OBJECTIVE: Patient-interactive, real-time continuous glucose monitors (RTCGMs) represent the future of diabetes management and have the potential to improve health outcomes and reduce diabetes-related complications. This assessment will evaluate the net health outcomes obtained in patients with insulin-dependent diabetes while using RTCGMs such as the FreeStyle Navigator™ (NAV), GlucoDay® S (DAY), Guardian® RT (GRT), DexCom™ STS™ and Long-Term Systems (DEX) and GlucoWatch® Biographer G2™ (GWG2), in comparison to standard self-monitoring of blood glucose. METHODS: Medline MeSH heading searches of the published peer-reviewed clinical literature identified all relevant studies since 2001. Technologies were evaluated based on their ability to provide clinically accurate glucose readings and improve glycemic control and overall health outcomes. RESULTS: The available data surrounding these devices is limited at this time because only GWG2 and GRT are currently FDA approved. GWG2 demonstrated less than adequate accuracy and a high false-positive rate (50-73%). DAY, GRT and DEX demonstrated acceptable overall accuracy in Clarke Error Grid studies (>95% zones A+B), however NAV is the most accurate of the RTCGMs (99% overall, 92.4% during hypoglycemia). Significant data surrounding the effects of DAY, DEX and NAV on glycemic control was not found, however GWG2 was shown to have no positive, and perhaps a negative, effect on glycemic control. Limited evidence with GRT revealed a decrease in the frequency and duration of hypo- and hyperglycemic excursions. GWG2 which reported excessive skin irritation in up to 76% of patients, often requiring discontinuation of use, however the other RTCGMs displayed no significant adverse event occurrence. CONCLUSION: Given the limited evidence presented in this assessment and based on its design and preliminary clinical data, it appears that NAV is the most favorable of the RTCGMs. Fulfillment of customary health technology assessment criteria will require FDA approval and additional data documenting successful implementation.