Critical Appraisal: Diabetes and Glucose Monitoring Research Report

This report presents a critical appraisal of a research study investigating the accuracy of continuous glucose monitoring (CGM) systems using different reference methods. The study, conducted on 21 individuals with type 1 diabetes, compared venous, arterialized-venous, and capillary glucose reference measurements. The analysis evaluates the study's methodology, including randomization, allocation concealment, and blinding, assessing potential biases. Key aspects examined include the similarity of baseline and treatment groups, the reliability of outcome measurements, and the appropriateness of statistical analysis, specifically the Mann-Whitney U test. The report also discusses the study's design, its deviations from a standard randomized controlled trial, and the reflection on the study's strengths and limitations. The study's primary endpoint was the median absolute relative difference (ARD) of the different glucose monitoring methods. The findings, including the effectiveness of arterialization and the comparison of the different reference methods, are evaluated. The report also discusses the study's limitations, particularly the lack of blinding, and the impact of these limitations on the validity of the study's conclusions.

Running head: CRITICAL APPRAISAL
CRITICAL APPRAISAL
Name of the Student
Name of the University
Author Note

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True randomisation
Yes. The sampling technique was in described with clarity and the 21 participants were
selected who were type 1 diabetes affected. Hence, every participant of the study has the chance
of generating similar risks (Kropff et al., 2017). Thus, according to Deaton and Cartwright
(2018), it can be highlighted as the true randomisation. Moreover, the process of the random
selection of the participants has been described in a systematic way, that is the participant
selection criteria and the allocation procedure has been described in a flow chart with proper
causal description. Hence, the randomisation can be marked as true randomisation procedure.
Concealed allocation
No. The study staffs and the participants were aware about the allocation process.
Although the allocation process was random however, as the allocation and the intervention was
known to the participants the concealed allocation has not been achieved (Clark, Fairhurst &
Torgerson, 2016). Thus, the lack of proper blinding of the participants and the study staffs can
develop a bias as well. Hence, it can be clearly seen that the process of the allocation has not
been concealed from the participants.
Similarity of baseline and treatment groups
Yes. It has been seen that the study has been conducted on the type 1 diabetes patients
and the baseline data of the patients were calculated with the help of Bland-Altman analysis
(Doğan, 2018). Moreover, three baseline conditions of the patients have been considered and the
difference after the treatment provided to the participants has been assessed. Based on the
assessment it has been seen that the outcome of the treatment has been related to the baseline
data. The changes have been based on the treatment and the change of the baseline data of the
participants as well (Kropff et al., 2017). However, the process was effective in terms of

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hyperglycaemia patients and not effective for the participants of hypoglycaemia patients. The
selection process has not been showed any biasness and the change is similar to the intervention
provided to the participants in relation to the baseline data.
Participants blind to treatment assignment
No. The participants have not been blind to the treatment. It has been seen that the
participants and the study staffs were aware about the intervention and the allocation of the
intervention as well. Hence, according to (Aftab et al., 2016), it can develop significant threat of
the biasness in the study results as well. Moreover, the change can be biased as well despite of
the random selection of the participants as well.
Study staffs blind to treatment assignment
No. The study staffs have not been blind to the treatment. It has been seen that the study
staffs were aware about the intervention and the allocation of the intervention as well. Hence,
according to Chandereng and Chappell (2019), it can develop significant biasness in the study
results as well. Moreover, the change can be biased as well despite of the random selection of the
participants as well.
Assessors blind to treatment
Unclear. There has not been any kind of specific mentioning about the consideration of
the knowledge of the assessors. Hence, it is unclear that the assessors have any knowledge about
the assignment of the treatment for the participants or the allocation of the participants in this
study (Kropff et al., 2017). Moreover, three baseline conditions of the patients have been
considered and the difference after the treatment provided to the participants has been assessed.
Based on the assessment it has been seen that the outcome of the treatment has been related to
the baseline data.

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Treatment groups treated identically
No. The treatment group has been treated with the identical intervention for the
comparison of the control group for the change. On this context it can be stated that the YSI
2300 STAT Plus has been used for the measurement of the glucose level change among the
control group and the participants in the intervention group (Schlueter et al., 2017). Thus, it can
be seen that the change would be significant through the intervention provided or not has been
measured by the comparison between that the control group and the intervention group. Hence,
the intervention group has not been provided with the different intervention. Hence, based on this
process it can be stated that the study is effective as per the knowledge development regarding
the accuracy of the venous, arterialized-venous, or capillary glucose reference measurements for
the accuracy assessment of monitoring of glucose level of a person. Hence, it can be stated that
the study is proper in terms of the effectiveness of the specific knowledge development.
Adequate description of analysis and follow up
Yes. The follow up and the effectiveness of the analysis process have been described in
the article and the factor of the significant intervention was analysed (Kropff et al., 2017).
However, the result has not been certain about the effectiveness of three different processes of
the measurement. However, the factor of the knowledge development regarding the process of
the measurement of the Continuous Glucose Monitoring (CGM) has not been achieved properly
(Danne et al., 2017). Hence, the Factor of the significance has not been achieved. However, the
process of the analysis and the follow up has been described properly throughout the article
result and method section.
Participants analysed in the groups

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Yes. The participants has been analysed with the consideration of the proper
randomisation. Thus, it can be seen that the authors analysed the process of the measurement in
different sample obtained throughout the research process and the follow up as well. On this
context it has been seen that the analysis has been conducted in different cases and the different
random groups as well. Hence, as per the process of the random allocation and the random
analysis has been done in the article. Based on the views of Rengerink et al. (2017), it has been
seen that the effective random analysis would be most required compliance for proper result
development.
Outcomes measured in the same way for treatment groups
Yes. The measurement of the changes throughout the research has been conducted with
the consideration of the random selection and the random allocation (Kropff et al., 2017).
However, the measurement has been done with the same process as for the control group and the
treatment group as well. Thus, it has been seen that the process of the measurement is similar for
every group. As per the views of Liu et al. (2016), the similarity of the measurement process can
reduce the risk of the bias of the research. On this context it can be stated that the process of the
measurement has been seen to be YSI 2300 STAT Plus tool usage. Thus, it can be stated that the
process of the measurement has been simple and effective as well. However, the outcomes were
not that much significantly different.
Outcomes measured in a reliable way
Yes. The process of the measurement has been chosen based on the reliability. The YSI
2300 STAT Plus tool has been an international process of the glucose level measurement. Hence,
it can be stated that the process of the measurement has been reliable for the measurement. On
the other hand the process of the measurement also used for the consideration of the arterialized-

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venous reference, capillary glucose reference or venous reference. Hence, it can be stated that the
process of measurement has been used for the significance of the monitoring process based on
the earlier mentioned three references. However, the result showed that the process of the
monitoring has not been effectively highlighting any significant difference between the
references. According to Fitzgerald, Rawdon and Dooley (2016), outcome measurement
reliability is dependent on the acceptability of the process and the similarity of the measurement
process for each group.
Statistical analysis used
Yes. The statistical analysis used here was the Mann–Whitney U test. It is one of the
effective processes for the statistical analysis for the comparison. Based on the process of the
statistical analysis the data has been described properly with consideration of the p value and the
confidence interval as well. On this context it can be stated that the statistical analysis is
appropriate for the test. Moreover, it has been depicted by MacFarland and Yates (2016), that the
Mann–Whitney U test is one of the most effective processes for the statistical analysis of the
comparing group data of similar interventions.
Trial design appropriate for the topic and deviation from standard RCT
Yes. The design of the trail has been appropriate for the topic as the research was based
on the effective monitoring system identification for the Continuous Glucose Monitoring
(CGM). The comparison of different processes have analysed with the consideration of the
similar measurement technique of glucose level. Hence, the randomised control trial would be
very much effective as it can develop an effective idea about the significance of three processes
identified here for the monitoring. On this context Spijkerman, Pots and Bohlmeijer (2016),
stated that the randomised control trial would be very much effective for the knowledge

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development about the effectiveness of one process or intervention among different type of
processes.

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Reflection
Aftab, R. A., Khan, A. H., Adnan, A. S., & Jannah, N. (2016). A systematic review on
randomized control trials on rennin angiotensin aldosterone system inhibitors role in
managing hypertension among hemodialysis patients. Renal failure, 38(3), 474-480.
Chandereng, T., & Chappell, R. (2019). Robust Response-Adaptive Randomization Design.
arXiv preprint arXiv:1904.07758.
Clark, L., Fairhurst, C., & Torgerson, D. J. (2016). Allocation concealment in randomised
controlled trials: are we getting better?. Bmj, 355, i5663.
Danne, T., Nimri, R., Battelino, T., Bergenstal, R. M., Close, K. L., DeVries, J. H., ... & Beck, R.
(2017). International consensus on use of continuous glucose monitoring. Diabetes care,
40(12), 1631-1640.
Deaton, A., & Cartwright, N. (2018). Reflections on Randomized Control Trials. Social science
and medicine., 210, 86-90.
Doğan, N. Ö. (2018). Bland-Altman analysis: A paradigm to understand correlation and
agreement. Turkish journal of emergency medicine.
Fitzgerald, A., Rawdon, C., & Dooley, B. (2016). A randomized controlled trial of attention bias
modification training for socially anxious adolescents. Behaviour research and therapy,
84, 1-8.
Kropff, J., van Steen, S. C., deGraaff, P., Chan, M. W., van Amstel, R. B., & DeVries, J. H.
(2017). Venous, arterialized-venous, or capillary glucose reference measurements for the
accuracy assessment of a continuous glucose monitoring system. Diabetes technology &
therapeutics, 19(11), 609-617.

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Liu, J. G., Hou, L., Pan, X., Guo, Q., & Zhou, T. (2016). Stability of similarity measurements for
bipartite networks. Scientific reports, 6, 18653.
MacFarland, T. W., & Yates, J. M. (2016). Mann–whitney u test. In Introduction to
nonparametric statistics for the biological sciences using R (pp. 103-132). Springer,
Cham.
Rengerink, K. O., Kalkman, S., Collier, S., Ciaglia, A., Worsley, S. D., Lightbourne, A., ... &
Irving, E. A. (2017). Series: Pragmatic trials and real world evidence: Paper 3. Patient
selection challenges and consequences. Journal of clinical epidemiology, 89, 173-180.
Schlueter, K., Johnson, J., Warner, C., & Miller, W. (2017). Glucose Analytical Comparability
Evaluation of the YSI 2300 STAT Plus™ and YSI 2900D Biochemistry Analyzers.
Xylem, Inc.
Spijkerman, M. P. J., Pots, W. T. M., & Bohlmeijer, E. T. (2016). Effectiveness of online
mindfulness-based interventions in improving mental health: A review and meta-analysis
of randomised controlled trials. Clinical psychology review, 45, 102-114.