Indications and Guidelines

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 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.

Clinical Guidelines for Managing Diabetes with CSII Therapy

2007 American Association of Clinical Endocrinologists. Medical Guidelines for Clinical Practice for the Management of Diabetes Mellitus¹

In type 1 diabetes, insulin pump therapy is indicated for patients:

• Who are unable to achieve acceptable control using MDI
• With histories of frequent hypoglycemia and/or hypoglycemia unawareness
• Who are pregnant
• With extreme insulin sensitivity
• With a history of the dawn phenomenon
• Who require more intensive diabetes management because of complications including neuropathy, nephropathy, and retinopathy
• Using MDI who have demonstrated willingness and ability to comply with prescribed diabetes self-care behavior, including frequent glucose monitoring, carbohydrate counting, and insulin adjustment

Type 2 diabetes: insulin pump therapy can be considered in insulin-treated patients.

CSII = continuous subcutaneous insulin infusion; MDI = multiple daily injections

2006 American Academy of Pediatrics Position Statement: Continuous Subcutaneous Insulin Infusion in Very Young Children With Type 1 Diabetes²

• Children with diabetes, regardless of age, should be considered potentially eligible for CSII
• The decision to use CSII should rest solely with physician and parents or legal guardians
• Make an effort to ensure parents have realistic expectations and requirements with CSII
• Eligibility criteria for CSII include motivated compliant parents with mastery of carbohydrate counting
• Selecting against CSII is as reasonable as selecting for CSII
• Evidence that insulin pump therapy a priori improves diabetes control in children aged 6 years and younger is currently lacking

CSII Contraindications

• Insulin 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 insulin pump therapy requires sufficient vision or hearing to allow recognition of the pump signals and alarms

Patients who meet the above descriptions might be good candidates for insulin pump therapy.