A stepwise approach for the addition of prandial insulin is recommended when intensification from basal to basal-bolus therapy is required. Rationale for this approach includes patient resistance to multiple daily injections and a stepwise approach has been associated with lower rates of hypoglycemia. Unfortunately, evidence suggests within a year of initiating prandial insulin, up to 75% of patients require full basal-bolus therapy. This results in the ongoing need to address the same barriers that initially delayed intensification to full basal-bolus therapy. In light of these considerations, insulin delivery options that simplify basal-bolus therapy while offering clinical benefit without increased safety risk may be an attractive option. This study retrospectively evaluated the use of a wearable basal-bolus insulin delivery device (V-Go) in 73 patients with type 2 diabetes inadequately controlled with basal insulin. Change in A1C, insulin basal and total daily doses (TDD) and prevalence of hypoglycemia were analyzed. Mean ± SD characteristics at baseline included duration of diabetes 12 ± 7 years, A1C 9.6 ± 1.5%, basal TDD 52 ± 34 u/day (range 10 to 170), and basal TDD 0.53 ± 0.35 u/kg. Concomitant anti-hyperglycemic agents were prescribed in 93% of patients. After a mean of 5 months of V-Go use, mean ± SD reductions in A1C (-1.3 ± 1.5%; p<0.0001) and basal TDD (-22 ± 30 u/day; p<0.0001 and -0.24 ± 0.31 u/kg; p<0.0001) were observed. Compared to baseline, TDD was similar on V-Go, 52 ± 18 u/day; p=0.946, however, insulin dose was redistributed to incorporate prandial coverage (22 ± 9 u/day) and basal coverage (30 ± 13 u/day). With V-Go use, severe hypoglycemia was reduced from 10% at baseline to 3% and fewer concomitant agents were prescribed. Intensification from basal insulin to basal-bolus therapy with V-Go was effective and resulted in a lower prevalence of hypoglycemia.
T. Zeidan: Advisory Panel; Self; Corcept Therapeutics. Research Support; Self; Valeritas, Inc. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Valeritas, Inc. C.C. Nikkel: Employee; Self; Valeritas, Inc. Stock/Shareholder; Self; Valeritas, Inc. E.A. Dziengelewski: Employee; Self; Valeritas, Inc. Stock/Shareholder; Self; Valeritas, Inc.