Critical Analysis: Closed-Loop Insulin Delivery in Pregnancy

This report provides a comprehensive critique of the journal article titled 'Closed-loop insulin delivery during pregnancy in women with type 1 diabetes.' The critique begins with a brief overview of the study, which investigated the efficacy of closed-loop insulin delivery systems compared to sensor-based pump therapy in pregnant women with type 1 diabetes. The report then critically evaluates the methodology, highlighting the strengths and weaknesses of the study design, including the use of a crossover trial and the lack of comparison to sensor-based systems. The results section is examined, noting the statistical analysis and presentation of data, while also pointing out potential biases and limitations in the statistical methods. The discussion section is analyzed for its strengths, such as its grounding in recent findings, and its limitations, like the small sample size and lack of cultural considerations. The critique also references supporting literature to strengthen arguments and concludes by emphasizing the need for future research, particularly focusing on comparative studies and addressing the identified limitations. The report meticulously assesses the article's credibility, validity, and reliability, drawing on evidence from other studies to support the evaluations and arguments.

Running head: JOURNAL ARTICLE CRITIQUE
JOURNAL ARTICLE CRITIQUE
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Author’s Note:

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The journal chosen was ‘Closed-loop insulin delivery during pregnancy in women
with type 1 diabetes’ that had an aim of understanding the efficacy and efficiency of closed-
loop (automated) insulin delivery system that offer a better control of glycemic level as
compared to sensor-based pump therapy among the target population, pregnant women who
have diabetes type 1. Thus, an open-label, randomised, crossover research was conducted
upon the population mentioned above to assess the efficacy level on a day and night therapy,
which was followed by a continuation phase (Sagedal et al. 2017). The sample size was 16
pregnant women with Type 1 diabetes who had completed four weeks of interventional
therapy as well as a controlled trial on a random basis. At the time of the continuation phase,
14 respondents were used; thus, the final sample was selected upon which the analysis was
done. The result was statistically analysed, and from it, the primary result indicated that on an
overnight basis, the percentage of glucose levels was within the range of 63 to 140 mg per
decilitre. This demonstrated that the fact that the system is more effective in controlling the
glycemic level in the body and is considered to be a better therapy that helps in mitigating the
challenges of pregnancy.
The study intended to understand the effectiveness of the therapy on pregnant women
because, as per the previous study, it was found that in the case of patients that are not
pregnant and suffer from type 1 diabetes, the use of automated or closed-loop delivery of
insulin was more apt (Diabetes.co.uk, 2019). The use of a cross-over trial was stated to be
useful as it is a primary observation study that effectively focused on the purpose of the
study, and since the study was based on the target population, thus the result helped in
mitigating the complications of pregnant ladies having diabetes type 1. Even though in the
purpose, it was stated that the study would be conducted with the aim of understanding the
efficacy level of closed-loop as compared to the sensor-based system, however, the clinical
crossover trial did not include any study related to the sensor-based pump. Therefore, a

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comparison could not be drawn in the research. The researcher made a misinterpretation of
the purpose in this case. The introduction of the article was relevant in nature with respect to
the method used; however, the justification was not wholly aligned with the purpose. This is
one of the most significant issues found in the study (Perkins, Cardinez, and Opsteen 2019).
The overemphasis of the journal on understanding the practical level of the closed-loop
system rather than assessing the effectiveness between two systems was a weakness. The East
of England Research Ethics Committee of the Health Research Authority sanctioned the
study protocol, and the UK Medicines and Healthcare Products Regulatory Agency noted that
it does not have any objection against the study (Stewart et al. 2016). Thus, since a regulatory
body approves, it indicates it has high credits in the term of research.
From the result, it can be seen that the use of a closed-loop system was able to have
better glycemic control over pregnant women in case of hospitalization, labour and delivery
time. As per the opinion of Brown, Ceysens and Boulvain (2017), this is one of strength in
the article because it allowed in inferring that usage of this method will be able to reduce the
complications related to pregnancy. In this case, for analyzing the data, the use of statistical
analysis was used that primarily helped in calculating and presented the result in the
numerical range (Atkinson, Eisenbarth and Michels, 2014). The results were presented in
tabular form as well as a graphical representation, which was clearly understood by the
audience. Moreover, it can be stated that it was understandable for people that do not have
any idea about statistics as the range-based calculation indicated in frequency. This can be
said that the closed-loop system was more reliable and efficient as compared to the sensor-
based system, which is frequently used in the target population. As per the study of Farrar
(2019), it can be augmented that there are certain shortcomings in the results section, such as
the statistical method used for analysing was not strong enough to back up the claims
presented. The use of SPSS or other statistical methods would have been more effective as

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those are less biased in nature. The results can be easily manipulated without any concerns
and presented as per the researcher’s perception. Therefore, there can be bias demonstrating
that reliable issue is associated in this case. In addition to this, there is less evidence that
backs up the result in this journal article, as found in other articles. Garnæs et al. (2018)
opined that in an excellent article the results need to be supported by evidence from past
studies that will indicate the rationale of the article, as well as various statistical data, need to
be linked with the primary data obtained using data collection method which is lacking in this
case.
One of the biggest strengths in the discussion section of the article is it is entirely
based on recent findings as primary data collection method was used; therefore, the
reliability, efficacy, and effectiveness of the outcome were more as compared to any other
results found in the previous studies related to the same research topic. The findings of the
study are linked to the research aim stating that the significance of the use of closed-loop
system therapy among pregnant women suffering type 1 diabetes (Stewart et al. 2016). This
satisfactorily says that discussion has highlighted the main findings compactly thus, linking it
to the aim. Moreover, it indicated that the limitations in the study that affected the scope. The
participants do not have any experience related to sensor-augmented therapy, which limited
the context of comparative research in the pump users. The sample size was small, that is, 14
participants, and there were short trails within the therapy that did not allow evaluation of the
effect on neonatal and obstetrical results (Stewart et al. 2016). Moreover, it did not state any
future scope of the study that indicates the requirement of conducting more studies in order to
investigate the topic in a vivid manner taking into account the limitations stated in the
discussion. However, since it is being undertaken in the UK population, thus, there is a
limitation to the investigation as cultural variations, environmental factors, and country-
specific healthcare facilities were not taken into account. Therefore, a global study needs to

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be conducted to state the effectiveness and efficacy of the automated insulin delivery system
among the specified population (Trevitt, Simpson and Wood 2016).
From the critique, it can be stated there were numerous issues in the article that have
been highlighted. In addition, the strengths and weaknesses related to the research were
mentioned that require more focus on the perception of the researcher. There is a need for
conducting future research on this topic, taking into consideration the limitations stating in
the journals. One of the major problems was the comparison that was not highlighted in the
study between the interventional and control trail group. Thus, in the further study to evaluate
the difference in efficacy and effectiveness of the closed-loop system and sensor-augmented
therapy.

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References
Atkinson, M.A., Eisenbarth, G.S. and Michels, A.W., 2014. Type 1 diabetes. The
Lancet, 383(9911), pp.69-82.
Brown, J., Ceysens, G. and Boulvain, M., 2017. Exercise for pregnant women with pre‐
existing diabetes for improving maternal and fetal outcomes. Cochrane Database of
Systematic Reviews, (12).
Diabetes.co.uk (2019) Diabetes Prevalence. [online] Available at:
https://www.diabetes.co.uk/diabetes-prevalence.html [Accessed 24 Jan. 2020].
El Fathi, A., Smaoui, M.R., Gingras, V., Boulet, B. and Haidar, A., 2018. The artificial
pancreas and meal control: an overview of postprandial glucose regulation in type 1
diabetes. IEEE Control Systems Magazine, 38(1), pp.67-85.
Farrar, J., 2019. Science, innovation and society: what we need to prepare for the health
challenges of the twenty-first century?. International health, 11(5), pp.317-320.
Garnæs, K.K., Mørkved, S., Salvesen, K.Å., Salvesen, Ø. and Moholdt, T., 2018. Exercise
training during pregnancy reduces circulating insulin levels in overweight/obese women
postpartum: secondary analysis of a randomised controlled trial (the ETIP trial). BMC
pregnancy and childbirth, 18(1), p.18.
Perkins, B.A., Cardinez, N. and Opsteen, C.F., 2019. Talking Points for Helping Your Type 1
Diabetes Patient Decide About Hybrid Closed Loop. Canadian Journal of Diabetes.
Sagedal, L.R., Vistad, I., Øverby, N.C., Bere, E., Torstveit, M.K., Lohne-Seiler, H.,
Hillesund, E.R., Pripp, A. and Henriksen, T., 2017. The effect of a prenatal lifestyle
intervention on glucose metabolism: results of the Norwegian fit for delivery randomized
controlled trial. BMC pregnancy and childbirth, 17(1), p.167.

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Stewart, Z.A., Wilinska, M.E., Hartnell, S., Temple, R.C., Rayman, G., Stanley, K.P.,
Simmons, D., Law, G.R., Scott, E.M., Hovorka, R. and Murphy, H.R., 2016. Closed-loop
insulin delivery during pregnancy in women with type 1 diabetes. New England Journal of
Medicine, 375(7), pp.644-654.
Trevitt, S., Simpson, S. and Wood, A., 2016. Artificial pancreas device systems for the
closed-loop control of type 1 diabetes: what systems are in development?. Journal of
diabetes science and technology, 10(3), pp.714-723.