POSITIVE IMPACT OF SELF-MONITORING OF BLOOD GLUCOSE ON DIABETES MANAGEMENT IN MALE PATIENTS WITH TYPE 2 DIABETES FROM ASEER DIABETIC CENTER, ABHA, KINGDOM OF SAUDI ARABIA

Abstract

Self-monitoring of blood glucose (SMBG) is one of the major components for effective diabetes management in modern therapy. However, the efficacy of SMBG is highly controversial for type 2 diabetes mellitus (T2DM) patients. In view of this controversy, the present study was done to design an appropriate plan and to evaluate the true impact of SMBG on T2DM management. This cross sectional retrospective and prospective study was carried out for two and half years involving 400 male T2DM patients from Aseer Diabetic Center, Abha, Kingdom of Saudi Arabia. Patients with glycated hemoglobin levels in the range of 9%-10% were divided equally into SMBG - and non-SMBG groups. The SMBG group monitored their blood glucose levels daily while non-SMBG remained as a control. Results of our study shown significant decrease of HbA^sup 1c^ levels in SMBG group from 9.5% to 7.8% in 30 months, while non-SMBG group shown no significant difference (9.3% to 8.9%).

Headnote

ABSTRACT

Self-monitoring of blood glucose (SMBG) is one of the major components for effective diabetes management in modern therapy. However, the efficacy of SMBG is highly controversial for type 2 diabetes mellitus (T2DM) patients. In view of this controversy, the present study was done to design an appropriate plan and to evaluate the true impact of SMBG on T2DM management. This cross sectional retrospective and prospective study was carried out for two and half years involving 400 male T2DM patients (age; 40-50; obesity grade I) from Aseer Diabetic Center, Abha, Kingdom of Saudi Arabia. Patients with glycated hemoglobin (HbA^sub 1c^) levels in the range of 9%-10% were divided equally into SMBG - and non-SMBG groups. The SMBG group monitored their blood glucose levels daily while non-SMBG remained as a control. Patients in both the groups were requested to follow healthy diet recommended by diabetologists and perform walking as an exercise regularly for 30-70 min/1-3 mile/2,400-6,400 steps daily. To avoid various drug influences on HBA^sub 1c^ levels, all the patients were administered only extended release tablets of metformin 1000 mg twice daily. Results of our study shown significant decrease of HbA^sub 1c^ levels in SMBG group from 9.5% to 7.8% in 30 months, while non-SMBG group shown no significant difference (9.3% to 8.9%). Similarly patients consuming healthy diet, performing exercise and compliance to drug increased in SMBG group than in non-SMBG group. In conclusion, SMBG had positive influence on glycemic control, awareness and attitude of patients towards lifestyle modifications and compliance to medication.

Keywords: SMBG, Metformin, Type 2 Diabetes Mellitus, Diet and Exercise.

INTRODUCTION

Diabetes mellitus (DM) is a chronic metabolic disorder resulting from the interaction of genetic and environmental factors among which lifestyle has a fundamental role1,2. DM particularly type 2 accounts for 90 - 95% of all cases3. Most individuals with diabetes need medications such as pills or insulin, proper diet and exercise and self monitoring of blood glucose (SMBG) at home4,5. There are many factors that influence how well patients are able to comply with these requirements including age, education, income, and cultural and lifestyle issues6.

T2DM and its complications are a major cause of morbidity and mortality worldwide7. High blood glucose levels in DM often results in major complications such as

cardiovascular diseases, retinopathy, neuropathy and nephropathy8,9. Hence, SMBG plays a crucial role in management of DM by detecting or confirming the hypoglycemia and severe hyperglycemia in domestic settings10,11. This patient centric tool aids to collect blood glucose at many time points that could assist in maintenance of constant glucose level by precise therapeutic plan. Further, it helps diabetic patients and their family members to make appropriate day to day changes in diet and physical activity, as well as adjusting the dose of insulin or other DM management pills12,13. It enhances the patient's understanding of the importance on diet and life style modifications in managing the disease13. It is almost universally agreed by health professionals that SMBG should be available to all diabetic patients regardless of their therapeutic regimen11.

Various clinical trials conducted worldwide shown the significance of higher frequency of SMBG in glycemic control in both types of DM (1 and 2)14-17. Contrarily, some studies suggests that SMBG has not achieved its true potential impact as an aid to improve the glycemic control18-20.

In view of this controversy and to design an appropriate plan for managing T2DM, the present study was carried out to evaluate the true impact of SMBG on diabetes management.

SUBJECTS & METHOD

Subjects

Total number of 400 male T2DM patients in the age group of 40-50, obesity grade I (BMI - 30-34.9) referred to Aseer Diabetic Center, Abha, Kingdom of Saudi Arabia, were included in this hospital based cross sectional retrospective and prospective study. At the time of recruitment to avoid bias; all the patients were carefully divided into two groups based on their HbA1c levels. Patients having HbA1c percentage in the range of 9-10 were divided equally into SMBG and Non-SMBG groups. One group was asked to monitor SMBG regularly (one time/day; 7 days/week) and note down their blood glucose levels; other group served as negative control; they did not self-monitor their blood glucose in their homes. This study was done for two and half years (November 2010 to April 2013). Patients were informed about the purpose of the study, confidentiality of the data and anonymity. Only patients who agreed were interviewed. Post the end point, the results were compiled and analyzed to know the impact of SMBG on HbA1c, life style changes and compliance to therapy.

SMBG measurement

Patients in SMBG group were taught and directed to perform blood glucose test each day in their home. Test mostly involves pricking a finger with a lancet device to obtain small blood sample, applying a drop of blood onto a reagent strip and determining the glucose concentration by inserting the strip into a reflectance photometer for an automated reading. Test results were then recorded by patient in a logbook or stored in glucose meter's electronic memory.

HbA1c Determination

Patients recruited in the study were requested to visit the ADC once in 3 months till the end of the study, in each visit the HbA1c levels were monitored and awareness and educational materials were provided. About 5 ml of venous blood collected in EDTA-containing tubes from all patients, were immediately processed for quantitative determination of HbA1c. Briefly, the erythrocytes were lysed to liberate haemoglobin. The measurement of HbA1c in the lysate was determined by turbid metric inhibition immunoassay (TINIA) utilizing Dimension Clinical Chemistry System (Siemens, Germany) at 340 nm. The HbA1c result is represented as percentage; the higher the percentage, higher the person's blood glucose has been. American Diabetes Association (ADA) recommends HbA1c levels < 7% as treatment goal for most of the DM patients. Stand-alone HbA1c levels above 6.5% meet the ADA criteria for diagnosis of diabetes.

Compliance to life style changes and medication

Life style changes included dietary modifications and exercise regimen. Patients in both SMBG and non-SMBG group were requested to follow healthy diet, which includes intake of low calorie, low fat diet and taking food in small portions. Patients were asked to reduce red meat - and chicken-intake. Further they were advised not to eat regularly in restaurants to avoid saturated and transfat foods. Eating healthy also included using unsaturated oils for cooking, not skipping morning breakfast, taking same amount of food/calorie every day and consuming a balanced diet. A questionnaire was developed based on these parameters (Table 1).

Patients in both SMBG and non-SMBG group were recommended to walk at least 1-3 miles/day or 30-70 min or 2,400 -6,400 steps/day. All the patients in our study can normally walk without any external aid or human support. SMBG group of patients were advised to check their blood glucose levels before and during the exercise and recommended to take a source of carbohydrate in case of hypoglycemia. Patients in non-SMBG group were educated to take a source of carbohydrate in case of giddiness felt while performing regular exercise.

To avoid the influence of different antidiabetic drugs on HbA1c levels, all the patients were administered only extended release tablets of Metformin 1000 mg with breakfast and evening meals.

The collected raw data was recorded and statistically analyzed with Windows Microsoft Excel 2007. Descriptive statistics of Mean, Standard Deviation (SD) and frequencies were performed on the sample, one way ANOVA was used to analyze the continuous data by using graph pad prism software version-5; p ≤ 0.05 was considered statistically significant.

RESULTS AND DISCUSSION

SMBG plays a critical role in diabetes management. Proponents worldwide consider it as a useful tool to maintain near normal blood glucose levels. Regular usage of it could help to analyze effectiveness of therapy and detect asymptomatic hypoglycemia and extreme hyperglycemia10,11,21. In line with this results of our study involving male T2DM patients shown significance of SMBG in maintaining the diabetes and improving patient healthy life style.

HbA1c levels significantly decreased in SMBG group from 9.5% to 7.8% in 30 months. The graph (Figure 1) shows downward trend indicating that the levels may further decrease with time.

However, non-SMBG group shown no significant difference in HbA1c levels from the time of referral to the end point of the study (9.3% vs 8.9%). These results indicate that the patients monitoring blood glucose are responding positively to the therapy than patients without SMBG follow-up. Reduction in HbA1c levels indicates lowered risk of diabetes associated complications9.

A meta - analysis study done by Jansen et al shown that application of SMBG improved glycemic control, expressed as reduction in HbA1c levels in comparison to interventions without self - monitoring in T2 DM patients14. As well, a prospective international multicenter study on a group of 610 patients with uncontrolled T2DM treated with gliclazide (oral hypoglycemic agent) shown significant reduction in HbA1c levels in SMBG group when compared to non- SMBG group in 24 weeks of observation4,16.

In another study Stratton et al showed that each 1% reduction in HbA1c was associated with 37% decrease in risk for microvascular complications and a 21% decrease in risk for any end point or death related to diabetes8. Further same study shown that in T2DM patients, small percent (0.39%) decrease in HbA1c is expected to reduce the risk of microvascular complications by 14%. Similarly, an epidemiological cohort study done by Martin et al for 8 years involving 3268 T2 DM patients revealed that total rate of fatal and non-fatal events, micro - and macrovascular complications was lower in the SMBG group than in the non- SMBG group15.

In our study we observed fourfold decrease in HbA1c levels in SMBG group when compared with non-SMBG group (1.7% vs. 0.4%) in 2.5 years of follow up. This significant decrease in HbA1c levels may reduce the morbidity and mortality in SMBG group of patients than non - SMBG patients8.

Current guidelines for glycemic control recommends HbA1c values < 7% as a treatment for most DM patients6. SMBG is beneficial in patients who do not use insulin because lifestyle and oral medications may be modified to control blood glucose levels in a similar way to insulin doses. By making patients aware of their blood glucose levels, SMBG encourages modification of behavior, greater adherence to treatment regimens and patient commitment in controlling the disease.

In an earlier study Faas et al. described that education on how to change lifestyle habits is essential to show positive effects of SMBG on glycemic control22. In line with this in our study both the SMBG and non- SMBG group received the same topics on lifestyle with the same intensity to evaluate the effect of SMBG. Life style changes included exercise and dietary changes.

In our study, we found that increased number of patients in SMBG group followed given instructions on diet than non-SMBG (Table 1). Most of the patients in our study changed their cooking oil; among the oils given as a choice (olive, safola or canola) patients mostly preferred olive oil for cooking post referral. SMBG group of patients did significant changes to their diet on comparison to the diet they consumed at the time of referral.

Number of patients consuming healthy diet increased significantly in SMBG group at the end of the study than at the time of referral (143 vs. 25). Also number of patients taking healthy diet increased in SMBG group on comparison to non- SMBG group (143 vs. 109; Figure 2).

Results of our study shown increase in number of patients performing walking as physical exercise in SMBG group than in non - SMBG group (182 vs. 88; Figure 3a). Comparison made within the group of patients from the time of referral to the end of the study shown significant increase in both the group. SMBG group shown increased number of patients going for walking regularly from 22% to 91%, whereas non-SMBG group shown increase from 19% to 44% (Figure 3a).

Analysis of frequency of walk performed/week shown no significant difference in number of people walking 7 days/ week regularly in both the group (2% SMBG vs 1% nonSMBG). But at the time of referral not even a single patient walked for 7 days in a week regularly (Figure 3b and 3c). The observed fold increase was higher in people walking 3 days/week than any other days of the week in SMBG group on comparison to non - SMBG group (5.7 fold; 58 vs. 11). Number of T2DM patients walking for 2, 4, 5 and 6 days regularly in a week also increased in SMBG group than in non- SMBG group. However, number of people walking 1day/week was high in non - SMBG group than in SMBG group, this may be due to increased distribution of people in other days (2-7 days/week) in SMBG group. Overall, the number of people regularly walking and their frequency of walking increased in SMBG group than nonSMBG group (Figure 3b and 3c). Though this result seems to be encouraging more awareness and motivation needed to encourage the T2DM patients to do walking for 5-7 days/week.

Walking is the most recommended form of exercise throughout the world for people with diabetes23,24. It is a convenient and easy form of exercise that can be performed at ease at any place. For T2DM patients, exercise is nearly as important as diet in controlling the disease25. Decades of studies had proven the relationship of walkability to reduce diabetes associated complications. Walking can improve the body's insulin sensitivity, which may lead to improved blood glucose control23,24. A brisk walk after a meal may lower the spike in blood glucose, hence it could result in hypoglycemia (low blood glucose)26. Patients in SMBG group is aware of this phenomenon, whenever they feel low blood glucose or giddiness, they tend to check their blood glucose and take some carbohydrate. Patients in SMBG group when enquired told that if they observe hyperglycemia they adjust their diet and go for brisk walking for ~ 30 - 70 min. Since non-SMBG were not monitoring their blood glucose levels, their awareness of this phenomenon is low and they feel walking make them more sick (data not shown), thereby avoid walking.

In addition to diet and exercise, compliance to drug therapy is considered as important parameter in beneficial therapy of T2DM patients. In our study, SMBG group shown better compliance to Metformin monotherapy than non-SMBG group (182 vs. 120). Number of patients taking Metformin regularly increased from the time of referral to end of study in both the groups (Figure 4). Forgetfulness is one of the major contributing factors in non-compliance to medication in non-SMBG group.

A study done by Knowler et al showed that metformin and lifestyle modifications were two highly effective means of preventing or delaying diabetes. Further the same study shown lifestyle modification to reduce diabetes incidence by 55%, while metformin by 31% and concluded that lifestyle intervention to be more effective than metformin27. In line with this, synergism of both lifestyle modifications and compliance to medication exhibited by SMBG group would have decreased HbA1c levels when compared to non- SMBG group.

CONCLUSION

Results of current study concludes that SMBG has positive impact on glycemic control, expressed as decrease in HbA1c levels with time post referral. T2DM patients following SMBG shown better lifestyle changes and compliance to drug therapy. It could be due to regular monitoring of blood glucose levels thereby patients got motivated and understood the importance of dietary changes, regular exercise and intake of antidiabetic pills in controlling the disease and its associated complications. Patients following SMBG also shown positive attitude and awareness about diabetes and risk factors associated with it than patients without SMBG follow-up.

References

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