Insulin Pump Safety 1

Running Head: INSULIN PUMP SAFETY

Insulin Pump Safety in the Management of Pediatric Patients and Adult Patients with

Diabetic Mellitus Type I and Type II

Erika Capalla

University of San Diego

ENLC 556 Management of Health Care System Quality Outcomes and Patient Safety
 Insulin Pump Safety 2

Insulin Pump Safety in the Management of Pediatric Patients and Adult Patients with

Diabetic Mellitus Type I and Type II

Foot amputation, blindness and kidney failure can be a possibility that can darken

the future for those diagnosed with diabetes mellitus. Being newly diagnosed with

diabetes mellitus type I or diabetes mellitus type II may not only be frightening but also

extremely overwhelming and confusing. The state of anxiety is further heightened by the

realization that the situation cannot just go away, but is something that will have to be

managed chronically. Not only are there devastating consequences with the disease

process itself, but substantial risks with the treatment of the disease. Treatment for the

diabetic patient includes oral hypoglycemics, insulin and possible use of an insulin pump.

With the proper coordination with a healthcare team, management of pediatric and adult

patients with diabetes mellitus specifically on insulin pumps can be performed safely and

effectively with improved patient outcomes.

Diabetes Management

Care of the pediatric and adult patient with diabetes mellitus type I and diabetes

mellitus type II involves careful collaboration with the healthcare team and can involve

the primary care physician, endocrinologist, nurse, registered dietitian and social worker.

Normally, the pancreas secretes the peptide hormone insulin in individuals without

diabetes mellitus (Bussell, 2015). Diabetes mellitus type I, when the body cannot produce

insulin, can be controlled mainly by insulin administration (Diabetes Care, 2004).

Diabetes mellitus type II, when the body develops insulin resistance, can be controlled by

diet, exercise, oral hypoglycemics and insulin administration (Diabetes Care, 2004).

Insulin administration can involve delivery via multiple daily injections or continuous
 Insulin Pump Safety 3

subcutaneous insulin infusion through an insulin pump, which delivers insulin by

connecting to the subcutaneous tissue via a cannula (Dajkovich & Barkley, 2015). Safety

while the insulin pump is in use is of prime importance as complications associated with

pump use can lead to severe consequences such as diabetic ketoacidosis (Dajkovich &

Barkley, 2015). Recognizing those consequences is one of the first steps in ensuring

patient safety. With continuous subcutaneous insulin infusion therapy, the patient is able

to have meals and participate in exercises that do not have to be on a set schedule with set

monitoring times (Dajkovich & Barkley, 2015). The flexibility of such a treatment

modality is a welcome approach since the patient has to manage their condition on a

long-term basis. With this method, the patient is still able to maintain a good quality of

life.

In a systematic review with meta analysis by Yeh et al. (2012), 33 randomized

controlled trials in children or adults were reviewed, between 1966 and 2012, using

Medline and the Cochrane Central Register of Controlled Trials. The randomized

controlled trials compared continuous subcutaneous insulin infusion therapy with

multiple daily injections, real time continuous glucose monitoring with self-monitoring of

blood glucose and sensor augmented insulin pump use with multiple daily injections and

self-monitoring of blood glucose. The purpose was to study how either the mode of

insulin delivery or mode of monitoring blood glucose affected patient outcomes.

According to Yeh et al., limitations of the study included the general age limits of

participants to be between 12 and 65 years old and lack of information on the long-term

micro and macro vascular complications. Further limitations of the study were the lack of

information on how patients adhered to their treatment plan. Another limitation was the
 Insulin Pump Safety 4

lack of generalizability of the analysis, since not all patients with diabetes will meet the

qualifications of obtaining an insulin pump. Only patients who are skilled in their

diabetes care and agree to be engaged in their diabetes care are able to work with

continuous subcutaneous insulin infusion and real time continuous glucose monitoring.

Yeh et al. (2012) found that multiple daily injections and continuous

subcutaneous insulin injections produced similar results in with lowering HbA1c levels.

However, with continuous subcutaneous insulin injections, patient satisfaction was higher

for both adult and pediatric patients with diabetes mellitus type I. With the flexibility of

the continuous subcutaneous insulin injections, some patients may gradually decline from

adhering to their specific treatment plan since they may soon rely too much on the device.

Due to such outcomes, the treatment plan would have to be based on the individual

patient and how they would like to manage their condition.

As far as the comparison of monitoring methods, the meta analysis found that real

time continuous glucose monitoring worked better than self-monitoring of blood glucose

in lowering HbA1c levels. Also, adding real time continuous glucose monitoring to

continuous subcutaneous insulin injections was more effective in lowering HbA1c levels.

With this additional finding, the patient can be assisted in choosing the correct method of

treatment. This systematic review has shown that use of the insulin pump in managing

diabetes is a method that is both favorable and effective. The role of the healthcare

provider is then to assist either the adult patient or family of the pediatric patient in

choosing the correct method that results in positive patient outcomes. Explaining the

benefits and disadvantages of the pump would be included in the patient education.

Included in that role is ensuring that the insulin pump delivery is not only appropriate but
 Insulin Pump Safety 5

also safe. Further studies would have to be conducted that would extend the information

gained in this particular research. By better understanding the background and function of

the insulin pump, the healthcare provider can continue to serve as an advocate in the

diabetic patient’s care.

Insulin Pump Development

Insulin pump therapy was initiated in the 1960’s by Arnold Kadish, who designed

the first insulin pump in a closed loop mode (Alsaleh, Smith, Keady and Taylor 2010).

This closed loop system is a system that is able to monitor blood glucose and then deliver

insulin within the device. However, the size of the device, which was similar to a large

backpack, was a disadvantage (Alsaleh, Smith, Keady and Taylor 2010). Daily use had to

be considered and if the patient could not have ease of use during regular tasks,

modifications had to be made. Although this innovative device was not included as a part

of diabetes management, this type of advancement is necessary, so that future technology

can be propelled forward.

In 1974, a second device called the Biostator was created, composed of a glucose

analyzer and computer that had algorithm programs which analyzed blood glucose and

calculated the amount of insulin or dextrose to be infused (Alsaleh, Smith, Keady and

Taylor 2010). By moving in a direction where information is exchanged through one

program, insulin pump technology progressed. However, in addition to its size, the

complex nature of the Biostator did not allow for the device to be put to use in practice

(Alsaleh, Smith, Keady and Taylor 2010). A second device was created in the same year,

with insulin infusion through the intravenous route, at a basal rate, but because of the risk

of infection and thrombosis, the risk was too high for the device to be a part of a diabetic
 Insulin Pump Safety 6

treatment plan (Alsaleh, Smith, Keady and Taylor 2010). Although technology was

advancing in the world of the insulin pump, developers had to consider the patient

population, their activities and their safety. Mobility still had to be maintained while the

patient received treatment.

During the following years in the development of the insulin pump, safety issues

arose, due to how the machine operated and also due to the components of the machine

itself. There were issues with the safety alarms, minimal control in the delivery of the

insulin, as well as needle failure and blockages with the pump tubing (Alsaleh, Smith,

Keady and Taylor 2010). Changes regarding safety were made by the developers and

manufacturers, which led to the state of insulin pumps today. According to Alsaleh,

Smith, Keady and Taylor (2010), the current insulin pumps are the size of a pager and are

an open loop type, meaning that patients are responsible for the calculation of the basal

and bolus insulin infusion administration. By creating a smaller and safer device, the

patient can still be encouraged to maintain an active lifestyle without limitations, which

can then lead to better patient outlooks and outcomes.

Insulin Pump Therapy

The current insulin pump is composed of four main components: the insulin pump

utilizing a battery, a reservoir which contains the insulin, the infusion set which includes

the tubing and the needle that reaches the subcutaneous tissue (Dajkovich & Barkley,

2015). The reservoir contains rapid acting insulin only, as the pump delivers a basal rate

and a bolus rate (Dajkovich & Barkley, 2015). Providing teaching to the newly diagnosed

DM patient about different types of insulin and their function serve to assist the patient in

recognizing how their disease process is treated. Were any issues to arise during insulin
 Insulin Pump Safety 7

pump therapy, the informed patient would be able to troubleshoot effectively if medical

assistance was not immediately available. This empowerment can lead to self-awareness

and in turn lead to patients being accountable for their own safety. Dajkovich & Barkley

(2015) explained that the pump works by providing insulin over 24 hours and also

allowing for a bolus to be given in response to an increased intake of food, which is

calculated by the patient. Calculation of food intake is a part of the patient’s role in being

responsible for their own safety while on insulin pump therapy.

Since the patient has agreed to the use of the pump, they must be willing to be

active participants in their treatment. The patient must not only take into account their

safety while using the insulin pump, but they must be in a position to be independent in

their care. This active participation involves monitoring blood glucose from four to six

times per day (Dajkovich & Barkley, 2015). The pump itself is a machine that has the

potential to fail and the patient must recognize that there cannot be a total reliance on the

machine. Alsaleh, Smith, Keady and Taylor (2010) explained that the future of insulin

pumps is through a closed loop type of system, which includes the pump and glucose

sensor, working as a type of artificial pancreas, similar to the original concept of Kadish.

Learning from the original developer is a part of the process in the advancement of

technology in diabetes care. Continued communication and collaboration must also take

place between the health care team and the developers of insulin pumps so that patient

safety is at the forefront of issues being addressed.

Insulin Pump Complications

Many expected and unexpected situations can occur when working with machines

and devices. Health care providers must recognize such unexpected hazardous events and
 Insulin Pump Safety 8

work to prevent the events from occurring or provide plans of action if the event does

occur. Treatment using the current insulin pump has shown that certain complications

still occur. A hazard of pump therapy is when the pump fails to deliver the insulin that it

was programmed to deliver. When such an event occurs, the patient has to be ready, by

having all back up supplies at hand, including testing supplies and rapid acting insulin, so

that injections can be performed and deadly consequences can be prevented (Dajkovich

& Barkley, 2015). The patient must be able to function independently in these types of

scenarios.

Also, according to Dajkovich & Barkley (2015), infection at the pump insertion

site can occur, which can also lead to possible cellulitis or abscess. The nurse must also

play an active role in ensuring that the patient has all supplies necessary for their care at

home, as outpatient physician visits can be full of information that the patient may miss.

With impaired skin healing already a part of the diabetes disease process, it is also

essential for the nurse to provide teaching in order to prevent this complication from

ensuing. Following preventative teaching would be reinforcement, which serves to allow

for a time for the patient to solidify their understanding and clarify any misconceptions.

A retrospective study was performed by Cope, Samuels-Reid and Morrison

(2012) to evaluate adverse events in pediatric DM patients aged 1-12 years old who used

insulin pumps. The study was performed using the FDA’s Manufacturer and User

Facility Device Experience (MAUDE) database for the dates of January 1, 1996 through

December 31, 2009. The study found that hyperglycemia and/or diabetic ketoacidosis

were the primary adverse events that occurred during treatment. Of the 1774 adverse
 Insulin Pump Safety 9

events that occurred, 614 events were for hyperglycemia and/or diabetic ketoacidosis and

required hospitalizations.

Causes of such events were found to be either related to the mechanism of the

device, such as alarm or battery issues or user error. Of the two main causes, user error

made up the majority. Cope et al. (2012) found that users did not understand the pump,

did not follow the operation instructions and did not program the pump appropriately.

This finding reinforces the importance of proper training of patients using the insulin

pump. Cope et al. found that the study had limitations due to age limits studied, the

adverse event reports were mainly from the manufacturer and not all of the insulin pumps

were returned to the manufacturer. With the information being specific to a small group,

not all data can be captured and related to other population groups. Also, information on

the insulin pumps must be studied to determine where in the delivery the system failed to

function to its normal capabilities. Despite the limitations, useful insight can be gained

from such studies, since any recurrent events and trends can be recognized and further

analyzed.

Improving Safety of the Insulin Pump

Examining the insulin pump and recognizing the adverse events that can occur

allows for the healthcare provider to participate in the improvement process of the insulin

pump. As a method of improving patient safety with the insulin pump, Zhang, Jones and

Jetley (2010) followed the concept of model-based engineering that the FDA/Center for

Device and Radiological Health/Office of Science and Engineering Laboratories has been

involved in. Model-based engineering focuses on the improvement of medical devices,

software and systems through first presenting a standardized model and then studying the
 Insulin Pump Safety 10

model so that design flaws can be rectified and improvements made. Zhang et al.

presented a standardized model of the insulin pump, known as the generic insulin

infusion pump, which can be used as a reference and improved upon, especially in

relation to patient safety. The goal was to present a device that can be used in comparison

with devices currently in the market so that improved product development could be

done. Zhang et al. also wanted to have a set of standardized safety properties that could

be used to measure the safety of the insulin pumps.

The researchers presented their version of the generic insulin infusion pump,

which includes a pump controller component, currently being used in the pumps on the

market. This pump controller serves as a mechanism to communicate between the user

and the device to deliver the correct amount of insulin. It can also recommend a bolus of

insulin, depending on the amount of food intake. Due to the potential failures that can

occur with such a component with a large responsibility, Zhang et al. proposed adding a

bolus calculator subcomponent that specifically functions to recommend the correct

amount of bolus. They also added a feature on the pump, which allows access to food

databases that contain nutritional serving information such as the amount of

carbohydrates included in a meal. By presenting a standardized model through which

researchers could improve upon and then presenting the hazards involved in the

standardized insulin pump, the avenue was opened for development of a safer insulin

pump.

In order to learn from the generic insulin infusion pump, an assessment of the

hazards that can occur had to be made. This was done through a preliminary hazard

analysis that revealed certain instances in which harm could occur in the use of the
 Insulin Pump Safety 11

insulin pump. The hazards were grouped in categories and were found to be therapeutic,

such as overdosing of insulin, energetic, such as electric shock from the pump,

chemical/biological, such as infection, mechanical, such as stress on the device

components and environmental, such as the user exposing the pump to unsafe

temperatures (Zhang et al, 2010). By recognizing the hazards, solutions could be

proposed, based off of the generic insulin infusion pump, not only by the researchers but

also by the health care community.

Complacency must not overpower vigilance, as can tend to occur with medical

devices that can function continuously. To aid further research with the insulin pump,

Cope et al. (2012) explained that issues with insulin pumps could be reported by

manufacturers and users through the FDA MedWatch program. Having a centralized

database of complications that have occurred allows for the healthcare community to gain

useful information that can be used in product improvement. By continuing to study and

improve insulin pumps and addressing the education needs of the diabetic patient,

adverse events can be minimized.

Improving safety with the delivery of insulin via the pump not only involves the

pump itself but the user of the pump. Another method to improve patient safety with the

insulin pump is through the human factors procedure. Undergoing the human factors

process can reveal additional useful information in the journey towards a safer insulin

pump. The study of human factors is analyzing human beings and their interactions with

technological products or the environment (Schaeffer, 2012). Examining those

interactions leads to improvements in medical devices. One such medical device

reviewed by Schaeffer (2012) was the t:slim insulin delivery system and its user
 Insulin Pump Safety 12

interface. The human factors process was followed which is composed of preliminary

analysis, formative evaluation and design modification and finally, validation testing

(Schaeffer, 2012). Each step of the process is imperative in gaining information about the

users can adjust to the technology.

In the preliminary analysis, the population make up and environment of potential

insulin pump users were studied. Additionally, the user interface of the device was

analyzed. The next step of formative evaluation and design modification involved

gathering participants, placing them in real world scenarios and studying their behavior

while interacting with the devices. From studying the behaviors, certain factors were

identified that could cause hazards during insulin delivery. Such factors were with data

entry, navigation and information retrieval tasks (Schaeffer, 2012). Improvements were

then made to the user interface, which was tested by patients with diabetes, during the

validation section of the human factors process. From the validation section, it was

revealed that active confirmation screens prevented errors (Schaeffer, 2012). Having a

mechanism that allows for confirmation of a choice is a method to serve as a type of

secondary checkpoint is necessary in the patient population when medication such as

insulin is involved. The importance of a user friendly interface was also highlighted in

the study by Zhang et al. (2010) as they discussed how the type of interface must fit the

user, such as senior citizens who require easy to read devices. Also, with so much

information already required of by the diabetic patient, too much information presented

on the interface can lead to negative consequences such as information overload (Zhang

et al, 2010). Having too much information to process can lead to inability to focus. Such

focus is required during certain processes such as calculation of bolus doses.

 Insulin Pump Safety 13

Assessment of the patient while under nursing care should not only include

assessing the patient’s current health status but also include the patient’s response to the

education that is presented about their health status. Proper assessment is another manner

in which patient safety with the insulin pump can be addressed. The study by Cope et al.

(2012) highlighted the importance of user education and training. The nurse working with

the adult or pediatric patient has the opportunity to prevent adverse events from occurring

by taking the initial step in ensuring that the patient or patient’s family understands all

aspects of care with the device. The user should be able to understand all components of

the device, be able to troubleshoot as needed and explain the steps of using the device to

the provider. They must also have access to a support line in the event that issues occur in

the use of the insulin pump. Anticipating the patient’s needs and questions and providing

comprehensible information can effectively lead to a well-prepared patient capable of

managing their diabetic care.

The diabetic patient has many barriers to face in their disease process. Not only

must they provide appropriate self-care to prevent the long-term consequences, but they

must make decisions in their daily care to prevent the immediate consequences that can

occur with errors in administering their medication. If such medication administration

involves the use of the insulin pump, even more factors have to be considered to ensure

patient safety. The diabetic patient using the insulin pump has to work in collaboration

with their healthcare team. There has to be appropriate education and training along with

research and improvement of the insulin pump. Additionally, integration between user

training and device modification has to occur, in the form of studying human factors.

Patient safety during the use of the insulin pump involves various elements that must take
 Insulin Pump Safety 14

place. Although the process is not easy or rapidly occurring, but one that undergoes a

process of assessment and modification, insulin pump delivery with the pediatric and

adult diabetic patient can be safe, effective and have beneficial outcomes.
 Insulin Pump Safety 15

References

Diagnosis and classification of diabetes mellitus (2004, January). Diabetes Care, 27, S5-

S10.

Alsaleh, F.M., Smith, F.J., Keady, S., & Taylor, K.M.G. (2010). Insulin pumps: from

inception to the present and toward the future. Journal of Clinical Pharmacy and

Therapeutics, 35, 127-138.

Bussell, G. (2015). Understanding the relationship between type 1 diabetes and diet.

Journal of Community Nursing, 29, 24-30.

Cope, J.U., Samuels-Reid, J.H., Morrison, A.E. (2012). Pediatric use of insulin pump

technology: a retrospective study of adverse events in children ages 1-12 years.

Journal of Diabetes Science and Technology, 6, 1053-1059.

Dajkovich, G., & Barkley, T.W., (2015). Understanding insulin pump therapy. Journal of

Community Health Nursing, 32, 131-140.

Schaeffer, N.E. (2012). The role of human factors in the design and development of an

insulin pump. Journal of Diabetes and Science and Technology, 6, 260-264.

Yeh, H., Brown, T.T., Maruthur, N., Ranasinghe, P., Berger, Z., Suh, Y.D., et al. (2012).

Comparative effectiveness and safety methods of insulin delivery and glucose

monitoring for diabetes mellitus. Annals of Internal Medicine, 157, 336-347.

Zhang, Y., Jones, P.L., Jetley, R. (2010). A hazard analysis for generic insulin infusion

pump. Journal of Diabetes Science and Technology, 4, 263-283.

Insulin Pump Safety 16
Insulin Pump Safety 17
Insulin Pump Safety 18
Insulin Pump Safety 19
Insulin Pump Safety 20