Clinical Outcomes

Overview

Studies reveal continuous glucose monitoring increases glycemic awareness, reduces A1C levels, and improves long-term health.

Better Detects Dangerous Glucose Variability

• Detects 4 times more dangerous highs and lows than fingersticks alone^1*
• 60% of lows may not be revealed by fingerstick testing¹
• People with diabetes only use fingersticks an average of 4 to 5 times per day
• A1C testing provides a 2 to 3 month average of glucose levels, but isn’t intended to track highs and lows²
• Prevents or reduces the duration of hypoglycemic episodes

Improves Diabetes Management

• In a pilot study (n=16) people with diabetes using Guardian^® continuous glucose monitoring reported³:
  • 94% used readings and/or alerts to control their glucose levels
  • 81% had greater satisfaction with their glucose level
  •  75% adjusted their insulin delivery
  • 63% changed their diet
  • 31% made lifestyle changes
• Utility and accuracy supported by over 200 clinical publications

View the coverage and reimbursement options for continuous glucose monitoring.

Indications for Use

The Guardian^® REAL-Time Continuous Glucose Monitoring System is intended to continuously record interstitial glucose levels in persons 7 years of age or older who have Type 1 or Type 2 diabetes. This information is intended to supplement, not replace, blood glucose information obtained using standard home glucose monitoring devices. This information collected by The Guardian REAL-Time Continuous Glucose Monitoring System may be downloaded and displayed on a computer and reviewed by healthcare professionals. This information may allow identification of patterns of glucose-level excursions above or below the desired range, facilitating therapy adjustments that may minimize these excursions. A version of the product specially designed for children is indicated for patients age 7-17.

Contraindications

Successful operation of The Guardian REAL-Time Continuous Glucose Monitoring System requires adequate vision and hearing. Use of The Guardian REAL-Time Continuous Glucose Monitoring System is not recommended for patients whose impaired vision or hearing does not allow full recognition of the monitor signals and alarms, or who do not have a caregiver that can perform this function for them.

Warnings/Precautions

The Guardian REAL-Time Continuous Glucose Monitoring System users should be educated to program and operate the monitor and respond to alarm conditions prior to attempted use of the system. The current and voltage signals shown in the monitor are to be used only for finding potential problems with The Guardian REAL-Time Continuous Glucose Monitoring System and do not indicate current glucose value. Infection and/or site irritation may result from improper insertion and maintenance of insertion site.

Safety Information

Patients should always discuss potential risks and benefits with a physician. Please review the product manual prior to use for detailed instructions and disclosure.

For complete safety information, including contraindications, warnings/complications, and potential complications, see product label or visit the Indications, Safety, and Warnings page.

* A confirmatory fingerstick test is required prior to taking action.