Scope of Work

Update 2010-2011

Diabetes and Chronic Kidney Disease
Clinical Practice Guidelines and Clinical Practice Recommendations

Led by: Katherine R. Tuttle, MD and Robert G. Nelson, MD, PhD
Click here to see the entire Work Group roster
May 17, 2010

Intent:

The intent of this update to the KDOQI Diabetes and Chronic Kidney Disease Clinical Practice Guidelines and Clinical Practice Recommendations is to perform an evidence-based review of topics that may have been meaningfully impacted by clinical trials and other relevant research published since the original Guidelines were produced (2003-2007). The update will also include evaluation of other clinical practice guidelines or government educational programs that overlap in scope. As such, the Work Group was constituted to include representation from the following organizations: American Diabetes Association, American Association of Clinical Endocrinologists, National Diabetes Education Program, and National Kidney Disease Education Program. Additionally, this Work Group will work collaboratively with the KDIGO Clinical Practice Guideline on Blood Pressure in CKD Work Group, which is also performing an update, to achieve harmonization and avoid redundancy in areas of potential overlap.

The evaluation and management of patients with diabetes and chronic kidney disease (CKD), whether due to diabetes or other causes, remains the focus of the updated version. The evidence review will include CKD stages 1-5 as well as prevention of diabetic kidney disease (DKD).The specific focal points of the update are the statements in Guidelines 2 and 4 and Clinical Practice Recommendation 1, as the recent clinical trials and other relevant research are concentrated on these topics.

Although statements in Guidelines 1 and 3 and Clinical Practice Recommendations 2, 3, and 4 are not intended to be modified as part of this update, review of the literature to address the key questions (KQ) may prompt the Work Group to modify its assessment of the background information, rationale, and limitations of these topics as well. For example, recent evidence that will be reviewed under KQ 7 may provide a quantitative basis for encouraging the combined use of albuminuria and estimated glomerular filtration rate for CKD definition, staging and risk stratification. It may also highlight the prognostic value of early renal function decline among diabetic patients with microalbuminuria. These are issues relevant to both Clinical Practice Recommendation 1 and Guideline 1.

Key questions for systematic literature review:

1. Management of Hyperglycemia (Guideline 2)
   • KQ 1: In patients with diabetes (type 1 or 2), with or without CKD, what evidence is there that specific glycemic treatment targets (defined as goals for hemoglobin A1c) prevent initiation or improve intermediate or clinical endpoint outcomes?
   • KQ 2: What harms result from more intensive glycemic control in individuals with diabetes (type 1 or 2)?
2. Management of Dyslipidemia (Guideline 4)
   • KQ3: In patients with diabetes (type 1 or 2), with or without CKD, what evidence is there that specific treatment targets (defined as goals for total, LDL, and HDL cholesterol, and triglycerides) improve intermediate or clinical endpoint outcomes?
   • KQ4: Is there evidence for specific lipid-lowering agent use in patients with diabetes (type 1 or 2) and chronic kidney disease?
   • KQ5: What harms result from more intensive lipid treatment targets or use of specific lipid-lowering agents in individuals with diabetes (type 1 or 2) and CKD?
3. Management of Albuminuria in Normotensive Diabetic Patients with or without Chronic Kidney Disease (Clinical Practice Recommendation 1)
• KQ6: What interventions prevent incident albuminuria and/or progression of albuminuria in diabetic patients for whom further reduction in blood pressure is not the specific treatment objective?
• KQ7: Is albuminuria a valid surrogate for clinical outcomes in diabetes?

Criteria for study inclusion in evidence review

• Human studies.
• Studies involving management of glycemia, lipids, or albuminuria in populations with type 1 or 2 diabetes with or without CKD.
• Studies that assigned participants to different interventions (i.e., intensive glycemic control vs. usual care/placebo).
• Studies that measured outcomes or harms of interest (i.e., cardiovascular, kidney).
• Treatment duration of at least 12 months.
• Observational studies may be considered if relevant to key questions.