Expanded Approval for Insulin Delivery System for Pediatric Patients
June 21, 2018 – The U.S. FDA has expanded the approval of MiniMed 670G® hybrid closed looped system, manufactured by Medtronic. Originally approved in 2017 for use in patients at least 14 years of age who have type 1 diabetes, the system can now be used by patients as young as seven years old.
Type 1 diabetes is a life-threatening condition that requires careful monitoring and treatment. Systems such as the MiniMed 670G can reduce the burden of treatment, particularly constant monitoring of blood glucose levels. The MiniMed 670G automatically measures blood glucose levels at five-minute intervals and administers a dose of insulin if needed. It consists of an insulin pump, catheter, infusion patch, and subcutaneous sensor. Individuals who use the system will still need to manually administer insulin doses at meal times.
In a clinical trial, the MiniMed 670G was determined to be safe for use in children who are at least seven years of age and have type 1 diabetes. The expanded approval is contingent upon a post-market study to evaluate the product’s performance in real-world settings. Potential risks associated with the system include hypoglycemia, hyperglycemia, and skin irritation around the infusion patch. The system should not be used by patients who require less than 8 units of insulin per day.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.