The effectiveness of diabetes self-management education (DSME) on glycemic control among T2DM patients randomized control trial: systematic review and meta-analysis protocol

Background Type 2 Diabetes mellitus (T2DM) has been a global pandemic resulting in physical, financial and psychosocial crises. Thus, it is important to investigate pooled effectiveness of Diabetes Self-Management Education (DSME) on glycemic control among T2DM patients. Objective The aim of this systematic review and meta-analysis is to investigate the association between DSME or Support (DSME/S) and glycemic control among T2DM patients. Methods The systematic review and meta-analysis will include studies conducted throughout the world from 2010 to 2019. T2DM patients and their clinical, anthropometric, biomarkers from baseline to end line will be recorded. We will search all relevant articles from five databases namely; Cochrane Library, BioMed Central, MEDLINE (EBSCOhost), MEDLINE/PubMed and SCOPUS. Key terms will be used for questing relevant articles. Further efforts will be made to check quality of studies base on quality assessment instruments. Finally, the report will be made according Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines. Pooled standard mean difference in HbA1c will be used to calculate the effect size between the variables with random effects analysis assumption. Further subgroup analysis will be carried out for assessing the risk difference among groups. Conclusion Based on the existing and eligible researches this systematic review and meta-analysis will bring the best evidence on the effectiveness of DSME/S on glycemic control among the T2DM patients. Moreover, the subgroup analysis will inform the effectiveness heterogeneity based on continent, International Diabetes Federation (IDF) region, intervention period, World bank economic classification and glycemic markers used to follow the patients. The proposed review has been registered in the International PROSPERO website with registration number CRD42020124236. Electronic supplementary material The online version of this article (10.1007/s40200-020-00584-3) contains supplementary material, which is available to authorized users.


Introduction
Nowadays diabetes mellitus (DM) affecting nearly half a billion (463 million) people worldwide. If this figure left uncontrolled, it would hit exponentially around 700 million in 2045. Direct and indirect expenses for DM treatment was more than 760 US$ in 2019 [1]. This shows that DM has a tremendous negative impact on physical, psychosocial and financial aspects throughout the world.
Diabetes Self-Management Education/Support (DSME) is an ongoing process of facilitating skill, knowledge and ability for diabetes self-care [2]. It has multifaced importance in improving quality of life, clinical outcomes and behavioral changes among patients [3]. According to the reviews, DSME has positive impact on improving quality of life in all domains, reducing cardiovascular risk reduction, macro and microvascular complications of T2DM among patients [4,5]. But these studies reported that lack of adequate number of randomized control trial (RCT) studies made the conclusion less inferential. Also, these studies targeted developed regions under their methodology. Similarly, other three meta-analysis concluded that personal care of diabetes has positive impact in improving quality of life of patients. However, these studies were done among Hispanic [6], from 1999 to 2009 [7] and 1980 to 1999 [8]. From these perspectives, the existing reviews are outdated and limited to particular settings in the globe. Among sixteen systematic review and meta-analysis conducted before, none of them included studies from lower and middle income countries (LMICs) specifically Africa [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21]. After those systematic review and meta-analysis findings, original studies were conducted in Nigeria, Egypt, Ethiopia, and South Africa which met the inclusion criteria [22][23][24]. Therefore, it is very vital to assess pooled effectiveness of DSME on glycemic control after including the recent studies. This is one of the bold gaps we are trying to fill in this systematic review and meta-analysis (Table 1).
On the other hand, we did not find any ongoing systematic review and meta-analysis considered to investigate the effectiveness of DSME/S on glycemic control among T2DM patients. Moreover, International Diabetes Federation (IDF) region, World Bank economic classification, study design, follow up period, and the glycemic markers used to determine T2DM could result in the heterogeneity of the effectiveness. Furthermore, investigating the pool standard mean difference (SMD) in glycated hemoglobin (HbA1c) among intervention and control group will signal early scaling up of the intervention for resource limited settings.
Therefore, we aimed to carry out a subgroup analysis for assessing the pooled effect of DSME/S on glycemic control under consideration of both LMICs and high-income countries. This systematic review and meta-analysis will be important in delivering secondary and tertial prevention for T2DM patients. Also, it will bring a vital information for reducing sufferings and improving quality of life through cost-effective approach in resource constrained settings.

Methods
The proposed systematic review and meta-analysis has been registered in the International PROSPERO website with registration number CRD42020124236 [25].

Type of participants
The criteria for inclusion will be primary studies reported glycemic control based on HbA1c among T2DM patients using Randomized control trial (RCT) design. While studies conducted/reported Gestational or pregnancy and/or Type 1 diabetes mellitus, patients with known history of diabetes, high risk groups like individuals with HIV/AIDS, malignancy, hepatitis, Tuberculosis or any related morbidity will be excluded.

Exposure variable
This systematic review and meta-analysis will consider studies those targeted DSME as an intervention for glycemic control.

Outcome variable
This systematic review and meta-analysis will focus on studies ascertained blood glucose level. This will be defined glycemic control algorithm that patients with a HbA1C <7% were considered to have good glycemic control. Conversely, those patients HbA1C ≥7% to have poor glycemic control [26]. This cutoff points of HbA1c may vary to some extent from studies to studies. Secondary interest of the study will be the pooled mean differences in the anthropometric and clinical biomarkers.

Types of study
This systematic review and meta-analysis will include only RCT in the analysis.

Study context and period
This systematic review and meta-analysis will focus on the pertinent previous findings conducted in the seven continents from January 01, 2010 to 31st December 2019.

Search strategy
Searching for will be carried to find all relevant articles from accessible and the most useful databases both electronically and manually. Electronic databases namely; Cochrane Library, BioMed Central, MEDLINE (EBSCOhost), MEDLINE/PubMed and SCOPUS will be used to search relevant articles. Hand searches will be applied for grey and unpublished researches from Google, Google Scholar, and WHO websites. Key terms will be used to search for articles. These Key terms will be diabetes self-management education, diabetes self-management education and support, DSMES, DSME, diabetes, diabetes mellitus type 2, type 2 diabetes mellitus, type II diabetes mellitus, T2DM, impaired glucose tolerance, NIDDM, Noninsulin Dependent Diabetes Mellitus, outcome, effectiveness, randomized control trial, and RCT.

Methodological quality assessment
Four independent reviewers (BBB, SN, Bogale B, Balcha B, DG & MT) will make all effort to check quality of studies based on quality assessment instruments. The Jadad scale (also known as the Oxford quality scoring system) will be used. It is the standard method for evaluating RCTs and consists of three items: randomization, blinding and description of patients' withdrawals/ dropouts [27]. Any disagreement that arise among the reviewers will be solved thorough discussion or with third reviewer (FW). Authors of the articles will be contacted to find missing full text articles.

Data extraction
Data will be extracted from included articles in the review using standardized data extraction tool from JBI-MAStARI (see Appendix I). The extracted data will include first author, year, baseline and end line sample size of intervention and control group, baseline and end line intervention and control group mean HbA1c, country, settings, WB economic classification, IDF region, intervention provider and main outcomes those are pertinent to the review question.

Data synthesis
Initially all quantitative data will be abstracted to Microsoft excel. Then it will be exported into STATA version 14 for pooled in meta-analysis. The heterogeneity following either methodological or clinical among the studies will be assessed using intuitive Index (I 2 ). Pooled standard mean HbA1c difference will be used to calculate the effectiveness of DSME on glycemic control among T2DM patients. Metaregression will be made for extraneous factors affecting the association. The publication bias will also be assessed using funnel plot. Both egger and Begg regression tests will be done for the existence of evidence of substantial publication bias for the analysis between DSME and mean glycated hemoglobin (P < 0.05 for both tests). Random effect analysis will be considered in the analysis.

Results
Finally, the report will be made according preferred reporting Items for systematic review and Meta-analysis (PRISMA) [28].

Discussion
By showing a major paucity of the existing reviews and we started to carry to the current systematic review and meta-analysis. This systematic review and meta-analysis will focus on only RCT studies on the effectiveness of DSME on glycemic control regardless of geographic and economic classification conducted from 2010 to 2019. The final result would help to combat against the complications of diabetes and improving the quality of life particularly LMICs. The main reason and impression are to investigate the DSME approach effectiveness is whether vary by IDF regions, economic levels, follow up periods, education provider. However, the would be few pitfalls in our way while doing this systematic review and meta-analysis. For instance, inclusion of only English language published results, non-health information technology assisted studies will result in low number of studies. Also excluding studies used FPG as a glycemic marker for glucose control among T2DM patients in some of studies would limit the number of studies included in the analysis.

Conclusion
The planned systematic review and meta-analysis will investigate the effectiveness of DSME on glycemic control by calculating then pooled mean difference in HbA1c among T2DM patients.
Abbreviations ADA, American Diabetes Association; DSME, diabetes self-management education; FPG, Fasting plasma glucose; HbA1c, glycated hemoglobin; HIT, Health Information Technology; IDF, International Diabetes Federation; LMICs, Lower-and middle-income countries; NIDDM, Noninsulin Dependent Diabetes mellitus; RCT, randomized control trial; SMD, standard mean difference; T2DM, Type 2 Diabetes mellitus; WHO, World Health Organization Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.