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Injection area
Take Control with InsuPad®
Achieve therapeutic target with less hypoglycemia and less insulin
InsuPad®
THE CHALLENGE
• Worldwide, there are millions of diabetes patients treated with multiple daily injections
therapy
• Insulin-dependent diabetes patients must constantly monitor their glucose levels
and must adjust their insulin dose according to their food intake
• Subcutaneous insulin delivery is:
Slow compared to normal physiology, resulting in high postprandial glucose levels
Associated with a high level of variability, depending on site of injection,
local blood flow, local temperature and level of physical activity
Increased blood glucose variability
Increased rate of hyper- and hypoglycemic events
Achieves HbA1c goal similar to Standard of Care**
Reduces the hypoglycemia event rate by 46%
Reduces the required prandial insulin dose by 28%
Reduces postprandial blood glucose excursions
Innovative Skin Temperature Stabilization (STS) technology
Non-invasive, safe, simple and easy to use
*The claims are based on the BARMER[1] and MTT[2] studies which are further detailed in this document
**Standard of Care as used in the BARMER Study
THE SOLUTION- InsuPad®
STS innovation enables controlled and consistent insulin injection site
conditions.
• Warms the skin surface of the insulin injection site to 40°C, after the injection
• There are three warming cycles of ten minutes each, followed by a ten minutes break
in warming
• This leads to a local increase of cutaneous blood flow caused by the skin temperature
regulation mechanism
• Cycles cause consistent, stronger and longer-lasting increase of blood flow
• Increased local blood flow enables consistent and efficient insulin delivery from the
subcutaneous site
Measured sub-skin temperature in response to InsuPad® warming Measured local blood flow in response to 10 minutes of InsuPad®
InsuPad®
InsuPad® rapidly increases
local blood circulation*
0 5 10 15 20 25 30 35 40
50
100
150
200
250
300
350
400
Time (Min.)
* One warming cycle
Stop WarmStart Warm
BloodFlow(a.u.)
Start Warm
InsuPad® heating profile
Sub Skin Temp
Heater Temp
Time (Min.)
Temperature(ºC.)
70503010
30
32
34
35
38
40
-10
0
1
2
3
4
5
6
7
Hypoglycemic events/pat. Hyperglycemic events/pat.
InsuPad®’s clinical efficacy and safety has been evaluated in
multiple clinical studies with over 200 Type I & Type II diabetes patients.
• 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).
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.
InsuPad®
-46%
P=0.032
-37%
P=0.221
Month
PrandialInsuline(IU)MeanNumberofEvents
/patient/3month
5
50
55
60
65
70
75
80
41 2 30
Control
-28%
P<0.05
BARMER Study: InsuPad® Reduces prandial insulin dose by 28%[1]
BARMER Study: InsuPad® Reduces the hypoglycemia event rate by 46% [1]
Control
InsuPad®
InsuPad®
BARMER Study: InsuPad® achieves HbA1c goal similar to Standard
of Care[1]
MTT Study: InsuPad® reduces post-prandial
blood glucose excursions[2]
• In the BARMER long term follow-up, InsuPad® maintained or further
reduced HbA1c levels over 15 additional months of use
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.
InsuPad®
Control
Control
InsuPad®
Month
HbA1c(%)
5
6.2
6.4
6.3
6.5
6.6
6.7
6.8
41 2 30
P=n.s.
Time (Min.)
GlucoseExcursion(mg/dL)
35030025020015010050
90
150
130
110
190
170
240
230
210
0
InsuPad®
InsuPad is Non-invasive, safe, simple and easy to use
• Well tolerated. No serious adverse events (SAEs) were observed[1]
• Discreet and allows patients to continue with their daily activities
• Composed of a disposable injection window part (Fenster)
and a reusable control unit. Both very easy to assemble
InsuPad®
5 64
Once the InsuPad® is closed
(green indicator light),
the warming cycle starts
automatically. It then switches off
automatically after 50 minutes.
At the end of the day or when the
control unit's red indicator blinks
and turn off, remove the InsuPad®
from the skin and separate the
Fenster from the control unit.
Charge the control unit and
dispose of the used Fenster.
1
Simply assemble together a fully
charged control unit and a new
Fenster.
3
To inject, open the disposable
Fenster to reveal the skin injection
area and inject within the
Fenster’s window.
2
Attach the InsuPad® to the skin
using the Fenster’s adhesive tape.
product design
product design award
InsuPad® has won two prestigious international awards for its design
InsuPad®
InsuPad® enables patients on intensive insulin therapy to take control
of their disease and reach treatment targets in a more efficient and
safer way.
InsuPad® is particularly recommended for use in diabetic patients
with*[4]:
• High prandial insulin requirements
• High prandial blood glucose excursions
• High blood glucose variability
• High risk of hypoglycemia
* InsuPad® should not be used when initiating prandial insulin treatment for the first time or in patients with consistent allergy to the plaster
P., P. (*1939, type 2 diabetic, qualified economist)
Before using the InsuPad®, my blood glucose values ranged from 76 mg/dl (4.2 mmol/l)
to 378 mg/dl (21 mmol/l). Now my values range from 74 to 121 mg/dl (4.1 to 6.7
mmol/l). My improved blood glucose values also significantly improved my quality of life.
P., W.G. (*1945, type 2 diabetic, engineer)
I noticed a change in my diabetes management. The Pad is neither a physical nor
psychological stress to me. There are no limitations when taking a shower or a bath. It is
a genuine improvement for patients with diabetes!
O., M. (*1944, type 2 diabetic, qualified engineer)
First of all, I would like to mention my motivation, as I markedly lost weight within the
first weeks. Furthermore, I had less appetite due to the smaller amount of insulin I had to
inject. At the end of the study, I had lost 8 kg. My HbA1c ranged from 5.7 % to 6.4 %
during the last nine months. Before the start of the study, I could only dream of these
values.
Klaus Funke (MD)
Being a diabetologist, I was initially skeptical if a reduction of prandial insulin by 30 %
can result in stable and good blood glucose values. At the telephone visit after 7 days,
many patients reported that their blood glucose values were within the target range.
Less hypoglycemic events occurred. Training patients how to use the InsuPad® was
easy. Using the InsuPad® was reported as being uncomplicated and easy. Some
patients were initially concerned about skin reactions. However, these did not occur.
• BARMER Study: Patients were as satisfied with InsuPad® as with
SoC, measured by the DTSQ* and PAID** scores[4]
*Diabetes Treatment Satisfaction Questionnaire. **Problem Areas in Diabetes.
Use of the InsuPad®: Testimonials
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)
To learn more about or to order InsuPad® | www.insuline-medical.com
Approved for sale in the European Union, Canada and Israel.
Insuline Medical Ltd. // 70 Pinsker St, P.O.Box 10299 Petach Tikva 4900202, Israel //P: +972-3-9301094 F: +972-3-9341094
Achieve therapeutic target with less hypoglycemia and less insulin
Take Control with InsuPad®
PN-4081008-01

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InsuPad Professional Brochure

  • 1. Injection area Take Control with InsuPad® Achieve therapeutic target with less hypoglycemia and less insulin
  • 2. InsuPad® THE CHALLENGE • Worldwide, there are millions of diabetes patients treated with multiple daily injections therapy • Insulin-dependent diabetes patients must constantly monitor their glucose levels and must adjust their insulin dose according to their food intake • Subcutaneous insulin delivery is: Slow compared to normal physiology, resulting in high postprandial glucose levels Associated with a high level of variability, depending on site of injection, local blood flow, local temperature and level of physical activity Increased blood glucose variability Increased rate of hyper- and hypoglycemic events Achieves HbA1c goal similar to Standard of Care** Reduces the hypoglycemia event rate by 46% Reduces the required prandial insulin dose by 28% Reduces postprandial blood glucose excursions Innovative Skin Temperature Stabilization (STS) technology Non-invasive, safe, simple and easy to use *The claims are based on the BARMER[1] and MTT[2] studies which are further detailed in this document **Standard of Care as used in the BARMER Study THE SOLUTION- InsuPad®
  • 3. STS innovation enables controlled and consistent insulin injection site conditions. • Warms the skin surface of the insulin injection site to 40°C, after the injection • There are three warming cycles of ten minutes each, followed by a ten minutes break in warming • This leads to a local increase of cutaneous blood flow caused by the skin temperature regulation mechanism • Cycles cause consistent, stronger and longer-lasting increase of blood flow • Increased local blood flow enables consistent and efficient insulin delivery from the subcutaneous site Measured sub-skin temperature in response to InsuPad® warming Measured local blood flow in response to 10 minutes of InsuPad® InsuPad® InsuPad® rapidly increases local blood circulation* 0 5 10 15 20 25 30 35 40 50 100 150 200 250 300 350 400 Time (Min.) * One warming cycle Stop WarmStart Warm BloodFlow(a.u.) Start Warm InsuPad® heating profile Sub Skin Temp Heater Temp Time (Min.) Temperature(ºC.) 70503010 30 32 34 35 38 40 -10
  • 4. 0 1 2 3 4 5 6 7 Hypoglycemic events/pat. Hyperglycemic events/pat. InsuPad®’s clinical efficacy and safety has been evaluated in multiple clinical studies with over 200 Type I & Type II diabetes patients. • 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). 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. InsuPad® -46% P=0.032 -37% P=0.221 Month PrandialInsuline(IU)MeanNumberofEvents /patient/3month 5 50 55 60 65 70 75 80 41 2 30 Control -28% P<0.05 BARMER Study: InsuPad® Reduces prandial insulin dose by 28%[1] BARMER Study: InsuPad® Reduces the hypoglycemia event rate by 46% [1] Control InsuPad® InsuPad®
  • 5. BARMER Study: InsuPad® achieves HbA1c goal similar to Standard of Care[1] MTT Study: InsuPad® reduces post-prandial blood glucose excursions[2] • In the BARMER long term follow-up, InsuPad® maintained or further reduced HbA1c levels over 15 additional months of use 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. InsuPad® Control Control InsuPad® Month HbA1c(%) 5 6.2 6.4 6.3 6.5 6.6 6.7 6.8 41 2 30 P=n.s. Time (Min.) GlucoseExcursion(mg/dL) 35030025020015010050 90 150 130 110 190 170 240 230 210 0 InsuPad®
  • 6. InsuPad is Non-invasive, safe, simple and easy to use • Well tolerated. No serious adverse events (SAEs) were observed[1] • Discreet and allows patients to continue with their daily activities • Composed of a disposable injection window part (Fenster) and a reusable control unit. Both very easy to assemble InsuPad® 5 64 Once the InsuPad® is closed (green indicator light), the warming cycle starts automatically. It then switches off automatically after 50 minutes. At the end of the day or when the control unit's red indicator blinks and turn off, remove the InsuPad® from the skin and separate the Fenster from the control unit. Charge the control unit and dispose of the used Fenster. 1 Simply assemble together a fully charged control unit and a new Fenster. 3 To inject, open the disposable Fenster to reveal the skin injection area and inject within the Fenster’s window. 2 Attach the InsuPad® to the skin using the Fenster’s adhesive tape. product design product design award InsuPad® has won two prestigious international awards for its design
  • 7. InsuPad® InsuPad® enables patients on intensive insulin therapy to take control of their disease and reach treatment targets in a more efficient and safer way. InsuPad® is particularly recommended for use in diabetic patients with*[4]: • High prandial insulin requirements • High prandial blood glucose excursions • High blood glucose variability • High risk of hypoglycemia * InsuPad® should not be used when initiating prandial insulin treatment for the first time or in patients with consistent allergy to the plaster P., P. (*1939, type 2 diabetic, qualified economist) Before using the InsuPad®, my blood glucose values ranged from 76 mg/dl (4.2 mmol/l) to 378 mg/dl (21 mmol/l). Now my values range from 74 to 121 mg/dl (4.1 to 6.7 mmol/l). My improved blood glucose values also significantly improved my quality of life. P., W.G. (*1945, type 2 diabetic, engineer) I noticed a change in my diabetes management. The Pad is neither a physical nor psychological stress to me. There are no limitations when taking a shower or a bath. It is a genuine improvement for patients with diabetes! O., M. (*1944, type 2 diabetic, qualified engineer) First of all, I would like to mention my motivation, as I markedly lost weight within the first weeks. Furthermore, I had less appetite due to the smaller amount of insulin I had to inject. At the end of the study, I had lost 8 kg. My HbA1c ranged from 5.7 % to 6.4 % during the last nine months. Before the start of the study, I could only dream of these values. Klaus Funke (MD) Being a diabetologist, I was initially skeptical if a reduction of prandial insulin by 30 % can result in stable and good blood glucose values. At the telephone visit after 7 days, many patients reported that their blood glucose values were within the target range. Less hypoglycemic events occurred. Training patients how to use the InsuPad® was easy. Using the InsuPad® was reported as being uncomplicated and easy. Some patients were initially concerned about skin reactions. However, these did not occur. • BARMER Study: Patients were as satisfied with InsuPad® as with SoC, measured by the DTSQ* and PAID** scores[4] *Diabetes Treatment Satisfaction Questionnaire. **Problem Areas in Diabetes. Use of the InsuPad®: Testimonials
  • 8. 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) To learn more about or to order InsuPad® | www.insuline-medical.com Approved for sale in the European Union, Canada and Israel. Insuline Medical Ltd. // 70 Pinsker St, P.O.Box 10299 Petach Tikva 4900202, Israel //P: +972-3-9301094 F: +972-3-9341094 Achieve therapeutic target with less hypoglycemia and less insulin Take Control with InsuPad® PN-4081008-01