Clinical Evidence for Insulin Pump Therapy 9501169-011
Objective Review the clinical evidence supporting the use of insulin pump therapy Key Points The benefits of CSII are: Improved metabolic control (A1C) Reduced incidence of hypoglycemia Better patient quality of life 2
CSII is the most physiological method of insulin delivery currently available -- Consensus statement on use of insulin pumps in pediatrics endorsed by the ADA and European Association for the Study of Diabetes (EASD) Phillip M, Battelino T, Rodriguez H, et al. Diabetes Care. 2007;30:1653-1662. 3
Insulin Pumps Use Only Rapid-Acting Insulin Pharmacodynamic Variability in Insulin Action* Intermediate-acting insulin *Percentages represent the coefficients of variation (CV) for insulin action as measured by the maximum glucose infusion rate in these euglycemic glucose clamp studies 46% Long-acting insulin 36% Rapid-acting insulin 16% Rapid-acting insulin has the lowest intrapatient variability Glucose lowering effect of intermediate and long-acting insulin can vary up to 46%, which explains drastic day-to-day variations in glucose levels despite using the same amount. Heinemann L et al. Diabetes Care. 1998;21:1910 1914; Heise T, Nosek L, Rønn BB, et al. Diabetes. 2004; 53:1614-1620. 4
Long Acting and Intermediate Acting Insulin Can Have Similar Variability Scholtz He et al., Diabetologia 1999, 42(Suppl):A235. Abstract 882. 5
Insulin Pumps Work More Like a Healthy Pancreas Users Can Program Multiple Basal Rates According To Daily Routine A typical profile of basal insulin rates in CSII: Many people are more active in the late afternoon, more sedentary after dinner, or hypoglycemic at night, necessitating adjustment to the basal rate. Lenhard MJ, Reeves GD. Arch Intern Med. 2001;161:2293-2300. Reused with permission. 6
Insulin Pumps Also Deliver Customized Boluses for Different Types of Meals Insulin pumps offer smart calculators to help determine how much bolus insulin is needed, and can deliver precise amounts of insulin based on the amount of carbs to be taken. Lenhard MJ, Reeves GD. Arch Intern Med. 2001;161:2293-2300. Reused with permission. 7
Some Advantages of Using an Insulin Pump - Quotes from the ADA Insulin pumps deliver insulin more accurately than injections Using an insulin pump eliminates unpredictable effects of intermediate or long-acting insulin Using an insulin pump usually results in fewer large swings in blood glucose levels American Diabetes Association. Available at: http://www.diabetes.org/type-1-diabetes/insulin-pumps.jsp. 8
CSII Improves A1C Compared with MDI A meta-analysis of 52 studies (1, 547 patients) shows that CSII is significantly more effective in lowering A1C compared to MDI and conventional insulin therapy (MD 0.95) Bruttomesso D, et al. Diabet Med. 2002;19(8):628-634. Bell DSH, et al. Endocr Pract. 2000;6(5):357-360. Rudolph DS, et al. Endocr Pract. 2002;8(6):401-405. Chantelau E, et al. Diabetologia. 1989;32(7):421-426. Boland EA, et al. Diabetes Care. 1999;22(11):1779-1784. Maniatis AK, et al. Pediatrics. 2001;107(2):351-356. Litton J, et al. J Pediatr. 2002;141(4):490-495. 9 Weissberg Benchell J et al. Diabetes Care. 2003
Concern About an Increase in Hypoglycemia with Intensive Management Rate of Severe Hypoglycemia in DCCT (per 100 patient-years) Severe hypoglycemia* Coma or seizure Intensive group 61.2 16.3 Conventional group 18.2 *Defined as episodes in which patient required assistance and had documented blood glucose <50 mg/dl. 5.4 P value <0.001 <0.001 Despite the risk of hypoglycemia, intensive management is recommended for most patients with diabetes given the proven benefits: reduction of long-term complications of diabetes DCCT Research Group. Diabetes Care. 1995;18:1415-1427. 10
CSII Reduces Incidents of Severe Hypoglycemia Rudolph JW, Hirsch IB. Endocrine Practice. 2002; 8:401 405. Bode,BW, Steed RD, Davidson PC. Diabetes Care. 1996;19:324-7; Boland EA, Grey M, Oesterle A, et al. Diabetes Care. 1999; 22:1779 84; 11
In the 5-Nations Study, CSII Improved A1C without Increased Risk of Hypoglycemia Hoogma RP et al. Diabet Med. 2006;23:141-147. Reused with permission. 12
CSII Use Does Not Increase Risk of DKA DeVries JH et al; Diabetes Care 2002 M. Dur = 32 weeks, n = 79, Mean Age = 36.5 No change compared to MDI: 1 episode during study Plotnick LP et al; Diabetes Care 2003; 26 (4):1142-1146 BruttomessoD.; Diabet Med. 2002; 19 (8):628-634 Linkeschova, M. et al. Diabetes 2002, 19, 746-751 DeVries JH et al; Diabetes Care 2002; 25 (11):2073-2079 Steindel BS et al. Diabetes Res Clin Pract. 1995; 27(3):199-204 13
Patient Satisfaction is Improved with CSII vs MDI Health-Related Quality of Life Assessment in 197 Adults With Type 1 or Type 2 Diabetes Peyrot M, Rubin R. Diabetes Care. 2005;28:53 58. 14
Professional Guidelines and Recommendations for Use of Insulin Pump Therapy 2007 American Association of Clinical Endocrinologists (AACE) Clinical Guidelines For Managing Diabetes Mellitus 2007 Consensus Statement on Use of Insulin Pump Therapy in the Pediatric Age-Group Endorsed by American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) 2006 American Academy of Pediatrics Position Statement on Use of Insulin Pump Therapy in Very Young Children With Type 1 Diabetes 15
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