Type 1 diabetes (T1D) is an autoimmune condition commonly diagnosed in childhood and early adolescence. Among people living with T1D, the islet cells in the pancreas produce insufficient amounts of the glucose-regulating hormone, insulin, resulting in the need for chronic insulin replacement therapy.1 While type 2 diabetes (T2D) is more common globally and is largely related to preventable risk factors, T1D cannot be prevented and is more immediately deadly in the absence of daily insulin injections.2
Epidemiological information on T1D is limited in low- and lower-middle income countries (LLMICs). This is due in part to lack of awareness of the disease, lack of differentiation between diabetes types in adults, as well as gaps in the availability of glucose testing at primary health care facilities.3 The International Diabetes Federation (IDF) estimated in 2019 that 463 million adults (20 to 79 years of age) are living with diabetes, and according to the Centers for Disease Control and Prevention, approximately 5% of adult-diagnosed cases of diabetes are diagnosed as T1D.4,5 The IDF also estimated that in 2017 there were more than 1.1 million children and adolescents under the age of 20 living with T1D, with more than 130,000 new patients diagnosed each year.4 The IDF estimates suggest that as a result of low case finding and high case fatality, only 15% of those currently living with T1D reside in sub-Saharan Africa or South Asia.4
The International Society of Pediatric Diabetes and Endocrinology has issued guidelines regarding chronic care services for people living with T1D in resource-limited settings.6 It has also worked with the European Society for Pediatric Endocrinology to establish training centers for pediatric endocrinologists in sub-Saharan Africa.7 Efforts such as the Life for a Child program and Changing Diabetes in Children initiative have worked to increase insulin access in the poorest countries.8,9
Improving survival for people living with T1D in LLMICs will, however, require early diagnosis and greater access to high quality chronic care service delivery models for T1D. The authors define a service delivery model as the distribution of services within the health system (primary care facility, primary referral facility, secondary referral facility); and the organization of services within the facility itself (general outpatient department, integrated chronic disease clinic, integrated non-communicable disease [NCD] clinic, diabetes specialty clinic); the organization of services for people living with T1D by primary-provider type (cadre) and team structure (specialty team, nurse/physician lead team, comprehensive team of specialists, mid-level providers and auxiliary staff); the financing of these services (direct government expenditure, philanthropic support, insurance reimbursements and out of pocket expenses); and the relationship with non-governmental organizations and philanthropy groups. Essential chronic care services for people living with T1D consist of multiple daily blood glucose checks via finger sticks, and titrated insulin delivery via subcutaneous injections coupled with carbohydrate counting and symptom management, with the need for consistent interactions with a trained health service provider to adjust management decisions appropriately.
Managing T1D adds a significant financial burden to the individual and accompanying health system, resulting in familial and social tension. This tension is compounded when lack of education and health resources leads to stigmatization and fear amongst patients, families and communities.10 Currently, the few chronic care services that are available to people living with T1D in LLMICs appear to be restricted largely to urban tertiary referral facilities staffed by specialist physicians. Large-scale efforts to decentralize and integrate chronic care services for diabetes have focused on therapy for T2D with oral medications. These efforts include, for example, the World Health Organization's Package of Essential NCD Interventions (WHO PEN).11 More recently, WHO and its partners have begun to develop strategies to make integrated chronic care services available for people living with T1D at secondary-care or primary referral facilities, such as district hospitals through PEN-Plus approaches.12-15 PEN-Plus service delivery models address priority conditions such as T1D, rheumatic heart disease, and sickle cell disease, as well as palliative care for advanced malignancies and other conditions via an integrated platform at first-referral level hospitals that complements and expands PEN service delivery models that primarily focus on more common, less severe NCDs out of primary care facilities.
More information regarding promising service delivery models to decentralized chronic care services for people living with T1D will be essential to increase the impact and reach of PEN-Plus strategies. Little is known, however, about the organization and distribution of chronic care services for people living with T1D in LLMICs. Previous literature reviews regarding service delivery models for diabetes in LLMICs have not made a distinction between T1D and other forms of diabetes.16,17 These reviews have mainly focused on decentralization of therapy with oral medications for T2D at primary care facilities and in the community rather than the organization of chronic care services for insulin-dependent patients at secondary-care facilities.
This protocol outlines the methods used for conducting a scoping review of publications describing existing service delivery models for people living with T1D from LLMICs. A scoping review methodology was selected for this review as it allows the research team to map the wide range of evidence that encompasses service delivery models for people living with T1D in various LLMIC contexts. The identification and reporting of the subsequent service delivery model typologies for people living with T1D will allow for more specific research questions regarding the individual typologies in subsequent systematic reviews.
The scoping review will follow JBI methodology.18 A preliminary search for existing scoping reviews on service delivery models for people living with T1D in LLMICs was conducted in PubMed on March 1, 2019, and yielded no results.
The objective of this scoping review is to identify and describe the distribution and organization of chronic care service delivery models for people living with T1D in LLMICs.
Specifically, the review sub-questions are:
- i) At what level of the healthcare system (primary health facilities, primary referral hospitals, secondary referral hospitals) are chronic care services provided for people living with T1D in LLMICs?
- ii) What cadre of healthcare providers manage people living with T1D and what is their level of specialization?
- iii) What other services do these healthcare providers deliver (eg, general acute care, care for diabetes generally, care for other chronic conditions)?
- iv) How are these services financed (eg, entirely out-of-pocket, philanthropic support, government subsidized)?
This review will include people living with T1D.
Any studies describing primary care services provided out of homes or communities or which exclusively focus on services for the management of people living with T2D will not be included in this review. Additionally, any study that mentions patients living with diabetes, but does not differentiate by diabetes type, will not be included in the review.
For the purposes of this review, the authors are interested in understanding the organization and distribution of chronic care services for the management of people living with T1D provided out of facilities. The components of a service delivery model that will be compared include the following identifying features: level/location of services provided out of a facility within the health system (primary care facility, primary referral facility, secondary referral facility); organization of services within the facility itself (general outpatient department, integrated chronic disease clinic, integrated NCD clinic, diabetes specialty clinic); organization of services for people living with T1D by primary-provider type (cadre) and team structure (specialty team, nurse/physician led team, comprehensive team of specialists, mid-level providers, auxiliary staff); financing of these services (direct government expenditure, philanthropic support, insurance reimbursements, out of pocket expenses); and relationship with non-governmental organizations and philanthropy groups.
In this scoping review, the context is facility-based service delivery for people living with T1D in LLMICs. Low- and lower-middle-income country classifications will be determined according to the World Bank Income Classification from 2019.19
Types of studies
In this scoping review, all types of literature will be considered based on the inclusion and exclusion criteria. To help identify all models of care delivery for people living with T1D, any publications that describe facilities that provide services for people living with T1D in English from 2000 to the present will be included. This date range was selected to accurately capture the most current model of care. Any publication originally identified in the search strategy will be used as sources to then search references, gray literature, and organizational websites for supplementary information.
The JBI methodology for conducting scoping reviews will be employed to guide the conduct of the review.18
A search was conducted on January 9, 2020 the results of which are reported in Appendix I.
The search strategy was developed by the research team in collaboration with an experienced medical librarian and will be implemented through three electronic databases: PubMed, Embase, and Web of Science, as well as the WHO regional indexes, including: African Index Medicus (AIM), Latin American and Caribbean Center on Health Sciences Information (LILACS), Index Medicus for South-East Asia Region (IMSEAR), Eastern Mediterranean Region Library Network (EMRLN), and WHO Regional Office for the Western Pacific's Institutional Repository for Information (WPIRI).
The search strategy consists of subject headings, keywords and terms related to T1D, service delivery, and LLMICs. The research team will use free text and Medical Subject Headings (MeSH), where applicable. A sample search strategy is shown in Appendix I.
In instances where a service-delivery model is referenced in the publication, but there is insufficient detail to characterize the model, the reviewer will refer to any supplementary information available in gray literature or organizational websites, through a Google search, or through direct correspondence with the study authors. These supplementary sources will also be included in the appendix.
The results from the search will be imported into EndNote X9 (Clarivate Analytics, PA, USA), where the citations will be collated and duplicates removed. The study selection process will consist of three parts. First, a selection of 20% of the studies will be initially screened for any mention of services for people living with T1D provided out of a facility and to determine the referral level of the said facility by CN and AA, so any important issues can be resolved before the full screen is conducted. Any discrepancies in this step will be adjudicated by GB for final determinations. Next, one reviewer will screen the titles and abstracts of all initially selected publications and include all publications that mention services for people living with T1D provided at a facility. Next, a second reviewer will independently screen 20% of the initially selected publications to validate the screening process. Studies that meet or could potentially meet the inclusion criteria will be saved for full text review in EndNote.
Next, a full text review of any publications that report on services for people living with T1D out of first-referral level hospitals and rural primary care facilities will be conducted to extract data on the organization of services at these facilities. These facilities are of particular interest as they are examples of decentralized service delivery models for people living with T1D that have not been well described in the literature. The referral categories will include: i) primary care facilities, defined as those having a catchment area of 10,000 to 100,000 people, ii) secondary care facilities, defined as those having a catchment area of 100,001 to 250,000 people and functioning as a first-referral level hospital; and iii) tertiary care facilities, defined as those having a catchment area of over 250,000 people and functioning as a secondary or higher-referral level hospital. If there is any question regarding the category of any particular facility, the publication will be flagged and discussed with the assistance of a second independent author. For each country identified as providing services for people living with T1D, only the most recent information will be extracted to accurately capture the most current model of care. For example, if two studies are found that describe the same facility that provides services for people living with T1D, both studies will be recorded in the full publication count, but only the information from the most recent study will be charted. There could also be multiple different service delivery models described within a country. If this is the case, the most recent information describing each service delivery model will be charted and cited appropriately. This step will also be validated by a second independent author who will conduct a full-text review of 20% of the selected studies.
This protocol has been prepared according to the Scoping Reviews chapter of the JBI Reviewer's Manual.18 To organize data, a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram will be used.20
Assessment of methodological quality
A formal assessment of methodological quality or a confidence assessment will not be performed since this scoping review is aimed at providing an overview of the existing evidence, regardless of quality, while offering a landscape of what evidence has been produced as opposed to seeking only the best evidence to answer the research questions.
Full text of the publications selected will be reviewed and data will be extracted using a pre-structured and tested data collection form in Microsoft Excel 2016 (Redmond, Washington, USA). The data extracted will include specific details about the distribution and organization of services according to the review questions and specific objectives of the study. The components of service delivery as defined by this study are shown in Appendix II. Any disagreements that arise between reviewers will be resolved through discussion with a third reviewer. Authors of papers will be contacted in instances where additional data is unavailable from publicly available sources, including white and gray literature and via a Google search.
A draft charting table has been developed to record the key information of the source, including title, author(s), journal, date of publication, study year, and results relevant to the review questions (Appendix II). This charting table may be further refined at the review stage and updated accordingly. Any updates will be reported transparently in the final scoping review publication.
For this scoping review protocol, the review team became familiar with the source results by piloting the charting table on a small collection of studies to ensure the sought after data informed the answers to the review questions. This will be an iterative process that will continue into the full review in a consistent manner upon final presentation.
All publications identified that describe services provided for people living with T1D out of facilities in LLMICs will be charted according to the number of facilities described and the number of unique facilities described, disaggregated by country, facility type, World Bank income category, and WHO region. Any information describing the number of people living with T1D active and in care within each facility's catchment area will also be charted to show the case load of people living with T1D in that setting. The descriptive findings extracted from the service delivery models for primary care and primary referral facilities identified will be charted to summarize the results of the objectives of this review. The charted data will then undergo a narrative review or descriptive analysis to identify emerging themes found in the data that can then be summarized into related service delivery typographies. The distribution and organization of these typographies will provide a summary answer to the review questions proposed and the population, concept, and context (PCC) elements used to develop these questions. Additionally, these findings will inform where services are still needed in LLMICs and provide examples of how these services for people living with T1D can be organized for improved patient health and health system efficiencies.
P. Scott Lapinski from the Harvard Medical School Countway Library for his assistance in defining the search criteria for this scoping review.
CN, AA, PP, and GB were partially funded by the Leona M. and Harry B. Helmsley Charitable Trust. The funders will not have a role in the review process.
Appendix I: Search strategy
Web of Science
Appendix II: Data extraction instrument
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