Running head: PEDIATIC USE OF INSULIN PUMP THERAPY 1

Pediatric Use of Insulin Pump Therapy and its Impact on Glycemic Control

Jeanine M. Diaz

Cedar Crest College

PEDIATRIC USE OF INSULIN PUMP THERAPY 2

Abstract

The purpose of this paper is to address the significance of choosing the correct mode of insulin

delivery amongst the pediatric population. Additionally, the impact of continuous subcutaneous

insulin infusion (CSII) therapy on glycemic control is discussed. Literature was searched,

retrieved, appraised, and synthesized. Recommendations for practice change after careful

evaluation of evidence is given. Furthermore, an implementation plan on how to change current

practice involving the use of CSII is given.

Keywords: pediatric, type 1 diabetes, glycemic control, multiple daily injections,

continuous subcutaneous insulin infusion

PEDIATRIC USE OF INSULIN PUMP THERAPY 3

Pediatric Use of Insulin Pump Therapy and its Impact on Glycemic Control

Insulin pump therapy, or continuous subcutaneous insulin infusion (CSII), is an

increasingly popular method in children and adolescents to obtain tight glycemic control.

Continuous subcutaneous insulin infusion works by imitating the body’s normal pattern of

insulin secretion by allowing a 24-hour adjustable basal delivery of insulin, while also giving a

bolus dose of insulin to cover additional carbohydrate intake (Kordonouri, Hartmann, & Danne,

2011). Although the use of CSII is increasing, multiple daily injections (MDI) remain the

standard treatment of type 1 diabetes (T1D) in both adults and children (Kordonouri et al., 2011).

Children and their families have the right to exercise autonomy and choose the mode of insulin

delivery that works best for them; however, if a certain method of insulin delivery works best to

achieve lower glycated hemoglobin levels (HbA1c), it is important for nurses to educate and

advocate for pediatric clients and their families to use this mode.

Significance

As pediatric nurses are often the ones to discuss treatment options with children and their

families, it is important for nurses to be knowledgeable of the difference in benefits between

CSII and MDI. In order to properly manage T1D, lifelong administration of insulin is required

(Woerner, 2014). As such, the importance of the correct mode of insulin delivery is a major

decision. Tight glycemic control is needed in pediatric patients with T1D in order to prevent

long-term microvascular and macrovascular complications in later years of life. According to

Rica et al. (2017), The Diabetes Control and Complications Trial (DCCT) revealed that in

adolescents and adults, strict diabetes management significantly reduces the risk of chronic

complications in T1D. Furthermore, it was shown that near-normalization of blood glucose

levels is more difficult to achieve in adolescents and young children than adults (Rica et al.,
PEDIATRIC USE OF INSULIN PUMP THERAPY 4

2017). Therefore, it is necessary for pediatric nurses to be advisable of the correct mode of

insulin delivery that will best deliver precise glycemic control. The American Diabetes

Association (ADA) and the International Society for Pediatric and Adolescent Diabetes (ISPAD)

established targets for HbA1c <7.5% across all age groups in pediatric clients (Rica et al., 2017).

With such a tight target range of HbA1c levels, nurses must be knowledgeable of the mode of

insulin delivery that best achieves such levels. The purpose of this paper is to investigate and

analyze research that answers all components of the formulated population, intervention,

comparison, and outcome (PICO) question: In pediatric clients with type 1 diabetes, does the use

of an insulin pump compared to multiple daily injections result in lower glycated hemoglobin

levels?

Literature Review

A comprehensive search and retrieval was conducted to find literature to answer the

PICO question. A labor intensive search included databases such as Google Scholar, Cumulative

Index to Nursing and Allied Health Literature (CINAHL), Public Medline database (PubMed),

Wiley Online Library, and Elton B. Stephens Company (EBSCO). Among these databases, the

majority of literature that answered the PICO question was found through PubMed. A broad

search was first conducted using the keywords: “pediatrics,” “type one diabetes,” and “insulin

pump therapy.” In the database PubMed, these keywords resulted in 282 articles. Adding

keywords “multiple daily injections” and “hemoglobin A1c,” the results reduced to 20 articles.

Further refinement of the date, including years 2011 to 2018, resulted in 11 articles. After careful

review of each article, four were selected that specifically addressed each component of the

PICO question. After adding the keyword “adolescent” to this same search, an additional article

was chosen.
PEDIATRIC USE OF INSULIN PUMP THERAPY 5

In addition to PubMed, using Google Scholar resulted in the remainder of articles that

directly addressed and answered all components of the PICO question. Keywords “pediatric,”

“insulin pump,” and “hemoglobin A1c” were used. After refining the date to include the years

2011 to 2018, the results included 4,870 articles. Adding key words “multiple daily injections”

further narrowed the results to 2,420 articles. Dates were refined to include years 2013 to 2018,

resulting in 955 articles. Further addition of keywords “continuous subcutaneous insulin infusion

pump” reduced the number of articles to 35. After reviewing each article for the necessary

components of answering the PICO question, an additional three articles were chosen. A total of

eight articles were compiled and an annotated bibliography was completed to carefully analyze

each component of the studies. From these eight articles, three were chosen by further analyses

of each study.

Critical Appraisal

After three studies were carefully chosen to answer the formulated PICO question, a

critical appraisal was performed to further analyze each component of the study. Two tools were

used to appraise the quality and strength of the three studies, including the Johns Hopkins

Nursing Evidence-Based Practice Rating Scale (Newhouse, Dearholt, Poe, Pugh, & White, 2005)

and the Rating System for Hierarchy of Evidence (Melnyk & Fineout-Overholt, 2005). The

Rating System for Hierarchy of Evidence rates the strength of the evidence on a level from I to

VII with level I being the strongest on the hierarchy. The Johns Hopkins Nursing Evidence-

Based Practice Rating Scale rates the quality of the evidence as either an A (high), B (good), or

C (low).
PEDIATRIC USE OF INSULIN PUMP THERAPY 6

Alsaleh, Smith, Thompson, Al-Saleh and Taylor (2014)

The purpose of this study was to examine the impact of switching from multiple daily

injections to insulin pumps on glycemic control of pediatric clients, and the impact this switch

had on the daily lives of children and their families (Alsaleh, Smith, Thompson, Al-Saleh, &

Taylor, 2014). The design of the study was observational. The researchers showed that parents

and young children reported overall improvement in ability to participate in home, school, and

social activities with CSII use. Additionally, significantly improved HbA1c levels resulted after

switching to CSII from MDI. Mean HbA1c values were reduced from 8.25% to 7.6 % after six

months of CSII initiation and these results sustained after a three year follow-up (Alsaleh et al.,

2014). Limitations of this study included a small sample size, and the study was conducted

outside of the United States. This study was still considered applicable as the health care systems

are comparable between London and the United States, and the same international standardized

HbA1c levels were used to measure glycemic control. The strength of this study was assessed to

be a level VI. The quality of this study was assessed as a level B. The researchers concluded that

the majority of participants reported greater benefits in terms of glycemic control and general

well-being with CSII use compared to MDI use (Alsaleh et al., 2014).

Mameli et al. (2013)

The purpose of this study was to evaluate the usefulness and safety of insulin pump

therapy in a large cohort of pediatric patients with T1D during a seven year follow-up in three

diabetes centers from three different countries (Mameli et al., 2013). The design of the study was

an observational retrospective multicenter cohort study. The researchers showed that HbA1c

significantly improved after a one-year follow-up, showing a positive trend throughout the

follow-up, but this difference varied according to country. Severe hypoglycemia decreased from
PEDIATRIC USE OF INSULIN PUMP THERAPY 7

baseline to the end of the follow-up, and a significant decrease in diabetic ketoacidosis (DKA)

episodes was observed. Patients using advanced pump features did show significantly better

HbA1c levels compared to those who did not (Mameli et al., 2013). Limitations to this study

included the retrospective nature, the inability to assess all three countries for advanced pump

features, as well as Tanner staging, and the study was conducted in three foreign countries, not

including the United States. The study was still considered applicable to the United States as

health care systems are comparable between all four countries, and the international standardized

HbA1c levels were used to measure glycemic control. The strength of this study was assessed as

a level VI, and the quality was assessed as a B. The researchers concluded that insulin pump

therapy is safe and effective in the pediatric population (Mameli et al., 2013).

Fendler, Baranowska, Mianowska, Szadkowska and Mlynarski (2011)

The purpose of this study was to evaluate the impact of treatment with CSII on metabolic

control (expressed as HbA1c) and its variability in children with diabetes (Fendler, Baranowska,

Mianowska, Szadkowska, & Mlynarski, 2011). The design was a prospective observational

study. The researchers found that mean post-study HbA1c levels were statistically higher in MDI

users than in CSII-treated patients. Percentage of patients that reached the therapeutic goal of

<7% of HbA1c levels equaled 32.9% in the CSII group compared to 25.7% in the MDI group

(P=0.12) (Fendler et al., 2011). Limitations of this study included the non-random allocation of

patients that could lead to the potential for bias, and that the study was conducted in Poland. This

study was still chosen as the findings are applicable to the United States. Both Poland and the

United States have similar health care systems, and the internationally standardized measurement

of HbA1c was used to measure glycemic control. The strength of this study was assessed to be a

level VI, and the quality of this study was assessed as a B. The researchers concluded that better
PEDIATRIC USE OF INSULIN PUMP THERAPY 8

metabolic control of T1D was found in CSII users in terms of HbA1c levels compared to those

using MDI (Fendler et al., 2011).

Synthesis of Evidence

After careful review of each study individually, a collective analysis was performed.

Researchers chose the same observational study design to evaluate the impact on HbA1c levels

that switching to CSII use had. Among two of the studies, additional research was done to

evaluate the effects of switching from MDI to CSII on diabetic complications. Mameli et al.

(2013) showed a significant reduction in severe adverse events in the CSII group. Furthermore,

Fendler et al. (2011) showed that although there was no difference in the number of episodes of

complications between groups, the CSII group did have a significantly lower number of total

hospital days per year compared to the MDI group. This concludes that switching to CSII does

not impose a greater risk for complications. Although the PICO questions does not address

complications from switching from MDI to CSII, it is important to evaluate the risks involved to

determine that the intervention is safe.

In all three studies, researchers showed significantly improved HbA1c levels when

switching from MDI to CSII in pediatric clients with T1D. As reported by Fendler et al. (2011),

the MDI group had statistically higher mean post-study HbA1c levels compared to CSII users.

Additionally, this reduction was continuous throughout follow-ups done in all three of the

studies; however, the length of time when the follow-up was concluded was different between

the studies. Alsaleh et al. (2014) reported significantly reduced HbA1c values six months after

initiation of insulin pump therapy and a sustained reduction throughout the three year follow-up.

Furthermore, Mameli et al. (2013) reported a significant improvement in HbA1c levels after a

one-year follow-up, and although trends were different between comparing countries, the
PEDIATRIC USE OF INSULIN PUMP THERAPY 9

improvement was maintained after a seven-year follow-up. This evidence answers the PICO

question by directly addressing each component and showing that the use of CSII does reduce

HbA1c levels compared to the use of MDI in the pediatric population.

Recommendations

After a complete analysis was done of all three studies, and evidence was extracted to

answer the composed PICO question, three recommendations were determined from the

researchers.

Recommendation #1: Need for Greater Uptake of CSII in Line with Guidelines

As the researchers have shown that the use of CSII compared to MDI is associated with

reduced HbA1c levels, it has been recommended that there is a need for greater uptake of CSII in

accordance with National Institute for Health and Care Excellence (NICE) guidelines as stated

by Alsaleh et al. (2014). National Institute for Health Care Excellence guidelines are evidence-

based recommendations for healthcare in England. As stated previously, a limitation to this study

was that it was conducted outside of the United States; therefore, NICE guidelines do not transfer

to the United States. As such, greater use of CSII in the pediatric population can be implemented

according to clinical practice guidelines within the United States. As the importance to keep

HbA1c levels as close to the recommended target range of <7.5% (Rica et al., 2017), and as

researchers have shown this is best achieved by the use of CSII, nurses should follow the

recommendations and advocate for the greater use of CSII in practice.

Recommendation #2: Insulin Pump Therapy should be Tailored to the Specific Patient

In the study done by Mameli et al. (2013), it was shown by the researchers that in a

subgroup using advanced pump features that controlled bolus and basal rates, significantly better

HbA1c levels were obtained compared to those who did not use advanced features. According to
PEDIATRIC USE OF INSULIN PUMP THERAPY 10

Mameli et al. (2013), using these advanced features better allows insulin pump therapy to mimic

physiologic insulin secretion. Therefore, it is recommended that advanced pump features be used

and reinforced by ongoing education to allow insulin pump therapy to be tailored to the specific

patient (Mameli et al., 2013). For example, educating patients on how to use advanced bolus

features to allow for different bolus doses depending on the meal consumed can help improve

HbA1c by giving correct carbohydrate coverage each time (Mameli et al., 2013). Therefore, it is

important for nurses to recognize the importance of continuing education of advanced pump

features for insulin pump therapy to be tailored to the specific patient.

Recommendation #3: Timing of Initiating Pump Therapy is Crucial

According to Alsaleh et al. (2014), integration of pump therapy into the busy lives of

pediatric clients and their families can be burdensome at first. This is due to the complexity of

the insulin pump system. As stated above, proper education needs to be implemented for

teaching of advanced features to best mimic natural physiologic insulin secretion (Mameli et al.,

2013). As such, the timing of initiating pump therapy can have either a positive or negative effect

on successful implementation of CSII. Alsaleh et al. (2014) recommends that timing of initiating

pump therapy is crucial. Although CSII has been proven to show reduced levels of HbA1c levels

compared to MDI users, initiation of pump therapy when a client and their family does not have

the time to correctly learn how to use CSII may result differently. Therefore, it is necessary for

nurses to follow the recommendation for initiating pump therapy at the correct time in the lives

of clients and their families.

Implementation Plan

According to Craig and Smyth (2012), there are five core elements to implementing

evidence-based change into practice. These include identifying the need for change, planning for
PEDIATRIC USE OF INSULIN PUMP THERAPY 11

the change, implementing practice change using agreed-upon methods, studying the change

process as it progresses, and evaluating the outcomes achieved (Craig & Smyth, 2012). As the

first part of this paper focuses on identifying the need for greater use of CSII in the pediatric

population, this next section will demonstrate how the implementation can take place.

As the use of CSII is currently in place, the focus is to make CSII the standard of care and

to make sure the use of CSII is held in accordance with clinical practice guidelines. This ensures

that safe and accurate use of CSII is being implemented and allows for best results. Additionally,

it is important that nurses and practitioners understand why CSII is being used in practice and the

implications this can have on pediatric clients achieving target HbA1c levels. This can be done

by developing care pathways, which allow research evidence to be incorporated into a

framework in which the anticipated management and progress of usual patients with specific

diagnoses (such as T1D) are mapped daily (Craig & Smyth, 2012). This allows for ‘best

practice’ features to be identified and used (Craig & Smyth, 2012) and will further cement the

importance for use of CSII among practitioners and nurses. Furthermore, it is important for

continued evaluation to occur in order to determine whether change has indeed taken place and

to evaluate the effectiveness of the change (Craig & Smyth, 2012). This can be done by

continually monitoring and comparing outcomes of patients switching from MDI to CSII, to

evaluate if the expected outcome is actually occurring, and to see if additional changes need to

take place. These changes may have to do with the recommendations of implementing CSII use

at the appropriate time, or making sure that proper education is being tailored to patients’

specific needs.
PEDIATRIC USE OF INSULIN PUMP THERAPY 12

Conclusion

As T1D requires lifelong administration of insulin to manage the disease, the importance

of choosing the correct mode of insulin delivery is a major decision among pediatric clients and

their families. Additionally, tight glycemic control is needed amongst the pediatric population to

prevent both long-term microvascular and macrovascular complications. A formulated PICO

question was identified to determine which mode of insulin delivery will result in lower HbA1c

levels amongst the pediatric population. Literature was reviewed to determine eight studies that

answered the PICO question. From these eight studies, further analysis was done to choose three

studies that best answered the PICO question, and a critical appraisal was performed on each

study. The evidence from all three studies was synthesized as a whole, and from these studies

three recommendations for practice change were identified. Furthermore, an implementation plan

for practice change was determined.

PEDIATRIC USE OF INSULIN PUMP THERAPY 13

References

Alsaleh, F. M., Smith, F. J., Thompson, R., Al-Saleh, M. A., & Taylor, K. M. (2014). Insulin

pump therapy: Impact on the lives of children/young people with diabetes mellitus and

their parents. International Journal of Clinical Pharmacy, 36(5), 1023-1030.

doi:10.1007/s11096-014-9990-1

Craig, J. V., & Smyth, R. L. (2012). The evidence-based practice manual for nurses. Edinburgh:

Churchhill Livingstone Elsevier.

Fendler, W., Baranowska, A. I., Mianowska, B., Szadkowska, A., & Mlynarski, W. (2011).

Three-year comparison of subcutaneous insulin pump treatment with multi-daily

injections on HbA1c, its variability and hospital burden of children with type 1

diabetes. Acta Diabetologica, 49(5), 363-370. doi:10.1007/s00592-011-0332-7

Kordonouri, O., Hartmann, R., & Danne, T. (2011). Treatment of type 1 diabetes in children and

adolescents using modern insulin pumps. Diabetes Research and Clinical Practice, 93.

doi:10.1016/s0168-8227(11)70027-4

Mameli, C., Scaramuzza, A. E., Ho, J., Cardona-Hernandez, R., Suarez-Ortega, L., & Zuccotti,

G. V. (2013). A 7-year follow-up retrospective, international, multicenter study of insulin

pump therapy in children and adolescents with type 1 diabetes. Acta Diabetologica,

51(2), 205-210. doi:10.1007/s00592-013-0481-y

Melnyk, B., M., & Fineout-Overholt, E. (2005). Evidence-based practice in nursing and

healthcare: A guide to best practice. Philadelphia, PA: Lippincott Williams and Wilkins.

Newhouse, R., Dearholt, S., Poe, S., Pugh, L., C., & White, K. (2005). The John Hopkins

Nursing Evidence-Based Practice Rating Scale. Baltimore, MD: The John Hopkins

Hospital; Johns Hopkins University School of Nursing.

PEDIATRIC USE OF INSULIN PUMP THERAPY 14

Rica, I., Mingorance, A., Gómez-Gila, A. L., Clemente, M., González, I., Caimari, M., . . .

Barrio, R. (2017). Achievement of metabolic control among children and adolescents

with type 1 diabetes in Spain. Acta Diabetologica, 54(7), 677-683. doi:10.1007/s00592-

017-0991-0

Woerner, S. (2014). The benefits of insulin pump therapy in children and adolescents with type 1

diabetes. Journal of Pediatric Nursing, 29(6), 712-713. doi:10.1016/j.pedn.2014.08.010

 PEDIATIC USE OF INSULIN PUMP THERAPY 15

Appendix

Evidence Summary

Study
Variables:
Author, Date, Title Research Independent Rating of Evidence/
of Study, Journal Questions/ Methods (IV) Measures/ Results/Findings Limitations Recommendations
Hypothesis/ Dependent Reliability Validity
Purpose (DV)
Research
(RV)
Alsaleh, F., Smith, F., Purpose: To Design: RV: Instruments: Semi- Parents and young Small sample size Level = VI
Thompson, R., Al-Saleh, examine the impact Observational Multiple daily structured interview children reported overall makes it harder to Quality = B Good
M., & Taylor, K. (2014) of switching from study injections (MDI) created by the improvement in ability to generalize findings to
multiple daily researchers participate in home, greater population Recommendations:
Insulin pump therapy: injections to Sample: A total Continuous school and social There is recognition of the
impact on the lives of insulin pumps on of 42 families, subcutaneous Methods of Data activities with CSII use Foreign research need for greater uptake
children/young people the glycemic 38 parents and insulin infusion Collection: as well as significantly adds limitation to and appropriate use of
with diabetes mellitus control and daily 34 children (CSII) Cross-sectional face-to- improved HbA1c levels apply findings to the CSII in line with NICE
and their parents lives of aged 5-17 years face interview conducted after switching to CSII United States guidance.
children/young Glycemic by a researcher trained in from multiple daily
International Journal of people and their Setting: 25 control (HbA1c) qualitative interviewing injections
Clinical Pharmacology families. families in and research with Mean HbA1c values
and Therapeutics London home, Impact of pump children were reduced from 8.25
17 families at therapy on to 7.6 % after 6 months
University home, social and HbA1c values recorded of CSII initiation and
College London school lives from patients’ medical sustained for 3 year
Hospital records 6 months pre- follow-up
Age and post-initiation of
pump therapy
Gender

Mameli, C., Scaramuzza, Purpose: To Design: RV: Gender Instruments: Data HbA1c significantly Retrospective nature Level = VI
A., Ho, J., Cardona- evaluate the Observational collection tool for chart improve after 1 year of study Quality = B Good
Hernandez, R., Suarez- usefulness and retrospective Age review follow up, showing
Ortega, L., & Zuccotti, safety of insulin multicenter positive trend throughout Unable to assess Recommendations:
G. (2013) pump therapy in a cohort study Disease duration Methods of Data follow-up, but varied Canada for advanced Future prospective studies
large cohort of Collection: according to country. No pump features would be useful to
A 7-year follow-up pediatric patients Sample: 115 Age at CSII Retrospective review of differences observed evaluate reasons for
retrospective, with type 1 pediatric initiation charts between January regarding insulin differences observed in
 PEDIATRIC USE OF INSULIN PUMP THERAPY 16

Study
Variables:
Author, Date, Title Research Independent Rating of Evidence/
of Study, Journal Questions/ Methods (IV) Measures/ Results/Findings Limitations Recommendations
Hypothesis/ Dependent Reliability Validity
Purpose (DV)
Research
(RV)
international, multicenter diabetes mellitus patients aged 5- 2011 and December 2011 requirement according to Unable to assess trends of sustained
study of insulin pump during 7-year 20 years with Body mass by site investigator country or gender. BMI Tanner staging improvement of HbA1c
therapy in children and follow-up in 3 type 1 diabetes index (BMI) increased due to level over 7 years among
adolescents with type 1 diabetes centers and CSII use for physiological growth. Foreign research three countries such as
diabetes from 3 different >5 years HbA1c Severe hypoglycemia adds limitation to different dietary habits,
countries decreased from baseline apply findings to the lifestyle and pump
Acta Diabetologica Setting: Insulin to end of follow-up and United States education
Ospedale Luigi Requirement significant decrease in
Sacco (Milano, DKA episodes was
Italy), Alberta Serious adverse observed. Age and
Children’s events disease duration at CSII
hospital initiation was found to
(Calgary, Advance pump have no influence on
Canada), features glycemic control.
Hospital Sant Patients using advanced
Joan de Deu pump features did show
(Barcelona, significantly better
Spain) HbA1c levels compared
to those who did not use
them
 PEDIATRIC USE OF INSULIN PUMP THERAPY 17

Study
Variables:
Author, Date, Title Research Independent Rating of Evidence/
of Study, Journal Questions/ Methods (IV) Measures/ Results/Findings Limitations Recommendations
Hypothesis/ Dependent Reliability Validity
Purpose (DV)
Research
(RV)
Fendler, W., Purpose: To Design: RV: Gender Instruments: Mean post-study HbA1c Non-random Level = VI
Baranowska, A., evaluate the impact Prospective Age at Data collected by levels were statistically allocation of patients Quality = B Good
Mianowska, B., of treatment with observational enrollment manually curated higher in MDI than in leads to potential for
Szadkowska, A., & CSII on the study database of discharge CSII-treated patients. bias Recommendations:
Mlynarski, W. (2011) metabolic control Duration of summaries Percentage of patients Previous studies have
(expressed as Sample: 454 diabetes at reaching the therapeutic Foreign research shown increased long-term
Three-year comparison glycated level— children with enrollment in Methods of Data goal of <7% of HbA1c adds limitation to complications resulting
of subcutaneous insulin HbA1c) and its type 1 diabetes years Collection: equaled 32.9% in the apply findings to the from variability of HbA1c.
pump treatment with variability in Data collected from CSII and 25.7% in the United States Therefore further studies
multi-daily injections on children with Setting: Study Daily insulin study center of patients MDI group (P=0.12). aimed at interventions
HbA1c, its variability diabetes center within dose hospitalized between Total duration of hospital reducing HbA1c
and hospital burden of Lodz C-peptide level January 2002 to stays did not differ variability would be
children with type 1 administration December 2010 significantly between worthy.
diabetes region, Poland HbA1c groups, however patients
treated with CSII had
Acta Diabetologica Multiple daily significantly lower
injections number of total hospital
days per year compared
Continuous to MDI group
subcutaneous
insulin infusion

Days in hospital
per year

Days in hospital
per year for
emergency