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In patients with type 1 diabetes mellitus, does insulin pump In patients with type 1 diabetes mellitus, does insulin pump
therapy provide greater patient satisfaction than use of multiple therapy provide greater patient satisfaction than use of multiple
daily injections? daily injections?
Jacob Miller
Philadelphia College of Osteopathic Medicine
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In patients with type 1 diabetes mellitus, does insulin pump therapy provide greater patient
satisfaction than use of multiple daily injections?
Jacob Miller, PA-S
A SELECTIVE EVIDENCE BASED MEDICINE REVIEW
In Partial Fulfillment of the Requirements For
The Degree of Master of Science
In
Health Sciences – Physician Assistant
Department of Physician Assistant Studies
Philadelphia College of Osteopathic Medicine
Philadelphia, Pennsylvania
December 18, 2020
ABSTRACT
OBJECTIVE: The objective of this selective EBM review is to determine whether or not “In
patients with type 1 diabetes mellitus, does insulin pump therapy provide greater patient
satisfaction than use of multiple daily injections?”
STUDY DESIGN: Review of two randomized controlled trials (RCT’s) and one cross-sectional
study. All studies were published in English.
DATA SOURCES: The two randomized controlled trials and one cross-sectional study were
found via Cochrane Collaboration and PubMed. All sources were published in peer-reviewed
journals and were chosen based on their relevance to the clinical question.
OUTCOMES MEASURED: The primary outcome measured in the selective EBM review was
treatment satisfaction. Treatment satisfaction was measured using an Insulin Treatment
Satisfaction Questionnaire (ITSQ)- based on six items of insulin device delivery satisfaction, an
eight-item treatment satisfaction questionnaire (scored on a 1-5 scale), and a treatment
satisfaction questionnaire (scored on a 7-point Likert scale).
RESULTS: In a cross-sectional study conducted by Hussain et al., insulin pump users showed a
statistically significant increase in treatment satisfaction than those on multiple daily injections.
Overall mean of scale for treatment satisfaction questions was 25.3 and 29.7 for the MDI and
pump treatment groups, respectively. In an RCT by Speight et al., ITSQ scores were analyzed at
the 6-month RCT interval, in which insulin pump participants reported a statistically significant
increase in satisfaction with their insulin “device delivery” than those allocated to MDI (94.4 and
75.0), respectively. Lastly, in an RCT by Thrailkill et al., patients using insulin pump therapy
reported a statistically significant increase in satisfaction with form of treatment compared to
those allocated to MDI. At 12 months, 2.7 times the odds were reported in favor of the insulin
pump treatment group (OR = 2.74, 95% confidence interval 1.41, 5.29, P = 0.001).
CONCLUSIONS: All three studies in this evidence-based review confirmed that in patients
with type 1 diabetes, insulin pump therapy provides greater treatment satisfaction that use of
multiple daily injections. Future trials emphasizing increased sampling sizes and expanded
follow-up intervals may be found beneficial in supporting this data.
KEYWORDS: type 1 diabetes, treatment satisfaction, insulin delivery
Miller | Insulin Pump vs. MDI
1
INTRODUCTION
Type 1 diabetes mellitus, also known as insulin-dependent diabetes, is a chronic disease
of insulin deficiency, resulting from an autoimmune-mediated progressive destruction of
pancreatic b-cells. Insulin, produced by these pancreatic b-cells, is an essential hormone that
facilitates the final digestion of glucose into energy. As glucose is the main source of energy
used by cells of the human body, insulin deficiency prevents these cells from using glucose as
fuel needed to function. As seen in type 1 diabetes, lack of this hormone causes glucose (blood
sugar) levels to rise, leading to a myriad of health ramifications. While the pathology of the
disease is not fully understood, research has shown that certain genetic factors, such as HLA-
DR3 and HLA-DR4, may increase the likelihood of developing the disease. Other data suggests
a possible environmental component, such as a virus, to play a role in the development of type 1
diabetes.
1-2
Approximately 1.6 million Americans are affected by type 1 diabetes, averaging 64,000
new cases per year.
An estimated 5 million Americans are expected to have type 1 diabetes by
the year 2050. With the disease on the rise, healthcare costs for type 1 diabetes have increased as
well. In the US, $16 billion are associated with type 1 diabetes-associated health care
expenditures annually.
3
There are no data currently available estimating type 1 diabetes office
visits per year, although the CDC estimates 11.5% of visits indicate diabetes (both type 1 and
type 2) on the medical record.
1
Despite promising research of the disease in the last few decades, there is currently no
cure for type 1 diabetes. Mainstay of treatment includes the use of exogenous insulin to
supplement the lack of the hormone produced by the body. Insulin is indigestible; therefore, it
cannot be taken orally but rather administered subcutaneously via injections.
1-2
While all type 1
Miller | Insulin Pump vs. MDI
2
diabetics must take insulin, the route of insulin administration may vary based on patient
preference. Insulin delivery methods include multiple daily injections via insulin vials and
syringes, pre-filled insulin pens, and insulin pumps. Treatment also includes carbohydrate
counting, frequent blood sugar monitoring via finger sticks or continuous glucose devices,
maintaining a healthy diet, exercising regularly, and maintaining a healthy weight.
1-2
The treatment options mentioned above all play a role in decreasing mortality rates and
long-term complications of the disease. Insulin, being the mainstay of treatment, was first
invented by Sir Frederick G Banting, Charles H Best, and JJR Macleod at the University of
Toronto in 1921. An illness once known for its high fatality, often within 2 years of onset, had
suddenly transformed into a manageable disease. The discovery has ultimately saved millions of
lives throughout the years, revolutionizing the disease forever.
4
Since then, insulin is known to
be the only effective treatment for the disease. While treatment of type 1 diabetes has not
changed over the last several decades, the route of insulin administration has evolved. With
enhancing technology, insulin delivery methods have advanced from multiple daily injections via
vials/syringes and pre-filled insulin pens, to now continuous subcutaneous insulin therapy via
insulin pumps. While several studies have proven the efficacy of these advancing technologies,
limited studies have attempted to evaluate treatment satisfaction between these insulin delivery
methods. This paper evaluates two randomized control trials and one cross-sectional study
comparing patient satisfaction among type 1 diabetic patients using insulin pump therapy vs.
multiple daily injections.
OBJECTIVE
The objective of this selective EBM review is to determine whether or not “In patients
Miller | Insulin Pump vs. MDI
3
with type 1 diabetes mellitus, does insulin pump therapy provide greater patient satisfaction than
use of multiple daily injections?”
METHODS
The studies used in this review were found by searching Cochrane Collaboration and
PubMed databases with the key words “type 1 diabetes”, “treatment satisfaction”, and “insulin
delivery”. Studies were chosen for this review if they proved relevance to the clinical topic,
results were measured by Patient-Oriented Evidence that Matters (POEMs) and fit the inclusion
and exclusion criteria for this study. Inclusion criteria consisted of studies published after 2010.
Exclusion criteria consisted of studies published earlier than 2010 and studies evaluating type 2
diabetes. The statistics analyzed in this review included OR, mean treatment satisfaction, and p-
value. All of the studies selected were written in English and published in peer-review journals.
Two randomized controlled trials and one cross-sectional study were utilized in this
review. The focused population for the studies of this review included patients with type 1
diabetes mellitus. The intervention applied in all three studies was insulin pump therapy,
compared to the use of multiple daily injections (MDI). Demographics and characteristics of the
studies can be found below in Table 1.
OUTCOMES MEASURED
The primary outcome measured in this selective EBM review was treatment satisfaction.
Treatment satisfaction was measured using an Insulin Treatment Satisfaction Questionnaire
(ITSQ)- based on six items of insulin device delivery satisfaction, an eight-item treatment
satisfaction questionnaire (scored on a 1-5 scale), and a treatment satisfaction questionnaire
(scored on a 7-point Likert scale).
5-7
Miller | Insulin Pump vs. MDI
4
Table 1. Demographics & Characteristics of Included Studies
5-7
RESULTS
Hussain et. al conducted a cross-sectional study comparing treatment satisfaction and
health perception in children and adolescents with type 1 diabetes on multiple daily injections,
insulin pump, and sensor-augmented pump therapy. A total of 72 patients were selected for this
study based on the inclusion/exclusion criteria found in Table 1.
5
Patients were divided into
three groups based on treatment used: multiple daily injections (30), insulin pump (23), and
sensor-augmented pump therapy (19). Data were collected using a customized questionnaire
Study
Type
# Pts
Age
(years)
Inclusion
Criteria
W/D
Hussain
5
(2017)
Cross-
sectional
72
11.4 ±
4.4
Children and
adolescents
with type 1
diabetes
mellitus
0
Speight
6
(2019)
RCT
96
18-74
Adults with
longstanding
type 1 diabetes
mellitus and
problematic
hypoglycemia
20
Thrailkill
7
(2011)
RCT
24
8-18
Children and
adolescents
with newly
diagnosed type
1 diabetes
mellitus
2
Miller | Insulin Pump vs. MDI
5
during patient follow-up visits at the Mafraq Hospital diabetes clinic in Abu Dhabi. Answers
were obtained via 30-40-minute interviews in a private room at the clinic department.
5
The questionnaire consisted of two parts, treatment satisfaction and health perception.
The treatment satisfaction portion included an eight-item questionnaire (scored on a 1-5 scale).
The questionnaire analyzed four subscales: perceived general management (Q1-3), feeling
toward hypo/hyperglycemia (Q4-5), perceived frequency of use of treatment method to correct
high blood glucose or give extra insulin for snacks (Q6-7), and perceived compatibility of the
treatment methods with the lifestyle related to dietary habits (Q8).
5
The higher the score, the
higher the satisfaction. Overall mean of scale for treatment satisfaction questions was 25.3 and
29.7 for the MDI and pump treatment groups, respectively. The difference was significantly
different between the groups with a p value of 0.00.
5
Table 2. Treatment Satisfaction Analysis
5
MDI (23)
Pump (23)
P-value
Treatment Satisfaction
Total Mean
25.3
29.7
0.00
Speight et al. conducted a randomized controlled trial assessing treatment satisfaction
with the use of different technologies for insulin delivery and glucose monitoring among adults
with longstanding type 1 diabetes and problematic hypoglycemia. This study is a follow-up
from the HypoCOMPaSS randomized clinical trial performed by Speight et al. in 2014. In brief,
the study was a multicenter trial (including five UK tertiary referral diabetes centers). A total of
96 patients were selected for this study based on the inclusion/exclusion criteria found in Table
1.
6
Participants were randomized into two groups, MDI (50) and insulin pump therapy (46).
Half of this sample (n=48) was randomized to either self-monitoring of blood glucose (SMBG)
or real-time continuous glucose monitoring (RT-CGM). Data was collected using two subscales
Miller | Insulin Pump vs. MDI
6
of an Insulin Treatment Satisfaction Questionnaire (ITSQ): “hypoglycemic control” (five items)
and “device delivery” (six items).
6
Participants responded to questions about their insulin
treatment based on six items of insulin device delivery satisfaction, higher scores indicating
greater satisfaction. Patient-reported outcome measures were completed at baseline, 6-months
(RCT endpoint), and 2 years (study endpoint). At the conclusion of the 6-month RCT,
participants had the option of switching their insulin delivery modality. At 2 years, 20 (21%) of
participants were lost to follow-up.
6
Due to this limitation, only data from the 6-month interval
was used in this review.
ITSQ scores were analyzed at the 6-month RCT interval, in which insulin pump
participants reported greater satisfaction with their insulin “device delivery” than those allocated
to MDI (94.4 and 75.0), respectively. The difference between the groups were significantly
different with a p-value of <0.001. Furthermore, the insulin pump group reported greater
satisfaction with “hypoglycemic control” compared to the MDI group (76.7 and 63.3),
respectively. This disparity was also found to be significantly different with a p-value of 0.048.
6
Table 3. Insulin Treatment Satisfaction Questionnaire (ITSQ)
6
Endpoint
MDI
Insulin Pump
P-value
Delivery
RCT 6
months
75.0 (61.1-94.4) (n=45)
94.4 (83.3-100) (n=38)
<0.001
Hypoglycemic Control
RCT 6
months
63.3 (63.3-80.0) (n=45)
76.7 (63.3-88.3) (n=37)
0.043
Thrailkill et al. is a randomized controlled trial comparing MDI therapy with insulin
pump therapy in newly diagnosed type 1 diabetics. A total of 24 patients (8-18 years old) were
selected for the study, recruited from clinics at Arkansas Children’s Hospital, Little Rock.
Further inclusion/exclusion criteria can be found in Table 1.
7
Patients were randomly assigned
into two treatment groups, MDI (12) or insulin pump treatment (12), with the use of
Breeze/STAT software. As a secondary outcome measure, treatment satisfaction was assessed in
Miller | Insulin Pump vs. MDI
7
this study via a self-report questionnaire. Questions were scored on a 7-point Likert scale at the
6-month and 12-month follow up visits. Differences between groups on the satisfaction
responses were examined using Fisher’s Exact P-value test.
7
Participant satisfaction was significantly different between treatment groups for various
aspects of the assigned treatment. While overall patient satisfaction with treatment efficacy did
not differ between groups, the route of treatment administration did significantly differ. As seen
in Table 4, participants assigned to insulin pump treatment reported increased satisfaction with
form of treatment at both time intervals. At 12 months, 2.7 times the odds were reported in favor
of the insulin pump treatment group (OR = 2.74, 95% confidence interval 1.41, 5.29, P =
0.001).
7
Table 4. Participant Self-Report of Satisfaction, MDI vs. Insulin Pump
7
6 months
12 months
OR (95% CI)
Fisher’s Exact P
OR (95% CI)
Fisher’s Exact P
(Q8) Satisfied with
form of treatment
1.70 (1.01, 2.58)
0.033
2.74 (1.41, 5.29)
0.001
DISCUSSION
Type 1 diabetes mellitus is a chronic medical condition that comes with many unique
challenges. While advancing technologies have shown improvement in treatment and regulation
of glucose levels, adjusting to these insulin delivery methods can be a difficult process. Many
studies have examined the efficacy of these modalities, although few studies have addressed
treatment satisfaction among the type 1 diabetic population. This systematic review assesses the
treatment satisfaction of the two most common methods of insulin delivery, multiple daily
injections and insulin pump therapy. All three studies evaluated treatment satisfaction among
these two treatment groups via treatment satisfaction questionnaires. Hussain et. al demonstrated
an increased overall mean scale of treatment satisfaction among insulin pump users.
5
Speight et
Miller | Insulin Pump vs. MDI
8
al. confirmed participants were more satisfied with insulin pump therapy in terms of insulin
delivery device.
6
Thrailkill et al. reported greater satisfaction with route of treatment
administration of the insulin pump group as well.
7
While further studies including larger
treatment trials may help support this claim, it is clear in patients with type 1 diabetes, insulin
pump therapy provides greater treatment satisfaction that use of multiple daily injections.
Superiority of treatment satisfaction of pump therapy over MDI can be attributed to
several different factors. First, the added flexibility of pump function is an important added
benefit. With the insulin pump, patients have the flexibility to make various adjustments to their
insulin levels to suit exercise, sleep, and various types and timing of food.
8
Another reason for
this disparity is the decreased sense of physical and dietary restrictions. Hussain et al. found a
significant difference among study groups in relation to dietary restriction and insulin method
used, with insulin pump users scoring higher.
3
These results may be attributed to the user-
friendliness and accessibility of the insulin pump, rather than those who rely on multiple daily
insulin injections. Hussain et. al. also reported that insulin pump users found greater ease with
meal coverage and hyperglycemia correction compared to the MDI group.
5
Although the trials mentioned revealed promising data in regard to insulin treatment
satisfaction, various limitations were noted among the studies in this review. Hussain et. al
mentions the relatively low number of patients involved in the study. Similarly, Thrailkill et al.
emphasizes the trial’s intention as a pilot study. Consequently, the study cohort was small. In
both cases, larger trials involving more patient subjects may further support their findings.
5,7
Speight et al. highlights various limitations as well, including the impossibility of concealing
insulin delivery device allocations from clinicians/study participants when their features and
capabilities are so different. The study also discusses the possibility of bias involved in the
Miller | Insulin Pump vs. MDI
9
study, as treatment satisfaction is necessarily a subjective, patient-reported outcome. While
many biomedical outcomes are objective markers (e.g. HbA1C), the concept of satisfaction can
be subjected to ideas like “gratitude bias” (i.e. participants feel indebted for the opportunity to
access the latest treatments).
6,9.
Limitations were also noted in the research of this evidence-based review. While many
studies exist that focus on the treatment efficacy of type 1 diabetics, few studies concentrate on
patient treatment satisfaction. Research validity was also a limitation to this review, considering
the majority of studies available were not randomized controlled trials. Furthermore, of those
that were found to be RCT’s, several studies were found to be outdated and lacked significance
to this review.
The use of insulin pump therapy was noted in the 1970’s as an alternative to multiple
daily injections. Since then, the insulin pump is a common insulin delivery modality used
among type 1 diabetics. An estimated 400,000 people in the U.S use insulin pumps today.
10-11
Currently, there are multiple variations of insulin pumps available on the market. Medtronic
Minimed, T-slim, and the Omnipod are some of the more popular pump brands that exist today
that offer touchscreen, tubeless, and user-friendly options. In addition to improved treatment
satisfaction, increasing evidence indicates insulin pump therapy to be associated with improved
glycemic control and lower levels of HbA1C. However, similar to MDI therapy, side effects
such as erythema and scar tissue formation at administration sites may be seen in patients.
Additional side effects of the insulin pump include increased risk of infection due to cannula
insertion and possible psychological problems on account of 24/7 device attachment.
10
Another
issue with insulin pump therapy is that many insurance plans require patients to meet certain
criteria to earn coverage eligibility. This criteria includes prior authorization from a healthcare
Miller | Insulin Pump vs. MDI
10
provider and evidence of medical necessity. As the average cost of an insulin pump can range
from $3,000-$6,000 annually, insurance coverage is a substantial factor when considering insulin
pump therapy.
CONCLUSION
All three studies in this evidence-based review demonstrated that in patients with type 1
diabetes, insulin pump therapy provides greater treatment satisfaction that use of multiple daily
injections. With the use of insulin treatment satisfaction questionnaires, all studies found a
significant difference among the two groups, favoring insulin pump therapy.
5-7
As treatment
satisfaction is a subjective patient-reported outcome, an insulin treatment satisfaction is a
practicable method of assessment. Future trials emphasizing increased sampling sizes and
expanded follow-up intervals may be found beneficial in supporting this data. It is also
important to monitor safety, adverse side effects, and satisfaction of treatment of both treatment
modalities long-term. Type 1 diabetes is a chronic auto-immune disease that has surged to
historic high levels of incidence across the globe.
11-12
Although research today is focused much
on finding a cure for the disease, insulin therapy has been the only known effective treatment for
the past 98 years. Additional research trials are imperative at this time to further provide care
and treatment satisfaction to those afflicted by type 1 diabetes.
References
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20353017. Accessed October 5, 2020.
3. Type 1 Diabetes Facts. Juvenile Diabetes Research Foundation website.
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Published 2018 Oct 23. doi:10.3389/fendo.2018.00613
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and health perception in children and adolescents with type 1 diabetes mellitus on
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[doi].
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doi:10.1111/j.1524-4733.2004.72252.x
10. Umpierrez GE, Klonoff DC. Diabetes technology update: use of insulin pumps and
continuous glucose monitoring in the hospital. Diabetes Care. 2018;41(8):1579-1589.
doi:10.2337/dci18-0002
11. National Diabetes Statistics Report, 2020. Centers for Disease Control and Prevention.
https://www.cdc.gov/diabetes/data/statistics-report/index.html Accessed October 5,
2020.
12. Type 1 Diabetes Health Insurance Guide. Juvenile Diabetes Research Foundation
website. https://www.jdrf.org/t1d-resources/living-with-t1d/insurance/. Accessed
December 5, 2020.