Research Proposal on the Prevalence of Hypoglycaemia Among Patients with T2DM

1.    Simplified Abstract

Introduction and Justification: For patients with type 2 diabetes (T2DM), severe hypoglycemia is usually associated with adverse effects that have impact on their quality of life and the economy (Davis et al., 2005; Lee et al., 2006; Lundkvist et al., 2006). For this reason, strict controls are being emphasized in the treatment of T2DM, especially in the DCCT studies (DCCT Research Group, 1993). The latter study is important as it highlighted the need to manage hypoglycemia, which is vital because it averts the unprecedented risk of cardiovascular risk factor (Chopra & Kewal, 2012). In essence, currently, in managing diabetes, glycemic 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 hypoglycemia, including cardiovascular risk and brain dysfunction (Hirabayashi, Kitahara & Hishida, 1980). It may also be associated with stroke, cardiac arrhythmias, and myocardial infarction (Frier, Schernthaner, & Heller, 2011; Frier, 1986; Ohshita et al., 2015).

Aims: The aim of the research is to study prevalence of hypoglycaemia among patients with T2DM, 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 follow a systematic review and will incorporate several methods. Primary and secondary sources will be used and the data will be harmonized to come up with relevant findings and conclusions. 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.

2. Literature Review/Background

According to Amiel et al. (2008), the primary cause of hypoglycaemia in patients with T2DM 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). Shriraam et al. (2017) suggested that hypoglycaemia topped the list of hurdles that were encountered in the prevention of tights glycaemic control and was mostly observed in patients that are undergoing the intake of insulin or 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 (Hemmingsen et al., 2011). There are many symptoms associated with hypoglycaemia, and include seizures, slurred speech, loss of consciousness, headache, aggression, blurred vision, confusion, irritability, prickly skin, palpitation, shaking, sweating, drowsiness, hunger, dizziness and weakness (Sheu et al., 2012; Burson & Moran, 2014; Ha et al., 2012; Laurenius et al., 2014; Shriraam et al., 2017). These are shown in Figure 1.

Figure 1: Symptoms of hypoglycaemia in type 2 diabetic patients. Source: (Shriraam et al., 2017).

Various medicines are currently in use to manage hypoglycaemia, and metformin remains the most widely used medicine (Rosenstock et al., 2014). Other medicines include a-glucosidase inhibitors, biguanides, bile acid sequestrants, dipeptidyl-peptidase-4 inhibitors, incretin mimetics, insulin therapy and sulfonylureas (AlMaatouq, 2012; Delfino et al., 2014; Desai et al., 2012; Bays, 2012). Inzucchi, Bergenstal, and Buse (2012) suggested the treatment to subsequently maintain glycaemic control requires the use of multiple antidiabetic medicines, including sulfonylurea (SU) which are administered orally or insulin. Yet the side effects of certain medicines should be considered. For instance, sulfonylurea (SU) derivatives often result in hypoglycaemia and weight gain and that requires consideration of alternative therapies (Rodbard et al., 2009; IDF, 2012).

Although the previous study came up with some helpful information, there were some significant shortcomings affiliated with the study design. For instance the interpretations were quite misunderstood and some important details were left out. This research seeks to cover the areas that were ommitted using another approach in terms of study design (De Galan & Hoekstra, 2001). Current research needs to incorporate a sysstematic review that will address the following areas of interest:

1. The use of different antidiabetics and combinations.

2. The effectiveness of the drugs

3. The side effects of the drugs. (Sheu et al., 2012; Burson & Moran, 2014; Ha et al., 2012).

The research will also take into account several factors such as the therapeutic effects of the drugs across different age groups, comorbidities and symptoms associated with hypoglycaemia. Therefore, it can be concluded that newer methods of counter regulating hypoglycaemia are paramount, and the focus of the study, and future studies, should incorporate these variants, as well as effective methods of dealing with the condition.

3. Aims and Objectives

The research seeks to investigate the prevalence of drug induced hypoglycaemia, its signs and symptoms, severity of the main comorbidities associated with it and the main drugs contributing to it.

The objectives will be:

To establish the prevalence of drug induced hypoglycaemia among diabetic patients.

To assess the incidence and prevalence across different age groups.

To establish the signs and symptoms of drug induced hypoglycaemia.

To 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 such as sugar control and how to reduce the antidiabetics side effects.

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

4. Methodology/Strategy

In accordance with Merriam (2009), qualitative research entails controlling the variables that are of interest to the researcher. Qualitative analysis will follow a descriptive 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 categorisations. 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 conducted. The researcher will use PubMed and Web of Knowledge as they are valid, reliable and easily accessible. To capture many articles and secondary sources, the researcher will capitalise 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 to come up with a variety of sources. 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.

Ethical Approval

A prior visit to the Kings College Hospital will be made to get the necessary permission from the administration. The research team will assure total confidentiality of the patients and the real names will be substituted with other to ensure the same. 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 from 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 includes 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 the newest SPSS 22 software, which is one of the most essential 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 hypoglycae...