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Articles of Interest

Contributing Factors to Insulin Pump Errors in Children, Adolescents and Adults (March 2012)

Helene Clayton-Jeter, OD


Objective:

The objective of this project was to research available information related to adverse events associated with the use of insulin pumps by children, adolescents and adults. The research was conducted utilizing the internet, FDA intranet, and phone interviews. The issue was brought to the agency's attention by the American Association of Clinical Endocrinologists (AACE). AACE and the Center for Devices and Radiological Health approached the Office of Special Health Issues (OSHI) to further investigate and propose a plan to address this concern. OSHI's role is to identify options to be considered to address the issue of support and educational outreach.

 

Background:

There is a concern in the medical community and in Diabetic Education Centers across the US, regarding complications with the insulin pump. Concerns about adverse events were raised by AACE to CDRH's Office of Surveillance and Biometrics (OSB). OSB reviewed the adverse event reports and spoke with general practitioners, endocrinologists, diabetes educators, and insulin pump manufacturers regarding their incident reports. During their telephone follow up on the reported adverse events, OSB staff provided information about the insulin pump to patients, caregivers, and diabetes educators.

Despite these efforts, FDA continues to receive reports of serious adverse events occurring with the use of insulin pumps. In order to properly educate and alert healthcare providers, patients, and manufacturers to the problems incurred with insulin pumps, other factors need addressing.

 

Summary of Findings:

CDRH and AACE's assessments indicate patient errors in the use of insulin pumps appear to be the cause of the adverse events associated with these devices.  Prior to pursuing insulin pump therapy, patients must master and understand the use of insulin in basal/bolus therapy, carbohydrate counting and logging, interpreting numbers and trends, etc. in order to  optimize the treatment regimen. Insulin pump users must be well trained in the use of the pump, both initially and throughout their pump treatment and receive continued education in balancing food, insulin and activity levels. Proper extended follow up care by the health care provider is necessary in order for diabetes management goals to be achieved and sustained. Additionally, the provider of the insulin pump should be well educated and trained on the benefits and limitations of the device. (1, 2)

Patient selection should be based on numerous factors such as maturity, psychological and behavioral factors, which play a vital role in the patient's ability to adhere to the medical treatment regimen. Most of the current seven pump manufacturers appear to actively engage with health professionals in providing patient education, guidelines for patient selection, patient and provider support for their products. The pump manufacturers, Animus Ping, Accu-Check Spirit, DANA Diabecare, Deltee Cozmo, Insulet Omnipod, Minimed Paradigm, and Nipro Amigo provide important phone support, but it is limited since the support personnel neither prescribe the insulin doses nor are directly involved in the patients' care. (3-9)

 

Methods:

A search for information on patient errors in the use of insulin pumps was conducted over a two-week period and consisted of reviewing numerous peer-reviewed scientific articles, reviewing non-peered reviewed articles, reviewing blogs and advocacy group websites, researching different pump manufacturers, interviewing Diabetes Educators, and interviewing OSB personnel. Some of the references reviewed include the following:

Trade/Scientific Journals

  1. American Academy of Family Physicians
  2. Diabetes Care
  3. Pediatrics
  4. Diabetes Technology Therapeutics
  5. Pediatrics in Review
  6. Medical News Today
  7. American Family Physician

FDA Websites

  1. MedWatch - The FDA Safety Information and Adverse Event Reporting Program
     
  2. Manufacturer and User Facility Device Experience Database (MAUDE)
  3. FDA.gov

Internet Websites

  1. Diabetes Life
  2. Center for Disease Control/National Institutes of Health
  3. Juvenile Diabetes Research Foundation
  4. Insulin Pump Manufacturers: Animas Ping, Accu-Check Spirit, DANA Diabecare, Deltee Cozmo, Insulet Omnipod, Minimed Paradigm, Nipro Amigo
  5. 2008 Scripps Texas Newspapers/Caller.com
  6. American Association of Clinical Endocrinologists
  7. American Association of Family Practitioners
  8. American Association of Diabetes Educators


Journals

Peer reviewed and non-peered reviewed articles found in scientific journals and in newspapers collectively supported data of better or similar glycemic control with insulin pump therapy in pediatric and adult populations when the patient is motivated and willing to do the work of diabetes care combined with proper patient selection, education and training, and an effective support system. The studies substantiate safety and effectiveness of insulin pump therapy in selected children, adolescents, and adults with type I diabetes. (10, 12, 13, 14, 15, 17, 22) Several articles indicated psychological and emotional maturity, along with proper and thorough training in the correct use of the pump, significantly decreases patient vulnerability for misuse. (12, 13, 14, 15)

Appropriate education and training are paramount to successful insulin pump therapy, despite the different risk factors of youth and adult populations. (1, 2, 18) Regardless of treatment modality (multiple insulin injections or insulin pump therapy), greater risks for hypoglycemia are found in the pediatric, elderly, and people who have  had  diabetes for a long period of time. (15, 18) Some risks in adolescents with diabetes are unique to this group, but they share with adults common reasons for insulin pump misuse such as lack of motivation, inadequate education, and lack of appropriate support. (1, 18) Studies revealed similar medical complications between youth and adult populations, and similar adverse events occurred with multiple insulin injections compared to insulin pump therapy. (10, 13, 15)

Studies showed when suboptimal performance of the insulin pump occurred, the primary cause was patient error. (1, 16, 22) The causes range from youth missing mealtime insulin boluses, patients failing to adhere to treatment plans, to patients having inadequate familial, provider, or manufacturer support. (16, 17)

Many of the insulin pump studies revealed limitations that might have contributed to the data reflecting the number of adverse events noted. Such limitations included non­ randomization of patients and insulin pump devices, inappropriate patient selection - which included such factors as motivation, cognition and subjective assessment of parental/familial involvement. These factors were often not determined prior to conducting the study and affected the outcome. The exclusion of these patients would have made it easier to determine if the problems were with the device or the patient. Other studies were skewed because of patient selection, for only motivated, well­supported and high levels of cognition were determined prior to the study, therefore, reporting fewer adverse events. (11, 15, 18)

 

FDA Websites

FDA websites provided information on device approvals, adverse event reporting, and consumer materials on insulin pumps. CDRH's review of insulin pump adverse events reporting revealed problems with proper patient and provider training and education in the safe use of the device. The FDA website includes specific information described in the paragraphs that follow.

Dr. Judith Cope's article, which appeared in the May, 2008, Pediatrics journal, provided new safety data from a 10 year retrospective study of adverse events with adolescent use of insulin pumps. There were 1594 injuries reported in children and adolescents; 82% of reported cases resulted in hospitalizations and 13 reported deaths. (11)

Joy Samuels-Reid, MD defined the insulin pump (a closed-loop system) as a high risk device in her study. High rates of adverse events among hospitalized adolescents were noted. These events occurred due to lack of requisite skills needed to take care of the device, rapid growth and development during puberty and risk-taking behavior. Special concerns revolved around adequate education, proper patient selection, adequate monitoring and emergency preparedness, among other issues relevant to this unique population. (18)


Internet Websites

The seven insulin pump manufacturers' websites currently highlight information on pump technology. All manufacturers offer on-line support and some provide links to national associations and conferences. Some offer certification programs for pump dispensers, and some provide side-by-side comparisons of the devices functionality and features. One pump manufacturer offers continuing medical education for health care providers, while others provide manuals, demonstration kits and self-help videos. (3-9)

Many diabetic advocacy groups have newsletters and patient blogs that provide information, which further substantiated the need for proper patient selection and adequate education and training. (2, 26)  Some teens that discontinued insulin pump usage, expressed the desire to disconnect when they wanted to get into a hot tub or swimming pool, beyond the recommended time limit. While other diabetic teens and youths, found the amount of work required to become a proficient pump user coupled with some inconveniences, not to be enough reason for them to continue using the insulin pump and thus, reverted back to multiple daily injections, even with the benefit of great glycemic control. On the other hand, parents and older adults appeared to embrace the freedom, flexibility and constant availability of insulin. (2, 19)

A common theme of insulin pump problems experienced in the adult and youth populations involved the pump's failure to administer a proper insulin dose. In some cases no insulin was delivered, in others an unexplained over dosage was delivered. (19) One study revealed that the position of the insulin pump caused a difference in insulin delivery with six of the seven insulin pumps now on the market. The Omnipod is not affected by position, because there is no tubing involved in insulin delivery. (21)

After review of several insulin pump user manuals, it was revealed that positioning of the insulin pump was not addressed by any of the manufacturers. Safety information, cautions and warnings were found throughout the manuals, but no caution or warning on pump positioning. (3-9)

A February 1982 article in Morbidity and Mortality Weekly Report by the CDC revealed 11 deaths in patients ranging in age from 11 years to early 60's. (22) In none of the cases was there any evidence of pump malfunctions. Problems identified included:

  • limited access by patients to education and training
  • inappropriate patient selection by healthcare providers
  • lack of available support  during emergencies
  • lack of health care provider knowledge with trouble shooting pump malfunctions or insulin dosage mistakes

Data from this study suggest that while most of the studies were conducted in pediatric populations, similar results of death and serious injuries occur among adults with diabetes as in children with diabetes. (22, 11, 18)

 

Interviews

OSHI's search for Certified Diabetes Educators (CDE) led to the Past-Chair of the American Association of Diabetic Educators (AADE), Montgomery County Chapter and a colleague of hers. They are CDE’s, employed by Kaiser Permanente- Mid-Atlantic States (KP-MAS), the nation's largest not-for-profit health insurer, with over 8.6 million members. The CDEs provided information on the coordination of care provided in their clinical setting. When KP-MAS began using the insulin pump technology, KP-MAS contracted with Pump Specialists from the pump manufacturers to train the patients.

Now KP-MAS' strategic plan for pump education and training consists of training Diabetic Educators (rather than contracted Pump Specialists) to deliver the insulin pumps to patients. KP-MAS use a team approach to diabetes care.

Endocrinologists distribute the insulin pumps via referrals from Primary Care Physicians/Internists. The Endocrinologists gives the required patient information to the Diabetic Educator, who sets the pump and teaches the patient on its use. Prior to delivery of the insulin pump, patient’s undergo a six-month trial period, which consists of learning about carbohydrate counting, BSL monitoring, multi-daily injections, using the pump filled with saline, etc. Ongoing support is delivered via monthly pump support group meetings. (23, 24)

OSHI's interviews with CDE's and a reviewer in the CDRH-OSB revealed that CDE's (nurses, nutritionists, physicians, etc.) believe case management or a team approach is most likely the best way to provide continued monitoring of diabetic patients. (1, 23, 24) Sources such as the Juvenile Diabetes Research Foundation (JDRF), indicate education should reach not only the physicians but also others who interact with the insulin pump user for an extended amount of time. 

Furthermore, as part of the total healthcare plan for children, JDRF indicates these adults need to achieve technical competence with basic pump therapy tasks and have accessible, needed supplies for the insulin pump patient. (2)

According to OSB, Diabetic Education Centers across the US cited recurring complications related to knowledge, information, and training associated with insulin pump usage in certain vulnerable populations such as youth, elderly and populations that are technologically challenged where behavior and cognition plays a role - to name a few. This information was obtained via adverse event reporting follow up telephone calls to the patient, hospital or guardian. (1) AACE and OSB discussed ideas for stricter oversight in both distribution and use of theses devices by restricting insulin pump use in certain vulnerable populations to reduce and eliminate risk to the user. (1, 25) In addition to the need for appropriate initial and continued patient education. Proper patient selection for insulin pump therapy was a resounding message throughout the discussions.

 

Conclusions and Proposed Actions:

Children, adolescents, and adults with diabetes deserve careful consideration, education, training, supervision, monitoring and long-term follow up in order to properly use the insulin pump technology. A multi- disciplinary team approach is needed for the safe usage of this device. A number of adverse events reported were directly related to improper patient selection and inadequate education. Recognizing the limits of this device i.e. electronic programmable technology, one must also recognize the fact that the insulin pump will not outperform its owner's abilities in every instance.
 
In an effort to promote adequate education, the FDA is exploring opportunities to collaborate with AACE and other health professional and advocacy groups to bring awareness to this issue. Below are three options that may be used to achieve this educational goal:

  1. Utilize available communication tools such as E-Health cards, widgets, or use the Patient Safety Network as an educational tool to disseminate educational messages and information for insulin pump users, diabetes educators, and other health care providers.
  2. Collaborate with AACE to develop a continuing education module for healthcare professionals to address this issue.
  3. Develop an educational initiative, consisting of an informational workshop via a collaborative effort with AACE, other health care professionals who treat/care for diabetic patients, manufacturers of insulin pumps, diabetic patient advocacy groups, CDRH and any other agencies within DHHS deemed appropriate.

 

Recommendation:

OSHI's preferred option is to develop an educational initiative. This effort would reach several targeted audiences (patients, patient advocates, and healthcare providers). This would augment the programs and initiatives that are being individually deployed by the FDA and these groups and would foster an inclusive collaborative effort, which would disseminate the needed information/education in a broad-based fashion. To this end, the FDA Infusion Pump webpage and links provide continuous updates on infusion pumps and can be accessed at: 

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/
InfusionPumps/ucm202495.htm


Helene D. Clayton-Jeter, O.D., is a patient and health professional liaison in the FDA Commissioner’s Office of External Affairs in the Office of Special Health Issues.


References:

1.  Morrison, Audrey (personal communication, January 22 -February 20, 2009).
2.  Marschilok, Catherine ( 2006, September) Ask a Medical Professional: What Your Child's School Should Know About Insulin Pumps. [WWW document].
URL http://www.jdrf.org/index.cfm?page_id=103439 14 January 2009.
3.  Deltec Cozmo 1800 (2009, February 20) Cozmore Insulin Technology System. [WWW document]
URL http://www.cozmore.com 28 January 2009.
4.  Accu-Check (2008, February 02) Accu-Check Spirit Insulin Pump System. [WWW document].
URL http://www.disetronic-usa.com 28 January 2009.
5.  Animas Ping (2008, December 22) Animas Cooperation. [WWW document].
URL http://animascorp.com 28 January 2009.
6.  DANA Diabecare IISG (2008) Sooil. [WWW document]. URL http://www.sooil.com 28 January 2009.
7.  Insulet Omnipod (2008) Omnipod Insulin Management System. [WWW document]. URL http://www.myomnipod.com 28 January 2009.
8.  Minimed Paradigm 522/722 (2008) Medtronic. [WWW document]. URL http://medtronicdiabetes.com 28 January 2009.
9.  Nipro Amigo (2008) Nipro Diabetes Systems. [WWW document]. URL http://www.niprodiagnostics.com/our_company/about_us.aspx 28 January 2009.
10. Plotnick, L.P.; Clark, L.M.; Brancati, Frederick; Edinger, Thomas. Safety and Effectiveness of Insulin Pump Therapy in Children and Adolescents with Type
1 Diabetes. Diabetes Care, 26:1142-1146,2003.
11. Cope, J.U., Morrison, A.E., and Samuels-Reid, J. Adolescent Use of lnsulin and Patient-Controlled  Analgesia Pump Technology: A 10-Year Food and Drug Administration Retrospective Study of Adverse Events. Pediatrics, 121(5):e1133-e1138.  1 May 2008.
12. Sadovsky, R. Insulin Pumps in Young Children with Type 1 Diabetes. American Family Physician, 1, March 2003.
13. Berhe, T., Postellon, D., Wilson, B., and Stone, R. Feasibility and Safetyof Insulin Pump Therapy in Children Aged 2 to 7 Years With Type 1 Diabetes: A Retrospective Study, Pediatrics 117, 2132-2137, 6 June 2006.
14. Rubin, P. Patient-Reported Outcomes for an Integrated Real-Time Continuous Glucose Monitoring/Insulin Pump System. Diabetes Technology Therapeutics lL (1):57-62, February 2009.
15. Siegel-Csarkowski, L., Herold, K.C., Goland, R.S. Continuous Subcutaneous Insulin Infusion In Older Patients With Type 1 Diabetes. Diabetes Care 27:3022-3023, 2004.
16. Burdick, J., Chase, H.P., Slover, R.H., Knievel, K., Scrimgeour, L. Maniatis, A.K., Klingensmith, G.J. Missed Insulin Meal Boluses And Elevated Hemoglobin AlC  Levels In Children Receiving Insulin Pump Therapy. Pediatrics, 113(3ptl):e221-4. March 2004.
17. Wood, J.R., Moreland, E.C., Volkening, L.K., Svoren, B.M., Butler, D.A., Laffel, L.M. Durability Oflnsulin Pump Use In Pediatric Patients With Type 1 Diabetes. Diabetes Care.29, (11):2355-60, November 2006.
18. Samuels-Reid, J. Pediatric Issues In Closed-Loop Systems And Diabetes Mellitus. [Electronic Document]. URL http://inside.fda.gov/downloads/Document/UCM017866.ppt. January 2009.
19. Kaplan-Mayer, G. (2008, May 14). Type 1 Diabetes: Insulin Pump Therapy. Diabetes Life. [WWW document]. URL http://www.dlife.com/diabetes/information/search/index.html?uri=%252FdLife%252Findex.html&__locale=en&query=&query2=kaplan-mayer 15 January 2009.
20. Ponder, S. (2008, August 24). Maturity Is A Must For Using An Insulin Pump. Caller.Com. [WWW document]. URL http://www.caller.com/news/news/ Scripps Texas Newspaper. 24 August 2009.
21. New Study Finds Changes In Position Of Conventional Insulin Pumps Can Cause Fluctuations In Insulin Delivery Rates. (2008, November 15) Medical News Today. [WWW document]. URL http://www.medicalnewstoday.com/releases/129510.php. 15 January 2009.
22. Center for Disease Control. (1982, February 26). Epidemiologic Notes And Reports Among Patients Using Continuous Subcutaneous Insulin Infusion Pumps-United States. Morbidity and Mortality Weekly Report. [WWW document]. URL http://www.cdc.gov/mmwr/preview/mmwrhtml/00000207.htm 22 January 2009.
23. Mcintyre, C. (2009). Personal communication with the author on January 12, 2009. [telephone discussion with Certified Diabetic Educator, Mcintyre]
24. Eynon, E. (2009). Personal communication with the author on January 5, 2009. [telephone discussion with Certified Diabetic Educator, Eynon]
25. Hellman, R. AACE Calls For New Standards for Safer Pump Use. [WWW document]. URL http://media.aace.com/section_display.cfm?section_id=1&start_row=71. 15 January 2009.
26. Blass, A. Juvenile Diabetes Research Foundation International: Blogger Round Table Discussion Session 2: Insulin Pumps. [WWW document]. URL http://www.jdrf.org/index.cfm?page_id=108189 15 January 2009.