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WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIEES Saravanan et al. SJIF Impact Factor 5.21 Volume 4, Issue 2, Research Article ISSN SELF MONITORING BLOOD GLUCOSE FREQUEY AND MEDICATION ADHEREE IN THE MANAGEMENT OF TYPE-II DIABETES PATIENTS: A PROSPECTIVE CROSS SECTIONALSTUDY *K. Saravanan, P.K. Manna and G.P.Mohanta Department of Pharmacy, Annamalai University, Annamalai Nagar-682. Article Received on 26 Aug 215, Revised on 18 Sept 215, Accepted on 9 Oct 215 *Correspondence for Author K. Saravanan Department of Pharmacy, Annamalai University, Annamalai Nagar-682. ABSTRACT The objective of the study was to describe the frequency of self monitoring blood glucose (SMBG) in non insulin type II diabetes mellitus, assesses the patients' behavior and responses, and to evaluate self reported medication adherence and investigate the patients' perception about the continuation of medication while diseases under control to improve the diabetes management. KEYWORDS: SMBG, Medication adherence Type- II diabetic mellitus a prospective study. 1. INTRODUCTION SMBG helps the patients to identify high and low blood sugar and react to the abnormal blood glucose values. The purpose of the SMBG is to collect the blood glucose levels at different time intervals and enable the maintenance of a more constant glucose level by more precise regimens. Frequency of SMBG varies from patient to patients.idf guideline for SMBG for type II diabetes recommend SMBG should be used only when individuals with diabetes (and /or their caregivers) and /or their health care providers have the knowledge, skills and willingness to incorporate SMBG monitoring and therapy adjustment in to their diabetes care plan in order to attain agreed treatment goals'' 1.IDF all so recommended SMBG should also be considered as part of ongoing diabetes self management education to assist people with diabetes to better understand their disease and provide a means to actively and effectively participate in its control and treatment, modifying behavioural and [1] pharmacological interventions as needed in consultant with healthcare provider. The first glucometer was patented in the year of Since then it was possible to monitor blood Vol 4, Issue 11, glucose more frequently, even in the domestic condition. Subsequently glucose self monitoring became an integral part of treatment. Self monitoring of blood glucose is essential for insulin treated patients with type1 diabetic (DM1) to adjust the insulin dosages. It helps to reach and maintain normoglycemia. Such treatments provide continuous control of blood glucose levels. [2] Type2 diabetes (DM2) has the complex pathogenesis and more progressive course than DM1.The gradual increase of glycosylated hemoglobin(hba1c) over time is observed. [3] However, evidence supporting the use of SMBG for patients with DM2. Not requiring insulin or treated with fixed dose. One of the first studies which documented beneficial role of SMBG was trial published by Devencianaet al. on gestational diabetes. The author compared the efficacy of postprandial vs preprandial monitoring in achieving glycemic control in women with insulin treated gestational diabetes. They proved that adjustment of insulin therapy, according to the result of postprandial, rather than preprandial blood glucose values, improves prognosis of pregnancy [4] however, the results obtained for gestational diabetes does not relate to the whole population of diabetic patients. Adherence with medication usage is defined as the proportion of prescribed doses of medication actually taken by a patient over a specified period of time. [5] Compliance, a synonymous term which was commonly used in the past, implies a passive role and simply following the demands of a prescriber and non-compliance has been regarded as associated with deviant or irrational behaviour. [6] Non-adherence or non-compliance, poverty, lack of knowledge and poor follow ups are the main factors observed in poor glycemic control. [7] Individuals with poor management of diabetes are at a greater risk of developing long-term micro and macro-vascular complications that lead to the damage of end organs such as kidneys, heart, brain and eyes, affects the direct and indirect health care costs and overall quality of life [8] Optimal glucose control can be achieved through strict adherence to medications, diet and lifestyle Adherence with medication usage is defined as the proportion of prescribed doses of medication actually taken by a patient over a specified period of time [9]. The aim of the study was to health care providers in RMMCH advice to Type II diabetic patients who are in stable glycemic control,regarding the frequency and timing of SMBG and evaluated self reported medication adherence and to identify the factors linked with poor adherence. Vol 4, Issue 11, 2. MATERIAL AND METHODS The institutional Human Ethical Committee of Annamalai University has been approved the study of being carried out at the Raja Muthiah Medical College and Hospital RMMCH. 12 Type 2 diabetic patients, which include 69 males and 51 females, were recruited as per the inclusion and exclusion criteria Patients who are regularly visiting hospital for the treatment from March 212 to May 213 have been taken as subjects for the study. Patients were recruited as per the inclusion and exclusion criteria Inclusion criteria Those patients are having the following categories only were recruited for the study a. Patients who diagnosed with Type-2 diabetes complications b. Patients with age of 3 years and above c. Fasting glucose 14mg/dl d. Postprandial blood glucose level (at 2hr) 2mg /dl e. Patients with associated diseases of Hypertension, Coronary artery diseases, Bronchial Pneumonia, Asthma, 2.2. Exclusion criteria a. Patients who diagnosed with outtype-2 diabetes complications b. Patients below the age group of 3 years. c. Patients who are not willing to participate in the study. d. Nursing or pregnant women. e. Hepatic or renal disease patients f. Patients with History of Ketoacidosis Patients were divided into three groups of 4 patients in each named as 1, 2 and 3. The 1 patients were treated with Metformin 5 mg whereas 2 was treated with Glimepiride 2mg and group 3 treated with combination therapy of Glimepiride 2mg with Metformin5mg 2.3 Data collection The data collection and documentation of patient profile form was designed which includes information on patient's demographic details (e.g. Patient s Name, Age, Sex, employment and date of admission for in patients and out patients review dates presenting complaints, provisional/confirmed diagnosis, social history, current medications, laboratory test reports Vol 4, Issue 11, 2.4 Measures The SMBG assessment and frequency has been assessed during pre designed questionary a framework of (sonupoulse.,et al 211) were measures using 95% confidence interval.adherence to treatment has been assessed during a personal interview with each patient using a questionnaire. (Each patient takes 1 minutes to complete) medication adherence to diabetes medicines was determined using a modified version of the four items,self reported Morisky medication adherence scale (11) Each item is in Yes/no format with a maximum possible score of four equating very poor adherence and consider as good adherence Table 1: Socio demographic characteristics of patients. Characteristics Number of patients Percentage Gender Male Female Age Education Status Primary Secondary Tertiary Illiterate Place of residence Village Town Clinical Characteristics of diabetes patients No of Patients Percentage Duration of Diabetes (in years) Co-morbidities Hypertension Peripheral Neuropathy Gastritis 6 5 UTI Parkinson's LRTI Vol 4, Issue 11, Table1 explains A total 12 patients were enrolled in the study out of which male 69(57.5%) and females 51(42.5%) Co morbidities of patients with Type ll diabetes mellitus.the most common which were Hypertension (27.5%) Peripheral neuropathy(17.5%) and the effect of age on diabetes most patients belong to the age group of 51-6 years (45%) followed by (41-5) years (26.6%). Table 2: Proportion of patient assessment of SMBG S.No Questionary Do you know self monitoring blood glucose meter? Do you check your blood glucose using self monitoring blood glucose meter? Patients agree Patients disagree I II III I II III 14 ( ) 6 ( ) 25 ( ) 11 ( ) 31 ( ) 14 ( ) 26 ( ) 34 ( ) 15 ( ) 29 ( ) 5 ( ) 22 ( ) In the present study, out of 116 patients recruited, 7 patients (.95-.9) know about self monitoring blood glucose meter. Whilst 46 (.9-.95) patients were not aware of the device. Meanwhile, 31 patients (.78-.9) were using the SMBG for blood glucose estimation and 85 patients (.9-.78) were estimated by conventional methods (Table- 2). Vol 4, Issue 11, Table 3: Proportion of patient Frequency of SMBG S. No 3. Questionary How often do you check Patients Monthly Checked By SMBG I 4 ( ) II 6 ( ) III 13 ( ) Patients Weekly Checked By SMBG I 2 ( ) II 4 ( ) III 2 ( ) Patients Daily Checked By SMBG I II III Patients didn't undergo SMBG I 34 ( ) II 3 (.77-.8) III 21 ( ) S. No 4. Questionary The physician has recommended to do SMBG Physician Monthly Recommended I II III (.33- (.59- ( )..78).87) Physician Weekly Recommended I II III 4 ( ) 4 ( ) I Physician Daily Recommended II III Physician not Recommended I II III (.81- (.62- ( ).8).,4) (Table -3) shows the proportion and frequency of SMBG usage among the subjects of different groups. From the results it was shown that 23 patients check their blood glucose level monthly using SMBG; 8 patients check by weekly and 85 didn t used SMBG. Vol 4, Issue 11, Physician s recommendation for the usage of SMBG among the subjects in different groups. (Table- 4) Displays the outcome of physician recommendation to use SMBG patients with type 2 diabetic mellitus. From the results it was shown that 49 ( ) patients were measured monthly, 8 ( ) were measured weekly and 59 patients ( ) were not recommended to use SMBG. Table 4: Summary of Patients' responses to the modified Morisky adherence predictor Scale Questions Yes No Response (Score coding) Number Percentage Number Percentage Do you ever forget to take your medicine(s)? Do you sometimes not being careful in taking your medicine(s)? When you feel better, do you sometimes stop taking your medicines? Sometimes If you feel worse when you take your medication(s) do you stop taking them? Distribution of scores Total Percentage Category of adherence High adherence Medium adherence Low adherence Table 5 Correlation between patient s socio demographic characteristics Categories Number of patients (%) High Adherence N (%) Medium Adherence N (%) Low adherence N (%) Gender Male 69 (57.5) 32 (46.37) 24 (34.78) 13 (18.84) Female 51 (42.5) 19 (37.25) 27 (52.94) 5 (9.8) Age (Years) (11.66) 7 (5.) 4 (28.57) 3 (21.42) (26.66) 8 (25.) 19 (59.37) 5 (15-62) (45.) 22 (4.74) 17 (31.48) 15 (27.77) (16.66) 9 (45.) 6 (3.) 5 (25) Education status Vol 4, Issue 11, Primary 36 (3.) 16 (44.44) 12 (3.33) 8 (22.22) Secondary 44 (36.66) 15 (34.9) 2 (45.45) 9 (2.45) Literary 28 (23.33) 1 (35.71) 12 (42.85) 6 (21.42) Illiterate 12 (1.) 7 (58.33) 3 (25.) 2 (16.66) Employment Status Employed 37 (3.83) 14 (37. 83) 2 (54.5) 3 (8.57) Unemployed 74 (61.66) 36(48.64) 29 (39.18) 9 (13.23) Retired 9 (7.5) 5 (55.5) 3 (17.64) 1(11.1) Place of Residence Village 87 (72.5) 59 (67.81) 15 (17.24) 13 (14.94) Town 33 (27.5) 12 (36.36) 13 (39.39) 8 (24.24) Table 6:Factors affecting rate of medication adherence in type II diabetic patients Cause Number of patients Percentage(%) Non adherence to taking medication as prescribed 1) Therapy related factors a) Side effects b) Long duration of treatment period 2) Patients related factors a) Lack of knowledge about the diseases b) Inadequate knowledge regarding therapy c) Forgetfulness d) When felt better e) When felt worse f) Others Hypoglycemia, etc..) Table 7:Association between adherence with medication and plasma glucose control Parameters Number of Patients Blood glucose status Good Controlled Moderate Controlled Number % Number % Good Adherence Medium Adherence Low Adherence Total Among 116 patients 78.26% patients had better glycemic control and 21.73% patients moderate controls. 17 patients who had goal of blood glucose control,78.26% were high adherent, 59.52% were medium adherent and 35.71% low adherent.the blood glucose control rate was significantly higher in those that high adhere to an anti diabetic medication when compared with non-adhering( medium and poor adherence)table 7 Vol 4, Issue 11, DISCUSSION Diabetes mellitus is one of the major non communicable diseases which are growing very fast in the modern world. Diabetes and associated complication a major health care burden worldwide. Males predominate in the study population, which is an agreement which results of various other studies in India [1] and United states educational status The higher prevalence in younger age group may be due to the lifestyle of the younger population and also the stress factor which unmasks diabetes causing blood sugar to rise. [16] The level of education and place of residence are important determinants of how quickly a diagnosis will be made. Level of education and economic status can have a positive and negative impact on the quality of life of diabetes patients, as a result, on the level of metabolic control. Satisfaction with treatment and quality of life are positively associated with employment and a higher income. People with lower education levels and unemployment persons, have, in general, a lower satisfaction with life and are less satisfied with diabetes treatment, as well as having worse metabolic control. [17] In the study was found more in secondary education with higher prevalence rate 36.66% in the employment status unemployed patients had more prevalence to 56.6% than employed 29.16% The duration of diabetes plays an important role in the management of diabetes.the study showed that most of the patients of years patients with a long duration of diabetes mellitus developed complications [12] In the present study, only 36 (78.26%) of the subjects had better glycemic control.a total 54 patients suffered from Co-morbid conditions, the most common which were Hypertension (27.5%) peripheral neuropathy (17.5%). This study finding consists with similar study hypertension is a more complication affecting 2-6% of people with diabetes. [13] A four item modified Morsiky adherence predictor scale used to assess medication adherence. It is a self report method. The assessment of patients' response to the 4 items modified Morsiky adherence predictor scale [15] showed that 39.65% (N=46) of the patients had good adherence with prescribed medications whereas 36.2% had medium adherence,and 24.13% had low adherence. Medication adherence is a key component for patients with diabetes. The present study has found a high rate of good adherence in male (46.37%) than female. This result consists with similar study, conducted among Americans in which men scored higher than women on self care adherence [14] Vol 4, Issue 11, The side effect of drugs which is considered as a factor for non- adherence appeared with 6.3%. In the present study, 53.44% patient with Inadequate knowledge regarding therapy was found. The identified cause of non-adherence to take antidiabetic medications as prescribed forgetfulness, when felt better, when felt worse others Hypoglycemia were found to be 12.93%, 33.62%, 31.89% and 1.34% A study identified busy work schedule, especially for patients in the working population as one of the reasons for not taking their anti diabetic medication as prescribed was found to be 12.93% and forgetfulness is a widely reported factor that cause non-adherence with medication. Which are lower than the study conducted in Nigeria. [15] 4. COLUSION Diabetes mellitus is one of the disorder, we cannot cure the diseases.but it can be controlled with the help of oral hypoglycemic drugs, Physician and pharmacist improve the areas of patient education and medication counselling. Encouraging the patients to monitor the blood glucose in house using (SMBG), instructed to note in the diary every review visit checks the blood glucose status to adjust the dosage, diet, and modulation of exercise and all so to educate the importance of SMBG in management of diabetes mellitus.the habit of doing SMBG reduced the symptoms related diabetes complications. ACKNOWLEDGEMENT The authors thank the hospital and other university staff who have for their supporting this study. REFEREE 1. Guideline on Self-MonitoringofBloodGlucoseinNon-Insulin Treated type2diabetes, Available http: // Essen May 1,212, The Diabetes control and complications trial research group. The effect of intensive treatment on the development and progression of long term complication in insulin dependent diabetes medicine.n Englj J Med., 1993; 329: Straightening, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA et al. Association of glycaemia with macrovascular and Microvascular complications of type 2 diabetes (UKPDS 35): Prospective observational study., BMJ 2; 321: De Veciana M, Major CA, Morgan MA, Asrat T, Toohey JS, Lien JM, et al. Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus Requiring insulin therapy. N Engl J Med., 1995; 333: Vol 4, Issue 11, 5. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med., 25; 353: H. Lee M, Keeffe EB. Study of adherence comes to the treatment of chronic hepatitis B ( Editorial). Journal of Hepatology., 211; 54: Kalyango J, Owino E, Nambuya A. Non-adherence to diabetes treatment at Mulago Hospital in Uganda: prevalence and associated factors. Afr. Health Sci., 28; 8: Maddigan, S.L, Feeny, D.H., Johnson, J.A. Health related quality of life deficits associated with diabetes and co morbidities in a Canadian national population health survey. Qual. Life Res., 25; 14: , 9. Morisky DE, Green LW, Levine DM. Concurrent and Predictive Validity of a Self Reported Measure of Medication Adherence. Medical Care., 1986; 24(Suppl 1): Sony poulose et al, Self- monitoring of blood glucose frequency and awareness among non- insulin treated Type 2 diabetes patients, a community pharmacy survey., 211; Vengurlekar S, Shukula P,Patidar P,Bafna R,Jain S. Prescribing pattern of antidiabetic drugs Indore city hospital.indian JPharm Sci., 28; 7: Upadhyay DK, Palaian S, Ravi Shankar P, Mishra P, Sah AK. Prescribing pattern in diabetic outpatients in a tertiary care teaching hospital in Nepal. J Cardiovasc Dis Res., 27; 4: Montague MC. Psychosocial and functional outcomes in African Americans with diabetes mellitus. ABNF J., 22 Sep 13; 5: Roland Nnaemeka Okoro, Cyprian Kingsley Ngong. Assessment Of Patient s Anti- Diabetic Medication Adherence Levels in Non-Comorbid Diabetes Mellitus in A Tertiary Health Care Setting in Nigeria. Pharmacy Globale, International J of Comprehensive Pharmacy. July 212; 7(Suppl1): Roland Nnaemeka Okoro, Cyprian Kingsley Ngong. Assessment Of Patient s Anti- Diabetic Medication Adherence Levels in Non-Comorbid Diabetes Mellitus in A Tertiary Health Care Setting in Nigeria. Pharmacy Globale, International J of Comprehensive Pharmacy., July 212; 7(Suppl1): Santhosh YL, Naveen MR. Medication Adherence Behavior in Chronic Diseases like Asthma and Diabetes Mellitus. International J of Pharmacy and Pharmaceutical Sciences., 211; 3 (Suppl 3): Maria Kurowska, Jerzy S. Tarach, Joanna Malicka, Anna Chitryn, Anna Dabrowska. The Impact of the level of education and paid work on HbA1c concentrations in patients with type 1 diabetes- preliminary findings. Lublin- Polonia., 21; 23 (Suppl 2): Vol 4, Issue 11,
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