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Worldwide, diabetes mellitus is one of the most common chronic diseases. International Diabetes Federation estimated that 366 million people worldwide had diabetes in 2011 and has expected this to rise to 552 million by 2030. Importantly, a large proportion of this diabetes population resides in low and middle income countries and therefore by 2030 these will be the countries facing more rapid increase in number of diabetes population.(Whiting, Guariguata, Weil, & Shaw, 2011)
Insulin is the major player in maintenance of glucose homeostasis. Complications of T2DM are associated with uncontrolled high level of blood glucose level, which on due course of time leads to macrovascular and microvascular complications. United Kingdom Prospective Diabetes Study (UKPDS)(UKPDS, 1998) showed a reduced incidence of long-term microvascular and neuropathic complications in T2DM by lowering blood glucose. Evidence suggests that the relative risk of retinopathy declines by an estimated 24% with each 10% decrease in HbA1c level.(Molyneaux, Constantino, McGill, Zilkens, & Yue, 1998). The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) identifies insulin as the most effective glucose-lowering agent for the management of T2DM.(Nathan et al., 2009)
Despite the well-established importance of adherence to insulin therapy, including in T2DM (Peyrot, Skovlund, & Landgraf, 2009), it still remains as a clinical care challenge and is closely linked to poor patient outcomes.(Cramer & Pugh, 2005; Donnelly, Morris, & Evans, 2007; Peyrot, Barnett, Meneghini, & Schumm-Draeger, 2012; Peyrot, Rubin, Kruger, & Travis, 2010). Different studies have independently identified broad range of factors that challenge the compliance in insulin therapy. Various socioeconomic factors identified as challenges to the adherence in insulin therapy includes medication cost, household income, education, sex and age.(Peyrot et al., 2010) Similarly , different perception of patients on insulin therapy as an end stage treatment, treatment for type 1 diabetes only(Tan et al., 2011), as a burden interfering with the daily activities and having to plan daily activities around insulin injection(Peyrot et al., 2010) are identified as challenges to adherence to insulin therapy. In addition to this, sense of failure with change in lifestyle, weight loss, adherence with oral medication,(Peyrot & Rubin, 2007) sense of permanence and emotional well-being of the patient (Gonzalez et al., 2007), are also identified as challenges to compliance with the therapy. Moreover their perceived fear of side effects of insulin(Peyrot & Rubin, 2007), fear of weight gain (Peyrot et al., 2009) and perception of social embarrassment because of inability of society to understand bring additional challenges to the adherence to therapy(Tan et al., 2011).Different injection related factors identified as challenges to adherence to insulin therapy are complexity of regimen(Rubin, 2005), painful and embarrassing experience with the injection(Peyrot et al., 2010) and selection of insulin delivery device(Lee, Balu, Cobden, Joshi, & Pashos, 2006). The influence of family members is also correlated both positively and negatively with adherence to physician's recommendations including recommendation for insulin therapy.(Davies, Lavalle-Gonzalez, Storms, & Gomis, 2008)
Lower compliance with insulin regimens is associated with higher glycosylated hemoglobin (HbA1c) levels (Cramer & Pugh, 2005; Morris et al., 1997) and with higher rates of hospital admissions for diabetes-related complications (Cramer & Pugh, 2005). Therefore in this study, in addition to the administered questionnaire, HbA1c will also be used to measure compliance to insulin therapy. It has been observed that there are challenges in insulin therapy in patient attending Patan Hospital. Compliance to insulin therapy has been a great challenge to clinicians, therefore leading to the poor blood glucose control of T2DM. Hence, this study designed to identify challenges to compliance to insulin therapy in T2DM so that management of diabetes patients can be improved reducing long-term complications associated with diabetes.
ToÂ assessÂ theÂ challenges for compliance to insulin therapy in T2DM patients.
To develop and validate a tool to assessÂ theÂ challenges for the compliance in insulin therapy in T2DM patients
To implement the developed tool to assessÂ theÂ compliance to insulin therapy in T2DM patients
To identify challenges to compliance in patients undergoing insulin therapy
To correlate HbA1c level with the compliance of insulin therapy
RESEARCH QUESTION AND PROBLEMS
It has been observed that there is a great challenge to insulin therapy in T2DM patients visiting diabetes clinic of Patan Hospital. Therefore, this study has been planned to identify the challenges for the compliance in insulin therapy.
II EXPECTED RESULTS, APPLICATION AND USES
EXPECTED OUTCOMES OF THE STUDY
There are several components for challenges to compliance to insulin therapy: education about disease, availability of materials and medications to administer insulin, recognizing potential problems during insulin therapy and troubleshooting the problems. Each of these components has effect on whether patient is able to comply with insulin therapy. Furthermore, in clinical encounters, deficits in each of these areas are observed. The expected outcome of this study will be identification of challenges to each of this component in the local context.
Identification of challenges to compliance in the context of Nepal will be of great importance in management of diabetes patients. These tools can be used in educating diabetes patients regarding proper use of insulin to control blood glucose in the diabetes. As insulin has been identified as effective glucose lowering agent, inability to use insulin when indicated would lead to poor glycemic control which will eventually leads to deleterious diabetes complications. This study will help in treatment and management of diabetes patients by increasing the compliance to insulin therapy.
SCOPE OF THE STUDY
There is increasing prevalence of diabetes in the developing countries. Nepal's trend also fits into that of other nations in south Asia. The study in Nepal has shown prevalence of diabetes in urban population is 14.6 % and that of rural population is 2.5 %(Singh & Bhattarai, 2003).
It is very likely that in near future there will be large number of T2DM patients who will be on insulin therapy. According to the IDF, estimated cases of T2DM in Nepal for 2011 was 488,000 and is projected to increase to 1,171,000 by the year 2030.(Whiting et al., 2011)
Knowing challenges to insulin therapy will be critical in clinical care of T2DM patients. This will also inform policy makers in planning long term measures for T2DM management.
As sample population is selected from only one tertiary level health care centre and sample size is limited, our results are largely hypothesis generating for a much larger scale study that would have major public health implications.
III THEORETICAL ASPECT /CONCEPTUAL FRAMEWORK
Adherence to insulin therapy
Perceived insulin therapy Vs life-style
Fear of hypoglycemia
Concern about weight gain
Sense of personal failure
Compromised sexual life
Therapy related factors:
Difficulties with injections
Availability of the insulin delivery devices
Problem in insulin delivery
Health care provider related factors:
Assessment by the different physician
Lack of good communication
Lack of adequate time for discussion
Problem in getting an appointment
Socio- Demographic Factors:
Dietary adherence according to activity
IV METHOD AND METHODOLOGY
It is hospital based cross sectional study on T2DM patients attending Diabetes Clinic at Patan Hospital. Ethical Clearance will be obtained from, The Ethical Review Board of Nepal Health Research Council (NHRC). Written informed consent will be sought from each participant of the study and objective of the research will be clarified to them. Participants will be assured about the privacy and confidentiality of the information they provided.
DEVELOPMENT OF THE TOOL:
Literature review will be done to identify developed and validated tools. The components of these tools will be adopted as per our requirement of our research topic and their relevance in our context. Some of the tool will be modified and contextualized to our context. Research team will also identify the new tools for the challenges to compliance to insulin therapy in our own social context. Content validation of the questionnaire will be done by pre-testing the administered tools on T2DM patients on insulin therapy who are receiving treatment in other hospital. Changes in the questionnaire will be made as per the feedback provided by the pretest interviewer in order to contextualize the tool. Finalized tool then would be administered on T2DM patients on insulin therapy visiting Diabetes Clinic of Patan Hospital.
This study will include 400 T2DM patients on insulin therapy attending Diabetes Clinic at Patan Hospital. Sample size is calculated with the highest number of minimum sample considering p value of 0.5 which turns out to be 384. Purposive sampling technique will be used. Patients who meet the inclusion criteria will be enrolled without a failure till the number of patient reaches to 400.
Socio-demographic parameters like name, age and gender will be identified. Measurement of HbA1c level will be analyzed by NycocardÂ® Reader based on boronate affinity assay.
Clinically diagnosed T2DM on insulin therapy
Clinically diagnosed T2DM on oral therapy who have been advised for insulin therapy in the past
T2DM respondents not consenting
Patients not able to provide information (e.g. mentally disabled patients)
DATA ANALYSIS SCHEME
First the data will be entered into MicrosoftÂ® Excel 2010 and IBM SPSSÂ® version 20 for WindowsÂ® to see relevant calculation from the findings. Descriptive statistics will be used to analyze demographic parameters and appropriate inferential statistics will be applied depending upon the data.
DATA ANALYSIS FRAMEWORK (Need to be prepared)
TASKS TO BE COMPLETED
(Discussion for questionnaire developments, preparation for sample collection and quality control of equipment)
Development of research Tools
Translating questionnaire in the local language, typing and photocopying
Preliminary Validation and Pre testing of the Questionnaire and finalization of questionairre
Confirmatory Validation and Questionnaire Printing
Orientation Training to research assistant and data collectors
Sample and DataCollection
(Obtain the informed consent, collection of data and blood sample)
Sample Analysis (Serum HbA1c level estimation)
Data Analysis (Data entering to SPSS, Interpretation of the data)
Initial Report writing
Discussion of the draft
Final Report Writing and submission
SECTION II: BUDGETING
No of Units
Total cost (NPR)
Micropipettes, Microtips, (PAHS Supported)
HbA1c Nycocard strips
Index and Binder File
Stapler and Staple pin
Pencils, Eraser and Sharper
Internet (PAHS Supported)
Report writing and printing
SECTION III: COLLECTION OF BIBLIOGRAPHIES FOR REVIEWS
Cramer, J. A., & Pugh, M. J. (2005). The influence of insulin use on glycemic control: How well do adults follow prescriptions for insulin? Diabetes Care, 28(15616237), 78-83.
Davies, M., Lavalle-Gonzalez, F., Storms, F., & Gomis, R. (2008). Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial. Diabetes Obes Metab, 10(18355327), 387-399.
Donnelly, L. A., Morris, A. D., & Evans, J. M. M. (2007). Adherence to insulin and its association with glycaemic control in patients with type 2 diabetes. QJM, 100(17504861), 345-350.
Gonzalez, J. S., Safren, S. A., Cagliero, E., Wexler, D. J., Delahanty, L., Wittenberg, E., . . . Grant, R. W. (2007). Depression, self-care, and medication adherence in type 2 diabetes: relationships across the full range of symptom severity. Diabetes Care, 30(17536067), 2222-2227.
Lee, W. C., Balu, S., Cobden, D., Joshi, A. V., & Pashos, C. L. (2006). Medication adherence and the associated health-economic impact among patients with type 2 diabetes mellitus converting to insulin pen therapy: an analysis of third-party managed care claims data. Clin Ther, 28(17157128), 1712-1725.
Molyneaux, L. M., Constantino, M. I., McGill, M., Zilkens, R., & Yue, D. K. (1998). Better glycaemic control and risk reduction of diabetic complications in Type 2 diabetes: comparison with the DCCT. Diabetes Res Clin Pract, 42(9886743), 77-83.
Morris, A. D., Boyle, D. I., McMahon, A. D., Greene, S. A., MacDonald, T. M., & Newton, R. W. (1997). Adherence to insulin treatment, glycaemic control, and ketoacidosis in insulin-dependent diabetes mellitus. The DARTS/MEMO Collaboration. Diabetes Audit and Research in Tayside Scotland. Medicines Monitoring Unit. Lancet, 350(9090), 1505-1510.
Nathan, D. M., Buse, J. B., Davidson, M. B., Ferrannini, E., Holman, R. R., Sherwin, R., & Zinman, B. (2009). Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care, 32(18945920), 193-203.
Peyrot, M., Barnett, A. H., Meneghini, L. F., & Schumm-Draeger, P. M. (2012). Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med, 29(22313123), 682-689.
Peyrot, M., & Rubin, R. R. (2007). Behavioral and psychosocial interventions in diabetes: a conceptual review. Diabetes Care, 30(17666457), 2433-2440.
Peyrot, M., Rubin, R. R., Kruger, D. F., & Travis, L. B. (2010). Correlates of insulin injection omission. Diabetes Care, 33(20103556), 240-245.
Peyrot, M., Skovlund, S. E., & Landgraf, R. (2009). Epidemiology and correlates of weight worry in the multinational Diabetes Attitudes, Wishes and Needs study. [Research Support, Non-U.S. Gov't]. Curr Med Res Opin, 25(8), 1985-1993. doi: 10.1185/03007990903073654
Rubin, R. R. (2005). Adherence to pharmacologic therapy in patients with type 2 diabetes mellitus. [Review]. Am J Med, 118 Suppl 5A, 27S-34S. doi: 10.1016/j.amjmed.2005.04.012
Singh, D. L., & Bhattarai, M. D. (2003). High prevalence of diabetes and impaired fasting glycaemia in urban Nepal. [Letter]. Diabet Med, 20(2), 170-171.
Tan, A. M., Muthusamy, L., Ng, C. C., Phoon, K. Y., Ow, J. H., & Tan, N. C. (2011). Initiation of insulin for type 2 diabetes mellitus patients: what are the issues? A qualitative study. [Research Support, Non-U.S. Gov't]. Singapore Med J, 52(11), 801-809.
UKPDS. (1998). Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes. [Clinical Trial]. Lancet, 352(9131), 837-853.
Whiting, D. R., Guariguata, L., Weil, C., & Shaw, J. (2011). IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. [Research Support, Non-U.S. Gov't]. Diabetes Res Clin Pract, 94(3), 311-321. doi: 10.1016/j.diabres.2011.10.029