Insulin Pump Safe Practices

Strategies to Address Insulin Pump Therapy Challenges

Adverse events associated with insulin pump therapy are most often related to user error rather than pump malfunction. Choosing the wrong pump candidate, inadequate education, and lack of ongoing support by clinicians who are knowledgeable of the benefits and limitations of insulin pumps are seen as contributing factors of the adverse events.¹²

Educational Priorities

CGM and/or SMBG

Some CGM/iCGM models can be used for dosing. Review the data frequently or self-monitor a minimum of 4-5 times daily to allow for early recognition of hypoglycemia or hyperglycemia and more often when initiating pump therapy and during periods of hyperglycemia, illness and 2 hours after infusion site changes.^{7, 11}

Infusion site selection and maintenance. The infusion site must be changed every 2-3 days and monitored for inflammation, signs of infection, lipodystrophy or infusion site leakage.^7,11

Troubleshooting and problem solving. Potential causes of high and low blood glucose levels, including catheter occlusion or dislodgement, insulin degradation if exposed to temperature extremes, battery failure, missed doses, over-correction of hyperglycemia, pump malfunction, incorrect pump programming of infusion rates or settings for date and time should be addressed. Teach patients how to identify these issues and how to take action to resolve them.^12,13

Alerts and alarms. Teach the benefits and limitations of using pump alarms and alerts. Although alarms can warn the wearer about catheter occlusion, low cartridge/reservoir volume, low battery, or other mechanical or software-related problems, these alarms may not always offer notification early enough to prevent hypoglycemia or hyperglycemia.

Alerts can be set to remind users to utilize SMBG, change the infusion site, change/charge the battery, missed bolus reminder, etc., but such alerts must be attended to in a timely way to prevent complications.^{7, 11,12} Too many alarms can also result in alarm fatigue and individuals may be inclined to ignore them, missing some critical alarms.

Hyperglycemia management. Teach the person to maintain supplies, including extra blood glucose test strips, ketone test strips and vials/syringes or insulin pens in case of unanticipated hyperglycemia, if pump failure occurs. Rapid-acting insulin should be administered by a syringe or pen in the presence of unresolved hyperglycemia and ketones.^11,14,15

Diabetes care and education specialists must facilitate safe use of insulin pumps through education about precautions and considerations during exercise, travel and other special situations:

Exercise. Additional glucose monitoring should be encouraged before, during, and after exercise with plans for treatment to prevent hypoglycemia. Individuals should also be taught to adjust basal settings (and/or bolus doses) to mitigate hypoglycemia risk as appropriate for the duration and intensity of activity.^7,16. Several of the AID systems have a specific target for exercise which should be initiated 60-90 minutes prior to the activity when possible.

Travel. Individuals should be encouraged to carry monitoring and pump supplies (including insulin) in carry-on luggage when flying in case luggage is lost, and to avoid extremes of temperature that are common in baggage compartments. Pumps must also be hand-checked rather than exposed to x-rays in airport security.^17,18

The pump wearer should check with the Transportation Security Administration (TSA) and their pump manufacturer for specific insulin pump travel guidelines.

School and daycare settings. An individualized diabetes medical management plan needs to be developed for the child with special instructions for management of the insulin pump at school. Appropriate training must be provided for school personnel who would assist with implementing and following the plan.^16,19

A 504 plan should also be written in conjunction with school personnel (school nurse, designated staff, principal etc.) to clearly delineate the role of the school in carrying out the medical management plan. The 504 plan is developed to ensure that a child who has a disability identified under the law and is attending an elementary or secondary educational institution receives accommodations that will ensure their academic success and access to the learning environment.

Medical procedures. Individuals should be made aware of pump manufacturers’ recommendations for insulin pumps during procedures that involve radiation exposure (including x-rays) and magnetic resonance imaging (MRI). Pumps should be kept outside of the imaging room until testing is complete. If the pump is disconnected for an hour or more, alternative insulin treatment should be provided.²⁰

Hospitalization. Diabetes specialists and/or diabetes care and education specialists should develop policies that specify requirements of caring for those who maintain insulin pumps during hospitalization.^20.21.22 Post COVID-19, many hospitals have been incorporating CGM into caring for their patients. The future of this option will evolve over time.

Hospital insulin pump policy content should address the following:

1. Determinants of continuing (or discontinuing) pump use.

2. Requirement of patient agreement.

3. Strategies to address interruption in insulin pump infusion.

4. Individual assessment requirements i.e., competency to self-manage, site assessment.

5. Documentation requirements i.e., assessments, self-administered doses.

6. Considerations for individuals going to surgery and/or procedures involving radiation or magnetic fields.

References:

^{1. Bergenstal R, Tamorlane W, Ahmann A et al. Effectiveness of sensor-augmented insulin-pump therapy in Type 1 diabetes. N Engl J Med. 2010:363:311-320. 2. Bally L, Hood T and Hovorka R. Closed-loop for Type 1 diabetes-an introduction and appraisal for the generalist. BMC Medicine. 2-17:15:14. Accessed 8/26/2017/ 3. Heinemann L, Fleming G, Petrie J et al. Insulin Pump Risks and Benefits: A Clinical Appraisal of Pump Safety Standards, Adverse Event Reporting, and Research Needs A Joint Statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Diabetes Care 2015;38:716–722. 4. Grunberger G, Abelseth J, Bailey T, et al. (2014) Consensus Statement by the American Association of Clinical Endocrinologists/American College of Endocrinology Insulin Pump Management Task Force. Endocrine Practice: 2014:20(5) 463-489. 5. Decision Memo for Insulin Pump: C-Peptide Levels as a Criterion for Use (CAG-00092R) available: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=109&. Accessed 9/6/2017 6. Beck J, Greenwood D, Blanton L et al. 2017 National Standards for Diabetes Self-Management Education and Support. https://doi.org/10.2337/dci17-0025. Accessed 9/9/2017. 7. Walsh J, Roberts R. Pumping Insulin: Everything for Success on an Insulin Pump and CGM. 6th Edition. Torrey Pines Press, 2016 8. McCrea, D. A Primer on Insulin Pump Therapy for Health Care Providers. Nurs Clin N Am 52 (2017) 553–564. 9. Bolderman K. “Pump Start-Up” in Putting Your Patients on the Pump. Alexandria VA: American Diabetes Association 2013. 10. Standards of Medical Care in Diabetes--2017. Diabetes Care. 2017;40 Suppl 1:S48-57. 11. Handelsman Y, Mechanick JI, Blonde L, et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract. 2011;17 Suppl 2:1-53. 12. Clayton-Jeter H. Contributing Factors to Insulin Pump Errors in Children, Adolescents and Adults Available: http://www.fda.gov/forhealthprofessionals/articlesofinterest/ucm295562.htm. Accessed February 13, 2014. 13. Aldasouqi S and Reed A. Pitfalls of insulin pump clocks: technical glitches that may potentially affect medical care in patient with diabetes. J Diabetes Sci Technol 2014;8(6):1215-1220. 14. Evert AB, Insulin pump therapy troubleshooting for optimal performance. Empower. 2015;7(4):23-24 15. Guilhem I, Leguerrier AM, Lecordier F, et al. Technical risks with subcutaneous insulin infusion. Diabetes Metab. 2006;32(3):279-284. 16. Maahs D, Horton L and Chase H. The use of insulin pumps in youth with Type 1 diabetes. Diabetes Technol Ther 2010;12(suppl1):S59-65. 17. Cornish A, Chase HP. Navigating airport security with an insulin pump and/or sensor. Diabetes Technol Ther. 2012;14(11):984-985. 18. American Diabetes Association. Fact Sheet – Air Travel and Diabetes Available: http://www.diabetes.org/living-with-diabetes/know-your-rights/discrimination/publicaccommodations/air-traveland-diabetes/what-can-i-bring-with-me.html?referrer=https://www.google.com/. Accessed 9/10/2017 19. Diabetes care in the school and day care setting. Diabetes Care. 2014;37 Suppl 1:S91-96. 20. McCrea D. Management of the hospitalized diabetes patient with an insulin pump. Crit Care Nurs Clin North Am. 2013;25(1):111-121. 21. Boyle ME, Seifert KM, Beer KA, et al. Guidelines for application of continuous subcutaneous insulin infusion (insulin pump) therapy in the perioperative period. J Diabetes Sci Technol. 2012;6(1):184- 190. 22. Buchko BL, Artz B, Dayhoff S, et al. Improving care of patients with insulin pumps during hospitalization: translating the evidence. J Nurs Care Qual. 2012;27(4):333-340. 23. Rodbard D. Continuous Glucose Monitoring: A Review of Successes, Challenges and Opportunities. Diabetes Technol Ther. 2016;18(Suppl2):S2-3-S2-13. 24. https://www.diabeteseducator.org/practice/practice-documents/practice-papers © Copyright © 2021 Association of Diabetes Care & Education Specialists. All rights reserved Reproduction or republication strictly prohibited without prior written permission 13 25. Bergenstal RM1, Tamborlane WV, Ahmann A, et al STAR 3 Study Group. Sensor-augmented pump therapy for A1C reduction (START 3) Study: results from the 6 month continuation phase. Diabetes Care. 2011;34(11):2403-5. 26. Abraham MB1,2, Nicholas JA1,3, Smith GJ3 et al; PLGM Study Group. Reduction in Hypoglycemia With the Predictive Low-Glucose Management System: A Long-Term Randomized Controlled Trial in Adolescents With Type 1 Diabetes. Diabetes Care. 2017;Nov 30. pii: dc171604. doi: 10.2337/dc17- 1604. [Epub ahead of print] 27. Forlenza G, Raghinaru D, Cameron F, et al. Predictive hyperglycemia and hypoglycemia minimization: In-home double-blind randomized controlled evaluation in children and young adolescents. Pediatric Diabetes. 2017;1-9. 28. Breton M, Chernavvsky D, Forlenza G et al. Closed-loop control during intense prolonged outdoor exercise in adolescents with Type 1 diabetes: the artificial pancreas ski study. Diabetes Care. 2017:40(12):1644-50. 12. 29. Tauschmann M, Thabit H, Bally L, et al. Closed-loop insulin delivery in suboptimally controlled Type 1 diabetes: a multicentre 12-week randomised trial. Lancet. 2018:13:92. 30. OpenAPS.Outcomes. Downloaded 3/2/2021. 31. Standards of Medical Care in Diabetes-2021Diabetes Care. 2021;44 Suppl 1:S89 32. Danne T, Nimri R, Battelino R et al. International consensus of use of continuous glucose monitoring. Diabetes Care. 2017:40(12):1631-1640. 33. Chase P and Messner L. Understanding insulin pumps, continuous glucose monitors and the artificial pancreas (3rd ed). 2016. Children’s Diabetes Foundation at Denver, Colorado. 34. Wallia A, Umpierrez G, Rushakoff R et al. Consensus statement on inpatient use of continuous glucose monitoring. J. Diabetes Sci Technol. 2017:11(5);1036-1041. 35. Shapiro A. FDA approval of nonadjunctive use of continuous glucose monitors for insulin dosing: A potential risky decision. JAMA. 2017:318(16);1541-1542. 36. Rinker J, Dickinson J, Litchmanb M et al. Diabetes Educator. 2018:44(3):260-268.}