BPHE5310: Diabetes Management Literature Search Strategy

This assignment presents a comprehensive literature search strategy focusing on recent technological advancements in diabetes management, specifically addressing the development of cost-effective medical devices for continuous glucose monitoring and insulin delivery. The assignment begins by formulating two PICOT questions, outlining the population, intervention, comparison, outcome, and time frame for each clinical question. The core of the assignment involves a detailed search of the PubMed database, utilizing specific search terms and Boolean operators to identify relevant scholarly articles. The methodology includes clearly defined inclusion and exclusion criteria, ensuring the selection of recent, peer-reviewed articles focused on continuous glucose monitoring and regulation of blood glucose levels. The process incorporates the PRISMA method for evaluating the relevance of the selected articles and a thematic analysis to extract key information. The assignment includes a PRISMA flow chart to illustrate the article selection process, along with a table summarizing the included and excluded articles. The final analysis focuses on a selection of articles, highlighting the efficacy of recent devices like the Bluetooth-enabled insulin pump for improved patient outcomes. The assignment provides URLs of the searched articles and concludes with a detailed table summarizing the articles selected for the literature search report, effectively answering the clinical question.

BPHE5310 CLINICAL TRIALS OVERVIEW: METHODS AND PRACTICE
BPHE5310
LITERATURE SEARCH STRATEGY
TO EMPHASIZE ON
RECENT DEVICES IN DIABETES MANAGEMENT
Name of the Student
Name of the University
Author’s Note

1LITERATURE SEARCH STRATEGY TO EMPHASIZE ON RECENT DEVICES IN DIABETES MANAGEMENT
Table of Contents
Part 1: Formulating PICOT Questions.......................................................................................2
Part 2: Searching the Literature..................................................................................................3
The 20 searched articles with URL:.........................................................................................11
References................................................................................................................................15

2LITERATURE SEARCH STRATEGY TO EMPHASIZE ON RECENT DEVICES IN DIABETES MANAGEMENT
Part 1: Formulating PICOT Questions
Assignment One PICO (TEMPLATE for students to complete)
Two PICO Questions
1a-1 (clinical question): What intervention would be effective in enhancing the
administration of insulin to the adults with type 1 diabetes mellitus compared to the regular
insulin pens available to maintain proper blood glucose level without the risk of
hypoglycaemia with a week since initiating the intervention?
1a-2 (PICO question):
Population: Type 1 diabetes affected adults
Intervention: Digital and technological intervention
Comparison: Regular insulin pens used for administering insulin to maintain glucose level
Outcomes: To regulate hypoglycaemia, HbA1c monitoring.
Time: The effective change must be visible within a week of intervention
1b-1 (clinical question): What could be a cost effective medical device which can
continuously monitor and regulate the blood glucose level compared to the current insulin
delivery technologies in the adults with chronic type 1 diabetes with poorly controlled blood
glucose level within two days of use?
1b-2 (PICOT question):
Population: Chronic type 1 diabetes adults with poorly managed blood glucose

3LITERATURE SEARCH STRATEGY TO EMPHASIZE ON RECENT DEVICES IN DIABETES MANAGEMENT
Intervention: Device for continuous insulin delivery and glucose monitoring
Comparison: Current insulin delivery technologies
Outcomes: Reduces overall cost of insulin with the aid of continuous insulin delivery and
glucose monitoring, improve quality of life for chronic type 1 diabetes patients, reduce
occurrences of nocturnal hypoglycaemia, remove the fear of developing hypoglycaemia, and
restrict unwanted change of weight.
Time: Within two days of using the device
Part 2: Searching the Literature
What could be a cost effective medical device which can continuously monitor and regulate
the blood glucose level compared to the current insulin delivery technologies in the adults
with chronic type 1 diabetes with poorly controlled blood glucose level within two days of
use?
As the interest was in finding a recent technology to continuously deliver insulin and
monitor blood glucose level, the construction of the relevant search terms was the most
essential phase of the study as they assisted in the extraction of the appropriate articles which
could address the clinical question at hand. During developing the appropriate terms to search
literatures to withdrawal the required scholarly evidences, frameworks for the search which
was published by Stillwell et al. (2010) along with the strategy developed by Centre for
Reviews and Dissemination or the CRD published in 2009 were considered. Using these
frameworks aided in providing the suggestion for evaluating the chief clinical question and
searching accordingly (Zeng et al. 2015). With the hints mentioned in the guidelines, the
acronyms along with alternative words in addition to the spelling modifications were also
taken into consideration. The scholarly articles were explored in the electronic database

4LITERATURE SEARCH STRATEGY TO EMPHASIZE ON RECENT DEVICES IN DIABETES MANAGEMENT
named PubMed under NCBI. The bibliographies and reference lists of some articles also
were checked manually to retrieve relevant articles which may have been left out in the
databases.
The search terms which were used to extract appropriate articles included “recent
insulin delivery device”, “new technology to treat type 1 diabetes”, “new technology type 1
diabetes treatment”, “new technology diabetes treatment”, “recent hypoglycaemia treatment”,
“hypoglycaemia recent treatment”, “recent treatment for diabetes”, “diabetes recent
treatment”, “new intervention for diabetes treatment”. Various Boolean operators like the '
OR ' and ‘AND’ have also been combined to these search terms to narrow and broaden the
outcomes of the search accordingly (McGowan et al. 2016).
The exclusion criteria and inclusion criteria were also developed for the literature
search technique to establish foremost attention to the literature search along with
emphasizing on the exact requirements in addition to setting the limits to restrict inclusion of
unwanted articles (Stern, Jordan and McArthur 2014). Added below is the table that
highlights inclusion criteria along with exclusion criteria which had been developed for the
literature search report (Table 1).
Table 1: The inclusion criteria and the exclusion criteria for the literature search report
The inclusion criteria for the
literature search report
The exclusion criteria for the
literature search report
Only the English language articles were
taken for the literature search report
Research works and articles in other foreign
languages were excluded from the literature
search report
The recent articles as in those published
in or after 2014 were only selected for the
The articles published before 2014 were not
selected as the recent technologically

5LITERATURE SEARCH STRATEGY TO EMPHASIZE ON RECENT DEVICES IN DIABETES MANAGEMENT
literature search report upgraded devices are being included in the
literature search report
The articles picked for literature search
report were primarily focused on the
continuous glucose monitoring and
regulation of blood glucose level
The articles which focuses on other
treatment plans and physiological analysis
of diabetes were not included in the study.
Only peer reviewed scholarly articles
were included in the literature search
report
Manuscripts and articles with only abstract
available were not included in the literature
search report
After the retrieval of the pertinent scholarly articles from the databases, relevance of
the scholarly writings was determined with the aid of the Preferred Reporting Items for
Systematic Reviews and Meta-Analyses or the PRISMA method of evaluation (Tricco et al.
2018). The PRISMA flow chart is a framework which is highly recommended to ensure
proper coverage of all the articles along with structured reporting of the facts in addition to
the evidenced based research works and referring to the articles for the literature search report
(Nyiredy, 2002). The fundamental purpose of the PRISMA model is to assist in improving
the search for the relevant data in addition with the inclusive reporting of the relevant
scholarly articles and published works (Enya, Dempsey & Pillay, 2018). Twenty total articles
were selected from PubMed of NCBI.
The initial platform incorporated the assessment of the given titles and headings of the
selected articles and study their significance to the clinical question. The 20 articles were
initially screened based on the content and the articles with only the abstract available were

6LITERATURE SEARCH STRATEGY TO EMPHASIZE ON RECENT DEVICES IN DIABETES MANAGEMENT
removed as comprehensive search and study of those articles were not possible. This lead to
in the exclusion of about 5 articles resulting in 15 remaining scholarly articles which were all
subjected to the full text investigation. The next round of elimination of the scholarly articles
were on the basis of the questionnaire formulated to screen articles to extract articles focussed
on addressing the clinical question (Table 2). Total 15 articles were then omitted from the
literature search report following finalising a total of 5 scholarly articles which were deemed
appropriate and significant for the literature search report.
Table 2
Questionnaire to screen selected articles that encompasses relevant information for
literature search report on continuous monitoring and regulation of blood glucose level.
1 The objective of the selected
article
Was the objective of the selected article pertinent
and relevant?
2 The technique incorporated in the
article
Was the technique mentioned in the article suitable
and appropriate in addressing the patient
population mentioned in the clinical question?
3 The design of the device Was design of the device able to meet the
requirements highlighted in the clinical question?
4 The methodology for collection of
data
Was the data collected competent to focus on
maintenance of blood glucose levels and avoiding
occurrences of hypoglycemia?
5 The assessment of data collected
and its statistical analysis
Were analysis protocols sufficient to evaluate the
collected data?
6 Was the new device improve the
quality of life of the type 1
diabetes mellitus patients?
Compared to the previously available devices and
methods of administering insulin, was the new
device suggested able to improve the quality of
life?

7LITERATURE SEARCH STRATEGY TO EMPHASIZE ON RECENT DEVICES IN DIABETES MANAGEMENT
7 The result of the study Was the study able to successfully manage poorly
controlled type 1 diabetes mellitus?
8 The gaps in the study Have all the gaps and aims in the study been
addressed accurately?
9 Feasibility and cost effectiveness
of the device mentioned in the
study
Is the device mentioned in the study feasible and
cost effective?
10 Implementation of the device Has the device successfully cleared all the
recommended clinical trials for proper
implementation in diabetes management?
The extensively used procedure of the thematic analysis with the aid of PRISMA was
considered suitable for the literature search report as it facilitated the identification of precise
patterns of the data along with proper evaluation of the articles which have been gathered
from the search in the electronic databases. The primary aim of performing this PRISMA
analysis was to draw out recent articles which can recommend a cost effective medical device
which can continuously monitor and regulate the blood glucose level compared to the current
insulin delivery technologies in the adults with chronic type 1 diabetes with poorly controlled
blood glucose level within two days of use (Figure 1).

8LITERATURE SEARCH STRATEGY TO EMPHASIZE ON RECENT DEVICES IN DIABETES MANAGEMENT
Figure 1: PRISMA flow chart for the selection of articles included in the meta-analyses.
Full text articles excluded as they
did not address the clinical question
properly
(n = 10)
The full text articles that
are assessed for eligibility
(n = 15)
The records excluded as they
were without full text
(n = 5)
The records screened
(n = 20)
The total number of articles selected from
Pubmed (NCBI) (n = 20)
Identification
Included Eligibility Screening
The studies that have been
included for the quantitative
synthesis and meta-analysis
(n = 5)
The studies that have been
included in qualitative synthesis
(n = 5)

9LITERATURE SEARCH STRATEGY TO EMPHASIZE ON RECENT DEVICES IN DIABETES MANAGEMENT
The article, entitled “Novel Bluetooth-Enabled Tubeless Insulin Pump: Innovating
Pump Therapy for Patients in the Digital Age” draws attention to a newly evolved diagnostic
tool for the medical intervention and management of diabetes in both children and adults (Ly
et al., 2019). The article focuses on the DASHTM Omnipod, which has been developed on a
new interface that employs wireless Bluetooth® technology to facilitate digitalization of the
pump device or Personal Diabetic Manager (PDM). The advancement in waterproofing
allows the user to bathe and swim with utmost freedom along with enhancing the quality of
life of the patients along with reducing the risks of hypoglycaemia. The table below
summarises all the articles searched and analysed and the ones selected for the literature
search report which will adequately answer the clinical question (Table 3).
Table 3: The articles which have been selected for the literature search report
Articles Year of
publication
Initially
selected
articles
Excluded in
first round
of screening
Excluded in
the second
round of
screening
The studies
that have been
included in
qualitative
synthesis
The studies that
have been included
for the quantitative
synthesis and meta-
analysis
Ly et al. 2019 X X X
Buckingham et
al. 2018 X X X
Layne, Parkin
& Zisser 2016 X X X
Bailey &
Stone. 2017 X X X
Pillalamarri,
Huyett, &
Abdel-Malek
2018 X X X
El-Khatib et al. 2017 X X
Choudhary et
al. 2016 X X
Russell et al. 2016 X X
Zisser 2014 X X

10LITERATURE SEARCH STRATEGY TO EMPHASIZE ON RECENT DEVICES IN DIABETES MANAGEMENT
Karges, Binder
& Rosenbauer. 2018 X X
Umpierrez &
Klonoff 2018 X X
Thomas et al. 2018 X X
Westen et al. 2018 X X
Lal,
Buckingham &
Maahs
2018 X X
Aronson et al. 2016 X X
Leelarathna et
al. 2017 X X
Shah et al. 2016 X X
Polonsky et al. 2016 X X
Knezevich &
Davidian 2017 X X
Gildon 2018 X X

11LITERATURE SEARCH STRATEGY TO EMPHASIZE ON RECENT DEVICES IN DIABETES MANAGEMENT
The 20 searched articles with URL:
1. Aronson, R., Reznik, Y., Conget, I., Castañeda, J. A., Runzis, S., Lee, S. W., ... &
OpT2mise Study Group. (2016). Sustained efficacy of insulin pump therapy
compared with multiple daily injections in type 2 diabetes: 12‐month data from the
OpT2mise randomized trial. Diabetes, Obesity and Metabolism, 18(5), 500-507.
https://www.ncbi.nlm.nih.gov/pubmed/26854123
2. Bailey, T. S., & Stone, J. Y. (2017). A novel pen-based Bluetooth-enabled insulin
delivery system with insulin dose tracking and advice. Expert opinion on drug
delivery, 14(5), 697-703. https://www.ncbi.nlm.nih.gov/pubmed/28359171
3. Buckingham, B. A., Christiansen, M. P., Forlenza, G. P., Wadwa, R. P., Peyser, T. A.,
Lee, J. B. & Ly, T. T. (2018). Performance of the omnipod personalized model
predictive control algorithm with meal bolus challenges in adults with type 1
diabetes. Diabetes technology & therapeutics, 20(9), 585-595.
https://www.ncbi.nlm.nih.gov/pubmed/30070928
4. Choudhary, P., Olsen, B. S., Conget, I., Welsh, J. B., Vorrink, L., & Shin, J. J. (2016).
Hypoglycemia prevention and user acceptance of an insulin pump system with
predictive low glucose management. Diabetes technology & therapeutics, 18(5), 288-
291. https://www.ncbi.nlm.nih.gov/pubmed/26907513
5. El-Khatib, F. H., Balliro, C., Hillard, M. A., Magyar, K. L., Ekhlaspour, L., Sinha,
M., ... & Malkani, S. (2017). Home use of a bihormonal bionic pancreas versus
insulin pump therapy in adults with type 1 diabetes: a multicentre randomised
crossover trial. The Lancet, 389(10067), 369-380.
https://www.ncbi.nlm.nih.gov/pubmed/28007348

12LITERATURE SEARCH STRATEGY TO EMPHASIZE ON RECENT DEVICES IN DIABETES MANAGEMENT
6. Gildon, B. W. (2018). InPen smart insulin pen system: product review and user
experience. Diabetes Spectrum, 31(4), 354-358.
https://www.ncbi.nlm.nih.gov/pubmed/30510392
7. Karges, B., Binder, E., & Rosenbauer, J. (2018). Complications With Insulin Pump
Therapy vs Insulin Injection Therapy—Reply. Jama, 319(5), 503-504.
https://www.ncbi.nlm.nih.gov/pubmed/29411030
8. Knezevich, E. L., & Davidian, M. H. (2017). Pumping It Up: New Advancements in
Insulin Delivery. US Pharm, 42(11).
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4787057/
9. Lal, R. A., Buckingham, B., & Maahs, D. M. (2018). Advances in care for insulin-
requiring patients without closed loop. Diabetes technology & therapeutics, 20(S2),
S2-85. https://www.ncbi.nlm.nih.gov/pubmed/29916743
10. Layne JE, Parkin CG, Zisser H. (2016) Efficacy of the Omnipod insulin management
system on glycemic control in patients with type 1 diabetes previously treated with
multiple daily injections or continuous subcutaneous insulin infusion. J Diabetes Sci
Technol. 2016;10(5):1130-1135 https://www.ncbi.nlm.nih.gov/pubmed/27290737
11. Leelarathna, L., Roberts, S. A., Hindle, A., Markakis, K., Alam, T., Chapman, A., ...
& Rutter, M. K. (2017). Comparison of different insulin pump makes under routine
care conditions in adults with Type 1 diabetes. Diabetic Medicine, 34(10), 1372-1379.
https://www.ncbi.nlm.nih.gov/pubmed/28636773
12. Ly, T. T., Layne, J. E., Huyett, L. M., Nazzaro, D., & O’Connor, J. B. (2019). Novel
Bluetooth-Enabled Tubeless Insulin Pump: Innovating Pump Therapy for Patients in
the Digital Age. Journal of diabetes science and technology, 13(1), 20-26.
https://www.ncbi.nlm.nih.gov/pubmed/30239214

13LITERATURE SEARCH STRATEGY TO EMPHASIZE ON RECENT DEVICES IN DIABETES MANAGEMENT
13. Pillalamarri, S. S., Huyett, L. M., & Abdel-Malek, A. (2018). Novel Bluetooth-
Enabled Tubeless Insulin Pump: A User Experience Design Approach for a
Connected Digital Diabetes Management Platform. Journal of diabetes science and
technology, 12(6), 1132-1142. https://www.ncbi.nlm.nih.gov/pubmed/30304951
14. Polonsky, W. H., Hessler, D., Layne, J. E., & Zisser, H. (2016). Impact of the
Omnipod® Insulin Management System on quality of life: a survey of current
users. Diabetes technology & therapeutics, 18(10), 664-670.
https://www.ncbi.nlm.nih.gov/pubmed/27673352
15. Russell, S. J., Hillard, M. A., Balliro, C., Magyar, K. L., Selagamsetty, R., Sinha,
M., ... & Damiano, E. R. (2016). Day and night glycaemic control with a bionic
pancreas versus conventional insulin pump therapy in preadolescent children with
type 1 diabetes: a randomised crossover trial. The lancet Diabetes &
endocrinology, 4(3), 233-243.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4799495/
16. Shah, R. B., Patel, M., Maahs, D. M., & Shah, V. N. (2016). Insulin delivery methods:
Past, present and future. Inte Peters, A. L., Ahmann, A. J., Hirsch, I. B., & Raymond,
J. K. (2018). Advances in glucose monitoring and automated insulin delivery:
supplement to Endocrine Society clinical practice guidelines. Journal of the
Endocrine Society, 2(11), 1214-1225.rnational journal of pharmaceutical
investigation, 6(1), 1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4787057/
17. Thomas, T. T., Nithin, S., Sivraj, P., & Guruvayurappan, K. (2018, July). Design of
an Embedded Controller for Next Generation Low Cost Insulin Pump. In 2018
International Conference on Inventive Research in Computing Applications
(ICIRCA) (pp. 200-204). IEEE. https://www.ncbi.nlm.nih.gov/pubmed/25128049

14LITERATURE SEARCH STRATEGY TO EMPHASIZE ON RECENT DEVICES IN DIABETES MANAGEMENT
18. Umpierrez, G. E., & Klonoff, D. C. (2018). Diabetes technology update: use of
insulin pumps and continuous glucose monitoring in the hospital. Diabetes
Care, 41(8), 1579-1589. https://www.ncbi.nlm.nih.gov/pubmed/29936424
19. Westen, S. C., Warnick, J. L., Albanese-O’Neill, A., Schatz, D. A., Haller, M. J.,
Entessari, M., & Janicke, D. M. (2018). Objectively measured adherence in
adolescents with type 1 diabetes on multiple daily injections and insulin pump
therapy. Journal of pediatric psychology, 44(1), 21-31.
https://www.ncbi.nlm.nih.gov/pubmed/30184209
20. Zisser, H. C. (2014). The OmniPod Insulin Management System: the latest innovation
in insulin pump therapy. Diabetes Therapy, 1(1), 10-24.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3118276/

15LITERATURE SEARCH STRATEGY TO EMPHASIZE ON RECENT DEVICES IN DIABETES MANAGEMENT
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