Type 1 and 2 diabetes mellitus can be regarded as a serious threat to people’s health worldwide. The disease is associated with numerous complications and can lead to a fatal outcome. Inhaled insulin is one of the most recent options to improve glycaemic control and raise patients’ satisfaction. The present research will focus on glycaemic control for patients with diabetes mellitus (type 1 and type 2) who are under 19 and will attempt to identify whether the use of inhaled insulin is beneficial for these patients. A literature review will be designed to evaluate effectiveness of inhaled insulin. Qualitative analysis of twenty-five relevant articles will be the core of this project.
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Diabetes is one of the most widespread diseases in the world. More than 340 million people suffer from diabetes worldwide (Danaei et al. 2011). This disease can affect all age groups and can lead to detrimental consequences. The two types of diabetes are type 1 insulin-dependent diabetes and type 2 insulin-resistance diabetes. Noteworthy, type 1 diabetes can often lead to complications such as development of type 2 diabetes, cardiovascular diseases, etc., which, in their turn, can lead to fatal outcomes. Diabetes mellitus type 2 is associated with such complications as kidney failure, cardiovascular diseases, poor circulation in limbs, which can lead to amputations. This type of diabetes can also lead to fatal outcomes. It is also noteworthy that type 1 diabetes is found in less than 10% of patients suffering from diabetes and these are mainly children and adolescents (Ghobrial 2007). The rest of the patients are diagnosed with type 2 diabetes which is often associated with family history and/or uncontrolled life style. Though, scientists have found that the rate of patients who are under 19 affected by diabetes mellitus type 2 is steadily increasing due to inherited predisposition or certain lifestyle (Danaei et al. 2011). In 2004, it was estimated that mortality rate reached 3.4 million people worldwide (Unger 2012). Therefore, the disease is seen as one of the most serious and urgent issues to solve.
Admittedly, diabetes mellitus has a devastating impact on patients. Lifelong therapy is needed to promote glycaemic control and prevent any possible complications. Insulin therapy has been regarded as an effective therapy to manage the disease (Akhrass et al. 2010). Injections remain one of the most widespread ways to issue the therapy.
Though, a new approach is being used to treat diabetes. Inhaled insulin therapy is regarded as a safe and painless way which is more favourable for patients (Galan et al. 2006). Numerous studies have been implemented on the benefits of the use of inhaled insulin. Nonetheless, the trials are not clearly described and analysed. Age groups are rarely explicitly defined. In this project, I will analyse the benefits of the use of inhaled insulin for glycaemic control in patients under 19 with type 1 and 2 diabetes mellitus via a review of a number of studies.
Does the use of inhaled insulin provide benefits for glycaemic control in patients under 19 who suffer from diabetes mellitus (type 1 and 2)?
Brief review of relevant literature
Patients affected by diabetes have to have a number of injections daily. This causes certain inconveniences to patients and scientists have been trying to reduce the number of daily injections to improve patients’ quality of life (Yaturu 2013). Apart from this, children as well as adolescents are often reluctant to have injections due to their fears of needles or associated pain (Heise et al. 2005). Thus, scientists have also made numerous attempts to develop alternative ways of insulin delivery. Inhaled insulin has been regarded as an effective alternative way of delivery.
Scientists report about positive outcomes of the use of inhaled insulin in patients affected by diabetes mellitus. Notably, the research is held in different parts of the world and the results are quite similar. Hence, researchers in India note that there are numerous advantages of the use of inhaled insulin, but it is too early to recommend all patients under 19 to switch to this type of delivery as the outcomes (especially long-term effects) of this use are still unclear (Yadav & Parakh 2006). Lots of researchers share these concerns and stress that further research is necessary (Testa & Simonson 2007; Gerber et al. 2009). Scientists note that though the use of inhaled insulin has proved to be effective, it is essential to continue the research and focus on long-term effects (White et al 2008; Moses et al. 2009; Comulada et al. 2009).
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Scientists also pay a lot of attention to possible negative effects of inhaled insulin and such side effects as cough (Cefalu et al. 2008). For instance, Garg et al. (2009) found that the use of inhaled insulin was associated with cough and some complications for patients with asthma, though the complications were insignificant. Ang et al. (2009) came to similar conclusions and Kuitert et al. (2005) claimed that airway hyperresponsiveness was not associated with inhaled insulin. At the same time, in two studies, Skyler et al. (2007) and Skyler et al. (2008) found no significant effects on lungs in patients using inhaled insulin. Whereas, Henry et al. (2003) found that the use of inhaled insulin had a positive effect in patients with asthma and diabetes mellitus as this type of glycaemic controlled was associated with decreased dosage.
Notably, the vast majority of scientists claim that benefits of the use of inhaled insulin outweigh its downsides (Bellary & Barnett 2006; Guntur & Dhand 2007). Thus, Taylor (2002) is optimistic about inhaled insulin as it is associated with patients’ satisfaction which can encourage them to start the therapy. Researchers emphasise that satisfaction of patients and effective glycaemic control justify the use of inhaled insulin especially in patients under 19 (Skyler et al. 2001; Rosenstock et al. 2004; Norwood et al. 2007). Moreover, researchers claim that inhaled insulin can be a good alternative for those who (for some reasons) cannot or do not want to have injections (Gerber et al. 2001; Kapitza et al. 2004). Scientists also agree that the use of inhaled insulin is especially effective with infants and children (Quattrin et al. 2004; Skyler et al. 2005). Notably, Petersen et al. (2007) focus on the correlation between effectiveness of inhaled insulin (and dosage) and the amount of exercise. Hayes, Muchmore and Schmitke (2007) stress that inhaled insulin is effective, but patients should have the right and opportunity to choose the type of the therapy which is most suitable for them. Admittedly, further research is necessary as inhaled insulin is still regarded as a new (which is often associated with unsafe) way that makes patients and their close ones uncertain or, in other words, deprived of the ability to make their choice.
A literature review will be conducted to analyse information available on benefits of the use of inhaled insulin for glycaemic control of for patients with diabetes mellitus type 1 and type 2 who are under 19. The literature review will provide the necessary evidence to reveal the gaps and opportunities for further research.
- To identify trials which focus on glycaemic control for diabetes mellitus (type 1 and 2).
- To identify randomised trials which focus on improvement of glycaemic control for diabetes mellitus (type 1 and 2) in patients under 19.
- To determine whether reports available provide sufficient evidence for benefits of the use of inhaled insulin in patients under 19.
The present project’s methodology will be a literature review. The research will be conducted via PubMed and Cochrane databases during January and May 2014. The articles used will focus on benefits of glycaemic control in diabetes mellitus (type 1 and 2). 25 articles will be the basis of the present research. Each article will be read in full. The relevance of each article will be evaluated in terms of several variables and major findings of each study will be presented in tabulation. This project will be based on qualitative analysis of the literature.
Randomized controlled trials will be searched via Pub Med and Cochrane. The articles published in English within 2000 and 2013 will be used. Key search terms will be as follows: inhaled insulin, diabetes mellitus type 1, diabetes mellitus type 2, type of insulin.
Trials which do not include impact data will be excluded.
This study will be implemented in accordance with all ethical principles of research. The study will also be approved by the Research Ethics Committee of the University of South Wales (Faculty of Health and Sport). No plagiarism will be recorded in this research.
Dissemination of findings
The findings of the present research will be disseminated in the following ways:
- a seminar will be held to present the findings of the present study
- the findings will be published in health journals and scientific website.
Akhrass, F, Skinner, N, Boswell, K & Travis, LB 2010, ‘Evolving trends in insulin delivery: in pursuit of improvements in diabetes management’, American Health & Drug Benefits, vol. 3. no. 2, pp. 117-122.
Ang, E, Lawrence, MK, Heilmann, CR, Ferguson, JA, Tobian, JA, Webb, DM & Berclaz, PY 2009, ‘Safety and efficacy of AIR inhaled insulin compared with subcutaneous insulin in patients having diabetes and asthma: A 12-month, randomized, noninferiority trial’, Diabetes Technology and Therapeutics, vol. 3. no. 3, pp. 179-185.
Bellary, S & Barnett, AH 2006, ‘Inhaled insulin (Exubera®): combining efficacy and convenience’, Diabetes and Vascular Disease Research, vol. 3. no. 3, pp. 179-185.
Cefalu, WT, Bohannon, NJ, Edwin Fineberg, S, Teeter, JG, Schwartz, PF, Reis, JM & Krasner, AS 2008, ‘Assessment of long-term immunological and pulmonary safety of inhaled human insulin with up to 24 months of continuous therapy’, Current Medical Research and Opinion, vol. 24. no. 11, pp. 3073-3083.
Comulada, AL, Renard, E, Nakano, M, Rais, N, Mao, X, Webb, DM & Milicevic, Z 2009, ‘Efficacy and safety of AIR inhaled insulin compared to insulin lispro in patients with type 1 diabetes mellitus in a 6-month, randomized, noninferiority trial’, Diabetes Technology & Therapeutics, vol. 11. no. 2, pp. 17-25.
Danaei, G, Finucane, MM, Lu, Y et al. 2011, ‘National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2.7 million participants’, Lancet, vol. 378. no. 1, pp. 31-40.
Galan, BE, Simsek, S, Tack, CJ & Heine, RJ 2006, ‘Efficacy and safety of inhaled insulin in the treatment of diabetes mellitus’, The Journal of Medicine, vol. 64. no. 9, pp. 319-325.
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Garg, SK, Mathieu, C, Rais, N, Gao, H, Tobian, JA, Gates, JR, Ferguson, JA, Webb, DM & Berclaz, PY 2009, ‘Two-year efficacy and safety of AIR inhaled insulin in patients with type 1 diabetes: an open-label randomized controlled trial’, Diabetes Technology & Therapeutics, vol. 11. no. 2, pp. 5-16.
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