TYPE 1 DIABETES Recommendations
3. Prevention or Delay of Type 2 Diabetes and Associated
Comorbidities: Standards of
Medical Care in Diabetes—2022
Diabetes Care 2022;45(Suppl. 1):S39–S45 | https://doi.org/10.2337/dc22-S003
American Diabetes Association Professional Practice Committee*
The American Diabetes Association (ADA) “Standards of Medical Care in Dia-betes” includes the ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Profes-sional Practice Committee, a multidisciplinary expert committee (https://doi .org/10.2337/dc22-SPPC), are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations, please refer to the Standards of Care Introduction (https://doi.org/10.2337/dc22-SINT). Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.
For guidelines related to screening for increased risk for type 2 diabetes (prediabe-tes), please refer to Section 2,“Classification and Diagnosis of Diabetes” (https://
doi.org/10.2337/dc22-S002). For guidelines related to screening, diagnosis, and management of type 2 diabetes in youth, please refer to Section 14,“Children and Adolescents” (https://doi.org/10.2337/dc22-S014).
Recommendation
3.1 Monitor for the development of type 2 diabetes in those with prediabe-tes at least annually, modified based on individual risk/benefit assess-ment.E
Screening for prediabetes and type 2 diabetes risk through an informal assessment of risk factors (Table 2.3) or with an assessment tool, such as the American Diabetes Association risk test (Fig. 2.1), is recommended to guide providers on whether per-forming a diagnostic test for prediabetes (Table 2.5) and previously undiagnosed type 2 diabetes (Table 2.2) is appropriate (see Section 2, “Classification and Diagnosis of Diabetes,” https://doi.org/10.2337/dc22-S002). Testing high-risk patients for predi-abetes is warranted because the laboratory assessment is safe and reasonable in cost, substantial time exists before the development of type 2 diabetes and its com-plications during which one can intervene, and there is an effective means of pre-venting type 2 diabetes in those determined to have prediabetes with an A1C 5.7– 6.4% (39–47 mmol/mol), impaired glucose tolerance, or impaired fasting glucose.
The utility of A1C screening for prediabetes and diabetes may be limited in the pres-ence of hemoglobinopathies and conditions that affect red blood cell turnover. See
*A complete list of members of the American Diabetes Association Professional Practice Committee can be found at https://doi.org/
10.2337/dc22-SPPC.
Suggested citation: American Diabetes Asso-ciation Professional Practice Committee. 3.
Prevention or delay of type 2 diabetes and associated comorbidities: Standards of Medical Care in Diabetes—2022. Diabetes Care 2022;45 (Suppl. 1):S39–S45
© 2021 by the American Diabetes Association.
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.
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3.PREVENTIONORDELAYOFTYPE2DIABETES
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Section 2, “Classification and Diagnosis of Diabetes” (https://doi.org/10.2337/
dc22-S002), and Section 6, “Glycemic Targets” (https://doi.org/10.2337/dc22-S006), for additional details on the appropriate use and limitations of A1C testing.
LIFESTYLE BEHAVIOR CHANGE FOR DIABETES PREVENTION
Recommendations
3.2 Refer adults with overweight/
obesity at high risk of type 2 diabetes, as typified by the Dia-betes Prevention Program (DPP), to an intensive lifestyle behavior change program consistent with the DPP to achieve and maintain 7% loss of initial body weight, and increase moderate-intensity physical activity (such as brisk walking) to at least 150 min/
week.A
3.3 A variety of eating patterns can be considered to prevent diabe-tes in individuals with prediabe-tes.B
3.4 Given the cost-effectiveness of lifestyle behavior modification programs for diabetes preven-tion, such diabetes prevention programs should be offered to patients. A Diabetes prevention programs should be covered by third-party payers and inconsis-tencies in access should be addressed.
3.5 Based on patient preference, cer-tified technology-assisted diabe-tes prevention programs may be effective in preventing type 2 diabetes and should be consid-ered.B
The Diabetes Prevention Program Several major randomized controlled tri-als, including the Diabetes Prevention Program (DPP) (1), the Finnish Diabetes Prevention Study (DPS) (2), and the Da Qing Diabetes Prevention Study (Da Qing study) (3), demonstrate that life-style/behavioral therapy with individual-ized reduced-calorie meal plan is highly effective in preventing or delaying type 2 diabetes and improving other cardio-metabolic markers (such as blood pres-sure, lipids, and inflammation) (4). The strongest evidence for diabetes
pre-vention in the U.S. comes from the DPP trial (1). The DPP demonstrated that intensive lifestyle intervention could reduce the risk of incident type 2 diabe-tes by 58% over 3 years. Follow-up of three large studies of lifestyle interven-tion for diabetes preveninterven-tion has shown sustained reduction in the risk of pro-gression to type 2 diabetes: 39% reduc-tion at 30 years in the Da Qing study (5), 43% reduction at 7 years in the Finnish DPS (2), and 34% reduction at 10 years (6) and 27% reduction at 15 years (7) in the U.S. Diabetes Prevention Program Outcomes Study (DPPOS).
The two major goals of the DPP intensive lifestyle intervention were to achieve and maintain a minimum of 7%
weight loss and 150 min of physical activity per week similar in intensity to brisk walking. The DPP lifestyle interven-tion was a goal-based interveninterven-tion: all participants were given the same weight loss and physical activity goals, but individualization was permitted in the specific methods used to achieve the goals (8). Although weight loss was the most important factor to reduce the risk of incident diabetes, it was also found that achieving the target behav-ioral goal of at least 150 min of physical activity per week, even without achiev-ing the weight loss goal, reduced the incidence of type 2 diabetes by 44% (9).
The 7% weight loss goal was selected because it was feasible to achieve and maintain and likely to lessen the risk of developing diabetes.
Participants were encouraged to achieve the 7% weight loss during the first 6 months of the intervention. Further anal-ysis suggests maximal prevention of dia-betes with at least 7–10% weight loss (9). The recommended pace of weight loss was 1–2 lb/week. Calorie goals were calculated by estimating the daily calo-ries needed to maintain the participant’s initial weight and subtracting 500–1,000 calories/day (depending on initial body weight). The initial focus was on reducing total dietary fat. After several weeks, the concept of calorie balance and the need to restrict calories as well as fat was introduced (8).
The goal for physical activity was selected to approximate at least 700 kcal/week expenditure from physical activity. For ease of translation, this goal was described as at least 150 min of moderate-intensity physical activity per
week similar in intensity to brisk walk-ing. Participants were encouraged to distribute their activity throughout the week with a minimum frequency of three times per week and at least 10 min per session. A maximum of 75 min of strength training could be applied toward the total 150 min/week physical activity goal (8).
To implement the weight loss and physical activity goals, the DPP used an individual model of treatment rather than a group-based approach. This choice was based on a desire to intervene before participants had the possibility of developing diabetes or losing interest in the program. The individual approach also allowed for tailoring of interventions to reflect the diversity of the population (8).
The DPP intervention was adminis-tered as a structured core curriculum followed by aflexible maintenance pro-gram of individual counseling, group sessions, motivational campaigns, and restart opportunities. The 16-session core curriculum was completed within thefirst 24 weeks of the program and included sessions on lowering calories, increasing physical activity, self-moni-toring, maintaining healthy lifestyle behaviors, and guidance on managing psychological, social, and motivational challenges. Further details are avail-able regarding the core curriculum sessions (8).
Nutrition
Dietary counseling for weight loss in the DPP lifestyle intervention arm included a reduction of total dietary fat and calories (1,8,9). However, evidence suggests that there is not an ideal percentage of calo-ries from carbohydrate, protein, and fat for all people to prevent diabetes; there-fore, macronutrient distribution should be based on an individualized assess-ment of current eating patterns, prefer-ences, and metabolic goals (10). Based on other intervention trials, a variety of eating patterns characterized by the totality of food and beverages habitually consumed (10,11) may also be appropri-ate for patients with prediabetes (10), including Mediterranean-style and low-carbohydrate eating plans (12–15).
Observational studies have also shown that vegetarian, plant-based (may include some animal products), and
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Dietary Approaches to Stop Hypertension (DASH) eating patterns are associated with a lower risk of developing type 2 diabetes (16–19). Evidence suggests that the overall quality of food consumed (as measured by the Healthy Eating Index, Alternative Healthy Eating Index, and DASH score), with an emphasis on whole grains, legumes, nuts, fruits, and vegeta-bles and minimal refined and processed foods, is also associated with a lower risk of type 2 diabetes (18,20–22). As is the case for those with diabetes, individual-ized medical nutrition therapy (see Sec-tion 5,“Facilitating Behavior Change and Well-being to Improve Health Outcomes,” https://doi.org/10.2337/dc22-S005, for more detailed information) is effective in lowering A1C in individuals diagnosed with prediabetes (23).
Physical Activity
Just as 150 min/week of moderate-intensity physical activity, such as brisk walking, showed beneficial effects in those with prediabetes (1), moderate-intensity physical activity has been shown to improve insulin sensitivity and reduce abdominal fat in children and young adults (24,25). On the basis of these findings, providers are encour-aged to promote a DPP-style program, including a focus on physical activity, to all individuals who have been identified to be at an increased risk of type 2 dia-betes. In addition to aerobic activity, an exercise regimen designed to prevent diabetes may include resistance training (8,26,27). Breaking up prolonged seden-tary time may also be encouraged, as it is associated with moderately lower postprandial glucose levels (28,29). The preventive effects of exercise appear to extend to the prevention of gestational diabetes mellitus (GDM) (30).
Delivery and Dissemination of Lifestyle Behavior Change for Diabetes Prevention
Because the intensive lifestyle interven-tion in the DPP was effective in prevent-ing type 2 diabetes among those at high risk for the disease and lifestyle behavior change programs for diabetes prevention were shown to be cost-effective, broader efforts to disseminate scalable lifestyle behavior change programs for diabetes prevention with coverage by third-party payers ensued (31–35). Group delivery of DPP content in community or primary
care settings has demonstrated the potential to reduce overall program costs while still producing weight loss and dia-betes risk reduction (36–40).
The Centers for Disease Control and Prevention (CDC) developed the National Diabetes Prevention Program (National DPP), a resource designed to bring such evidence-based lifestyle change programs for preventing type 2 diabetes to commu-nities (www.cdc.gov/diabetes/prevention/
index.htm). This online resource includes locations of CDC-recognized diabetes pre-vention lifestyle change programs (avail-able at www.cdc.gov/diabetes/prevention/
find-a-program.html). To be eligible for this program, patients must have a BMI in the overweight range and be at risk for diabe-tes based on laboratory diabe-testing, a previous diagnosis of GDM, or a positive risk test (available at www.cdc.gov/prediabetes/
takethetest/). Results from the CDC’s National DPP during the first 4 years of implementation are promising and dem-onstrate cost-efficacy (41). The CDC has also developed the Diabetes Prevention Impact Tool Kit (available at nccd.cdc.gov/
toolkit/diabetesimpact) to help organiza-tions assess the economics of providing or covering the National DPP lifestyle change program (42). In an effort to expand preventive services using a cost-effective model that began in April 2018, the Centers for Medicare & Medicaid Services expanded Medicare reimburse-ment coverage for the National DPP lifestyle intervention to organizations recognized by the CDC that become Medicare suppliers for this service (at innovation.cms.gov/innovation-models/
medicare-diabetes-prevention-program).
The locations of Medicare DPPs are available online at innovation.cms.gov/
innovation-models/medicare-diabetes-prevention-program/mdpp-map. To qual-ify for Medicare coverage, patients must have BMI >25 kg/m2(or BMI>23 kg/m2 if self-identified as Asian) and laboratory testing consistent with prediabetes in the last year. Medicaid coverage of the DPP lifestyle intervention is also expanding on a state-by-state basis.
While CDC-recognized behavioral coun-seling programs, including Medicare DPP services, have met minimum qual-ity standards and are reimbursed by many payers, there have been lower retention rates reported for younger adults and racial/ethnic minority popu-lations (43). Therefore, other programs
and modalities of behavioral counseling for diabetes prevention may also be appropriate and efficacious based on patient preferences and availability. The use of community health workers to support DPP efforts has been shown to be effective and cost-effective (44,45) (see Section 1,“Improving Care and Promot-ing Health in Populations,” https://doi .org/10.2337/dc22-S001, for more infor-mation). The use of community health workers may facilitate adoption of behav-ior changes for diabetes prevention while bridging barriers related to social determi-nants of health, though coverage by third-party payers remains problematic.
Counseling by registered dietitians/regis-tered dietitian nutritionists (RDNs) has been shown to help individuals with pre-diabetes improve eating habits, increase physical activity, and achieve 7–10%
weight loss (10,46–48). Individualized medical nutrition therapy (see Section 5,
“Facilitating Behavior Change and Well-being to Improve Health Outcomes,” https://doi.org/10.2337/dc22-S005, for more detailed information) is also effec-tive in improving glycemia in individuals diagnosed with prediabetes (23,46). Fur-thermore, trials involving medical nutri-tion therapy for patients with prediabetes found significant reductions in weight, waist circumference, and glycemia. Indi-viduals with prediabetes can benefit from referral to an RDN for individualized medi-cal nutrition therapy upon diagnosis and at regular intervals throughout their treat-ment regimen (48,49). Other allied health professionals, such as pharmacists and diabetes care and education specialists, may be considered for diabetes preven-tion efforts (50,51).
Technology-assisted programs may effectively deliver the DPP program (52–57). Such technology-assisted pro-grams may deliver content through smartphone, web-based applications, and telehealth and may be an accept-able and efficacious option to bridge barriers, particularly for low-income and rural patients; however, not all pro-grams are effective in helping people reach targets for diabetes prevention (52,58–60). The CDC Diabetes Prevention Recognition Program (DPRP) (www.cdc.
gov/diabetes/prevention/requirements-recognition.htm) certifies technology-assisted modalities as effective vehicles for DPP-based programs; such programs must use an approved curriculum,
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include interaction with a coach, and attain the DPP outcomes of participation, physical activity reporting, and weight loss. Therefore, providers should con-sider referring patients with prediabetes to certified technology-assisted DPP pro-grams based on patient preference.
PHARMACOLOGIC INTERVENTIONS
Recommendations
3.6 Metformin therapy for preven-tion of type 2 diabetes should be considered in adults with prediabetes, as typified by the Diabetes Prevention Program, especially those aged 25–59 years with BMI $35 kg/m2, higher fasting plasma glucose (e.g., $110 mg/dL), and higher A1C (e.g., $6.0%), and in women with prior gestational diabetes mellitus.A
3.7 Long-term use of metformin may be associated with bio-chemical vitamin B12 de fi-ciency; consider periodic mea-surement of vitamin B12 levels in metformin-treated patients, especially in those with anemia or peripheral neuropathy.B
Because weight loss through behavior changes in diet and exercise alone can be difficult to maintain long term (6), people being treated with weight loss therapy may benefit from support and additional pharmacotherapeutic options, if needed. Various pharmacologic agents used to treat diabetes have been evalu-ated for diabetes prevention. Metformin, a-glucosidase inhibitors, liraglutide, thia-zolidinediones, testosterone (61), and insulin have been shown to lower the incidence of diabetes in specific popula-tions (62–67), whereas diabetes preven-tion was not seen with nateglinide (68).
In addition, several weight loss medica-tions like orlistat and phentermine topiramate have also been shown in research studies to decrease the inci-dence of diabetes to various degrees in those with prediabetes (69,70). Studies of other pharmacologic agents have shown some efficacy in diabetes preven-tion with valsartan but no efficacy in pre-venting diabetes with ramipril or anti-inflammatory drugs (71–74). Although
the Vitamin D and Type 2 Diabetes (D2d) prospective randomized controlled trial showed no significant benefit of vitamin D versus placebo on the progression to type 2 diabetes in individuals at high risk (75), post hoc analyses and meta-analy-ses suggest a potential benefit in specific populations (75–78). Further research is needed to define patient characteristics and clinical indicators where vitamin D supplementation may be of benefit (61).
No pharmacologic agent has been approved by the U.S. Food and Drug Administration specifically for diabetes prevention. The risk versus benefit of each medication must be weighed. Met-formin has the strongest evidence base (1) and demonstrated long-term safety as pharmacologic therapy for diabetes prevention (79). For other drugs, cost, side effects, treatment goals, and dura-ble efficacy require consideration.
Metformin was overall less effective than lifestyle modification in the DPP, though group differences declined over time in the DPPOS (7), and metformin may be cost-saving over a 10-year period (33). During initial follow-up in the DPP, metformin was as effective as lifestyle modification in participants with BMI $35 kg/m2 and in younger participants aged 25–44 years (1). In the DPP, for women with a history of GDM, metformin and intensive lifestyle modification led to an equivalent 50%
reduction in diabetes risk (80), and both interventions remained highly effective during a 10-year follow-up period (81).
By the time of the 15-year follow-up (DPPOS), exploratory analyses demon-strated that participants with a higher baseline fasting glucose ($110 mg/dL vs. 95–109 mg/dL), those with a higher A1C (6.0–6.4% vs. <6.0%), and women with a history of GDM (vs. women with-out a history of GDM) experienced higher risk reductions with metformin, identifying subgroups of participants that benefitted the most from metfor-min (82). In the Indian Diabetes Preven-tion Program (IDPP-1), metformin and the lifestyle intervention reduced diabe-tes risk similarly at 30 months; of note, the lifestyle intervention in IDPP-1 was less intensive than that in the DPP (83).
Based onfindings from the DPP, metfor-min should be recommended as an option for high-risk individuals (e.g., those with a history of GDM or those with BMI $35 kg/m2). Consider
periodic monitoring of vitamin B12 lev-els in those taking metformin chroni-cally to check for possible deficiency (84,85) (see Section 9, “Pharmacologic Approaches to Glycemic Treatment,” https://doi.org/10.2337/dc22-S009, for more details).
PREVENTION OF VASCULAR DISEASE AND MORTALITY
Recommendation
3.8 Prediabetes is associated with heightened cardiovascular risk;
therefore, screening for and treatment of modifiable risk fac-tors for cardiovascular disease are suggested.B
People with prediabetes often have other cardiovascular risk factors, includ-ing hypertension and dyslipidemia (86), and are at increased risk for cardiovascu-lar disease (87,88). Evaluation for tobacco use and referral for tobacco cessation, if indicated, should be part of routine care for those at risk for diabetes. Of note, the years immediately following smoking ces-sation may represent a time of increased risk for diabetes (89–91), a time when patients should be monitored for diabe-tes development and receive the concur-rent evidence-based lifestyle behavior change for diabetes prevention described in this section. See Section 5,“Facilitating Behavior Change and Well-being to Improve Health Outcomes” (https://doi .org/10.2337/dc22-S005), for more detailed information. The lifestyle inter-ventions for weight loss in study popula-tions at risk for type 2 diabetes have shown a reduction in cardiovascular risk factors and the need for medications used to treat these cardiovascular risk factors (92,93). In longer-term follow-up, lifestyle interventions for diabetes preven-tion also prevented the development of microvascular complications among women enrolled in the DPPOS and in the study population enrolled in the China Da Qing Diabetes Prevention Outcome Study (7,94). The lifestyle intervention in the latter study was also efficacious in pre-venting cardiovascular disease and mor-tality at 23 and 30 years of follow-up (3,5). Treatment goals and therapies for hypertension and dyslipidemia in the primary prevention of cardiovascular dis-ease for people with prediabetes should
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be based on their level of cardiovascular risk, and increased vigilance is warranted to identify and treat these and other car-diovascular risk factors (95).
PATIENT-CENTERED CARE GOALS Recommendation
3.9 In adults with overweight/obe-sity at high risk of type 2 diabe-tes, care goals should include weight loss or prevention of weight gain, minimizing progres-sion of hyperglycemia, and atten-tion to cardiovascular risk and associated comorbidites.B
Individualized risk/benefit should be considered in screening, intervention, and monitoring for the prevention or delay of type 2 diabetes and associated comorbidities. Multiple factors, includ-ing age, BMI, and other comorbidities, may influence risk of progression to dia-betes and lifetime risk of complications (96,97). In the DPP, which enrolled high-risk individuals with impaired glucose tolerance, elevated fasting glucose, and elevated BMI, the crude incidence of diabetes within the placebo arm was 11.0 cases per 100 person-years, with a cumulative 3-year incidence of diabetes of 28.9% (1). In the community-based Atherosclerosis Risk in Communities (ARIC) study, observational follow-up of older adults (mean age 75 years) with laboratory evidence of prediabetes (based on A1C 5.7–6.4% and/or fasting glucose 100–125 mg/dL) but not meeting specific BMI criteria found much lower progression to diabetes over 6 years:
9% of those with A1C-defined prediabe-tes, 8% with impaired fasting glucose (97).
Thus, it is important to individualize the risk/benefit of intervention and con-sider person-centered goals. Risk mod-els have explored risk-based benefit, in general finding higher benefit of inter-vention in those at highest risk (9). Dia-betes prevention and observational studies highlight several key principles, which may guide patient-centered goals.
In the DPP, which enrolled a high-risk population meeting criteria for over-weight/obesity, weight loss was an important mediator of diabetes preven-tion or delay, with greater metabolic benefit generally seen with greater
weight loss (9,98). In the DPP/DPPOS, progression to diabetes, duration of dia-betes, and mean level of glycemia were important determinants of development of microvascular complications (7). Fur-thermore, ability to achieve normal glu-cose regulation, even once, during the DPP was associated with a lower risk of diabetes and lower risk of microvascular complications (99). Observational follow up of the Da Qing study also showed that regression from impaired glucose tolerance to normal glucose tolerance or remaining with impaired glucose tol-erance rather than progressing to type 2 diabetes at the end of the 6-year intervention trial resulted in significantly lower risk of cardiovascular disease and microvascular disease over 30 years (100). Prediabetes is associated with increased cardiovascular disease and mortality (88), emphasizing the impor-tance of attending to cardiovascular risk in this population.
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