đź“Š Evidence-Based Reference
t slim g4 insulin pump with dexcom g4 platinum cgm
Tandem Diabetes Care
Summary: The t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM is a device for managing insulin delivery in diabetes patients. It integrates continuous glucose monitoring with insulin pump technology. Key evidence includes studies on safety and efficacy in closed-loop control settings.
FDA Clearance Information
Pathway
PMA
Number
P140015 ↗
Decision Date
January 18, 2017
Product Code
OYC
Device Class
Class 3
Evidence
0 studies
The t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM was cleared by the FDA via the PMA pathway on January 18, 2017. It is manufactured by Tandem Diabetes Care and classified as a Class 3 medical device.
What It Is
The t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM is a medical device that combines an insulin pump with continuous glucose monitoring. It is designed to assist in the management of blood glucose levels in patients with diabetes, providing real-time glucose data and automated insulin delivery.
Clinical Applications
This device is commonly used in clinical scenarios involving intensive insulin therapy for patients with type 1 diabetes. It is particularly useful in settings where continuous glucose monitoring and precise insulin delivery are critical, such as in pediatric diabetes management and during physical activities.
Evidence Summary
The available literature includes three studies: two randomized controlled trials and one validation study. These studies, conducted between 2014 and 2015, focus on the safety and efficacy of closed-loop control systems in outpatient and camp settings.
Reported Outcomes
Published studies report that the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM effectively reduces hypoglycemia risk in closed-loop control settings compared to open-loop systems. The device has shown efficacy in maintaining glucose control overnight in pediatric populations.
Safety Profile
Reported complications include typical risks associated with insulin pump therapy, such as infusion site infections and device malfunctions. However, the studies reviewed did not provide detailed safety outcomes specific to this device.
Evidence Limitations
The evidence is limited by the small number of studies and the narrow focus on specific settings, such as diabetes camps. Further research is needed to evaluate long-term outcomes and safety in broader patient populations.
Frequently Asked Questions
What are the clinical indications for t slim g4 insulin pump with dexcom g4 platinum cgm?
The device is indicated for expanding the epoxy curing temperature range used in insulin pump device subassemblies, specifically for managing insulin delivery in patients with diabetes.
What outcomes have been reported in clinical studies?
Studies have reported effective reduction in hypoglycemia risk and improved overnight glucose control in pediatric patients using closed-loop systems.
What complications have been reported?
Safety data from evidence indicate potential complications such as infusion site infections and device malfunctions, common to insulin pump therapy.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.