Simultaneous goals of diabetes control include reduction of blood sugar to the recommended targets through lifestyle and pharmacotherapy; evaluation and decreasing of cardiovascular risk factors (overweight / obesity, hypertension, and dyslipidemia); regular screening for micro- and macro-vascular complications (22). In this study, we attempted to investigate the levels of access to each. There are very limited studies on the quality of diabetes care in Iran and their findings are limited to specific areas.
We divided our analysis into two subtitles; process evaluation and outcome evaluation.
While previous studies showed that only 6.4% of the patients had one or more tests per year for the HBA1c (7), our results showed that 9% of our patients had an optimum number of HBA1c tests (once every three months) per year. The mean number of HbA1c tests in the entire study period was less than two tests per year per patient.
Clinical guidelines suggest that for patients who have not had a hemoglobin A1C test for the past three months or even for one year, the physician should promptly set blood glucose targets and request hemoglobin A1c testing for each subsequent visits (23). When reaching control levels, the A1c test should be repeated every 3 to 6 months, and if uncontrolled, both regular A1c testing should be performed every 3 months and with the evaluation of the patient's medication used, intensification of drug therapy should be considered (24). The findings of the study show that the number of tests performed was less than half of the international clinical standards over a period of 5 years and this number did not change statistically significantly during the study (patients without tests decreased during the study).
But these values for patients with annual LDL testing vary from 24 percent in 2006 to more than 90 percent in 2016. On average, patients performed a lipid profile test approximately 1.50 times during the study period, which was optimal. Process analysis also showed that about 58 percent of patients do not do quantitative urine protein testing annually.
The results of simultaneous achievement of three process-related care indicators (hemoglobin A1c test once every three months, serum lipids test (low-density lipoprotein cholesterol) at least once a year, and urine protein test or urine albumin test once a year), show that on average about one percent of patients have achieved simultaneous goals and by adjusting the HbA1c test to “one or more tests every six months”, about 30 percent of patients were within the optimal range. The results show that, except for the annual LDL test, the measurement of other values was less than optimal.
Concerning the quality of care outcomes, the results of internal studies have shown different results, mainly due to the year of study and the sample population composition (age of diabetes, type of diabetes, ...).
Blood glucose control at the beginning and the end of our study was estimated at 0.32% of the total population despite very slight fluctuations over the 5 years (decreasing trend), and the changes were not statistically significant over this period (p -value > 0.05).
The results of recent studies have shown that the average HBA1c level in the diabetic population has reached above average (8.00 ± 0.01%) in 2017 and HBA1c control has reached to 44.10% (6). However, because the results are presented for all types of diabetes in general, comparing the control results with the present study may be associated with bias.
Findings of an unpublished study in 2011 about the non-communicable disease risk factor supervision showed that 56.7% of patients had an A1c level below 7%. Also in a study of cardiovascular risk factors in type 2 diabetic patients in Mashhad, findings showed that only 25% of patients had A1c level less than 7%. The differences in these studies can be related to the sampling method and patients’ diabetes age, which may support the hypothesis that with increasing diabetes age, their blood glucose control status worsens (26). Accepting these findings, it should be noted that many studies have shown that not only the age of diabetes diagnosis not the main cause of inadequate control findings but control status had a statistically significant improvement over time.
The findings of Mohammad Ali et al study over 12 years (1999–2010) showed that 44.3% of patients in the first 4 years and 52.2% of patients in the last 4 years had a hemoglobin A1c level of less than 7% (p-value ≥ 0.05) (27). Another study in the Spanish state of Catalonia between 2007 and 2013 showed that patients with hemoglobin A1c were less than 7%, from 52.2% at baseline to 55.6% at the end of the study (28). In another study in the Spanish state of Catalonia conducted between the years 2007 to 2013, findings showed that patients with hemoglobin A1c less than 7%, were from 52.2% at the beginning of the study to 55.6% at the end of the study (28).
Another study of Tehran Lipid and Glucose Study (TLGS) also found that 40.36% of men and 36.32% of women and 38.34% of the subjects on average had LDL levels of less than 100 mg/dL. Findings of the non-communicable disease risk factor supervision study (unpublished), obtained shortly after Tehran Lipid and Glucose Study (TLGS), showed that 39.9% of patients had LDL levels less than 100 mg/dL. Considering the time of publication of these studies, it can be hypothesized that patients' blood lipid levels were improving and this hypothesis was further strengthened in two published studies.
Findings of prospective analysis study on first national diabetes report from the National Diabetes Prevention and Control Program in 2015, as well as our study in 2016, conducted 5 and 6 years, respectively after the non-communicable disease risk factors supervision study, showed that around 60% and 70% (present study) of patients, respectively, had LDL levels less than 100 mg/dL.
Gradual changes in the treatment of hypertension in patients with type 2 diabetes, from the classic target blood pressure of less than 90/140 mmHg to more intensive blood pressure control (80/130 mmHg), have been affected by several major clinical trials. Evidence specifically indicates that a further reduction in blood pressure (to 130/80 mmHg) is possible in diabetic patients (29) and may lead to a significant reduction in cardiovascular complications in these groups of patients undergoing more intensive blood pressure treatment (29–31).
Various Iranian internal studies have shown that blood pressure is controlled by 40–50% (less than 130/80 mmHg) and these values for our study show that 55% of patients have achieved optimal goals on average. These values show a higher optimal level than most previous studies in Iran, but in our study patients with optimal blood pressure decreased during the study period, from 56% in 2012 to 49% in 2016 and these changes were statistically significant.
The findings of our study showed that about 14.2% of patients were able to achieve control goals simultaneously. This value was 13.6% at the beginning of the study, but the reported increase was not statistically significant (p-value > 0.05).
The findings of the study by Mohammad Ali et al. over 12 years (1999–2010) showed an increasing trend (4.6% in 2000, 9.5% in 2004, and 14.3% in 2010). In another study conducted to evaluate the simultaneous achievement of control goals between 1988 and 2010, the percentages of people with simultaneous achievement of control goals were 1.7%, 7.1% and 18.8% between years 1988–1994, 1995–2002, 2003–2006, and 2007–2010, respectively; and these changes were significant at all these intervals (32).
Among process-related care, optimal control has only been performed on the number of paraclinical tests for blood lipid levels, and the results of the study also show optimal outcomes for blood LDL levels, but in other cares, the results for the processes and their outcomes were undesirable.
Control level was not optimal at both process and outcome levels (at the process level, 30% of patients and at the outcome level, 13.8% of patients were in a desirable condition).
Different factors can be involved in the optimal control of diabetes that lack of multi-factor control can lead to undesirable results:
Overall, 83% of patients were overweight and obese, according to our study, and obesity alone or in combination with uncontrolled hemoglobin A1C, systolic and diastolic blood pressure, and LDL-cholesterol are a risk factor for microvascular and neuropathic complications in diabetic patients (33)
In addition, today's clinical guidelines not only generally state that patients who cannot reach the goals set for hemoglobin A1c should be followed up every 2–3 times to regulate treatment but also indicate that clinical judgment should be performed individually for each individual (34–39 and in patients with undesirable conditions, urgent attention should be paid to prompt and consistent treatment (40).
Researches have shown that approximately 50% of patients with type 2 diabetes achieve A1c levels below 7% (appropriate control according to ADA) with oral monotherapy for 3 years (41–46). This disappointing result is partly due to the delay in initiating the first drug treatment after reaching A1c levels above expected levels (47). This outcome may also be due to delayed timely diagnosis of pre-diabetic or diabetic patients, and also is largely due to the actions of specialist and primary care physicians who do not perform well early interventions, and thus, the critical window of treatment for effective disease management is often missed (44).
Despite a large number of guidelines for type 2 diabetes, studies have shown that many physicians do not have adequate information about existing clinical guidelines for type 2 diabetes. In one of these studies, only 39.8% of physicians participated in a continuous improvement program for diabetes management, and 52% of general practitioners were aware of the therapeutic targets for HbA1c (17). Another study showed that only 29% of physicians had adequate information about existing guidelines (41). A study of knowledge and attitudes in 8 countries found that 51% of patients had never heard of HgA1c before and more than 10% of physicians measured it once a year (44).
Before focusing on structured guidelines that emphasize more on the HgA1c recommended targets in different countries, diabetes management with Hypoglycemic Medications was often inadequate and appropriate changes in drug regimens were only made when A1C levels were above 9% (41, 43, 48). Poor blood glucose management and subsequent failure to achieve HbA1c target levels are often clinically related to physician inertia (failure to initiate therapy or to intensify or change therapy inpatients) and may inappropriately set personalized goals (49).
Although the efficacy of most insulins has been proven in several studies compared to most oral medications (50–53) and most patients with type 2 diabetes require insulin to maintain HbA1c levels less than 7%, about nine years after diagnosis (46) the share of insulin use, in 2016, was only 25% of the total anti-diabetic medications use (insulin pens have been covered by insurance in Iran since 2012)
The findings of the study also showed that, between 2012 and 2016, there was no significant change in the pattern of antidiabetic medications use (54) while the share of insulin in total anti-diabetic medications use was more than 40% in Sweden, Norway, Germany, Denmark and the UK (55).