Reviewed by: the ADCES Professional Practice Committee
Acknowledgements: Carla Cox, PhD, RD, CDE, CPT; Karen M. Bolderman, RD, LDN, CDE; Gary Scheiner, MS, CDE; Claire M. Blum, MS Ed, RN, CDE; Gwen Klinkner, MS, RN, APRN, BC-ADM, CDE; Janet Mertz, MS, RD, LD, CDE. Revisions: January 2018: Diana Isaacs, PharmD, BCPS, BC-ADM, CDE, Diane Battaglia, RN, CDE, Carla Cox, PhD, RD, CDE, CPT. Revisions: March 2021: Carla Cox, PhD, RDN, CDCES, CPT
CGM provides invaluable information that is unattainable using finger stick blood glucose measurements. The ability to display rate of change, alarm the user with impending low blood glucose, and collect data every 5 minutes can help to inform, motivate and alert persons with diabetes to enhance management.
Technology is changing rapidly and several options are now available for reading sensor data on the pump screen and responding to the data; Tandem X2 Basal IQ and Control IQ, Medtronic 670, 770G with Guardian sensor, non-FDA approved open source systems. These systems can alter basal rates and/or correctional insulin determined from sensor data and more systems are presently with the FDA for approval.
It is the role of the diabetes care and education specialist who works with PWD on multiple daily injections and/or an insulin pump to remain updated on the options. By providing PWD the knowledge of their availability in the marketplace, the individual can share in the decision making about tools that can be utilized to enhance their diabetes care, in addition to standard pump therapy.
Data supports the impact of sensor augmented pump therapy for A1C reduction in the Start 3 study.25 In addition, most research suggests that even if A1C is not reduced, there is a reduction in hypoglycemia while retaining A1C, suggesting a reduction in glucose variability which is in itself a success.26
In a recent study on predictive hyperglycemia and hypoglycemia minimization, the predictive hyperglycemia and hypoglycemia systems optimized overnight glucose management and increased the time in range in children 6-14 years of age.27
Breton et. al.28 reported improved glycemic management and a reduction in hypoglycemia during intensive winter cold and high-altitude activity with a closed-loop control system (the artificial pancreas), which is still in the research phase. This again demonstrates the value of sensor integrated insulin pump therapy. Tauschmann et al.29
It is important for the specialist to be aware of options being utilized by individuals that are not FDA approved but are being used by over 2200 individuals worldwide such as Do It Yourself (DIY) and Night Scout.30 This may be a particular challenge to the specialist in recognizing the concern over non-FDA approved devices and the individual’s successful utilization of these systems. The role of the diabetes care and education specialist is more of acceptance and promoting safety, rather than education in regard to these devices at this time.
The most recent Standards of Medical Care in Diabetes – 2021 states the following: When prescribing CGM “robust diabetes education, training, and support are required for optimal CGM implementation and ongoing use”.31This is supported by the International Consensus on the use of CGM32 which states “patient education should utilize standardized programs with the follow-up to improve adherence and facilitate appropriate use of data and diabetes therapies”.
The sensor augmented insulin pumps are more complex than sensor add-on technology without augmentation and require more in-depth education to the pump trainer and PWD. Pump training will often occur over multiple days, with an initial visit for pump training, another visit for CGM training and a subsequent visit to go into auto mode.
It is the role of the diabetes care and education specialist in sensor augmented insulin pump therapy to educate the PWD and caregivers on:
The specialist should also be able to download data from the integrated insulin pump, review the information with the individual and make recommendations based on sensor data that can enhance glucose goals. They should have an ongoing relationship with the prescriber and communicate these changes.
Education is ongoing and pump upgrades as they become available should be reviewed and discussed as appropriate. In addition, it is important for the diabetes care and education specialist to work with school nurses and support persons to enhance the understanding of sensor integrated pump therapy while children are at school. Employees may also want to integrate education within their workplace.
Sensors at this time are not approved for dosing in the hospital setting, but the specialist can (and should) be involved in creating hospital policy to allow sensor wear when appropriate and to augment POC data with sensor data in understanding individual BG variability during their hospital stay.34 It is important to note there has been some concern about the consistency of the accuracy of sensor data35 which cannot be ignored. Sensor integrated insulin pumps are becoming more common and will continue to improve over time with more options slated to come on the market in the near future. This may include dual hormone systems (glucagon and insulin) with sensor integration, implantable sensors and pumps and fully integrated sensor and pump systems (the artificial pancreas). And pumps that can be initiated with just the weight of the PWD, making it easier for primary care practices to initiate pump therapy.
The diabetes care and education specialist who chooses to work with individuals on sensor augmented insulin pumps must be aware of the options, keep up with the technology, understand the benefits and limitations, be able to download the technology and help direct the interpretation of the data.
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.
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