Take Control with InsuPad®

Achieve therapeutic target with less hypoglycemia and less insulin

Clinical Evidence

InsuPad®’s clinical efficacy and safety has been evaluated in 

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].

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

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® 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)

Links to scientific publications 

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.
A. Pfützner, N. Hermanns, K. Funke, T. Forst, T. Behnke, G. Bitton, R. Nagar, I. Raz, and T. Haak
The primary objective of this prospective controlled study was to investigate the impact of standardized injection-site warming on prandial rapid acting insulin dose and glycemic control when studied under real-world conditions,
Read more.
 
MTT Study, Standardized modulation of the injection site allows for insulin dose reduction without deterioration of metabolic control.
A. Pfützner, S. Dissel, C. Forkel, M. Grenningloh, G. Bitton, R. Nagar, and T. Forst
Use of an injection site modulation device (InsuPad) in intensive insulin treatment reduces frequency of hypoglycemia and prandial insulin requirements by enhancing subcutaneous microcirculation. This meal tolerance test (MTT) investigation was performed as a sub-study during the real-world BARMER study to demonstrate non-inferiority of the reduced insulin doses observed in this study with respect to metabolic control,
Read more.
 
Fidam Study, Effect of Local Heating on Postprandial Blood Glucose Excursions Using the InsuPad Device Results of an Outpatient Crossover Study.
Norbert Hermanns, PhD, Gabriel Bitton, PhD, André Reimer, MSc, Michael Krichbaum, MSc, Bernhard Kulzer, PhD, Thomas Haak, MD.
The InsuPad is a medical device to accelerate insulin resorption by applying local heat at the insulin injection site. This crossover study examined the impact of the InsuPad use on postprandial glucose excursions under daily life conditions,
Read more.
 
Review Article, 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.
Andreas Pfützner, MD, PhD1, Itamar Raz, MD2, Gabriel Bitton, PhD3, David Klonoff, MD4, Ron Nagar3, Norbert Hermanns, PhD5, and Thomas Haak, MD5
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,
Read more.
 
MTT Study, Improved Postprandial Glucose Control Using the InsuPad Device in Insulin- Treated Type 2 Diabetes: Injection Site Warming to Improve Glycemic Control.
Itamar Raz, MD1, Gabriel Bitton, PhD2, Dmitry Feldman, MD2, Tal Alon, MsC2, Andreas Pfützner, MD, PhD3,4, and William V. Tamborlane, MD5.
Background: Delays in the time-action profiles of premeal boluses of rapid-acting insulin analogs contribute to early postmeal hyperglycemia in patients with diabetes. We tested whether applying local heat to skin around the injection site to increase the rate of insulin absorption reduces postprandial hyperglycemia in patients with type 2 diabetes. Methods: Fourteen patients with type 2 diabetes (4 females; age 61.6 ± 8.4 years, HbA1c 8.42 ± 1.13%; BMI 29.10 ± 5.61 kg/m(2)) on intensified insulin therapy underwent 5-hour meal tolerance tests (MTTs) with a standardized liquid meal after an overnight fast on 2 study days. Subjects injected 0.2 U/kg of insulin aspart or lispro subcutaneously into the abdominal skin on both days with and without the use of the InsuPad device. Results: Following the premeal bolus injection of rapid-acting insulin analog, infusion site warming led to a rise in plasma insulin levels to peak concentrations that were significantly earlier than without skin warming (mean ± SD 52 ± 26.7 vs 80 ± 51.3 minutes, P < .005) as well as increase in plasma insulin levels during the first hour after injection (mean ± SD 63.5 ± 32.7 IU vs 48.0 ± 25.0 uU.min/ml, P = .019). As a result, the area under the curve of the postprandial glucose excursion during the first 2 hours (the primary study outcome) and the entire 5 hours after the meal were significantly reduced (P = .007 and P = .03, respectively) with skin warming around the injection site.
Discussions and Coclusions: Use of the InsuPad to increase the rate of insulin absorption provides an effective means to achieve better control of postmeal glucose excursions in type 2 diabetic patients receiving premeal injections of rapid-acting insulin analogs,
Read more.
 
Review Article, Towards a Physiological Prandial Insulin Profile: Enhancement of Subcutaneously Injected Prandial Insulin Using Local Warming Devices.
Ahmed H. El-Laboudi, Nick Oliver.
The need to develop an insulin delivery system that can closely mimic physiologically induces changes in prandial insulin release has been a major research target since the discovery of insulin. The challenges facing existing insulin delivery  systems, related to relatively slow pharmacokinetics and pharmacodynamics, have been further highlighted by rapid advances in diabetes technology and progress in artificial pancreas research. Despite the growing interest in alternative routes of insulin administration, the subcutaneous route remains- at least for now- the preffered route for insulin administration. In this article, we review efforts  aimed at developing subcutaneously injected ultrafast-acting insulin and measures aimed at enhancing insulin absorption, focusing on local warming devices,
Read more