multiple clinical studies with over 200 Type 1 & Type 2 diabetes patients.

 
BARMER Study: InsuPad® Reduces the hypoglycemia event rate by 46 % [1]
Study Design (BARMER Study): Open-label, randomized, parallel, comparative study to assess efficacy and safety of InsuPad®. 145 diabetic patients on intensified insulin therapy and high total daily insulin dose (> 0.6 IU/Kg) were enrolled to the study. After 4 weeks of the treatment optimization period, patients were randomized to continue therapy for 3 months without (Control group, 66 patients) or with the InsuPad® device (InsuPad®-group, 69 patients, data presented here from 135 patients who completed the study). Observation parameters included HbA1c, insulin dose, and frequency of hypoglycemia, body weight and adverse events
 
 
 
 
BARMER Long term follow up, InsuPad® maintained or further reduced HbA1c  [3]
• In the BARMER daily-life experience long term follow-up*, InsuPad® users 
   reduced their prandial insulin dose by 32 % over 18 months of use [3].
 
*BARMER long term follow-up: 52 patients from one study site of the BARMER Study, irrespective of their prior randomization to InsuPad® or Control groups, chose to use the InsuPad® device daily for up to 18 months of follow-up (including the 3 months of the BARMER study).
 
 
 
 
BARMER Long term follow up, InsuPad® users reduced their prandial insulin dose by 9% [3] 
 
• In the BARMER long term follow-up, InsuPad® maintained or further reduced HbA1c levels over 15 additional months of use
 
  • 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. 
 
 
 
MTT Study: InsuPad® reduces post-prandial blood glucose excursions[2]

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.

 

 

References:

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)