Insulin Monitoring System for Pediatric patients

By: Lyana Sayilar, PharmD Candidate c/o 2022

             On August 31, 2020, the FDA approved the first automated diabetes management device for patients aged 2 to 6-years old. The MiniMed 770G System automatically adjusts basal insulin doses based on glucose levels, facilitating the lives of the patient and caregiver. Prior to its approval, patients and/or caregivers had to continuously monitor blood glucose levels throughout the day and inject insulin using a syringe, pen, or pump^{. 3} Type 1 diabetes is a condition generally affecting the juvenile population where the pancreas produces little to no insulin due to an autoimmune attack of the beta islet cells. Without adequate insulin, blood glucose is unable to enter cells to be used as energy and remains in the blood. ¹

The MiniMed 770G System measures blood glucose levels every five minutes and either administers or suppresses insulin delivery. The system consists of a sensor with a wire that attaches to the skin of the abdomen and measures glucose levels and should be changed every 2- 3 days, an insulin pump that straps to the body with an infusion patch connected to the pump, and a catheter that delivers insulin from the pump^..³ The sensor, which is inserted up to seven days, is used on the abdomen or buttock for patients 2-13 years old and for patients 14-years and older, the sensor is used on the abdomen or arm. The MiniMed 770G System also contains the Accu-Chek Guide TM Link Blood Glucose meter and test strips. Users or caregivers have to calibrate the sensor at least two times a day. To calibrate the sensor, the glucose values from the Accu-Chek Guide TM Link Blood Glucose meter are transmitted by Bluetooth low energy to the pump. For calibration purposes, the meter should measure blood from the fingertip only. 5 Risks of the system may include hypoglycemia, hyperglycemia, skin irritation, and redness near the infusion patch. The MiniMed 770G System is a prescribed device and is not approved for patients who require less than eight units of insulin per day or more than 250 units of insulin per day. ^3,4

 MiniMed 670G System is an earlier version of this device that does not have the Bluetooth capability that the MiniMed 770G System has and was only approved for ages 7 and up. The MiniMed 770G System extends its use for ages 2 and above. The sensor of the MiniMed 770G System wirelessly transmits the glucose level values through Bluetooth low energy to the pump screen and the patient and caregiver can visualize glucose patterns on a cell phone screen. The system has a manual and auto mode. In the manual mode, basal insulin is delivered at a constant rate until the glucose levels fall below or are predicted to decrease below a predetermined value. In the auto mode, basal insulin is automatically adjusted and continuously increasing, decreasing, or suppressing insulin based on glucose values detected. At mealtime, the patient or caregiver manually requests bolus insulin doses based on the amount of carbohydrates being consumed. Additionally, the system provides alerts if hyperglycemic or hypoglycemic levels are detected^{. 4} The patient or caregiver can view the previous 90 days of glucose trends and the glucose data can be automatically shared with a healthcare professional. ²

The MiniMed 770G System should always be removed before entering a room for an x- ray, MRI, diathermy (use of high-frequency electromagnetic currents to provide heat for a medical purpose), or CT scan because the magnetic fields and radiation can damage the part of the pump that delivers insulin or make the device nonfunctional. The system should always be kept away from magnets. A low or high glucose alert should always be confirmed with a glucose meter. ² With advancements in technology, the lives of patients or caregivers become facilitated and guidance to proper therapy can be more accurately achieved.

References:

1. Centers for Disease Control and Prevention. What Is Type 1 Diabetes? [online] Available at: https://www.cdc.gov/diabetes/basics/what-is-type-1-diabetes.html Last Updated 01/20/2021. [Accessed 22 January 2021].
2. The MiniMed™ 770G System. Medtronic. https://www.medtronicdiabetes.com/products/minimed-770g-insulin-pump-system.
3. U.S. Food and Drug Administration. 2020. FDA Approves First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients. [online] Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-automated- insulin-delivery-and-monitoring-system-use-young-pediatric [Accessed 22 January 2021].
4. U.S. Food and Drug Administration. 2020. MiniMed 770G System – P160017/S076. [online] Available at: https://www.fda.gov/medical-devices/recently-approved-devices/minimed-770g- system-p160017s076 [Accessed 23 January 2021].
5. U.S. Food and Drug Administration. 2020. SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED). [online] Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160017S076B.pdf [Accessed 23 January 2021].