Research Proposal on Prevalence of Hypoglycaemia Among Patients with Type 2 Diabetes

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Introduction and Justification: For patients with type 2 diabetes, severe hypoglycaemia is usually associated with adverse effects on their quality of life, as well as economic impact (Davis et al., 2005; Lee et al., 2006; Lundkvist et al., 2006). For this reason, strict controls are being emphasized in the treatment of diabetes, especially after the DCCT studies (DCCT Research Group, 1993). The study is important as it highlights the need to manage hypoglycaemia, which is vital because it averts unprecedented risk of cardiovascular risk factor (Chopra & Kewal, 2012).

Aims: The aim of the research is to study prevalence of hypoglycaemia among patients with type 2 diabetes, as well as practices they adopt during and after the hypoglycaemic incidences for the sole purpose of averting future occurrences.

Overview of the methods: The research will use a variety of methods, which will entail statistical and qualitative analysis and review of articles. It entails providing questionnaires to patients, after which their responses will statistically analysed and reviewed.

Relevance to public health: The research will recommend most appropriate treatment options for patients, while also highlighting most appropriate mode of practices for the prevention of hypoglycaemia in type 2 diabetes patients.

Word Count: 200

2. Literature Review/Background

According to Amiel et al. (2008), the primary cause of hypoglycaemia in patients with Type 2 diabetes is medication, which is mainly intended to treat the condition, and in particular, those patients whose insulin levels rise independently of blood glucose, for example, exogenous insulin and sulphonylureas (SUs). In addition, as Shriraam et al. (2017) posit, hypoglycaemia tops the list of hurdles that are encountered in the prevention of tights glycaemic control and is mostly observed in patients that are undergoing the intake of insulin or in other cases, insulin secretagogue therapies.

Also, the significance of strict glycaemic control in limiting the risk of diabetic vascular complications is often undisputable, but there are numerous barriers that significantly obstructs its attainment (Zammitt & Frier, (2005). Importantly, hypoglycaemia is recognized as a minor problem when it comes to treating the modalities that are used for type 2 diabetes (UK Prospective Diabetes Study (UKPDS) Group, 1998). In essence, this might be a misperception that is based on inadequate information besides; counter regulatory responses to instances of hypoglycaemia have been investigated less systematically in patients with type 2 than in type 1 diabetes (Cryer, 2002; Gerich, 1988; Gerich & Bolli, 1993). Even though there are a variety of counter regulatory deficiencies, regarding hormones that have been described for patients with type two diabetes, they were mild, and the epinephrine secretions were invariably preserved. However, interpretations of these early studies were mainly barred by poor study design (De Galan & Hoekstra, 2001), differences in blood glucose nadir between the control groups and diabetic patients (Bolli et al., 1984; Campbell et al., 1979), lack of subjects who were age matched (Campbell et al., 1979), as well as disparate methods that were used to induce hypoglycaemia (Bolli et al., 1984; Campbell et al., 1979; Heller et al., 1987). Therefore, newer methods of counter regulating hypoglycaemia are paramount.

Various medications are currently in use to manage hypoglycaemia, and metformin remains the most widely used medication (Rosenstock et al., 2014). However, as Inzucchi, Bergenstal, and Buse (2012) posit, the treatment to subsequently maintain glycaemic control progresses to the use of multiple antidiabetic drugs, including sulfonylurea (SU) which are administered orally, as well as insulin. However, the drugs, for example, sulfonylurea (SU), have adverse effects, such as hypoglycaemia and weight gain, which are factors that need consideration when other therapies are needed (Rodbard et al., 2009; IDF, 2012).

Word Count: 400

Aims and Objectives

The aim of the research is to highlight the need of preventing hypoglycaemia in fighting type 2 diabetes. For this reason, the research aims to investigate the effects of oral medication used to treat hypoglycaemia, including SUs and metformin, as well as analysing the importance of the glycaemic index. In essence, currently, in managing diabetes, glycaemic control is majorly assessed using fasting; pre-meal, as well as long-term glucose levels (Heiss & Goldberg, 2016; Hirsch et al., 2016; Inzucchi et al., 2015). The research will also highlight the risks associated with hypoglycaemia, including cardiovascular risk and brain dysfunction (Hirabayashi, Kitahara & Hishida, 1980). It may also be associated with stroke, cardiac arrhythmias, and myocardial infarction (Desouza et al., 2002; Frier, 1986; Ohshita et al., 2015).

The objectives will be:

Establishing effective methods of dealing with hypoglycaemia in type 2 diabetes.

Establish incidence, prevalence, fear, and cost of hypoglycaemia and its impact on health-related quality of life.

Establish effective remedial measures that patients can undertake, as well as the preventive measures for future occurrences of the condition.

To comprehend the practices and perceptions of current treatment options and methodologies of hypoglycaemia, and investigate the most effective one that can be recommended to type two diabetes patients.

To find the reported prevalence of hypoglycaemia in type 2 diabetes in the Kings College Hospital.

Word Count: 224Methodology/Strategy

In accordance with Merriam (2009), qualitative research entails controlling the variables that of interest to the researcher. In this case, managing hypoglycaemia will be the dependent variables, and effective glucose levels will be the independent variables. Qualitative analysis will follow a critical study approach. Merriam and Tisdell (2015), points out that it entails gathering qualitative data by following an iterative approach that refines the research question, while theoretically sampling from the available literature the various categorizations. As such, this method will appraise the quality of materials as well as critically analysing their contribution to managing hypoglycaemia.

Focusing on the qualitative analysis and systematic review of the articles, a Medline search for relevant papers pertaining to managing hypoglycaemia in type 2 diabetes patients between 1980 and May 2017 will be undertaken. The researcher will use PubMed and Web of Knowledge. To capture many articles and secondary sources, the researcher will capitalize on a broad search strategy, which will entail the use of various main search items, including type 2 diabetes mellitus, hypoglycaemia, metformin, sulfonylurea, and insulin. Besides, key words that will be used include incidence, prevalence, fear, and cost of hypoglycaemia, glycaemic index and health-related quality of life. For this reason, the main search items will be used in different combinations, and truncations will be used whenever necessary. The researcher, besides PubMed and Web of Knowledge, will also examine relevant papers from medical bodies, such as European Medicines Agency (EMEA), United Kingdom Prospective Diabetes Study (UKPDS) papers.

In addition, to gather necessary statistics for the research, it will employ a hospital-based cross-sectional study in a diabetes clinic, specifically the Kings College Hospital, which is one of the UKs leading NHS Foundation Trusts. The hospital has over 2.2 million patient contacts on a yearly basis, and patients attend outpatient services on a daily basis. The patients entering the facility will be randomly selected, by issuing a questionnaire to every third patient who has type 2 diabetes, but they should be known to have type 2 diabetes for more than six months. Since the focus of the study is those patients with type 2 diabetes, those who had type 1 diabetes, secondary diabetes, as well as gestational diabetes will be excluded from this study.

Besides, since the research will include external personnel, it has to be approved by the Ethics Committee. Confidentiality issues may arise where the need may arise to protect respondents individual data identification, as well as keeping data safe and secure. In any occasion that any of these ethical provisions arises, the research will be conducted under the ethical guidelines, the Data Protection Act (1998), as well as other licensure restrictions. Written informed consent has to be obtained fro each patient who will be participating in the study.

The primary data collection procedure that will be employed is administering questionnaires that will seek information pertaining to the background characteristics of the individual patients, the duration of diabetes and the current treatment mechanisms, possible symptoms of hypoglycaemia, the frequency of the condition, the severity and duration of the condition, as well as the possible precipitating factors. Besides, important information that will be collected include remedial measures that each patient undertakes, preventive measures, and the methodology used in self-monitoring of the blood glucose levels. In addition, the patient was gauged whether they observed compliance to medications for diabetes.

The research will also employ the Whipples triad, which convincingly documents hypoglycaemia as a clinical syndrome. The Whipples triad considers three factors of the condition, which are low plasma glucose concentration, symptoms that are consistent with hypoglycaemia, as well as the relief of the symptoms when the plasma glucose concentration is raised (Thornton et al., 2015; Iglesias & Diez, 2014; Martens & Tits, 2014). Besides, the list of common symptoms that are associated with hypoglycaemia will be made using a variety of literature search (Kalra et al., 2013; Workgroup on Hypoglycaemia, American Diabetes Association, 2005; Shriraam et al., 2015). The patients will then be asked whether they had episodes of hypoglycaemia in the past one year. The severity of the hypoglycaemic episode will be gauged on whether it required the assistance of another individual, such as a family member, or the patient is hospitalized.

Regarding statistical analysis, data entry and analysis of the variables will be performed using SPSS version 16 software, which is one of the most important software for data analysis (Ott & Longnecker, 2015). In addition, descriptive statistics that will involve standard deviation mean, and proportion will be calculated for the background characteristics, duration, frequency of episodes, symptoms, as well as measures adopted to find the correlation of hypoglycaemia with the medications that were prescribed in treating the condition and the duration for treating it.

Word Count: 785

Implications for Public Health

The research will recommend most appropriate treatment options for patients, while also highlighting most appropriate mode of practices for the prevention of hypoglycaemia in type 2 diabetes patients. In patients with type 2 diabetes, the frequency of severe hypoglycaemia is usually considered low (Abrair et al., 1995; Stratton et al., 2000), but the risks are usually high and might include cardiovascular risk and brain dysfunction (Hirabayashi, Kitahara & Hishida, 1980). It may also be associated with stroke, cardiac arrhythmias, and myocardial infarction (Desouza et al., 2002; Frier, 1986; Ohshita et al., 2015). For this reason, the study will be important for effectively managing hypoglycaemia among these patients, thereby eliminating these risks. Also, the research will contribute to the medicine field by contributing to diabetic...