Diabetic Kidney Disease Prevention Care Model Development

In the United States, more than 37 million people are affected by diabetes, with the majority of diagnosed cases (∼90–95%) attributed to type 2 diabetes (1). It is well established that chronic kidney disease (CKD) is a highly prevalent complication of diabetes, such that ∼30–40% of people with type 1 or type 2 diabetes are affected by this condition. In turn, diabetes is the leading cause of kidney failure in the United States, contributing 47% and 38% of prevalent and incident end-stage kidney disease (ESKD), respectively. Among people with diabetes, CKD contributes to a heightened risk of cardiovascular disease (CVD), hypoglycemia, death, and other adverse outcomes (e.g., impaired health- related quality of life [HRQOL]) (2).

Diabetic kidney disease (DKD) is defined as a subset of CKD attributed to diabetes, and these terms are used interchangeably within this article. A multifaceted approach that incorporates education and self- management, lifestyle modification, pharmacological intervention, CVD prevention, and psychosocial support is crucial to mitigate the onset and progression of DKD. For example, hyperglycemia and hypertension are key factors responsible for the development of DKD; thus, optimizing glycemic status and reducing blood pressure are key to reduce the onset of DKD (primary prevention) and/or ameliorate its progression and ensuing complications (secondary prevention) (3). Additionally, despite DKD being one of the most prevalent complications of diabetes, large population-based studies show that less than one-fourth of people with DKD are aware of this condition (4), underscoring a major unmet need for improved screening and self-management education for people with diabetes. There are also needs for effective approaches to addressing negative impacts of social determinants of health (5) and vulnerable populations disproportionately affected by DKD (6), as well as enhanced access to recommended therapies, which, despite strong evidence for their use, remain underutilized (7,8).

To develop the DKD Prevention Model presented herein (Figures 1 and 2), the American Diabetes Association (ADA) convened an interdisciplinary panel of experts in primary care, diabetes care and education, patient advocacy, pharmacology, endocrinology, and nephrology to discuss key concepts of DKD prevention and treatment, including the crucial roles of interdisciplinary care team members; opportunities for community engagement in health promotion; up-to-date screening guidelines, tools, and approaches; and comprehensive, holistic interventions.

The target population for this DKD Prevention Model is adults with diabetes. The objectives of the model are to 1) reduce rates of incident DKD and 2) facilitate prompt and effective management of early DKD to prevent its progression and complications. This model outlines the interventions that are needed to achieve these goals in clinical settings and how to build capacity to implement these interventions on a public health scale. Interventions were prioritized based on which were likely to be most effective to address current gaps in DKD prevention and treatment. We also prioritized interventions that would help address the substantial health disparities that exist in diabetes management and outcomes (9–11).

The model focuses on the primary care setting, where most diabetes care occurs, and its interaction with people with diabetes through care teams and community partners (12). Many people with diabetes who are at high risk for DKD and adverse diabetes outcomes do not have access to specialty care, especially in rural and underserved areas. The model also emphasizes differences in DKD prevention for people with type 1 versus type 2 diabetes, as DKD develops over different time courses in these populations. The model’s key stakeholders are people with diabetes and their caregivers, primary and specialty care practices, health systems, community partners, and health policymakers and payers.

The main features of the model are 1) the role of interdisciplinary care teams, which are the optimal structure for providing coordinated diabetes care and can be leveraged for DKD prevention and treatment; 2) community involvement that extends DKD care beyond the traditional health care system through community resources and partnerships; 3) evidence-based practices for DKD screening and monitoring; 4) promotion of lifestyle and pharmacological interventions with demonstrated benefit for DKD prevention and treatment; 5) the building of health system capacity necessary to achieve the goals of this model; and 6) promotion of these goals through health policy and advocacy. Figure 3 shows how interventions for DKD prevention within this model map to the key stakeholders.

All staging of kidney disease requires the measurement of estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR). In this section, we discuss testing for DKD using guideline-recommended approaches.

Among adults with diabetes and no known kidney disease, the purpose of screening for new DKD is to establish a diagnosis at the earliest stage possible, enabling prompt intervention to reduce kidney disease progression, prevent its associated complications, and institute risk mitigation strategies such as avoiding nephrotoxins (13). Repeat testing among people with known DKD serves multiple purposes. These include 1) determining the stage and severity of DKD; 2) monitoring the rate of DKD progression, which has prognostic importance; 3) monitoring response to therapies and risk factor control; 4) monitoring electrolyte balance for treatment safety, especially changes in serum potassium levels resulting from kidney dysfunction and/or medications; 5) ensuring appropriate medication dosing, including selecting and/or adjusting diabetes medications that are cleared by the kidneys, such as metformin, certain glucagon like peptide 1 (GLP-1) receptor agonists, sodium–glucose cotransporter 2 (SGLT2) inhibitors, and some dipeptidyl peptidase 4 (DPP-4) inhibitors (13,14); and 6) evaluating the role of other therapeutic interventions. Therefore, ongoing monitoring of DKD is important even in individuals who are already using appropriate evidence-based therapies.

Screening for DKD should occur annually for all adults with diabetes, although when initial screening should take place depends on diabetes subtype (Table 1) (13,15). Ongoing testing after DKD diagnosis should occur at least annually for people with diabetes with early kidney disease; monitoring for those with more advanced kidney disease (eGFR <60 mL/min/1.73 m² or severe albuminuria) and diabetes is beyond the scope of this model. Testing should occur more frequently if needed for therapeutic decisions such as adding or adjusting medications.

CKD is defined as abnormalities in kidney structure or function that are persistent for at least 3 months (15). Low eGFR and the presence of albuminuria are the most common criteria used to diagnose CKD, but there are other potential qualifying abnormalities, including structural abnormalities (e.g., on imaging), abnormalities of the urinary sediment (e.g., glomerular hematuria), and other functional abnormalities (e.g., defects in proximal tubular reabsorption of glucose, amino acids, and electrolytes).

When CKD is observed in the context of type 1 or type 2 diabetes and there is no other clear cause of kidney damage, CKD is usually attributed to diabetes and labeled as DKD. Factors suggesting causes other than DKD that require further evaluation are shown in Figure 4 (13). Such findings may be an indication for kidney biopsy for definitive diagnosis. Biopsy series find that about half of people who undergo kidney biopsy for these reasons have a cause of CKD other than diabetes (16,17). Epidemiological data also suggest that CKD may be attributable to causes other than diabetes in up to half of people (18). Understanding the pathophysiological heterogeneity of DKD is an active area of investigation in precision medicine that may lead to new diagnostic and therapeutic approaches (19). Currently, however, empirical diagnosis of DKD is usually appropriate and useful for guiding prognosis and treatment.

ADA and Kidney Disease Improving Global Outcomes (KDIGO) guidelines recommend classifying CKD according to presumed cause, current eGFR, and UACR, sometimes referred to as “CGA” (cause, GFR, and albuminuria) classification (13,15,20). In addition, the pattern and rate of historical change in eGFR can be useful for guiding differential diagnosis and assessing prognosis (21). The KDIGO Heat Map summarizes risks of CKD progression, cardiovascular complications, and death according to eGFR and UACR levels (Figure 5). Such categorization is also useful to assess risk of CKD complications (e.g., CKD-mineral bone disease and anemia), recommended frequency of monitoring, need for nephrology referral, and appropriate drug treatment. As indicated in Figure 5, albuminuria as an early indicator of kidney damage is a strong risk factor for CKD progression and other adverse clinical outcomes. Lower eGFR and higher blood pressure are other known strong risk factors.

In clinical practice, GFR is usually estimated from serum creatinine concentration (or other endogenous substances) using an equation that also incorporates demographic information to maximize precision and minimize bias. Equations to estimate GFR have been refined over the years to improve performance. Most recently, a task force convened by the American Society of Nephrology and the National Kidney Foundation (NKF) recommended that 1) race modifiers should not be used in equations used to estimate kidney function and 2) race-based equations should be replaced by a substitute that is accurate, is representative, and provides a standardized approach to diagnosing kidney diseases (22–26). Although previous eGFR equations included age, sex, race, and/or body weight to approximate directly measured kidney function, race is a social, not a biological, construct. Additionally, race-based equations have led to gaps in the detection and treatment of CKD in minoritized individuals, contributing to the exacerbation of health disparities. Hence, many professional groups and institutions have now implemented the 2021 CKD Epidemiology Collaboration race-free eGFR equation to estimate GFR as recommended by the task force. GFR can also be estimated using serum cystatin-C concentration (instead of or in addition to serum creatinine and without use of race) to increase precision and decrease bias (26), especially to confirm CKD staging when classification using serum creatinine–based eGFR is in doubt.

UACR is the second key marker in screening and monitoring for DKD. In terms of practical implementation, spot urine measurement of albuminuria (i.e., UACR) is recommended over timed urine measurement (i.e., 24-hour urine albumin excretion) because the former is easier to implement and less subject to collection error. With respect to interpretation of results, UACR reported in mg/g approximates urine albumin excretion rate in mg/day because most people excrete ∼1 g or more of creatinine daily. In terms of timing of measurements, although collection of the first morning urine specimen is preferred/optimal, collection at any random time may be acceptable. It also bears mentioning that nonkidney factors may influence UACR results (e.g., exercise and presence of urinary tract infection), and, given that there may be substantial biological variability in levels, confirmation with repeated UACR measurements over time is particularly important.

Optimal DKD prevention and management involves a multifactorial approach that integrates person-centered education and support, optimized glucose and blood pressure management, and utilization of medications with evidence of kidney and cardiovascular benefit in people with diabetes who are at risk for or have existing DKD (Figure 6). An interdisciplinary and integrated team-based care approach that leverages the skills and strengths of all members of the diabetes and kidney care team is recommended, whenever possible (see InterdisciplinaryCare Team below).

Building and maintaining positive health behaviors is essential to the ability of people with diabetes to achieve individualized treatment goals, including preventing and slowing progression of diabetes-related complications (27). Referring people with diabetes for diabetes self-management education and support (DSMES) services that effectively incorporate their needs, goals, and life experiences helps to facilitate their acquisition of the knowledge, decision-making capability, and skills necessary for optimal diabetes self-care (27,28). DSMES services and behavioral interventions are considered foundational for both the prevention and management of DKD and other diabetes-related complications (13,20). Team-based integrated care approaches that utilize the strengths of all care team members are recommended (20). Referring people with diabetes for medical nutrition therapy (MNT) provided by a specialty-trained registered dietitian nutritionist is recommended to establish individualized meal plans (e.g., meal plans that are culturally and financially sensitive) that stress a balanced diet high in intake of vegetables, fruits, and whole grains and low in refined carbohydrates, processed foods, hidden salts, and sugar-sweetened beverages (20,27). Other beneficial lifestyle changes, such as engaging in moderate to intense/ vigorous physical activity ≥150 minutes/week, achieving and maintaining a healthy body weight, and ceasing smoking (when applicable), are recommended to both prevent and slow the progression of DKD (20,27). To achieve these goals, people with diabetes may need high-intensity interventions with ongoing support (29). When such interventions are not available within care teams, people with diabetes should be directed to community resources such as commercial weight loss programs (30). For those with early DKD, education about avoiding potentially nephrotoxic medications (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs] and proton pump inhibitors) is also crucial to prevent kidney disease progression.

Optimization of glucose control has long been recommended to reduce the risk and slow the progression of DKD (13,20). Intensive glycemic management (31–35) is known to delay the onset and progression of albuminuria and decline in eGFR in both type 1 diabetes (36,37) and type 2 diabetes. Accordingly, the ADA recommends an A1C goal of <7.0% for many nonpregnant adults with diabetes (38). Although this is the general recommended goal, glucose targets should be individualized based on person-specific considerations. More stringent A1C goals (e.g., <6.5%) may be appropriate and beneficial particularly in younger people with relatively short diabetes duration and those who are able to achieve such targets with medications that carry a low risk of causing hypoglycemia or treatment burden. Long-term follow-up of the UK Prospective Diabetes Study indicated that early glycemic control in type 2 diabetes provided enduring microvascular benefits (39). In contrast, less stringent A1C goals (e.g., <8.0%) may be appropriate in those with limited life expectancy and/or when the risks of more intensive glycemic management strategies outweigh anticipated benefits (38).

In people with diabetes and early DKD, glycemic management remains a key aspect of care to slow DKD progression. KDIGO guidelines recommend an individualized A1C target for people with DKD not treated with dialysis ranging from <6.5% to <8.0% based on consideration of CKD stage, comorbidity burden, life expectancy, and hypoglycemia risk (20). Choice and dosing of glucose-lowering agents in DKD is informed by kidney function (eGFR) and preferential use of agents with evidence of kidney and cardiovascular benefit (13) (see Pharmacotherapy Considerations below).

Hypertension is another strong risk factor for the development and progression of DKD (40), and antihypertensive therapy has been shown to reduce the risk of albuminuria (41–44). Blood pressure levels <140/90 mmHg are mandated to reduce the risk or show the progression of DKD, with strong consideration of lower targets (e.g., <130/80 mmHg) recommended based on individualized assessment of treatment benefits and risks (13).

Additional considerations for use of antihypertensive and glucose-lowering agents to prevent and slow progression of DKD are detailed below. As illustrated in Figure 7, renin-angiotensin system (RAS) inhibition with an ACE inhibitor or angiotensin receptor blocker (ARB) plus an SGLT2 inhibitor is considered foundational therapy to slow progression of early DKD and improve cardiorenal outcomes (45). Additionally, finerenone, a nonsteroidal mineralocorticoid receptor antagonist (NS-MRA) has been shown to slow progression of nephropathy and reduce heart failure hospitalization in the absence of an SGLT2 inhibitor. This agent should be added to the armamentarium especially if residual albuminuria is present.

To achieve individualized blood pressure goals, the ADA recommends initial use of antihypertensive agents from classes with demonstrated evidence of reducing cardiovascular events in people with diabetes, including ACE inhibitors, ARBs, thiazide-like diuretics, or dihydropyridine calcium channel blockers (CCBs; amlodipine or nifedipine). Initial antihypertensive monotherapy is recommended for people with an initial blood pressure >140/90 and <160/100 mmHg, with initial dual therapy recommended in those with an initial blood pressure ≥160/100 mmHg (46). An RAS inhibitor is recommended at the maximum tolerated dose indicated for blood pressure treatment in people with albuminuria (UACR ≥30 mg/g) to reduce the risk for kidney disease progression (46). Although they are foundational in slowing DKD progression (Figure 7), RAS inhibitors are not associated with superior cardioprotective effects when compared with thiazide-like diuretics and dihydropyridine CCBs and do not prevent the development of DKD. Therefore, in the absence of albuminuria (<30 mg/g) (47), RAS inhibitors, thiazide-like diuretics, and dihydropyridine CCBs are equally recommended for blood pressure management, and multiple classes are often required to meet goals.

As previously noted, optimization of glucose control is recommended to reduce the risk and slow progression of DKD (13). Use of glucose-lowering agents that provide adequate efficacy to achieve and maintain glycemic goals is recommended, with consideration of key comorbidities, person-centered treatment factors (e.g., preferences and access considerations), and management needs guiding agent selection (14). Current evidence does not strongly support the use of specific glucose-lowering agents for the primary prevention of DKD. Recently published findings from the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study reported no differences in kidney outcomes for people with type 2 diabetes treated with sulfonylureas, DPP-4 inhibitors, GLP-1 receptor agonists, or insulin glargine as add-ons to metformin (48). Notably, SGLT2 inhibitors were not studied in the GRADE Study.

For most people with type 2 diabetes and DKD, SGLT2 inhibitors with evidence of kidney benefit are recommended with an eGFR ≥20 mL/min/1.73 m², independent of A1C and the need for additional glucose lowering (45). SGLT2 inhibitors are considered foundational in combination with an RAS inhibitor based on strong evidence of benefit with regard to DKD progression and heart failure and atherosclerotic CVD risk in people with type 2 diabetes and DKD (49–51). Agents from the GLP-1 receptor agonist class have also demonstrated benefit on secondary kidney outcomes (i.e., progression of albuminuria) in large cardiovascular outcome trials (52–54), but primary kidney outcome data are not yet available. GLP-1 receptor agonists are preferentially recommended as an add-on to first-line glucose-lowering therapy (SGLT2 inhibitor plus metformin) in people with type 2 diabetes and DKD not meeting individualized glucose targets and/or those with persistent albuminuria (Figure 7) (45). Notably, although the glucose-lowering effects of SGLT2 inhibitors diminish as eGFR falls, their cardiorenal benefits are maintained. The glycemic efficacy of GLP-1 receptor agonists is preserved in DKD (45,55). In addition to their cardiorenal benefits, these newer glucose-lowering agents are also preferred to older agents such as sulfonylureas, which have heightened risk of hypoglycemia, particularly in CKD.

The NS-MRA finerenone is another option for people with type 2 diabetes and DKD to mitigate kidney and cardiovascular risk. Based on findings from two large clinical trials (56–58), finerenone is approved by the U.S. Food and Drug Administration for use in people with type 2 diabetes and CKD to reduce the risk of sustained eGFR decline, progression to ESKD, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure (59). Finerenone is recommended for people with type 2 diabetes, an eGFR ≥25 mL/min/1.73 m², normal serum potassium concentration, and albuminuria (UACR ≥30 mg/g) despite maximum tolerated RAS therapy (Figure 7) (45).

Diabetes is a chronic, complex disease that progresses over time and may manifest differently across settings, circumstances, and populations. Such complexity requires wide-ranging expertise to support person- centered care, with primary care clinicians acting as a conduit to and coordinator of other resources and supports. An interdisciplinary team, including but not limited to primary care and specialty clinicians, diabetes care and education specialists, dietitians, pharmacists, nurses, exercise specialists, podiatrists, dentists, and community-based providers (e.g., community health workers [CHWs] and community paramedics), can be utilized to provide continuous, accessible, consistent, comprehensive, and effective care focused on individuals’ priorities, needs, and goals. Indeed, an interdisciplinary team–based integrated care approach is endorsed by the ADA and KDIGO for the management of people with diabetes and CKD (20,45). Establishing collaborative, integrated working relationships among members of the interdisciplinary diabetes and CKD care team (including enhanced and active communication) and improving access to primary care and appropriate specialties is essential (60). Active participation and integration of people with diabetes and their caregivers in their disease management is crucial; it is therefore imperative to include them as part of the treatment team to enable regular communication and cocreation of management goals.

People with diabetes who have access to interdisciplinary care team expertise in self-management support report better experiences of chronic care (61). KDIGO recommends implementation of a structured self- management education program for people with diabetes and CKD (20), with a recent systematic review and meta-analysis concluding that self-management support interventions may improve self-care behaviors as well as key clinical measures such as systolic blood pressure and A1C (60,62). Team-based diabetes care that leverages the expertise of each member of the clinical team can also improve glycemic and blood pressure outcomes compared with usual care models (63).

Four critical times have been identified as key moments to refer people with diabetes for DSMES. These four times have been incorporated into the ADA’s Standards of Care in Diabetes and provide the areas of focus for educational content (64). The DSMES content is provided as a framework, while allowing for individual needs of people with diabetes to be addressed. Discussions regarding diabetes complications should occur as part of DSMES at each critical time to provide information on prevention, adaptation, and progression.

Insurance coverage for DSMES, which can include core components of CKD prevention and management, varies by health plan, and care team members should familiarize themselves with basic coverage requirements to minimize patients’ financial burden (Figure 8). The Centers for Medicare & Medicaid Services (CMS) reimburses for 10 hours of initial diabetes self-management training (DSMT; the CMS term for DSMES) as a Medicare part B benefit. These services must be administered through programs that have achieved accreditation from the Association of Diabetes Care and Education Specialists or are recognized by the ADA within 1 year of initial use (not necessarily within 1 year of first diabetes diagnosis) (Figure 8). Beyond the first year, 2 hours annually are reimbursed for continued DSMT, which we strongly advise in the setting of changes in individuals’ clinical situation or life context. Other health plans may have different eligibility requirements, and people with diabetes should be encouraged to check with their insurance plan for specific guidance. Importantly, a properly executed referral, written or electronic, from a beneficiary’s primary diabetes provider (physician or qualified nonphysician practitioner such as a nurse practitioner or physician associate) is required (65). The specific CMS guidelines for referring to these services can be found on the Centers for Disease Control and Prevention website (https://www.cdc.gov/diabetes/dsmes-toolkit/reimbursement/medicare.html).

Medicare beneficiaries with a diagnosis of either kidney disease or diabetes are also eligible to receive 3 hours of MNT services within the first year of diagnosis and 2 hours of MNT in each subsequent year (Figure 8). The CMS DSMT and MNT benefits are independent of each other, and both can be used. Private insurers and other plans often follow the Medicare guidelines. Details for MNT reimbursement can be found on the CMS website (https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=252).

In addition to formal DSMES, people with diabetes can benefit from engagement with clinical pharmacists (66–69). Integration of pharmacists into the interdisciplinary care team can address a variety of barriers to optimal diabetes and CKD care, including provision of education to patients and caregivers on the importance of avoiding potentially nephrotoxic medications (e.g., NSAIDs), evaluating and addressing concerns about drug interactions and polypharmacy, optimizing the use of agents indicated for kidney and heart protection, educating people with diabetes on risk mitigation strategies with agents initiated for organ protection, and assisting with medication cost barriers (70,71). Integration of pharmacists into the interdisciplinary care team may also help to address primary care provider time constraints by delegating some medication management tasks (e.g., medication dose titration and efficacy and safety monitoring) to clinical pharmacists (71,72).

Specialist referrals should be considered when additional guidance or support is needed to ensure optimal kidney health. This includes referrals to specialists in nephrology, cardiology, sleep medicine, mental health, podiatry, and others. Importantly, because people with diabetes often have multiple comorbidities and thus require the care of several specialists, robust primary care, such as is described within the Chronic Care Model (73), is crucial to reducing fragmentation of care and ensuring that treatments are person-centered and not contradictory and do not increase the burden of treatment or exceed individuals’ capacity for self-management.

Preventing the onset and progression of DKD requires comprehensive person-centered care to be available, accessible, and relevant to the people and communities affected by diabetes and its complications. Kidney health promotion, education, and medical care therefore need to extend outside of the walls of the traditional health care system to reach people with diabetes where they live (Figure 9). Although literature on kidney disease– focused community engagement is scarce, emerging models of care and community engagement introduced to improve glycemic control and CVD risk factors can be leveraged to explicitly prioritize kidney disease education, prevention, and management.

Lack of CKD awareness in the general population is a major barrier to prevention efforts. Nearly nine in 10 adults with kidney disease of any etiology do not know they have it, including four in 10 adults with severe kidney disease (4). Engaging people with DKD, their caregivers, and communities in kidney health promotion is a necessary first step toward improving awareness about CKD and interventions to support kidney health; supporting clinic/community partnerships to bring screening, health promotion, and disease management services to the community; and implementing healthy lifestyle initiatives to reduce CKD risk. Community screening and education initiatives targeting high-risk populations can spread awareness, enable early diagnosis, and deliver evidence-based education. For example, between 2000 and 2013, the NKF Kidney Early Evaluation Program (KEEP) conducted >185,000 free screenings of high-risk individuals in both medical (hospitals, health centers, and dialysis centers) and community (places of worship, schools, and community centers) settings and delivered education to individuals newly diagnosed with CKD (74,75). Comparison of KEEP participants versus non-KEEP patients from a national ESKD registry showed that KEEP participation was associated with higher rates of pre-ESKD nephrology care, receipt of home versus in-center dialysis, preemptive placement on the transplant waiting list prior to developing ESKD, and kidney transplantation (76). These efforts have continued as the NKF KEEP Healthy initiative (77) and as part of Annual World Kidney Day (78) health screenings conducted in communities, hospitals, and academic institutions worldwide. Advocacy and professional organizations also engage community members to raise awareness about kidney disease prevention and management through online communities (79), sponsored walks (80) and other community events, trained peer mentor programs (81), and other initiatives.

Community engagement is also needed to identify and address the underlying structural barriers to optimal kidney health that have been historically overlooked— specifically, the social, economic, political, and legal constructs that lead to and perpetuate disparities in disease management and health outcomes (6,82–84). Extending care from the clinic to the community is particularly important for underserved and marginalized communities. These communities include racial and ethnic minority populations (85–88), rural residents, and individuals with financial barriers to care (89–91), whose rates of CKD are disproportionately higher and who experience substantial morbidity and mortality stemming from diabetes and CKD, yet face gaps in access to evidence-based diabetes and kidney care.

Access to evidence-based care can be improved by engaging and training community-based care providers to deliver education and support self-management for individuals within their communities. Community pharmacists, particularly in rural areas, can review medications to ensure their renal safety, screen for kidney disease risk factors (e.g., hypertension and hyperglycemia), deliver self-management education, and connect people to clinical resources (92,93). CHWs can screen for kidney disease and cardiovascular risk factors, support self-management, and connect people with needed resources. In multiple studies, CHW engagement improved hypertension and diabetes control, supported smoking cessation and weight loss, and helped improve healthy eating and physical activity (94–99). Community paramedics can support delivery of diabetes self-management education and support, diagnosis and management of kidney disease, and optimization of glycemic and blood pressure control (100–104). Peer support programs for diabetes management have also been found to be helpful and can augment and enhance the care delivered by other members of the clinical team (105–109).

Education and medical services should be tailored to specific patient populations and brought to nontraditional community settings to make them accessible, timely, and relevant. Multiple studies have established the feasibility and effectiveness of faith-adapted obesity, diabetes, and CVD health promotion programs designed for African Americans and delivered in churches or with the engagement of faith leaders (110,111). These programs include adaptations of the Diabetes Prevention Program (112–114), diabetes self-management coaching classes (115), and general behavioral wellness programs (110). Faith leaders are respected and trusted members of the community and can facilitate the cocreation and implementation of culturally appropriate community health promotion programs (116–119). In addition to places of worship such as churches, successful CVD (i.e., hypertension) (120–123), diabetes (124), and obesity (125) screening, monitoring, and education efforts tailored to African American men and women have taken place in barbershops and hair salons, respectively. Finally, employers can support health promotion programs and health risk assessments to improve awareness and diagnosis of DKD and improve onsite nutrition and access to physical activity options (126,127). Employers can also improve access to evidence-based diabetes and kidney care by offering affordable health insurance and avoiding the use of high-deductible health plans, which are currently held by nearly one-third of employees with employer-sponsored health plans (128) and often hinder access to and utilization of high-value, evidence-based care (129).

Integrated health care models that bridge health care organizations, community partners, and people with diabetes can narrow existing gaps in evidence-based diabetes and kidney care (Figure 9). Virtual consultative models to expand access to diabetes care, such as Endo ECHO, can be enhanced to include kidney disease prevention and management (130). Mobile health (mHealth) technologies, including interactive care plans (recently developed for cancer survivorship care) (131) and self-management and educational apps (studied extensively in hypertension and diabetes management (132–134) are adaptable, cost-effective, and scalable solutions that can also be leveraged to improve kidney health. For maximal effectiveness, mHealth technologies can and should be tailored for and codesigned by the communities they are intended to serve. For example, the Fostering African American Improvement in Total Health (FAITH!) app to improve CVD risk factors (135) was cocreated by clinicians, researchers, and community members from African American churches in Minnesota (111,136) and was shown to improve diet (137) and support behavior change (138).

Domain-spanning partnerships between federal agencies, health care systems, public health agencies, payers, and community partners can create an infrastructure and environment for community-based health promotion. The Million Hearts Initiative (139,140) to prevent cardiovascular deaths across the United States provides an example of how evidence-based care processes can be adapted to different settings and populations to improve care delivery and health outcomes (119,141–143). The biggest barrier to all such efforts—including programs within the Million Hearts Initiative (144), faith-based programs (145), community pharmacist–led initiatives (93), community paramedic engagement (146), and CHW programs—is infrastructure funding; sustainable reimbursement models will be needed to foster, maintain, and reward health promotion programs, particularly in low-resource areas and fee-for-service systems.

Supporting the ability of clinic staff members to facilitate positive self-management behaviors (e.g., by encouraging blood glucose monitoring and home blood pressure monitoring and assessing and supporting better medication-taking behaviors) can provide support to the clinical team and improve visit efficiency. Also, it is important to build the capacity of medical staff to shift from directive one-way communication and counseling to focusing more on approaches and frameworks that foster positive behavior changes in people with diabetes such as shared decision-making and motivational interviewing.

Education and training efforts should always be integrated and assessed within institutions’ performance improvement initiatives and compared with national benchmarks. These performance improvement initiatives should be inclusive of appropriate organizational interventions, person-focused interventions, and incentives and should always be data-driven with adequate support from electronic health records and information technology staff. Practices should ascertain that staff have the needed quality improvement (QI) skills and processes, including teams meeting weekly/biweekly to assess their progress and staying in constant communication regarding workflows and new QI opportunities; reviewing data collectively; and exchanging ideas and sharing successful models and methodologies that could be implemented in various settings. It is worth noting that successful models may already exist within a health care system for disease states other than CKD that could be suitable for adaptation to fit this model. Finally, all members of the interdisciplinary health care team should be empowered to advocate for and engage in QI efforts.

The unveiling of the Advancing American Kidney Health Initiative executive order by the White House in 2019 (147–150), in which one of the main mandates is to reduce the risk of kidney failure, has brought discussions of DKD prevention and early identification to the forefront. To implement high-quality, evidence-based, accessible, and equitable care to prevent and reduce the burden of DKD, it is imperative to 1) improve access to care through innovative care delivery models that leverage technological advances and interdisciplinary team expertise; 2) implement payment models that prioritize quality of care over quantity of visits and adequately reimburse for DSMES, primary care, and community-based services; 3) reduce the financial burden of diabetes management on people with DKD by improving coverage and reducing patients’ cost-sharing responsibility for evidence-based medications and diabetes technology; 4) prioritize narrowing gaps in care and health outcomes among underserved populations, including minoritized populations, low-income individuals, and rural residents; and 5) empower team-based care.

Technological advances have improved access to evidence-based, high-quality care via various modalities, including digital technology, the use of artificial/augmented intelligence and machine learning tools that provide early and individualized risk assessment (151), and telehealth visits beyond face-to-face individual or group visits. For example, continuous glucose monitoring (CGM) systems have been recognized as the ideal monitoring system for glycemic control of people with diabetes because they enable a more personalized approach to diabetes management and resolve many of the limitations of A1C as a glycemic metric in DKD. Given the growing body of research showing the benefits of CGM with regard to improved A1C levels, increased time spent in the glycemic target range, and reduced hypoglycemic episodes, policy changes that enhance Medicare eligibility for CGM in type 2 diabetes and institutional changes that promote its use in primary care could make a major impact in improving diabetes management and reducing its downstream complications, particularly among the populations most in need (5). Additionally, the availability of improved infrastructure, resources/support, and reimbursement for virtual telehealth visits has alleviated impaired access to diabetes and DKD care, particularly in rural and/or underserved areas, enabling individuals to receive appropriate screening, timely diagnosis, and access to evidence-based interventions (6). The coronavirus disease 2019 pandemic catalyzed an unprecedented surge in the scientific and technology resources, and one of its most impactful enduring consequences is the accelerated adoption of technology in health care delivery.

Optimal implementation of the abovementioned ADA DKD Prevention Model also requires establishing benchmarks for successful model performance in the domains of intermediate and clinical end points, process measures (152), person-reported outcomes, healthy equity, and health economics/savings (Table 2). Furthermore, ongoing assessment of these areas is needed to further refine and optimize the model’s impact on people with diabetes and the broader health care community.

Evaluation of clinical metrics should include both short-term/intermediate and long-term end points. For example, assessment of short-term metrics, including achievement of guideline-based laboratory (e.g., A1C and UACR testing) and other clinical targets (e.g., blood pressure monitoring) and refining lifestyle factors/ behaviors (e.g., dietary patterns, physical activity, medication adherence, and self-management), may directly affect long-term metrics such as reduction in ESKD/kidney failure rates, hypoglycemic episodes, cardiovascular events, and mortality. Optimizing process measures is also crucial to ensuring the model’s impact on clinical outcomes, including enhancement of CKD awareness, completion of routine laboratory testing (e.g., eGFR and UACR) and clinical assessments, tracking of initiation and completion of referrals (e.g., for nephrology, cardiology, DSMES, and MNT services), and utilization of evidence-based therapies (e.g., RAS inhibitors and SGLT2 inhibitors).

Assessing person-reported outcome measures is also central to ensuring person-centered care; thus, model performance assessment should also encompass assessments of participants’ HRQOL, experience, treatment burden, self-management and self-efficacy, and behavioral changes. Given the disproportionate burden of diabetes and CKD among vulnerable populations, such as those of minoritized, low-income, and rural backgrounds, evaluation of health equity end points, including assessment of and reduction in variations in care, provision of culturally and linguistically appropriate services, engagement with and accountability to community partners and stakeholders, optimization of screening and access to care for other areas of need (e.g., social support), and expansion of outreach efforts to underserved areas, is needed (152). Ideally, achievement of these model targets will translate into health savings as another key end point. In turn, rigorous health economics cost-effectiveness/cost-benefit analyses can inform resource and staffing allocation for successful model performance.

Although the ADA DKD Prevention Model comprehensively encompasses the requisite elements of DKD prevention and management using a holistic approach, remaining clinical and knowledge gaps in the field require further research to generate high-quality evidence that will inform model refinement and optimize outcomes among people with diabetes and DKD. Additionally, ongoing collaboration and partnership with key stakeholders are needed to develop the requisite infrastructure and obtain the essential resources for implementation of this and other innovative care delivery models.

First, although self-management and behavior change are central to DKD prevention, primary care practices alone lack the capacity to deliver effective interventions to achieve this goal (153,154). Hence, there is a major unmet need for expanded services and increased access to existing services to support people with diabetes in achieving successful lifestyle/behavioral changes. Furthermore, given the high treatment burden of diabetes (e.g., multiple medical appointments, high copays, and fragmentation of care), interdisciplinary approaches and collaboration with key stakeholders (e.g., payers and employers) are needed to mitigate this burden and enhance effective self-management.

Second, further efforts are needed to ensure equitable implementation of the proposed model, including approaches that involve community engagement. These efforts must include identification of approaches that increase knowledge and awareness of DKD and the importance of its prevention among people with diabetes across all levels of health literacy and their providers; identification of factors that contribute to missed CKD diagnoses (i.e., system- and provider-level factors) (155), as well as the role of non–race-based eGFR equations in ameliorating this gap; improvement in providers’ communication of DKD diagnosis to people with diabetes; enhancement of access/referrals to DSMES; and the elimination of disparities in coverage and access to guideline-based therapies, particularly in racial/ethnic minorities (156–158) among whom there are higher rates of CKD but lower utilization of newer glucose- lowering medications with cardiorenal benefit (159).

Third, more research is needed with respect to effective approaches to the prevention of DKD, particularly lifestyle and pharmacologic approaches. Beyond glycemic control, there is sparse evidence for interventions that reduce the incidence of DKD, and existing management strategies are largely focused on reducing DKD progression or its complications (e.g., CVD) as opposed to DKD prevention.

The ADA DKD Prevention Model was developed to define key concepts of DKD prevention and treatment and guide the development of appropriate screening guidelines, tools, and approaches, as well as comprehensive and holistic interventions using an interdisciplinary approach. Partnering with and leveraging the collective expertise and resources of public and private organizations, government agencies, academic institutions, researchers, community stakeholders, and people with diabetes will be crucial to the successful implementation of this model and its ongoing refinement to ameliorate DKD and its progression and optimally serve the diabetes community.

The authors acknowledge Dr. Caroline Richardson of the University of Michigan School of Medicine for her intellectual contributions to the conceptualization of this project; Michael Bonar of the Leicester Diabetes Centre, at the University Hospitals of Leicester NHS Trust, for creating the figures for this article; and Jessica Wegner of the ADA for her project management assistance.

This publication was supported by an unrestricted educational grant to the ADA from Renalytix.

No potential conflicts of interest relevant to this article were reported.

All authors researched data, wrote the manuscript, edited and revised the manuscript, and approved the final version of the manuscript for submission. C.M.R. is the guarantor of this work and as such, had full access to all the information presented and takes responsibility for the integrity and accuracy of the work.