdominal skin on both days, on one day followed by the use of InsuPad® and on the other day without. Blood samples for glucose measurements were taken from a venous line.
1. Pfützner A., Funke K., Hermanns N. et al., The BARMER Study: impact of standardized warming of the injection site to enhance insulin absorption and reduce prandial insulin requirements and hypoglycemia in obese patients with diabetes mellitus. Curr. Med. Res. Opin., 30 (2014) 753-760.
2. Bitton G, Raz I, Pfützner A, Feldmann D, Alon T, Liviatan L, Nagar R. Reduced postprandial glucose excursion in type 2 diabetic subjects using the InsuPad device. Diabetologia 2012; 55(Suppl.1):A98
3. The BARMER Study Long Term Follow-up. Data on File
4. .Pfützner A., Raz I., Bitton G. et al. 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. J. Diabetes Sci. Technol. 2014 (accepted, in press)