Medtronic Extended Infusion Set: Extending the Patient Experience
Longer duration of wear has been a significant unmet need
Advanced insulin pump technology has the capability to deliver improved clinical outcomes with less effort by the user.1 However, a well-functioning infusion set is required to deliver insulin effectively and reliably to the body in order to realize these outcomes. Infusion sets are a critical component of insulin delivery, but infusion set wear can introduce burden for people with diabetes (PWD) using insulin pump therapy.
Medtronic engineers researched the problems users experience with infusion set wear, including skin complications and hyperglycemia due to site failure, or adhesive failure. We also know patients want to wear infusion sets longer.2 However, extending standard infusion set wear beyond the recommended duration increases the likelihood of these complications.3,4 Standard infusion sets require replacement approximately every 2 to 3 days, introducing burden for individuals with diabetes to manage infusion set changes and alternate insertion sites multiple times per week.
Addressing insulin infusion set challenges
Our engineers learned that insulin instability and loss of insulin preservatives contribute to infusion set failure, limiting the duration of infusion set wear.5 Reservoir size, adhesive, and issues with insertion can serve to further limit the wear time of an infusion set. Medtronic’s innovative Extended infusion set (EIS) with the Extended reservoir is designed to address these issues, as shown in the image below, extending the wear time by up to twice as long as the standard 2 to 3 days, making EIS the first and only infusion set to offer up to 7 days of dependable continuous insulin delivery.
Solving for extended wear through the insulin fluid path
Insulin infusion involves multiple key steps that may contribute to limiting infusion set wear duration.
In addition to these wear benefits, the EIS with Extended reservoir reduces waste. Frequent infusion set changes can lead to wasted insulin, but the Extended reservoir reduces insulin waste, resulting in savings from $881 to $1677 per year.6, 7 Less frequent infusion set changes also mean a reduction in 1.5 to 1.9 kilograms in plastic waste per year.8 These innovations in infusion set design allow for up to twice the wear time, with the goal of reducing the burden to the patient by enabling significant insulin-related cost savings as well as increasing the time available for tissue to rest and heal.
Proven results
Medtronic validated the EIS technology in a single-arm pivotal trial across 15 research sites throughout the United States.3 A total of 248 individuals with type 1 diabetes using the MiniMed™ 670G insulin pump participated in the study. Participants were provided with 12 EIS devices and instructed to wear each device for 174 hours or until the infusion set failed.
Results of the clinical trial indicated the EIS device was safe to use, with no serious or unexpected adverse device events. In addition, EIS failure rates at 7 days of wear were low, with issues and removal rates listed as follows:
- Adhesive issues: 6.2%
- Leakage: 2.2%
- Discomfort: 1.6%
- Mechanical failure: 1.0%
- Unexplained hyperglycemia: 0.7%
- Presence of serum ketones: 0.6%
- Signs of infection: 0.5%
- Cannula issues: 0.5%
- Loss of insertion: 0.0%
A1C and total daily insulin dose were stable throughout the study, confirming that EIS can be used as a part of an effective diabetes management regimen. Satisfaction ratings from study participants indicated a high degree of satisfaction with EIS, with statistically significantly better ratings for EIS relative to a standard infusion set. Satisfaction ratings are shown in the table below, with a rating of 5 indicating “extremely satisfied,” and a rating of 1 indicating “not satisfied.”
|
|
Standard infusion set |
EIS |
P-value |
|---|---|---|---|
| Ease of insertion |
4.0 ± 0.9 |
4.7 ± 0.8 |
<0.001 |
| Comfort of wear |
3.9 ± 0.9 |
4.5 ± 0.9 |
<0.001 |
| Duration of wear |
3.1 ± 1.2 |
4.4 ± 1.1 |
<0.001 |
| Time required to change |
3.7 ± 1.0 |
4.6 ± 0.7 |
<0.001 |
| Convenience of use |
3.9 ± 0.9 |
4.6 ± 0.8 |
<0.001 |
Summary
Medtronic is advancing insulin delivery in pump therapy by extending the current 2 to 3 days of infusion set wear up to 7 days. Clinical outcomes expected with insulin pump therapy are maintained; health care and insulin-related cost savings along with user satisfaction are increased and waste is reduced.
The EIS and Extended reservoir will be offered exclusively to Medtronic customers later this year.
1
Collyns OJ, Meier RA, Betts ZL, et al. Improved Glycemic Outcomes With Medtronic MiniMed Advanced Hybrid Closed-Loop Delivery: Results From a Randomized Crossover Trial Comparing Automated Insulin Delivery With Predictive Low Glucose Suspend in People With Type 1 Diabetes. Diabetes Care. 2021;44(4):969-975. doi:10.2337/dc20-2250.
2
Thethi TK et al. Consequences of delayed pump infusion line change in patients with type 1 diabetes mellitus treated with continuous subcutaneous insulin infusion. J Diabetes Complications. 2010; 24(2): 73–8.
3
Brazg R et al. Evaluation of infusion set performance in adults with type 1 diabetes: Infusion set survival rate and glycemic outcomes from a pivotal trial. Diabetes Technol Ther. 2022; 24(8):535-543 doi:10.1089/dia.2021.0540.
4
Pfutzner A et al. Using insulin infusion sets in CSII for longer than recommended usage time leads to a high risk for adverse events: Results from a prospective randomized crossover study. J Diabetes Sci and Technol. 2015; 9(6): 1292-1298.
5
Zhang JY, et al. Advances in Insulin Pump Infusion Sets Symposium Report. Journal of Diabetes Science and Technology 2021; DOI: 10.1177/1932296821999080.
6
Chattaraj S et al. CSII and insulin: Does extending the wear duration of infusion sets save expensive insulin? Diabetes. 2020; 69(Supplement 1): 1167-P.
7
Kwa T et al. The improved survival rate and cost-effectiveness of a 7-day continuous subcutaneous insulin infusion set. J Med Econ. 2021; 24(1): 837-845.
8
Fusselman H et al. The Extended Wear Infusion Set- A Design for Plastic Waste Reduction. J Diabetes Sci and Technol. 2021; 15(2): 397–477.
Important safety information
The Extended Infusion Set requires a prescription and is indicated for up to 7 days of wear for the subcutaneous infusion of insulin from an infusion pump. It is NOT indicated for intravenous (IV) infusion or the infusion of blood or blood products. Inaccurate medication delivery, infection and/or site irritation may result from improper insertion and maintenance of the infusion site. Before insertion, clean the insertion site with isopropyl alcohol. Remove the needle guard before inserting the infusion set. If using this infusion set for the first time, do the first set-up in the presence of your healthcare professional. Do not leave air in the infusion set. Prime completely. Check frequently to make sure the soft cannula remains firmly in place as you may not feel pain if it pulls out. The soft cannula must always be completely inserted to receive the full amount of medication. If the infusion site becomes inflamed, replace the set, and use a new site until the first site has healed. Replace the infusion set if the tape becomes loose, or if the soft cannula becomes fully or partially dislodged from the skin. Regularly replace the infusion set as indicated in the instructions for use, or per the insulin labeling, whichever duration is shorter.
The Extended Reservoir is indicated for the subcutaneous infusion of insulin from compatible Medtronic insulin pumps and infusion sets. Refer to your Medtronic insulin pump user guide for a list of compatible insulins and infusion sets. The reservoir is contraindicated for the infusion of blood or blood products. Use for a maximum of 7 days, or according to the insulin labeling, whichever duration is shorter. For more details, see https://www.medtronicdiabetes.com/important-safety-information