Draft Research Plan
Type 2 Diabetes Mellitus in Children and Adolescents: Screening
July 30, 2020
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* Eligible interventions include pharmacotherapy and primary care–relevant counseling focused on healthy diet and nutrition, physical activity, or both, as detailed in the Research Approach below.
1. a. Is there direct evidence that screening for type 2 diabetes mellitus (T2DM) and prediabetes in asymptomatic children and adolescents improves health outcomes?
b. Does the effectiveness of screening differ for subgroups defined by age, sex, race/ethnicity, or body mass index (BMI)?
2. a. What are the harms of screening for T2DM and prediabetes in asymptomatic children and adolescents?
b. Do the harms of screening differ for subgroups defined by age, sex, race/ethnicity, or BMI?
3. a. Do interventions for screen-detected T2DM and prediabetes provide an incremental benefit in health outcomes when delivered at the time of detection compared with initiating interventions later, after clinical diagnosis?
b. Do interventions for screen-detected T2DM and prediabetes improve health outcomes compared with no intervention, usual care, or interventions with different treatment targets?
c. Do interventions for recently diagnosed T2DM improve health outcomes compared with no intervention, usual care, or interventions with different treatment targets?
d. Does the effectiveness of these interventions differ for subgroups defined by age, sex, race/ethnicity, or BMI?
4. What are the harms of interventions for prediabetes, screen-detected T2DM, or recently diagnosed T2DM?
5. a. Do interventions for prediabetes delay or prevent progression to T2DM?
b. Does the effectiveness of these interventions differ for subgroups defined by age, sex, race/ethnicity, or BMI?
6. After interventions for prediabetes are provided, what is the magnitude of change in health outcomes that results from the reduction in T2DM incidence?
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
1. a. What percentage of children and adolescents with prediabetes progress to T2DM, remain prediabetic, or return to normal glycemia or glucose tolerance (without intervention), and over what time frame?
b. What percentage of children and adolescents with T2DM return to normal glycemia or glucose tolerance or to the prediabetes range (without intervention), and over what time frame?
c. How does this differ by baseline A1c level?
2. a. Does screening for prediabetes or T2DM change the intermediate outcomes of hemoglobin A1c, fasting plasma glucose, or 2-hour glucose tolerance test results for children and adolescents?
b. Do interventions for children and adolescents with screen-detected or recently diagnosed T2DM or prediabetes change the intermediate outcomes of hemoglobin A1c, fasting plasma glucose, or 2-hour glucose tolerance test results?
3. a. Do interventions for (or does knowledge of) prediabetes change BMI, weight, or healthy behaviors?
b. Do interventions for (or does knowledge of) T2DM change BMI, weight, or healthy behaviors?
4. What is the frequency of agreement among screening tests (hemoglobin A1c, fasting plasma glucose, and 2-hour glucose tolerance) for prediabetes and T2DM?
5. Are there risk assessment tools that are feasible for use in primary care settings, accurately predict the risk of prediabetes or T2DM for children and adolescents, and have been externally validated in U.S. populations?
The Proposed Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions.
|Populations||All KQs: Studies of participants without obvious symptoms of diabetes (e.g., for KQ 1, studies of unselected populations that may include some participants with unrecognized symptoms of diabetes such as fatigue); nonpregnant women with a history of gestational diabetes (if they are >1 year postpartum); studies that substantially overlap this age range (e.g., ages 14–65 years) will be included if results for younger participants are reported separately. At least 50% of the study population must meet the review eligibility criteria or results must be reported separately for the population eligible for the review.
KQs 1, 2: Asymptomatic, nonpregnant children and adolescents
KQs 3, 4: Asymptomatic, nonpregnant children and adolescents with screen-detected prediabetes or T2DM (KQs 3a and 3b) or with recently diagnosed T2DM (KQ 3c)KQs 5, 6: Asymptomatic, nonpregnant children and adolescents with screen-detected prediabetes
|All KQs: Studies limited to or predominately comprising adults or pregnant women; persons with symptomatic prediabetes or T2DM (e.g., weight loss, polyuria, blurred vision, headache); persons with a recent hospitalization; persons taking antipsychotics or glucocorticoids; persons with known cardiovascular disease or severe chronic kidney disease; persons living in an institution; other persons with medical conditions limiting their applicability to primary care–based populations (e.g., those with acute illness)
KQ 3c: Studies limited to or predominately comprised of persons who have had diabetes for more than 1 year or with more advanced diabetes (e.g., persons already taking insulin or other medications; persons with proliferative retinopathy, nephropathy)
|Screening||KQs 1, 2: Screening (targeted or universal) for prediabetes* or diabetes; tests include hemoglobin A1c, FPG, and the OGTT||All other tests, such as genetic testing for the risk of prediabetes or diabetes or testing for autoantibodies, which may be used for further evaluation after a diabetes diagnosis (e.g., to assess for type 1 or type 2 diabetes)|
|Interventions||KQs 3–6: Primary care–relevant behavioral counseling or pharmacotherapy interventions for glycemic control.
Behavioral counseling interventions can be provided alone or as part of a larger multicomponent intervention on diet and nutrition, physical activity, sedentary behavior, or a combination thereof, including but not limited to assessment with feedback, advice, collaborative goal setting, assistance, exercise prescriptions (referral to exercise facility or program), or arrangement of further contacts.
Interventions may be delivered via face-to-face contact, telephone, print materials, or technology (e.g., computer-based, text messages, remote video feed) and can be delivered by a number of potential interventionists, including but not limited to clinicians, nurses, exercise specialists, dietitians, nutritionists, and behavioral health specialists.
Dietary counseling may involve:
Physical activity counseling may involve:
|Comparisons||KQs 1, 2: No screening or alternative screening strategies
KQ 3a: Comparison based on timing; sooner vs. later intervention (i.e., starting intervention upon detection by screening vs. starting later based on clinical diagnosis); clinical diagnosis refers to any approach based on development of symptoms (e.g., polyuria, polydipsia, paresthesia) or monitoring of biomarkers (e.g., increase in hemoglobin A1c level above a certain threshold)
KQs 3b, 3c: No intervention, placebo, usual care (can include minimal intervention), different treatment targets (e.g., glucose or blood pressure targets), waitlist, or attention control (for lifestyle interventions)
KQ 4: All comparisons eligible for KQ 3KQs 5, 6: Sooner vs. later intervention, no intervention, placebo, usual care, waitlist, or attention control (for lifestyle interventions)
|Comparative effectiveness (head-to-head) trials of medications or behavioral counseling without another eligible control group|
|Outcomes||KQs 1, 3, 6: Mortality, cardiovascular morbidity (including myocardial infarction, stroke, congestive heart failure), chronic kidney disease, amputation, skin ulcers, visual impairment (including blindness), periodontitis (including tooth loss), moderate to severe neuropathy, and quality of life
KQ 2: Labeling, anxiety, harms from false-positive results, burden, inconvenience, depression, and unnecessary testing and treatment
KQ 4: Serious side effects from treatment, including gastrointestinal side effects, mortality, myocardial infarction, stroke, cancer, and hypoglycemic events requiring medical
|KQs 1, 3, 5, 6: Studies with less than 6 months of followup|
|Study Designs||All KQs: Controlled clinical trials
KQs 2, 4: Controlled prospective cohort studies and case-control studies are also eligibleKQ 6: Controlled prospective cohort studies are also eligible
|Modeling studies, systematic reviews,† case series, case reports, uncontrolled observational studies, retrospective cohort studies, editorials, and all other study designs not mentioned|
|Settings||Studies conducted in or recruited from primary care settings or settings otherwise applicable to primary care (i.e., screening/interventions that could feasibly be implemented in or referred from primary care)||Settings not generalizable to primary care (e.g., inpatient hospital units, emergency departments, nursing home and other institutional settings, school-based programs, occupational settings)|
|Countries||Studies conducted in countries categorized as “Very High” on the 2019 Human Development Index (as defined by the United Nations Development Programme)||Studies conducted in countries that are categorized as lower than “Very High” on the 2019 Human Development Index|
|Language||English||Languages other than English|
|Study Quality||Good or fair||Poor (according to design-specific USPSTF criteria)|
* Prediabetes includes individuals who meet criteria for IFG or IGT, and those with an A1c level from 5.7% to 6.4%.
† Systematic reviews will be excluded from the evidence review. However, separate searches will be conducted to identify relevant systematic reviews, and the citations of all studies included in those systematic reviews will be reviewed to ensure that the database searches have captured all relevant primary studies.
Abbreviations: A1c=glycated hemoglobin; FPG=fasting plasma glucose; IFG=impaired fasting glucose; IGT=impaired glucose tolerance; KQ=key question; OGTT=oral glucose tolerance test; T2DM=type 2 diabetes mellitus; USPSTF=U.S. Preventive Services Task Force.