Introduction
Traditional Insulin Pump Therapy
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A device about the size of a deck of cards that contains an insulin reservoir, a pumping mechanism, batteries, and a microchip that carries the user’s daily insulin delivery programs and delivery history. The device has a screen and buttons to aid the user in delivering the proper amount of insulin. Current pumps come with color screens, sleek outlines, and much-improved user interface. The patient usually wears the device in a pocket or hooked on a belt or waistband.
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An infusion set that attaches to the patient’s skin with adhesive and includes a short plastic cannula that is inserted just beneath the skin to allow access for the insulin. The patient either uses a mechanical inserter to attach the set and insert the cannula, or inserts the infusion set by hand.
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A length of tubing that delivers the insulin from the pump to the infusion set and cannula. Tubing ranges from 30 to 110 cm (11.8 to 43.3 inches).
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A separate blood glucose (BG) monitor. The patient uses the result on the monitor to calculate the dosage of insulin s/he should take and then inputs that instruction to the pump. Most pumps also include a bolus calculator to assist with these calculations. (In recent years, more pumps have added linked glucose meters that convey the BG value to the pump for correction bolus calculations.)
Manufacturer
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Products
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Animas Corp. | OneTouch® Ping® |
Insulet Corp. | OmniPod® (available only in US and Israel) |
mylife™ OmniPod® | |
Medtronic MiniMed, Inc. | Paradigm® |
Paradigm® Revel™ | |
Nipro Diagnostics, Inc. | Amigo® (available only in US, as of August 1, 2010) |
Roche Diabetes Care (AG) | Accu-Chek® Spirit |
Accu-Chek® Combo (not available in US) | |
SOOIL Development | DANA Diabecare® |
Benefits of Insulin Pump Therapy
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Dawn phenomenon
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Severe hypoglycemia unawareness
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An irregular daily schedule, such as people who work various shifts or have unforeseen physical activities requiring a reduction of basal insulin
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Pregnancy
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Diabetes complications that require very tight glucose control
Limitations of Traditional Insulin Pump Therapy
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Long tubing connects the insulin reservoir in a traditional pump to the infusion set. The tubing has to be managed by patients in all aspects of daily living (dressing, exercising, etc). This tubing can catch on things during daily use, resulting in disruption of insulin delivery.
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The process of inserting the cannula with mechanical inserters or by hand is awkward and can result in variable cannula insertion angles and depths. This mechanical or manual cannula insertion process can be intimidating to some patients.
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Managing the large number of components required during setup and infusion set changes is complex.
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Locations to insert infusion sets are relatively limited.
The Omnipod System: What is it and How Does it Work?
Year
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Award
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2006 | Gold Industrial Design Excellence Award (IDEA) from the Industrial Designers Society of America |
2006 | Medical Design Excellence Award (MDEA) for General Hospital Devices and Therapeutic Products |
2009 | Edison Best New Product Award™ in the Science and Medical category |
System Components
Contraindications
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Unable to perform at least four BG tests per day
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Unable to maintain contact with their healthcare provider
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Unable to use the system according to instructions.
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Testing newborns
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Testing arterial blood
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Diagnosing diabetes
Detailed Product Description
The Pod
Pod Motor Mechanism
Pod Insulin Reservoir
Fill Process
Cannula Insertion Process
Insulin Delivery
Incorporated BG Measurement
Suggested Bolus Calculation
Does the Omnipod System Promote Better Type 1 Diabetes Management?
Clinical trial report
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Results
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OmniPod Insulin Management System: patient perceptions, preference, and glycemic control
| • 90% (18 of 20) preferred using the OmniPod automated cannula insertion system vs. their current infusion sets. |
Howard Zisser and Lois Jovanoviç (2006)1
| • A1C values decreased from mean of 7.1% to mean of 6.8% (P<0.002). |
• 20 patients currently using CSII switched to OmniPod System for 30 days. | • Mean responses, on a scale from 1 to 5, where 1 = most favorable and 5 = least favorable, were: |
• All patients completed exit questionnaire comparing using the OmniPod System with using their current insulin pump. | Convenience of use = 1.85 |
Satisfaction with wearing OmniPod = 1.7 | |
Satisfaction with current insulin pump = 1.9 | |
Pain associated with automated cannula insertion = 2.0 | |
Wearing while sleeping = 1.15 | |
Wearing while showering = 1.1 | |
Time involved in Pod change process = 2.05 | |
Quantifying the impact of a short-interval interruption of insulin-pump infusion sets on glycemic excursions
| • Blood glucose levels rose 1 mg/dL for each minute insulin infusion was interrupted. |
Howard Zisser (2008)2
| • A 30-minute interruption in basal insulin infusion resulted in a rise of 30 mg/dL 3 hours after reconnecting the insulin pump. |
• Studied the effect on blood glucose of short interruptions of basal insulin delivery. | |
Siphon effects on continuous subcutaneous insulin infusion pump delivery performance
| • Traditional pumps with cannulas showed significant changes in insulin delivery, ranging from 74.5% of expected delivery when pumping towards a site above the pump, to 123.3% when pumping downward, at a 1 U/hour rate. |
Howard Zisser et al. (2010)3
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• Studied the effect of changing the position of traditional insulin pumps in relation to the position of the cannula on insulin delivery accuracy. | • The OmniPod System performed with minimal variation in insulin delivery, from 99% of expected delivery when pumping upward to 101% when pumping downward at the same 1U/hour rate. |
Clinical experience with a tubing-free insulin pump system
| • Average A1C values decreased a significant 0.49% (P<0.01). |
Michael Kane et al. (2009)4
| • 25.5% of patients obtained A1C value of <7% after 1 year using OmniPod System; only 5.7% of patients had obtained that value prior to using it. |
• Retrospective study of patients who had begun using the OmniPod System 1 year prior. | • Reduction of DKA episodes (1 vs. 3). |
• Of 59 patients, 47 had used MDI, 12 had used different brand of pump. | • Acceptance rate for the OmniPod was 92.2%. |
An innovative application of shape memory alloy (SMA) technology yields a novel therapeutic approach to diabetes management
| • SMA technology applied to the motor of the Pod enables improved reliability, a more compact system, reduced cost, and reduced weight. |
Steve Dilanni and John Garibotto (2006)5
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• Technical paper on the enabling technology for the development of the OmniPod System. | • SMA wire-actuated motor is unable to “run away” when power is applied directly, eliminating electromechanical failure and increasing accuracy and safety. |
Computer-aided learning in insulin pump training
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Sergey Sirotinin and Charles George (2010)6
| • All trainers agreed the OmniPod training CD helped patients new to insulin pump therapy gain a positive attitude toward it. |
• Study of acceptability of OmniPod interactive training tool to healthcare professionals experienced in diabetes education and certified in pump training. | • 80% of pump trainers approved of teaching methods used. |
• Over a 3-month period, 126 trainers trained 1244 patients on four different brands of insulin pump. | |
A prospective trial of U-500 insulin delivered by OmniPod in patients with type 2 diabetes and severe insulin resistance
| • Significant reduction in A1C of 1.23% (P=0.0008). |
Wendy Lane et al. (2010)7
| • Significant increase in percent of time spent within target blood glucose range, 70 to 180 mg/dL: 70.75% (P=0.0001). |
• One-year study tested efficacy and safety of U-500 insulin delivery via the OmniPod System to patients with uncontrolled type 2 diabetes and severe insulin resistance. | • 14 of 20 subjects elected to remain on OmniPod at study completion. |
In silico evaluation platform for artificial pancreatic beta-cell development—a dynamic simulator for closed-loop control with hardware-in-the-loop*
| • Allows full-system verification and validation, including hardware limitations. |
Eyal Dassau et al. (2009)8
| • Allows systematic analysis of monitoring and control algorithms. |
• Testing of artificial beta-cell systems on computers usually involves only the controller software; this development enables testing of hardware as well. | • Streamlines preclinical validation trials. |
Closed-loop artificial pancreas using subcutaneous glucose sensing and insulin delivery and a model predictive control algorithm: preliminary studies in Padova and Montpellier*
| • OmniPod System for insulin delivery as part of the Artificial Pancreas System developed at UCSB/Sansum Diabetes Research. |
Daniela Bruttomesso et al. (2009)9
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Closed-loop artificial pancreas using subcutaneous glucose sensing and insulin delivery and a model predictive control algorithm: the Virginia experience*
| • OmniPod System for insulin delivery as part of the Artificial Pancreas System developed at UCSB/Sansum Diabetes Research. |
William Clarke et al. (2009)10
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Review of Clinical Data
Clinical Trials and Reviews
Ongoing Research and Development
Comparison With Other Insulin Pumps
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Occasional Pod failure does occur. This may be due to inserting the Pod in a site with scar tissue, system failure, occlusion, or some other cause.
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In extreme heat, the Pod’s adhesive may not hold securely. As with traditional infusion sets, the patient may have to add extra adhesive.
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Some patients are especially self-conscious and may not want a “bump” on their bodies. They may feel they can hide a conventional pump more easily, even with tubing and the bulk of the pump itself.
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Patients who require more than 100 units of insulin per day may do better choosing a pump with a larger, 300-unit reservoir. Some may be able to change the Pod every 2 days instead of every 3 days.
Patient Concerns
Question
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Answer
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Is the OmniPod System approved for everyone—even children and teens? | Yes, the OmniPod is approved for people of all ages who have diabetes and use insulin—including children and teens. |
Can I swim with the OmniPod System? | The watertight Pod can go in the pool, the ocean, the shower, or the tub for up to 7.6 meters (25 feet) for 60 minutes with no need to disrupt insulin delivery. The PDM, though, is not waterproof. |
Does the OmniPod System provide data download capability? | In the US, the OmniPod System downloads insulin delivery, BG, and carbohydrate records to the CoPilot® Health Management System, enabling the user to create customized reports, charts, and graphs. CoPilot software can be downloaded at no charge. In the EU, other software is available. |
Can I travel while using the OmniPod System? | Yes. Contact your airline for information on current security requirements. The PDM and Pods can safely pass through airport x-ray machines. If the security detector goes off, tell the security screener that you have diabetes and wear an insulin Pod. |
Can I play sports while wearing a Pod? | Yes. You can play sports and participate in physical activities while wearing a Pod—just leave the PDM in your gym bag. |
How close do the OmniPod and the PDM need to be to communicate with each other? | For programming insulin delivery or responding to Pod alarms or alerts, the PDM and Pod need to be within 61 cm of each other. Otherwise, they do not need to be near each other at all. The Pod will continue to deliver your current background (or basal) insulin, even if your PDM is not nearby. |
What type of insulin should I use with the Pod? | The Pod is designed to be used with U-100 rapid-acting insulin. The following U-100 rapid-acting insulin analogs have been tested and found to be safe for use in the Pod: NovoLog®, NovoRapid®, Humalog®, or Apidra®. Before using different insulin with the OmniPod System, check the insulin drug label to make sure it can be used with a pump and consult with your healthcare professional. |
How much insulin does the Pod hold? | The Pod holds up to 200 units of insulin; it requires a minimum of 85 units of insulin to begin operation. |
What type of adhesive does the Pod use? | The Pod uses an adhesive similar to the adhesive used with common infusion sets. The adhesive is latex-free, acrylic-based, and ideal for holding the Pod, even in the presence of moisture. It is designed to hold the Pod securely in place for the duration of wear. |
Where on my body can I wear the Pod? | The Pod’s automated cannula insertion enables you to wear it many places. It is recommended that you begin on your abdomen, because it is easy to access and see what you’re doing. Once you have mastered using the Pod, however, you can wear it on your leg, upper thigh, lower back, or the back of your upper arm—in fact, anywhere you would give yourself an injection. Of course, you want to avoid wearing the Pod within 2 inches of your navel and in other areas where belts, waistbands, or tight clothing may rub against, disturb, or dislodge it. |
How long do I wear each Pod? | A Pod expires 72 hours after activation. You should refer to the insulin labeling and follow your healthcare provider’s directions concerning when to replace the Pod. |
How long do the batteries last in the PDM? | The PDM batteries last approximately 3 weeks. Extensive use of the bright-mode option may shorten this time frame. |
What if I leave home without my PDM or leave it somewhere? | Your Pod will continue to deliver your current background (or basal) insulin, even if you do not have your PDM with you. However, you will not be able to make changes to your basal delivery, deliver bolus doses, test your BG, or respond to alarms or alerts when your PDM is not with you. |
What happens if I lose my PDM? | Our experience has been that very few people lose their PDM. However, if you do, please contact Insulet Corporation immediately for a replacement. In most cases, you will receive your replacement within 24 hours. Of course, some people like to order a back-up PDM to have on hand just in case. |
Conclusion
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It frees patients with diabetes of being tethered to their pumps.
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It provides consistent, round-the-clock, uninterrupted insulin delivery.
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It allows for easier set up and automated cannula insertion.
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Greater convenience often leads to better compliance.