Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

We are interested in the comparative effectiveness of diabetes control/management strategies in the prevention of CKD. To evaluate this area, optimal glycemic targets first need to be established in the context of preventing CKD, a well-known complication of diabetes. Pharmacologic and/or non-pharmacologic strategies could be compared for effectiveness in achieving glycemic targets and preventing CKD. Behavioral/non-pharmacologic (dietary/weight control/exercise) strategies to prevent diabetes could be compared, although directly linking this to the prevention of CKD will be limited. However, establishing the most effective strategies to prevent diabetes has obvious relevance to preventing CKD.

• What is the optimal level of glycemic control (i.e. HgA1c, blood glucose level) in patients with diabetes to prevent CKD?
• Which pharmacologic agent/combination is most effective in lowering the incidence of CKD if the same glycemic target is achieved?
• What is the comparative effectiveness of dietary strategies/exercise/patient education/patient knowledge in preventing CKD in diabetic patients by achieving glycemic targets? [Strategies can be compared within category, across category, or with pharmacologic therapy; strategies could also examine primary outcome of preventing diabetes, rather than CKD-see Description].

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

• Comparison of different levels of glycemic control for lowering incidence of CKD in diabetic patients
• Comparison of different pharmacologic agents/combination for lowering incidence of CKD in diabetic patients
• Comparison of different dietary strategies/exercise/patient education/patient knowledge in preventing CKD in diabetic patients by achieving glycemic targets

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

Adult patients with type II diabetes mellitus

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

We are especially interested in subgroups with higher than normal rates of diabetes and CKD, such as African-Americans and obese middle-aged and elderly adults.

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

We are primarily interested in the prevention of CKD. Secondarily we are interested in glycemic control for mediation of the progression of CKD, and also in mediating complications associated with CKD.

Describe any health-related risks, side effects, or harms that you are concerned about.

We are interested in the usual risks, side effects, or harms associated with glycemic control pharmacologic agents, such as hypoglycemic events. We are also interested in any unique harms caused by interactions of interventions for glycemic control with other interventions for control of CKD.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Diabetes mellitus

AHRQ Priority Populations

• Low income groups
• Minority groups
• Elderly

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

Forty-seven percent of CKD patients are diabetic. Both CKD and diabetes are associated with hypertension and obesity. It is of interest to know the extent to which control of diabetes can prevent the onset and progression of CKD.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

This topic was identified in our AHRQ/EHC sponsored topic identification project. Among a large number of CKD topics, a group of stakeholders ranked this as a high priority topic.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

While it is generally believed that diabetes is related to the onset of CKD, the extent to which this is the case and the nature of the relationship are not well understood. It is also not clear if treatment of diabetes has special requirements for CKD patients, and vice versus.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

Answers to the above questions would help inform practice and guidelines for both diabetes and CKD.

Describe the timeframe in which an answer to your question is needed.

We would like to see this in a Topic Development & Triage project very soon.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Both diabetes and CKD are more prevalent among African-Americans, Hispanic-Americans, low income groups, the obese population, and the elderly.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

Answers to the above questions would help inform practice and guidelines for both diabetes and CKD.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program

We are an AHRQ/AHC EPC