Clinical Outcomes

Overview

Insulin pump therapy is proven to improve patient outcomes vs multiple daily injections (MDI) with long-acting insulin (glargine).^1,2 Similar to a pancreas, insulin pump therapy provides background insulin when fasting and an on-demand burst of insulin for meals.³

Reduces Hypoglycemia vs MDI With Long-acting Insulin (Glargine)

Reduce hypoglycemic events with insulin pump therapy

• Insulin pump therapy has been consistently associated with fewer cases of severe hypoglycemia^4-6
• 73.8% reduction in frequency of severe hypoglycemia vs MDI⁵
• MDI patients experienced 3 times as much time overnight at BG < 70mg/dL vs insulin pump therapy⁴

Better A1C vs MDI

• 50% achieved A1C of 7% or less vs 12% with MDI²
• Each 1% reduction in A1C reduces these long-term complications by 15% to 30%⁷

Learn about the Medtronic Paradigm^® REAL-Time Revel insulin pump.

Contraindications

Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day and to maintain contact with their healthcare professional.

Successful operation of an insulin pump requires good vision and hearing. While features exist to help facilitate pump usage, Medtronic does not recommend the use of this product by individuals whose impaired vision or hearing does not allow full recognition of the pump signals and alarms.

Warnings/Precautions/Adverse Reactions

Insulin pump therapy uses only faster-acting insulin. Therefore, any interruption in insulin delivery (due to infusion set clogs, leaks, loss of insulin potency, or pump malfunction) may result in hyperglycemia (high blood glucose) within 2 to 4 hours and, subsequently, the rapid onset of diabetic ketoacidosis (DKA) within 4 to 10 hours. Always carry an “emergency kit” of supplies that includes insulin, syringes or pens, blood glucose test strips and meter and urine ketone test strips, in case you develop a problem with your pump and your insulin delivery is stopped, or in case of high blood glucose. The onset of stress or illness (caused by infection or an emotional event) can also result in a rise of blood glucose levels and the development of DKA.

The intensive management of diabetes has also been associated with an increased incidence of hypoglycemia (low blood glucose). Never go to bed with a blood glucose value below your target level. Blood glucose tests should be performed before driving a vehicle or operating machinery, because hypoglycemia can have serious consequences.

The REAL-Time Continuous Glucose Monitoring components of the MiniMed Paradigm^® REAL-Time Insulin Pump and Continuous Glucose Monitoring System are indicated to record interstitial glucose levels in persons seven 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 blood glucose monitoring devices.

Establish a plan with your healthcare professional for rapidly identifying and treating both hypoglycemia and hyperglycemia, to prevent the onset of DKA and possible hospitalization. Act quickly to respond to out-of-target blood glucose. Notify your healthcare professional of low blood glucose requiring assistance or of high blood glucose, or of an increased frequency in low or high blood glucose.

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