Management of diabetes in Morocco: results of the International Diabetes Management Practices Study (IDMPS) – wave 5

Management of diabetes in Morocco: results of the International Diabetes Management Practices Study (IDMPS) – wave 5

Asmae Chadli, Siham El Aziz, Nawal El Ansari, Farida Ajdi, Mehdi Seqat, Hanane Latrech and Ghizlaine Belmejdoub

Abstract
Objectives: The International Diabetes Mellitus Practice Study (IDMPS) is a 5-year survey documenting changes in diabetes treatment practices in developing countries. The primary objective of this survey was to assess the therapeutic management of type 2 diabetes mellitus (T2DM) in real-life medical practice. The secondary objectives were to evaluate the clinical management of type 1 diabetes mellitus (T1DM) and to assess the proportion of all diabetic patients failing to reach the glycated haemoglobin (HbA1c) <7% target.
Methods: Data were analysed for 738 patients (240 with T1DM and 498 with T2DM) included in wave 5 of the IDMPS in Morocco in 2011.
Results: Nearly two-thirds (61%) of T2DM patients were treated with oral glucose-lowering drugs (OGLDs) alone, 13.1% were treated with insulin alone and 23.3% were treated with OGLDs plus insulin. Insulin use was less frequent, was initiated later and involved a greater use of premixes versus basal/prandial schedules compared to other populations evaluated in the IDMPS. The majority (92.5%) of T1DM patients were treated with insulin alone and the remainder received insulin plus an OGLD. Insulin protocols included basal + prandial dosing (37.5%) and premix preparations (41.3%). The recommended target of HbA1c <7% was achieved by only 22.2% of T1DM patients and 26.8% of T2DM patients. More macrovascular but fewer microvascular complications were reported in T2DM compared to T1DM patients. Late complications increased with disease duration so that 20 years after diagnosis, 75.7% of T2DM patients were found to have at least one late complication.
Conclusions: The clinical burden of diabetes is high in Morocco and the majority of patients do not achieve the recommended glycaemia target, suggesting that there is a huge gap between evidence-based diabetic management and real-life practice. Better education of patients and improved compliance with international recommendations are necessary to deliver a better quality of diabetic care.

Keywords: basal–prandial, complications, diabetes, glycaemic control, insulin, management

Introduction

Diabetes mellitus is a significant and increasing global health problem. The International Diabetes Federation estimated that there were 382 million people worldwide with diabetes in 2013, increasing to 592 million in 2015. Furthermore, it is considered that an additional 316 million individuals are at a high risk of developing diabetes mellitus due to impaired glucose tolerance and this has been estimated to increase to 471 million by 2035 [Guariguata et al. 2014]. While significant regional variability exists, the majority (80%) of people with diabetes live in low- and middle-income countries. Most cases of undiagnosed diabetes, both type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM), but especially T2DM, are also present in low- and middle-income countries [Beagley et al. 2014; Guariguata et al. 2014].

A large body of epidemiological data and clinical practice evidence exists in Europe and the USA to guide disease management and associated healthcare resource planning, but this may not be appropriate to develop strategies for other regions. In recognition of this, the International Diabetes Management Practices Study (IDMPS) was established to document diabetes management and barriers to care in developing countries across Africa, the Middle East, Latin America, Turkey, Eurasia and South-Asia [Chan et al. 2009]. The IDMPS is an ongoing multinational observational study composed of five cross-sectional registries (or ‘waves’) performed over a 7-year period in which changing practices in diabetes management can be assessed. From a global perspective, the results of earlier waves have already been reported [Chan et al. 2009; Ringborg et al. 2009; Gagliardino et al. 2012], as have data from specific countries, each in accordance with recommended Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines [von Elm et al. 2007; Al-Elq, 2009; Farouqi et al. 2010; Soewondo, 2011; Lavalle-González et al. 2012; Azar et al. 2013].

Previously, we reported data from Moroccan patients with diabetes collected at the cross-sectional part of wave 2 of the IDMPS, conducted between 2006–2007 [Farouqi et al. 2010]. Here we present data from IDMPS wave 5, collected in 2011, in which we assessed the disease characteristics (including complications) and current management of patients with T1DM and T2DM in Morocco, as well as evaluating treatment-related diabetes control (determined by HbA1c targets). We also discuss our findings in relation to the treatment strategies and goals recommended by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) [American Diabetes Association, 2016].

Methods

Study design and recruitment of patients
The IDMPS is a multinational, observational study. The method of patient recruitment was similar to that reported in previous waves of the IDMPS [Chan et al. 2009; Ringborg et al. 2009; Gagliardino et al. 2012]. In brief, endocrinologists, diabetologists and primary care physicians with experience in the initiation and titration of insulin therapy in diabetic patients were invited to participate in the study. More than one physician could be recruited from the same healthcare structure (i.e. hospital or diabetes centre). Physicians who agreed to participate were asked to enrol the first 5 T1DM patients and first 10 T2DM patients, aged ⩾18 years, who attended their clinics over a 2-week period.

Patients were excluded if they were already participating in another descriptive or interventional clinical study, if they had participated in a previous wave of the IDMPS, or if they were under temporary insulin treatment (gestational diabetes, surgery, pancreatic cancer, sepsis or other conditions). All patients provided written informed consent before entering the study.

Ethics
The IDMPS study protocol was approved and all procedures followed were in accordance with the appropriate regulatory and ethics committees of the participating countries and centres, including those in Morocco.

Data collection
Data were collected on standardized case report forms (CRFs) including: demographic and socioeconomic data, medical history, all relevant disease parameters and outcome measures, pharmacological and lifestyle therapy, glycaemic control (as measured by fasting blood glucose and glycated haemoglobin [HbA1c]), other treatment targets (blood pressure, lipid status and self-monitoring of blood glucose [SMBG]), access to diabetes education, access to specialized care and relevant hospitalizations. Other data collected included diabetes complications (where relevant and as documented by another nondiabetes specialist) and social impact, including absenteeism from work. Paper CRFs were sent to a data management affiliate that reviewed every CRF for consistency and completion and then registered the data in a centralized data capture system. In the case of any conflict or queries in the data, the CRF was returned to the participating physician for clarification.

Study objectives
The primary objective of the study was to assess the therapeutic management of T2DM patients in real-life medical practice in Morocco in 2011. The secondary objectives were to assess themanagement of T1DM patients and to determine the proportion of patients achieving the target of HbA1c <7% as recommended by international guidelines [American Diabetes Association, 2016].

Statistical analysis
Qualitative data are summarized as frequency and quantitative data as descriptive statistics (number, mean, standard deviation [SD], median and range). Categorical variables are expressed as percentages.

Results

Study population
In total, 748 patients with diabetes mellitus were recruited in wave 5 of the IDMPS in Morocco, by 41 endocrinologists and 8 physicians from other disciplines (general practitioners and internists). Of these patients, 738 (98.6%) met the inclusion criteria and were included in the final analysis: 240 with T1DM and 498 with T2DM. The majority of participating physicians were based either in a public hospital (44%) or in an office/ clinic setting (44%), with over 90% located in urban areas.

Characteristics of type 1 diabetes patients
The main demographic and clinical features of the T1DM cohort (N = 240) are presented in Tables 1 and 2. The average duration of diabetes was 11 ± 9 years and almost half (47.4%) of the patients had a family history of diabetes. A total of 19.6% of T1DM patients had been hospitalized because of their diabetes in the previous 3 months. Over 90% of patients had received screening for diabetes-related complications in the previous 12 months, although the proportion who received screening for specific complications varied (Table 2). The prevalence of late complications increased with disease duration; 20 years after diagnosis, 66.7% of patients with T1DM had at least one late complication (Table 3).

Treatment of T1DM patients, attainment of targets and self-care
The majority of T1DM patients (92.5%) were treated with insulin alone, while 7.5% were treated with insulin plus an OGLD (Table 4). For insulin therapy, most received either basal +prandial dosing (37.5%) or premix preparations (41.3%) (Table 5). The average duration of insulin therapy was approximately 10 years, matching the mean disease duration of this cohort. While 73% of T1DM patients had a personal glucose monitor, only 37% performed SMBG on a daily basis, with more than half (57.7%) citing cost as a barrier to more frequent monitoring (Table 6). For assessment of treatment targets, 210 (89.4%) of T1DM patients had had an HbA1c evaluation at some time, with a mean value at the last test of 8.4 ± 1.9%. Most patients had been evaluated on more than one occasion in the previous 12 months. For other relevant evaluations, 85% of patients had undergone blood pressure monitoring in the previous 12 months, although fewer (65.9%) had undergone a lipid assessment. Only 22.2% of T1DM patients had achieved the target HbA1c of <7%, and only 6.6% achieved the triple target (HbA1c <7%, blood pressure <130/90 mmHg and low density lipoprotein cholesterol <100 mg/dl high density lipoprotein).

Characteristics of type 2 diabetes patients
The main demographic and clinical features of the T2DM cohort (N = 498) are also shown in Tables 1 and 2. The average duration of diabetes was 9 ± 7 years and 64.6% had a family history of diabetes. In total, 12.4% of T2DM patients had been hospitalized due to their diabetes in the previous 3 months. Over 90% of T2DM patients had received screening for diabetes-related complications in the previous 12 months (Table 2). A late diabetes-related complication was recorded in 40.0% of T2DM patients. Late complications increased with disease duration, so that 20 years after diagnosis, three-quarters (75.7%) of T2DM patients were found to have at least one late complication (Table 3).Treatment of T2DM patients, attainment of targets and self-care Most T2DM patients (61%) were treated with an OGLD alone, 23% received an OGLD plus insulin and 13% received insulin only. Only 2% of patients were managed by lifestyle modifications or no specific therapy (Tables 4 and 5). Most patients receiving an OGLD received metformin plus a sulphonylurea, while these agents were prescribed as the sole OGLD therapy in similar proportions (Table 4). In those T2DM patients

Table 1. Demographic characteristics of patients with type 1 (T1DM) and type 2 (T2DM) diabetes mellitus included in wave 5 of the International Diabetes Management Practices Study.

Receiving insulin the dosing strategy varied depending on whether insulin was the sole therapy or was given with an OGLD.

Basal insulin dosing was used by 15.4% of patients receiving insulin only and by 62.1% of patients also treated with an OGLD. In contrast, a premix alone was used by 61.5% of patients receiving insulin only and by 29.3% treated with an OGLD. Only 7% of all T2DM patients treated with insulin used a basal + prandial strategy (Table 5). For those patients receiving insulin, this drug was initiated sometime after initial management with other agents; 40% of all T2DM patients receiving insulin had had diabetes for over 20 years. Less than half of T2DM patients (46.8%) performed SMBG at home and only 18% performed SMBG on a daily basis; again cost was cited as the reason for not performing monitoring more frequently (Table 6). With respect to glucose targets, the large majority (92.8%) of T2DM patients had undergone an HbA1c evaluation at some point (mean value: 8.3 ± 1.9%) and most had an evaluation on more than one occasion in the previous 12 months. In addition, 91% had undergone a blood pressure evaluation and 83.4% had a lipid screen performed in the previous 12 months. However, only 26.8% of T2DM patients had achieved the target HbA1c of <7% and only 2.7% achieved the triple target.

Discussion

In this study, involving wave 5 of the IDMPS, our findings echo previous results from an earlier wave and highlight the significant gap that remains between international recommendations and the current standard of care for diabetic patients in Morocco. In our study population diabetes was associated with a significant health and social impact; 40% of patients had at least one diabetes-associated complication, while 12% of T1DM and almost 20% of T2DM patients had been hospitalized in the 3 months prior to study entry. In addition, a significant number of diabetic patients took time off work as a result of their disease (mean absence of 6–13 days).

Table 2. Clinical profile of patients with type 1 (T1DM) and type 2 (T2DM) diabetes mellitus included in wave 5 of the International Diabetes Management Practices Study.

In our cohort, only 22.2% of T1DM patients and 26.8% of T2DM patients achieved the recommended target of HbA1c <7% and even fewer (6.6% of T1DM and 2.7% of T2DM patients) achieved the triple target of glycaemic, blood pressure and lipid control. Indeed, for patients with T2DM, the proportion achieving the target HbA1c <7% was lower than that seen in our previous study where 30.9% reached the target [Farouqui et al. 2010]. Furthermore, this result is lower than that reported in other regions and countries that participated in the IDMPS. In Mexico and Indonesia, for example, 37% of T2DM patients.

Table 3. Proportion of type 1 (T1DM) and type 2 (T2DM) diabetes mellitus patients with complications.

Table 4. Proportion of patients using oral glucose lowering drugs (OGLDs) in type 1 (T1DM) and type 2 (T2DM) diabetes mellitus.

Table 5. Types of insulin used in patients with type 1 (T1DM) and type 2 (T2DM) diabetes mellitus.

Achieved this target in the earlier waves and on average 40% of T2DM patients within the IDMPS program achieved the target [Chan et al. 2009; Soewondo, 2011; Lavalle-González et al. 2012]. In view of this finding, it is essential to gain a better understanding of the failings and barriers to improved diabetes care in Morocco.

Table 6. Proportion of patients carrying out self-monitoring of blood glucose.

The physicians participating in our study were all experienced in insulin therapy and it is therefore surprising that, while nearly all T1DM patients were being treated with insulin, only one-third of T2DM patients were receiving insulin, the majority of whom had long-standing disease. Most T2DM patients were being treated solely with OGLDs (usually metformin and sulphonylurea in combination). Another notable finding of our study was that in T1DM and in T2DM patients receiving insulin most were receiving either basal insulin only or were using premixed insulin, with twice-daily premixes (90% of which were 70/30 type) being particularly used in those T1DM patients receiving insulin as the sole therapy. The high proportion of T1DM and T2DM patients receiving premixes, and correspondingly fewer being treated with a basal/prandial strategy, differs from that seen in other countries reported across the IDMPS program [Chan et al. 2009; Lavalle-González et al. 2012]. However, this finding is consistent with that previously reported for Morocco in an earlier IDMPS wave [Farouqi et al. 2010]. It is also notable that in our T2DM cohort, basal insulin dosing was relatively low, especially in patients with a high body mass index (BMI), which may also contribute to poor glycaemic control.

This pattern of insulin use contrasts with the available international guidelines. For example, the ADA recommends that in T2DM, early initiation of insulin therapy should be considered in those patients not achieving the target HbA1c of <7% and that a flexible approach to dosing strategies should be used [American Diabetes Association, 2016]. Furthermore, in patients not controlled with OGLDs, the ADA recommends the use of basal insulin, with a basal/prandial schedule as a second-line schedule, rather than the alternative but less studied twice-daily premixed insulin strategy [American Diabetes Association, 2016]. This approach is supported by randomized studies. In a recent randomized study conducted over a 1-year period, Riddle and colleagues found that the use of basal plus a single prandial injection was as effective as the use of premixed insulin at achieving glycaemic control [Riddle et al. 2014]. In this study, although the differences were not large, basal + prandial insulin regimes were statistically better at achieving HbA1c <7% compared to the premixed regimen (44% versus 38%, respectively; p = 0.031) and also resulted in a significantly greater reduction in HbA1c from baseline (2.4% versus 2.0%, respectively; p = 0.0056). Basal + prandial insulin regimes were also associated with a lower incidence of hypoglycaemia, and slower weight gain [Riddle et al. 2014]. Furthermore, a meta-analysis has also shown the benefit of a basal/prandial strategy at reducing HbA1c. Giugliano and colleagues found that, compared with premixed insulin, patients treated with a basal + prandial regimen had a higher likelihood of achieving the target HbA1c (Odds ratio = 1.75, 95% CI: 1.11– 2.77) [Giugliano et al. 2011]. It should also be recognized that additional treatment options are now available for the management of poorly-controlled T2DM, including glucagonlike peptide (GLP)-1 receptor agonists and sodium-glucose co-transporter 2 (SGLT2) inhibitors, with data suggesting that these novel agents may provide greater control along with less hypoglycaemic episodes with a favourable weight control profile [American Diabetes Association, 2016; Downes et al. 2015; Gunton et al. 2014; National Institute for Health and Clinical Excellence, 2011]. At the time of the present study these agents were not available in Morocco.

Clearly, the earlier initiation of insulin treatment in T2DM patients in Morocco may be one way of improving diabetic control, as would more widespread use of a basal/prandial strategy when appropriate. However, there are a number of possible explanations for our findings which may act as barriers to the implementation of this approach. In Morocco, only neutral protamine hagedorn (NPH) insulin and metformin is paid for by the national public medical care system; other insulins (including longer-acting agents that are used in successful basal/prandial strategies), OGLDs and SBMG are not covered. As such, additional drug costs may act as a barrier to their use for many patients. The relative infrequency of SBGM by these patients may also be a reflection of cost. In line with infrequent SBMG, concerns regarding dose titration may also apply. These may explain why, while the managing physicians are experienced in insulin therapy, its use in suitable patients, and use of appropriate regimens may not necessarily be employed. Other factors may also have contributed to the low rate of insulin use and SBMG in our T2DM cohort. For example, in previous waves of the IDMPS program, a common feature from a number of countries was that a greater proportion of insulin use and SBGM was seen in educated patients [Gagliardino et al. 2012]. This mirrors our own findings, where the majority of T2DM patients had little or no formal education.

Our study has a number of limitations. The data are descriptive and while quantitative, no statistical analyses are presented. From such data it was not possible to determine the specific impact and interactions of variables such as particular regimens, SBMG, and HbA1c. The cross-sectional design and so lack of longer-term patient follow up is another limitation.

Conclusion

In Morocco, the majority of patients with diabetes mellitus did not achieve the recommended glycaemic goal, suggesting that there is a huge gap between evidence-based diabetes management and real-life practice. Improved compliance with international recommendations is necessary to deliver a better quality of diabetic care. This will require improvements in the education of patients on disease management and the earlier use of insulin and basal–prandial protocols, allied with improvements in SBMG in patients with T2DM. Achieving these changes in diabetic management remains a huge challenge.

Acknowledgements

The authors would like to thank all of the physicians and patients who participated in this study. Editorial assistance with the preparation of the manuscript was provided by Newmed Publishing Services.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The IDMPS epidemiological survey was supported by Sanofi- Aventis. Support for editorial assistance was also provided by Sanofi-Aventis.

Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: A. Chadli, S. El Aziz, N. El Ansari, F. Ajdi, H. Latrech and G. Belmejdoub declare that there is no conflict of interest. M. Seqat is an employee of Sanofi-Aventis, Morocco.