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 <70mg/dL vs insulin pump therapy⁴

Better A1C vs MDI

• Lower A1C reduces complications from diabetes

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

Better Detects Dangerous Glucose Variability

• 60% of lows may not be revealed by fingerstick testing⁷
• 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 lows⁸
• 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 reported:⁹
  • 94% used readings and/or alerts to control their glucose levels
  • 81% had greater satisfaction with their glucose control
  • 75% adjusted their insulin delivery
  • 63% changed their diet
• Utility and accuracy supported by over 200 clinical publications

View the coverage and reimbursement options for insulin pump therapy.

Indications for Use

The insulin pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons of all ages requiring insulin. The REAL-Time Continuous Glucose Monitoring components of the MiniMed Paradigm^® REAL-Time Revel Insulin Pump and Continuous Glucose Monitoring System are indicated to 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 blood glucose monitoring devices. A separate pediatric model is indicated for patients ages 7-17.

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 Diabetes 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 Revel Insulin Pump and Continuous Glucose Monitoring System are indicated to 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 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.