Student Name: M. Vincent John A.

Osorio

Title – Using Insulin Pump Therapy in Managing Type 1 Diabetes in New Zealand: A
Randomized Controlled Trial

ABSTRACT

Paediatric diabetes prevalence in New Zealand is one of the highest in the world. Researchers have
reported that the incidence of type 1 diabetes (T1D) had significantly increased over the previous
years, leading to concerns that a growing number of people would suffer complications and early
deaths due to this condition. This quantitative randomized control trial (RCT) study seeks to evaluate
the effects of insulin pump therapy compared to the conventional insulin injection approach on
managing T1D among New Zealanders. 30 participants who met the inclusion criteria are
randomized to the control group (CG), who will continue using insulin injection therapy (n=15), or
the intervention group (IG), who will use insulin pump therapy (n=15). Glycated haemoglobin
(HbA1c) levels will be measured at baseline, 3, and 6 months and hypoglycaemic events will be
recorded in a log book in both groups. Statistical analysis of the measurements will be done through
Microsoft Excel 2019, with descriptive statistics, and Statistical Package for the Social Sciences (SPSS)
version 29, with t-test analysis. Ethical research principles will be observed, and participants can
leave the study at any time. With this study, healthcare practitioners in New Zealand will be able to
optimize treatment methods for people with T1D, since it will evaluate the efficiency of insulin pump
therapy and insulin injections.

RESEARCH AIM

This study aims to evaluate how insulin pump therapy affects diabetes management among people
in New Zealand with T1D compared to those using the traditional insulin injection method.

BACKGROUND AND LITERATURE REVIEW

Introduction

T1D is an incurable illness often diagnosed in childhood, and New Zealand has one of the highest
rates of paediatric diabetes in the world (Derraik et al., 2012; Willis et al., 2022; Wu et al., 2023).
Willis et al. (2022) found that T1D incidence in New Zealand has increased fivefold in the last 50
years. In addition, the increasing incidence of T1D in New Zealand is causing concern, putting more
people at risk of complications and early mortality (Holder-Pearson & Chase, 2022). Nathan et al.
(1993) confirmed the importance of strict glycaemic control in minimizing insulin-dependent
diabetes complications. Therefore, this study will determine the effectiveness of insulin pump
therapy and insulin injections to aid healthcare professionals optimize treatment approaches for
individuals with T1D in New Zealand.

Type 1 Diabetes and its Prevalence in New Zealand

In T1D, insulin-secreting pancreatic cells are destroyed by the immune system, causing high blood
glucose levels (Kahanovitz, 2017). Poorly controlled sugar levels can result in several complications
such as kidney failure, coronary artery disease, stroke, atherosclerosis, etc. (Rask-Madsen & King,
2013). Currently, there is no definite data on what causes T1D (Giwa et al., 2020). According to
Parkkola et al. (2013), having a blood relative with diabetes increases the likelihood of developing
Student Name: M. Vincent John A. Osorio

T1D; this is supported by several studies that state that having first-degree relatives is eight to
fifteen times more likely to develop T1D, and second-degree relatives are two times more likely
(Hemminki et al., 2009; Weires et al., 2007). However, there are also studies stating that T1D is not
caused by genetics. Morran et al. (2015) found that 80% of people with T1D have no family history of
the disease. Another study seeks the possibility that T1D may be triggered by Coxsackieviruses, and
prolonged viral infection may increase a child's risk of developing it (Christen et al., 2012).

In New Zealand, T1D incidence and prevalence differ by region (Wu et al., 2023). There has been an
association between geographical variation and ethnic demographics, as the incidence of T1D is
highest among people of European descent (Derraik et al., 2012; Willis et al., 2022). Campbell-Stokes
et al. (2005) found a higher incidence rate on the South Island than on the North Island, mainly due
to the higher percentage of European ethnicity. However, although Māoris have a lower incidence of
T1D, Tomlin et al. (2006) found out that the Māoris and Pacific Islanders had poorer glycaemic
control than European ethnicity.

Methods to control blood glucose

Several methods are available for controlling blood glucose; however, the two most common
methods are using human insulin injections and using pumps to deliver insulin into the body (Shah et
al., 2016). First, insulin injection is a method that involves the use of a syringe or pen to deliver
insulin to the subcutaneous layer of the skin. Typically, an injection of insulin is given into the fatty
tissue of the thighs, abdomen, or upper arms, and the injection site is rotated to avoid tissue
damage or scarring (Hirsch & Strauss, 2019). Insulin injections come in a variety of forms, including
short-acting, rapid-acting, long-acting, and intermediate-acting insulin. A person's insulin needs,
blood sugar level, and the time of day they eat determine the type of insulin prescribed for them
(Janez et al., 2020). One advantage of insulin injection therapy is that they are relatively inexpensive
(Karges et al., 2017). Additionally, insulin injections allow for easy dosing adjustments based on
blood sugar levels and carbohydrate intake (Kryzmien & Ladyzynski, 2019). However, insulin
injection therapy also has challenges. Multiple daily injections can be inconvenient and time-
consuming as it requires regular blood glucose monitoring to ensure the correct insulin dose is
delivered (McHill & Ahmann, 2017). Also, if the insulin dose given is too high or the patient skips a
meal, the risk of hypoglycaemia rises (Trief et al., 2016). According to Karges et al. (2017), there is a
higher incidence of severe hypoglycaemia with injection therapy than with pump therapy, 13.97 vs
9.55 per 100 patient years respectively with a 95% confidence interval (CI). This is because it is more
difficult to achieve precise dosing, and there may be delays in insulin absorption due to factors such
as injection site variability, physical activity, and food intake (Gradel et al., 2018).

Diabetic patients can also receive insulin using insulin pumps, a portable device used to deliver
insulin. An insulin pump can be worn on a belt or pocket and is about the size of a small cell phone,
with a small catheter inserted under the skin to administer insulin subcutaneously (Al-Beltagi et al.,
2022). Insulin pump therapy offers more flexibility and convenience than insulin injections. The
pump allows for more precise insulin dosing, with the ability to adjust automatically and deliver
insulin as needed (Berget et al., 2019). This can provide greater freedom and flexibility in meal
timing and physical activity. Insulin pump therapy has also been associated with improved blood
sugar control, reduced hypoglycemia, and improved quality of life compared to insulin injection
therapy (Almogbel, 2020; Ghazanfar et al., 2016; Karges et al., 2017). As an example, in the study by
Karges et al. (2017), they found that pump therapy leads to lower HbA1c levels than injection
therapy, 8.04% vs 8.22%, respectively, and with a 95% CI. In addition, the risk of long-term diabetes
consequences such as retinopathy, neuropathy, and nephropathy may also be decreased with
Student Name: M. Vincent John A. Osorio

insulin pump therapy (Zabeen et al., 2016). However, insulin pump therapy also has challenges. One
major challenge is that it requires more technical skill and knowledge than insulin injections,
including the ability to program the pump, change infusion sets, and troubleshoot technical
problems (Berget et al., 2019). Finally, some individuals may find the pump and tubing cumbersome
or uncomfortable to wear, which can affect adherence to therapy (Reidy et al., 2018).

Gap

Among several ways to control diabetes, insulin pump therapy is one of the most attractive and
promising. There are, however, no studies that compare insulin injection with insulin pump therapy
among New Zealanders with T1D. Therefore, this research aims to evaluate whether insulin pump
therapy improves diabetes control and decreases hypoglycaemia incidence among New Zealanders.

RESEARCH DESIGN, METHODOLOGY, AND METHOD

The Design

To explore the impact of insulin pump therapy on managing blood sugar levels and the incidence of
hypoglycaemia among people in New Zealand with T1D, a quantitative randomized controlled trial
design will be utilized. This approach is the gold standard since it evaluates how well an intervention
or treatment works (Hariton & Locascio, 2018).

Participants

Participants will be recruited from the Virtual Diabetes Register and Diabetes NZ databases.
Researchers will explain the study to potential participants before they decide whether to
participate. To qualify, patients must be receiving two or more daily insulin injections, have had T1D
for at least 12 months, have parental consent if minors, and have been using insulin injections for at
least 3 months. People younger than 12 months and older than 20 years, and those taking blood
glucose-affecting medications, are excluded. The study will assess 30 participants, split into the IG
and the CG.

Data Collection

Participants, along with their parents if they are minors, must attend an education session, online via
Zoom or in-person, covering different types of insulin, carbohydrate counting, and insulin
adjustment. After the session, families that hadn't previously employed carbohydrate/insulin ratios
or corrective doses for management should start applying these methods. Before being randomly
allocated to begin insulin pump therapy in the IG or continue receiving insulin injections in the CG,
the participants must proceed to the nearest Diabetes NZ clinic, and their HbA1c levels will be
measured and used as their baseline blood sugar level. Then, randomization will be done by having
the participants draw sealed envelopes to know what group they will be in. Participants will be
required to use the Dexcom G7 to check their blood sugar levels before each meal, and the IG will be
provided with a MiniMed 770G insulin pump. Following the randomization, the IG will receive
another education session about pumps. During the study period, participants will have access to
the investigator 24 hours a day if they have any concerns. Then, follow-up visits 3 and 6 months after
the baseline will be conducted to assess both groups' HbA1c levels. HbA1c is measured in this study
since Sherwani et al. (2016) stated that Hba1c is a reliable indicator of long-term glycaemic control
reflecting the cumulative glycaemic history of the preceding two to three months. Furthermore,
premeal blood sugar levels will be recorded using log books, and data from meters and pumps. This
Student Name: M. Vincent John A. Osorio

will enable us to determine if there are any hypoglycaemic events, having a glucose level of ≤70
mg/dL.

Data Analysis

After the HbA1c levels and hypoglycaemic events have been measured and collected, the statistical
evaluation will be performed using Microsoft Excel 2019 for the descriptive statistics, which covers
the standard deviation, mean, median, mode, confidence level, etc. The descriptive statistics option
in Excel quickly gives all the data in one place and it is faster than using different formulas to
calculate different values (Divisi et al., 2017). Then, the researcher will do additional analysis using
SPSS v29, to conduct a t-test analysis on the data collected. The t-test will be utilized to assess the
difference between the mean HbA1c results during baseline, 3, and 6 months after as well as the
number of hypoglycaemic events in the two groups. The t-test is employed to compare the averages
of the two groups, such as the IG and the CG, and is appropriate for continuous outcome variables
(Najmi et al., 2021). Then, P values below 0.05 will indicate proof of substantial differences
(Andrade, 2019).  

SIGNIFICANCE/BENEFIT OF THE STUDY

By comparing two different treatment approaches, insulin pump, and insulin injection therapy, the
researcher can determine which method is more effective in controlling blood sugar levels and
reducing the frequency of hypoglycaemic events, which is considered a serious concern for
individuals with T1D (Cryer, 2010). This information can then impact clinicians' decisions in selecting
the most appropriate and appropriate treatment option for their patients, that minimizes the risk of
hypoglycaemia thereby improving overall patient safety. Furthermore, by conducting the study
among New Zealanders with T1D, the results will be more relevant to the local population. Factors
such as lifestyle, dietary habits, healthcare infrastructure, and cultural aspects may influence
treatment outcomes. Thus, conducting the study in this specific population allows for the
generalizability of the findings and provides valuable insights for healthcare practitioners in New
Zealand.

ETHICAL CONSIDERATIONS

Initially, consent from Diabetes NZ will be obtained to use their database to find participants for the
study. After finding possible participants, they will be told that the researcher will protect their
identities by changing their names by utilizing pseudonyms, as well as concealing places and unique
distinguishing details. The researcher will be the only person to whom information is disclosed.
Access to the material is restricted and kept in a safe and lockable file. Confidentiality will be
addressed in this study at all stages of the research process, from data collection to research
publication. After a detailed explanation of the study is given to each participant, or their parents if
the subject is under the age of 16, written informed consent will be obtained. If a participant feels
uncomfortable or unsafe, they can quit the study at any moment. Participants will also be informed
of the study's dangers, particularly those who will use pumps to regulate their blood sugar levels.
These risks include difficulties changing infusion sets correctly, air entering into tubing, blocked
cannulas, and skin infections. However, to address these risks, participants or their parents will have
24-hour telephone access to the researcher during the course of the study to get direct answers to
 Student Name: M. Vincent John A. Osorio

their questions. Additionally, a qualified healthcare professional will be on hand to check

participants' safety and make adjustments as necessary.

TIMEFRAME
Month
June July August September October November December January February March April May
Action
Research
Proposal
Research
Ethics
Approval
Recruiting of
Participants
and Informed
Consent
Education
Session
Intervention
and Data
Collection
Data Analysis
Writing a
Report

COSTING

 Dexcom G7 blood glucose sensor - $163.50/month X 7 months X 30 participants =

$34,335.00
 MiniMed 770G insulin pump - $1500.00 X 15 participants = $22,500.00
 HbA1c laboratory test – $34.00/test X 90 tests = $3060.00
 Statistical Package for the Social Sciences v.29 subscription = $99/month
 On-call healthcare professional fee = $1000.00
 Travel and miscellaneous expenses = $1006.00
 Total expenses = $62,000.00