Insulin Pump Therapy

 

Patient Selection

Many people with Type 1 or Type 2 diabetes can benefit from insulin pump therapy. Selecting the right candidates is important to their success.

Patient Selection

Insulin pump therapy is helpful for:

  • People with Type 1 and Type 2 diabetes
  • Reduction in A1C for both types1,2
  • Those who experience dangerous lows and highs
  • Those unhappy with multiple daily injections
  • Decreasing nocturnal and postprandial hypoglycemia3,4
  • Dawn phenomenon
  • A morning rise in glucose levels affecting up to 89% of people with Type 1 diabetes5
  • The insulin pump’s variable basal rate improves morning glucose stability6,7
  • Gastroparesis
  • The insulin pump’s predictable, fast-acting insulin helps people with gastroparesis better match insulin delivery to their body’s slower digestion8,9
  • Pregnancy
  • Post partum A1C 7.2% with pump users vs 9.1% using MDI10
  • Reduces the risk of severe adverse outcomes resulting from higher A1C levels before and during pregnancy11
  • Pediatric patients as young as 1 year old12
  • LADA (latent autoimmune diabetes in adults) patients misdiagnosed as Type 213

Patients who meet these descriptions may be good candidates for an 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 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.

References

  1. Hoogma RP, Hammond PJ, Gomis R, et al. Comparison of the effects of continuous subcutaneous insulin infusion (CSII) and NPH-based multiple daily insulin injections (MDI) on glycaemic control and quality of life: results of the 5-nations trial. Diabetic Med. 2005;141-147.
  2. Wainstein J, Metzger M, Boaz M, et al. Insulin pump therapy vs. multiple daily injections in obese Type diabetic patients. Diabetic Med. 2005:1037-1046.
  3. Rudolph JW, Hirsch IB. Assessment of therapy with continuous subcutaneous insulin infusion in an academic diabetes clinic. Endocr Pract. 2002;8:401-405.
  4. Bode BW, Steed RD, Davidson PC. Reduction in severe hypoglycemia with long-term continuous subcutaneous insulin infusion in type 1 diabetes. Diabetes Care. 1996;19(4):324-327.
  5. Perriello G, De Feo P, Torlone E, et al. The dawn phenomenon in type 1 (insulin-dependent) diabetes mellitus: magnitude, frequency, variability, and dependency on glucose counterregulation and insulin sensitivity. Diabetologia. 1991;34(1):21-28.
  6. Carroll MF, Schade DS. The dawn phenomenon revisited: implications for diabetes therapy. Endocr Pract. 2005;11(1):55-64.
  7. Koivisto VA, Yki-Jarvinen H, Helve E, et al. Pathogenesis and prevention of the dawn phenomenon in diabetic patients treated with CSII. Diabetes. 1986;35(1):78-82.
  8. Cucchiara S, Franzese A, Salvia G, et al. Gastric emptying delay and gastric electrical derangement in IDDM. Diabetes Care. 1998;21(3):438-443.
  9. Tanenberg RJ, Pfeifer MA. Continuous glucose monitoring system: a new approach to the diagnosis of diabetic gastroparesis. Diabetes Tech Ther. 2000;2(suppl 1):S73-S80.
  10. Gabbe SG, Holing E, Temple P, et al. Benefits, risks, costs, and patient satisfaction associated with insulin pump therapy for the pregnancy complicated by type 1 diabetes mellitus. Am J Obstet Gynecol. 2000;182(6):1283-1291.
  11. Jensen DM, Damm P, Moelsted-Pedersen L, et al. Outcomes in type 1 diabetic pregnancies: a nationwide, population-based study. Diabetes Care. 2004;27(12):2819-2823.
  12. Weinzimer SA, Ahern JH, Doyle EA, et al. Persistence of benefits of continuous subcutaneous insulin infusion in very young children with type 1 diabetes: a follow-up report. Pediatrics. 2004;114(6):1601- 1605.
  13. Schernthaner G, Hink S, Kopp HP, et al. Progress in the characterization of slowly progressive autoimmune diabetes in adult patients (LADA or type 1.5 diabetes). Exp Clin Endocrinol Diabetes. 2001;109 (suppl 2):S94-S108.

Patient Requirements

Patient requirements for starting:

  • Responsible and psychologically stable
  • Willingness to monitor and/or record blood glucose (BG) a minimum of 4 times a day
  • Willingness to quantify food intake
  • Willingness to comply with medical follow-up
  • Willingness to calibrate the glucose sensor a minimum of 2 to 3 times a day
  • Willingness to validate sensor glucose (SG) values with BG test prior to making treatment decisions

 Considerations before starting: 

  • Income, insurance and value placed on healthcare
  • Understanding the importance of trends versus “point-in-time” BG values
  • Understanding of SG versus BG and the potential differences in the 2 values

Patients who meet these requirements may be good candidates for an 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

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.

Patients should establish a plan with their healthcare professional for rapidly identifying and treating both hypoglycemia and hyperglycemia, to prevent the onset of DKA and possible hospitalization.

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

Last updated: 22 Sep 2010

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