Aims and Objectives
Poor control of blood sugars has been associated with a higher risk of complications of Diabetes mellitus (DM). However, there has been a deficiency in the data linking poor control of blood sugars as evidenced by elevated HbA1c and fructosamine levels. This study looks to fill this information gap using the diabetes situation in Australia.
Primary Objective:
To establish the blood sugar levels and to determine the efficiency of chronic control of blood sugar levels among known diabetic patients on oral hypoglycemic drugs who visit health facilities in Sydney for the refill of their medications.
Secondary Objectives:
- To determine the number of known diabetic patients who visit local health facilities in Sydney for the refill of their drugs.
- To determine the level of drug adherence in the patients.
- To determine reasons for non-adherence to prescribed drugs in those who do not adhere. Also, to determine the frequency of major side effects of the most commonly prescribed antidiabetic drugs in Australia.
- To find out the lifestyle changes that the patients have adopted in order to lower their blood sugar levels.
- To determine the blood sugar levels in the patients at the time of visit.
- To determine the chronic control of sugar levels in the patients by assaying their fructosamine and HbA1c levels.
- To inquire about the development of symptoms and to examine for the occurrence of new signs of the various complications of diabetes. The main complications that will be assessed here being hypertension, heart disease, chronic kidney disease, diabetic retinopathy, and lower limb gangrene.
Hypothesis:
Long-term poor control of blood sugar in diabetes mellitus is strongly associated with the occurrence of complications of the disease among known diabetic patients in Sydney, Australia.
Background and Rationale
Diabetes Mellitus is a chronic disease of the endocrine system which is marked by high blood sugar levels which can precipitate numerous physiologic abnormalities. DM is an important public health problem in Australia as its prevalence in the country has kept increasing (Ferrara, 2007 p.143). According to 2011 data on diseases by the Australian government, 6% of Australian males were diabetic while 4% of the females were diabetic (Australian Government, 2014 para 18). This debilitating disease is far more common in older individuals with 92% of all new cases of DM type II being in people aged above 40 years of age while the prevalence of the disease among people aged between 65 and 74 years was found to be 15% (Australian Government, 2014 para 18). Diabetes mellitus was found to be the sixth leading cause of death in Australia that year; the disease was the primary cause of 10% of deaths that year (Australian Government, 2014 para 18). As far as the diagnostic criteria and basic management principles for DM in Australia goes, the 1998 report by WHO prepared by Alberti and Zimmet is instrumental. The paper outlines the basic principles and tests for diagnosis of DM including random blood sugar, fasting blood glucose, oral glucose tolerance test, an assay for insulin levels, and imaging studies of the pancreas. The paper only mentions the value of assaying for HbA1c levels in the diagnosis of DM in passing. The paper also mentions the prevalence of DM whilst citing Australia as one of the places with the highest prevalence of DM. The bulk of the paper, however, is on the classification of DM and the pathogenesis of the various classes of the disease.
Jeffcoate (2004) emphasizes the importance of proper glycemic control in the management of DM. He also appreciates the importance of HbA1c assay in the monitoring of glycemic control for diabetic patients.The role of assaying for HbA1c in the diagnosis of DM was first considered by International Expert Committee in a 2009 paper (p.1329). Al-Ghamdi (2004 p.344) reveals the importance of monitoring HbA1c levels in the long-term management of diabetes mellitus; Heisler et al., (2005 p.819) also emphasize the same thing. In Australia, elevated HbA1c are acceptable as a diagnostic criterion for DM (d’Emden et al., 2012 p.220). Jeffcoate (2004 p.661) also talks about the importance of fructosamine levels in the long-term management of DM. The complications of this debilitating disease, which contribute to most mortalities, can be controlled by effective control of blood sugar levels. Modification of lifestyle and use of drugs like insulin and the oral hypoglycemic drugs are effective ways of lowering blood sugar levels (Marshall et al., 2012 p. 217). Monitoring the sugar levels by use of the fructosamine of HbA1c levels is key to ensuring proper care of patients with diabetes mellitus (Marshall et al., 2012 p. 209). The increased incidence of the complications of diabetes and the mortalities that result suggests poor control of blood sugar levels among known diabetic patients. This forms the rationale of this study. The study thus anticipates to demonstrate a causal link and a temporal sequence between long-term poor control of blood sugar as evidenced by elevated HbA1c and fructosamine levels and occurrence of complications of DM.
Research Plan
Study Design
This study will take the form of a cross-sectional study. As such, the study will be an observational study which looks to determine the effectiveness of glycemic control in known diabetic patients who visit health facilities in and around Sydney for their refills at a particular time (Hulley et al., 2015). The study will start by visiting the health facilities of interest and documenting the number of known diabetic patients who are supposed to be given refills over the course of the study. Questionnaires will be used as important data collection tools. The purpose of using questionnaire is to ensure that the history that is taken from the patients is standardized and that the same questions are posed for all the patients. Apart from standardization, questionnaires will ensure that important parts of the history are not missed in some patients. Most questions in this part of the questionnaire will be made to be closed-ended for purposes of reducing ambiguity. The second part of the questionnaire, which is meant to be filled by the researcher, will include examination findings and the results of the HbA1c and fructosamine levels. As in most cross-sectional studies, both the independent and the dependent variables will be determined in the same study (Hulley et al., 2015). The relationship of the two variables will then be established by determining to what extent the incidence of the independent variable is associated with the occurrence of the dependent variable. These variables are expounded on further in the next part.
The Outcome or the Dependent Variable
The outcome in this study, which is what the study is looking to ultimately control, is the occurrence of the various complications of DM. as earlier alluded to, in this study, the complications of most significance will be diabetic retinopathy, hypertension, heart disease, chronic kidney disease, and leg gangrene. The relative risk of developing these conditions and the incidence of the conditions where they have already occurred will be elicited by history and physical examination. For diabetic retinopathy, the questionnaire will probe the patient on the symptoms of the disease like vision loss, recent impairment in color vision, blurred vision or dark spots in their visual field. On physical examination, the health worker conducting the research will do a fundoscopy and report any retinal abnormalities seen. For hypertension, a history of severe headaches, easy fatigability, vision problems, palpitations, use of antihypertensive medication, and various other features of high blood pressure and its complications will be taken (Nissenson et al., 2009 p.365). On physical examination, the examiner will be interested in eliciting signs captured in the history and checking the blood pressure of the patient at the time of visit; in case a blood pressure record of past visits exists, it can also be checked to give more information. Heart disease, which can occur as a complication of hypertension, will follow. The history part, for heart disease, will look to inquire about symptoms such as exertion dyspnea, orthopnea, paroxysmal nocturnal dyspnea, chest pain on exertion, and limb edema (Kumar et al., 2013 p.357). During physical examination, the various features of ischemic heart disease and heart failure will be elicited.
A history of nausea or vomiting, anorexia, sleep disturbances, decreased mental acuity, muscle cramps, and skin itching among other features of chronic kidney disease will be taken from the patient using a predesigned questionnaire (Nissenson et al., 2009 p.152). A physical examination aiming to confirm the history and elicit any additional features of chronic kidney disease will then be conducted. For the case of the kidney, patients who accept to be part of the study will have blood samples removed for kidney function tests to be conducted. The results of any past kidney function tests for the patient will also be key for the research. Leg gangrene is something that can be elicited by the researcher on physical examination of the patient. A positive history that is confirmed by positive signs on physical examination or deranged kidney function tests for the case of chronic kidney disease will be considered a positive outcome. This is to mean that a complication of DM will have been diagnosed and as such the dependent variable will be said to be present. The possibility of diagnosing multiple complications in a single patient is also there. This can then be counterchecked with the results of the independent variable so as to prove the hypothesis of the research.
The Exposure or the Independent Variable
In this study, the exposure that is associated with an increase in the incidence of the complications of DM is poor glycemic control. Poor glycemic control is determined by assaying for HbA1c and fructosamine levels (Psaltopoulou et al., 2010 p.29). Measurement of the sugar levels at the time of the visit by way of a random blood sugar assay will also be done to help determine the effectiveness of glycemic patients in the patients included in the study. Further assessment of the patient’s glycemic control will involve inquiring about any lifestyle changes that have been made deliberately in an effort to control blood sugar levels – lifestyle and dietary modifications are very key in the management of DM (Psaltopoulou et al., 2010 p.29). Elevated HbA1c levels are an indicator of poor glycemic control over the last eight to twelve weeks. However, for one to conclude that there is poor glycemic control, it is important for them to rule out any other causes of elevated HbA1c such as hemoglobinopathies and red blood cell enzymopathies or membranopathies (Psaltopoulou et al., 2010 p.29). This can be ruled out by way of a detailed history of the patient and their family and doing some blood tests; a full hemogram will be done for this study. Assaying for fructosamine levels will complement the HbA1c results. Fructosamine is rarely affected by other systemic derangements other than poor glycemic control hence its importance (Garg and Williams, 2011, p.135). Moreover, elevated fructosamine shows more rapid changes in blood sugar control as it indicates the glucose levels over the last 14 to 21 days (Herman, 2010 p.132). The independent variable would be said to be present when a participant in the study has an elevated HbA1c level in the absence of erythrocyte abnormalities as indicated by their full hemogram. An elevated fructosamine level will be adjunct in such a scenario. For participants whose full hemogram results indicate significant erythrocyte abnormalities, the dependent variable will be said to be present only if they will have elevated fructosamine levels.
Study Population
As said earlier, the study population be made of known diabetic patients on medication who visit various health facilities in and around Sydney at regular periods for their refills. Because of the high prevalence of DM in Australia and the desired statistical significance of the study, a sample size of 1000 patients will be sufficient.
Data analysis
Analysis of the data collected will look to establish patterns. As in any other cross-sectional studies, data analysis will not have many complexities and intricacies (Hulley et al., 2015). The analysis is straightforward: Determine the proportion, as a percentage, of participants who are very likely or who have already developed complications of DM which they had not been previously diagnosed with; determine the proportion, as a percentage, of participants who have had poorly controlled blood sugar levels both in the long term and short term. The two percentages shall then be compared; the analysis will then focus on individual cases and determine the relative risk of developing the complications of DM when one is having poorly controlled blood sugar levels.
Anticipated Outcomes and their Significance
This study hopes to establish a temporal sequence between chronic poor glycemic control and the increased incidence of complications of DM. As such, the study anticipates that the percentage of participants with newly diagnosed complications or at high risk of developing certain complications of DM will be close to or equal to that of the participants that have poor glycemic control. Moreover, for individual participants, the study anticipates to show that poor glycemic control is a major cause of the various complications of DM. In essence, the study will not only enrich the knowledge available on DM but will also improve patient care.
Proposed Timeline
| Month | 1 | 2 | 3 | 4 | 5 | 6 | |
| Pilot study of questionnaire | X | X | |||||
| Recruitment of study personnel | X | ||||||
| Questionnaire design and testing final | X | ||||||
| Ethics approval for wider study | X | X | |||||
| Questionnaire sent | X | X | |||||
| Accrual of Cases | X | X | X | ||||
| Data Collection, range and consistency checks | X | X | X | ||||
| Data analysis | X | X | X | ||||
| Compilation of a report | X | X | X | ||||
Bibliography
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