Insulin Pumps Improve Diabetes Management

For patients with type 1 diabetes (T1D) and type 2 diabetes, insulin pumps offer a break from conventional insulin daily injections, while allowing patients to still reach and maintain their A1c levels and blood sugar targets.¹

Since the introduction of the first insulin pump in the early 1960s, the technology has evolved to become much more sophisticated, offering improvements in portability, as well as addressing therapeutic outcomes.²

Medtronic, since its founding in 1949, under the name of MiniMed, has become a leading maker of insulin pumps in Europe and the United States.³ Medtronic introduced its first pump, the MiniMed 502, in 1983. The 502A followed, offering a tremendous improvement in both programmability and size. The company introduced the MiniMed 506 insulin pump in 1992, with advancements in daily insulin totals and meal bolus memory. In 1999, Medtronic began offering the MiniMed 508, which offered new features, such as remote programming capabilities and dosing administration and suspension tools for patients.

In 2000, Medtronic received approval in Europe for its first implantable insulin pump, Model 2007-A. The FDA approved the MiniMed 530G with Enlite, a breakthrough system, in 2013, as a first-generation artificial pancreas device, communicating with the continuous glucose monitor (CGM) sensors. This was followed with the launch of the MiniMed 620G in Japan in 2014, the 640G outside the United States in 2015, and the 630G in the United States in 2016. In 2017, MiniMed 670G received approval as the first hybrid closed-loop system for patients with T1D. In August 2020, FDA approved MiniMed 770G hybrid closed loop system, to be used in patients ages 2 to 6 years. Most recently, the MiniMed 780G device was approved in Europe for patients with diabetes ages 7 to 80 years.⁴

Tandem Diabetes Care is another top player in the global insulin pump market. It received FDA approval in 2011 to market its first insulin pump, the t:slim. The insulin pump offered the first color touchscreen and was the smallest insulin pump system available at the time, making it attractive to consumers.⁵ In May 2015, Tandem launched the t:flex insulin pump, which was the largest capacity pump offered in the United States.⁶ Later that year, Tandem announced FDA approval of the t:slim G4 insulin pump system, the first and only touchscreen pump with CGM integration that combined the t:slim insulin pump with the Dexcom G4.⁷

Tandem’s first-generation t:slim insulin pump was replaced by the next-generation t:slim X2 Insulin Pump in October 2016. The new model offered advanced Bluetooth radio along with optimized software.⁸ The t:slim X2 insulin pump was then integrated with the Dexcom G5 CGM in 2017.⁹ In 2018, Tandem introduced the t:slim X2 insulin pump with Basal-IQ technology that was able to predict low glucose levels 30 minutes ahead of time and suspend insulin delivery to prevent hypoglycemic events.¹⁰ Finally, in 2019, Tandem announced FDA clearance of the t:slim X2 insulin pump with Control-IQ technology, an advanced hybrid closed-loop system that uses Dexcom G6 CGM values to not only predict glucose levels and suspend insulin delivery but to also adjust insulin delivery accordingly.¹¹

The Omnipod Insulin Management System is a novel insulin pump system designed by Insulet Corporation. The Omnipod system received its first 510(k) clearance from the FDA in mid-2003 and commercial clearance from the agency in 2005.¹² In 2013, Insulet announced FDA approval for a new Omnipod insulin pump that was 25% lighter and 34% smaller as well as a personal diabetes manager (PDM). Insulet scored another FDA approval in 2018 for the Omnipod Dash, a tubeless, waterproof insulin pump that connects wirelessly to a handheld PDM, which also received alternate controlled-enabled pump approval in 2019.¹³

With the number of individuals who receive diabetes diagnoses continuing to increase, these patients will benefit from the dramatic technology improvements of the past 20 years that give them more access to insulin pump delivery systems. This will significantly improve diabetes management and quality of life.

Saro Arakelians, PharmD, is vice president of pharmacy operations at Mini Pharmacy in Los Angeles, California. Ngoctran Tran is a PharmD candidate at the University of Southern California School of Pharmacy in Los Angeles.

REFERENCES

• American Diabetes Association. Insulin basics. Accessed October 21, 2020. https://www.diabetes.org/diabetes/medication-management/insulin-other-injectables/insulin-basics
• Reese SW, Williams CLH. Insulin pump class: back to the basics of pump therapy. Diabetes Spectr. 2014;27(2):135-140. doi:10.2337/diaspect.27.2.135
• Insulin pumps market analysis. iData Research. June 2, 2019. Accessed October 26, 2020. https://idataresearch.com/product/insulin-pumps-market/
• Innovation milestones. Medtronic. Accessed October 26, 2020. https://www.medtronicdiabetes.com/about-medtronic-innovation/milestone-timeline
• Tandem Diabetes Care announces FDA clearance of the t:slim™ insulin delivery system [news release]. San Diego, CA: November 16, 2011; Tandem Diabetes Care Inc. Accessed October 26, 2020. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-FDA-clearance-tslimtm-insulin
• FDA Approves t:flex™ large capacity insulin pump for diabetes treatment. Endocrineweb. May 1, 2015. Accessed October 26, 2020. https://www.endocrineweb.com/professional/type-2-diabetes/fda-approves-tflex-large-capacity-insulin-pump-diabetes treatment
• FDA approves Tandem t:slim G4, bringing CGM to the touchscreen pump. diaTribe Learn. September 21, 2015. Accessed October 26, 2020. https://diatribe.org/fda-approves-tandem-tslim-g4-bringing-cgm-touchscreen-pump
• Tandem Diabetes Care now shipping next-generation t:slim X2 insulin pump [news release]. San Diego, CA; October 24, 2016. Tandem Diabetes Care Inc. Accessed October 27, 2020. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-now-shipping-next-generation-tslim-x2
• Tandem Diabetes Care announces FDA approval and launch of t:slim X2 insulin pump with Dexcom G5 Mobile CGM integration [news release]. San Diego, CA; August 28, 2017. Tandem Diabetes Care Inc. Accessed October 27, 2020. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-fda-approval-and-launch-tslim-x2
• FDA. t:slim X2 insulin pump with Basal-IQ technology - P180008. August 3, 2018. Accessed October 27, 2020. https://www.fda.gov/medical-devices/recently-approved-devices/tslim-x2-insulin-pump-basal-iq-technology-p180008
• Tandem Diabetes Care announces FDA clearance of the t:slim X2 insulin pump with Control-IQ Advanced Hybrid Closed-Loop Technology [news release]. San Diego, CA; Tandem Diabetes Care Inc. December 13, 2019. Accessed October 27, 2020. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-fda-clearance-tslim-x2-insulin
• Zisser HC. The OmniPod Insulin Management System: the latest innovation in insulin pump therapy. Diabetes Ther. 2010;1(1):10-24. doi:10.1007/s13300-010-0004-6
• FDA approves Insulet’s new Omnipod Diabetes Management System. Medgadget. February 26, 2013. Accessed October 27, 2020. https://www.medgadget.com/2013/02/fda-approves-insulets-new-omnipod-diabetes-management-system.html