OBJECTIVE: This study assessed the clinical impact of four treatment strategies in adults with type 1 diabetes (T1D): real-time continuous glucose monitoring (rtCGM) with multiple daily insulin injections (rtCGM+MDI), rtCGM with continuous subcutaneous insulin infusion (rtCGM+CSII), self-monitoring of blood glucose with MDI (SMBG+MDI), and SMBG with CSII (SMBG+CSII).
RESEARCH DESIGN AND METHODS: This 3-year, nonrandomized, prospective, real-world, clinical trial followed 94 participants with T1D (rtCGM+MDI,= 22; rtCGM+CSII,= 26; SMBG+MDI,= 21; SMBG+CSII,= 25). The main end points were changes in A1C, time in range (70-180 mg/dL [3.9-10 mmol/L]), time below range (<70 mg/dL [<3.9 mmol/L]), glycemic variability, and incidence of hypoglycemia. n n n n
RESULTS: At 3 years, the rtCGM groups (rtCGM+MDI and rtCGM+CSII) had significantly lower A1C (7.0% [53 mmol/mol],= 0.0002, and 6.9% [52 mmol/mol],< 0.0001, respectively), compared with the SMBG+CSII and SMBG+MDI groups (7.7% [61 mmol/mol],= 0.3574, and 8.0% [64 mmol/mol],= 1.000, respectively), with no significant difference between the rtCGM groups. Significant improvements in percentage of time in range were observed in the rtCGM subgroups (rtCGM+MDI, 48.7-69.0%,< 0.0001; and rtCGM+CSII, 50.9-72.3%,< 0.0001) and in the SMBG+CSII group (50.6-57.8%,= 0.0114). Significant reductions in time below range were found only in the rtCGM subgroups (rtCGM+MDI, 9.4-5.5%,= 0.0387; and rtCGM+CSII, 9.0-5.3%,= 0.0235). Seven severe hypoglycemia episodes occurred: SMBG groups,= 5; sensor-augmented insulin regimen groups,= 2. P P P P P P P P P n n
CONCLUSIONS: rtCGM was superior to SMBG in reducing A1C, hypoglycemia, and other end points in individuals with T1D regardless of their insulin delivery method. rtCGM+MDI can be considered an equivalent but lower-cost alternative to sensor-augmented insulin pump therapy and superior to treatment with SMBG+MDI or SMBG+CSII therapy.
