Table 1.
Decision criteria outcomes
| Outcome | Definition | Data Source for Baseline Rate | Data Source for Treatment effects |
|---|---|---|---|
| Myocardial infarction | Fatal or non-fatal myocardial infarction | Validated risk equations (RECODe)15 (Appendix Text 1) |
Network meta-analysis 22 |
| Stroke | Fatal or non-fatal, and hemorrhagic or ischemic stroke | Validated risk equations (RECODe)15 (Appendix Text 1) |
Network meta-analysis 22 |
| Nephropathy | Renal failure/end-stage renal disease | Validated risk equations (RECODe)15(Appendix Text 1) |
Network meta-analysis 22 |
| Retinopathy | Severe vision loss defined as <20/200 visual acuity by Snellen chart | Validated risk equations (RECODe)15 (Appendix Text 1) |
Network meta-analysis 22 |
| Neuropathy | Pressure sensation loss on 10g monofilament testing | Validated risk equations (RECODe)15 (Appendix Text 1) |
Network meta-analysis 22 |
| HbA1c reduction | Hemoglobin A1c (absolute percentage points) | NHANES 2003-2014 52 | Network meta-analysis 22 |
| Whether or not medication is injected | Parenteral drug administration | - | American Diabetes Association28 |
| Body weight change | Body weight gain or loss (in kilograms) | NHANES 2003-2014 52 | Network meta-analysis 22 |
| Daily glucose monitoring | Recommended times per week for glucose self-monitoring | - | American Diabetes Association21 |
| Cost | Medication cost (defined in 2017 U.S. Dollars based on average standardized out-of-pocket price to consumers in the United States) | - | CMS53 |
| Serious treatment-related adverse events other than hypoglycemia | Side effects from medication, including severe nausea, fluid retention (edema), diarrhea, amputation, or rash that were fatal or life-threatening, that resulted in clinically significant or persistent disability, that required or prolonged a hospitalization, or that were judged by the trial investigator to represent a clinically significant hazard or harm | ACCORD24 | Network meta-analysis 22 |
| Hypoglycemia | Low blood glucose | Risk calculation based on age and hemoglobin A1c, using data from U.S. CDC23 (Appendix Table 2) | Network meta-analysis 22 |
ACCORD: Action to Control Cardiovascular Disease Risk in Diabetes; CDC: Centers for Disease Prevention and Control; RECODe: Risk Equations for Complications of Type 2 Diabetes; NHANES: National Health and Nutrition Examination Survey; CMS: Centers for Medicare & Medicaid Service