92612. Research in Health. Assessment 1: Development of

92612 Research in Health
Assessment 1: Development of a draft research proposal
DEVELOPMENT OF A DRAFT RESEARCH PROPOSAL
Name of the Student:
Name of the University:
Author note:
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92612 Research in Health
Assessment 1: Development of a draft research proposal
1. Study Title
Comparative exploration of patient experiences between
continuous subcutaneous insulin infusion (CSII) and multiple daily
insulin injections (MDII) across children and adolescents for the
treatment and management of type 2 diabetes mellitus (T1DM) : a
qualitative study
2. Introduction
Juvenile diabetes, also known as type 1 diabetes mellitus (T1DM) is
chronic metabolic condition prevalent across children and
adolescents, and is characterized by excessive and uncontrollable
levels of glucose in the circulating blood, due to an absence or
negligible amount of insulin produced by the pancreas (Sher et al.,
2016, p. 88). While dietary and exercise alterations comprise some
of the most prevalently recommended interventions, patients are
often required to externally take insulin injections for improve
management of blood glucose levels. Lack of long term control and
maintenance of stable levels of blood glucose, increases one’s risk
of life threatening chronic conditions like cardiovascular, renal and
hepatic disorders (Lind et al., 2018, p. 380).
Recent evidence suggests that continuous subcutaneous insulin
infusion (CSII) is associated with improved metabolic health
outcomes in T1DM patients in terms of glycaemic control, blood
glucose levels and HbA1c levels as compared to the traditionally
used, multiple daily insulin injections (MDII). Such findings have
raised a debate on the effectiveness of both these treatments in the
long term management of T1DM in young patients (Beck et al.,
2017, p. 375). According to the Australian Institute of Health and
Welfare (Phelan et al., 2017, p. 124), the number of Australians
who are using CSII for T1DM management has increased from 107
every month to 140 every month between 2004 to 2010. While
available evidence has reported findings on glycaemic outcomes,
there is limited research on the experiences of patients while using
CSII in comparing to MDII. It is worthwhile to note that CSII
methods of insulin administration comprises of continuous infusion
or administration of short-term insulin beneath the skin, with the
help of soft cannulas or needles (Biester et al., 2017, p. 175).
Despite its effectiveness, according to Szypowska (2016, p. 40),
CSII usage poses disadvantages in the form of higher costs, lack of
convenience during traveling and requirement of commendable
level of technological expertise. It is for this reason, there is an
increased interest to explore the experiences, preferences and
opinions of patients regarding its usage - hence, forming the
rationale underlying the study proposed for this research.
3. Background
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92612 Research in Health
Assessment 1: Development of a draft research proposal
For exploring the background underlying the development of the
proposed research, a literature review was conducted. Studies for
the literature review were selected on the following inclusion
criteria:
 Language: English
 Subjects: Only Human
 Methods: Quantitative studies like cohort studies,
randomized controlled trials.
 Key words: ‘Continuous Subcutaneous Insulin Infusion’,
‘Multiple Daily Insulin Injections’, ‘type 1 diabetes mellitus’,
‘children and adolescents’ along with Boolean operators like
‘AND’, ‘OR’.
 Publication: 2010 to 2019
 Type of studies: Peer reviewed
An electronic search strategy was conducted using Google Scholar,
where articles relevant to the above inclusion criteria was selected
while those irrelevant to the same, were excluded. The reviewed
studies have been summarized below and have also been tabulated
in the form of a summary table (Appendix 1) (McGowan et al.,
2016, p. 45).
The population cohort study performed by Karges et al., (2017, p.
1359), explored the relationship between CSII and glycaemic
control and severe hypoglycaemia-induced ketoacidosis as
compared to MDII across 30, 579 patients comprising of children,
adolescents and young adults suffering from type 1 diabetes
mellitus. The findings reported lower levels of glycosylated
haemoglobin levels in patients using CSII as compared to MDII,
between January 2011 and December 2015 (8.04% vs 8.22%;
difference, -0.18 [95% CI, -0.22 to -0.13], P < .001). Similarly,
decreased rates of ketoacidosis (3.64 vs 4.26 per 100 patient-years;
difference, -0.63 [95% CI, -1.24 to -0.02]; P = .04) and severe levels
of hypoglycaemia (9.55 vs 13.97 per 100 patient-years; difference, -
4.42 [95% CI, -6.15 to -2.69]; P < .001) were observed in patients
adhering to CSII as compared to MDII. The findings of this study,
comprising of such a large sample size and time period, hence
indicate the long term positive glycaemic outcomes of CSII as
compared to MDII.
Improved management of glycaemic outcomes is associated with
prevention of long term complications like cardiovascular disease,
as rightly evidenced in the observational study by Steineck et al.,
(2015, p. 1), which explored cardiovascular mortality 18, 168 T1DM
patients using CSII as compared to MDII, from January 2005 to
December 2012. Patients using CSII as compared to MDII were
found to posses lower hazard ratios in terms of 0.58 (0.40 to 0.85)
for fatal cardiovascular disease (stroke or coronary heart disease),
0.55 (95% confidence interval 0.36 to 0.83) for fatal coronary heart
disease and and 0.73 (0.58 to 0.92) for mortality associated with all
causes. Such findings prove to be useful for ensuring long term
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92612 Research in Health
Assessment 1: Development of a draft research proposal
positive health outcome and prevention of cardiovascular
complications for CSII as compared to MDII.
In criticism, it is worthwhile to note that none of the above studies
(Karges et al., 2017; Steineck et al., 2015) explored glycemic
outcomes associated with CSII usage as compared to MDII in terms
of frequency with which patients suffer from hypoglycaemic
fluctuations and the number of dosages of insulin required to be
administered. The retrospective study by Layne, Parkin and Zisser
(2016, p. 178) explored efficacy of an Omnipod Insulin
Management system (pumps using tubeless patches) on 873
patients with T1DM. The findings reported beneficial outcomes in
terms of 16.4% reduction in the total daily doses of insulin as
compared to insulin injections (p < 0.001) for 3 month as well as
reduced self-reporting of episodes of severe hypoglycemia (p <
0.001) every week.
However, despite the estimated benefits, negative outcomes have
been evidenced by the restrospective cohort study performed by
Dixon, Nankervis and Hopkins (2018, p. 2), which studied health
parameters associated with pregnancy for the women undergoing
CSII as compared to MDII. Across 298 cases of pregnancies,
appointed from 2006 to 2016, it was observed that pregnant
women using CSII for management of gestational diabetes were
associated with a higher susceptibility of giving birth to infants who
are larger than their gestational age (aOR 2.00, 95% CI 1.20–3.34)
and neonates who are premature (aOR 1.80, 95% CI 1.04–3.03) as
compared to MDII patients.
However, it must be noted that for all the reviewed papers (Karges
et al., 2017; Steineck et al., 2015; Dixon, Nankervis & Hopkins,
2018; Layne, Parkin & Zisser, 2016), there was no measurement of
outcomes associated with patient experiences or preferences
towards usage of both type of insulin therapy – the key focus for
this paper’s proposed research. Additionally, there was a lack of
randomization or incorporation of randomized controlled trials
observed in all papers. Randomized Controlled trials are
considered the strongest studies of evidence-based research.
Hence, despite obtaining interesting results in the above papers,
the lack of randomization raises doubts in terms of validity and bias
(Deaton & Cartwright, 2018, p. 15).
Hence, considering these limitations, additional papers
incorporating randomized controlled trials were also incorporation
for improved understanding of current evidence concerning CSII
and MDII usage. Thus, useful insights can be acquired from the
randomized controlled trial performed by Wan et al., (2016, p.
943), which evaluated cost effectiveness between CSII and MDII
usage across 75 T1DM patients. It was observed that patients using
CSII had higher overall cost of treatment by $ 112, 045 and
reduced scores of quality of life by 0.71 as compared to MDII users.
Similarly, the randomized controlled trial Blair et al., (2018, p. 1),
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