Clinical Outcomes

Overview

Numerous studies report that continuous glucose monitor data facilitates clinical decisions leading to improved glycemic control.^1-5

Clinical Value of Continuous Glucose Monitoring

• In a study, 85% (N=322) had distinctive peaks and drop-offs subject to considerable variability⁶
• Use of CGM is a minimally invasive method of determining individual basal rates vs BG meter testing⁶
• Significantly shorter duration of hypoglycemia than the BG group, overnight and overall⁷
• Significantly reduced A1C from 8.6 ±1.5% to 8.4 ±1.3% from 3 months before CGM to 6 months after⁴

View the coverage and reimbursement options for continuous glucose monitoring.

Indications for Use

The iPro™ System is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using standard home glucose-monitoring devices.

The information collected by the iPro 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. The iPro System:

• Is intended for prescription use only
• Will not allow readings to be made available directly to patients in real time
• Provides readings that will be available for review by physicians only after the entire recording interval (72 hours)
• Is currently intended for occasional rather than everyday use
• Is to be used only as a supplement to, and not a replacement for, standard invasive measurement
• Is not intended to change patient management based on the numbers generated, but to guide future management of the patient based on response to trends noticed. That is, these trends or patterns may be used to suggest when to take fingerstick glucose measurements to better manage the patient

The monitor, sensor, cable and test plug are intended for use with the Medtronic Diabetes iPro System.

The Sen-serter^® is indicated only for insertion of the Medtronic Diabetes glucose sensor.

Contraindications

Successful operation of the iPro System requires adequate vision and hearing. Use of the iPro 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 who can perform this function for them.

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