Abstract: |
OBJECTIVE: CeQur SimplicityTM (CeQur, Marlborough, MA) is a 3-day insulin delivery patch designed to meet mealtime insulin requirements. A recently reported 48-week, randomized, multicenter, interventional trial compared efficacy, safety and self-reported outcomes in 278 adults with type 2 diabetes (T2D) on basal insulin therapy who initiated and managed mealtime insulin therapy with a patch pump versus insulin pen. We assessed changes in key glycemic metrics among a subset of patients who wore a continuous glucose monitoring (CGM) device. METHODS: Study participants (patch, = 49; pen, = 48) wore a CGM device in masked setting during the baseline period and prior to week 24. Glycemic control was assessed using international consensus guidelines for percentage of Time In Range (%TIR: >70% at 70-180?mg/dL), Time Below Range (%TBR: 4% at 70?mg/dL; 1% at 54?mg/dL), and Time Above Range (%TAR: 25% at >180?mg/dL; 5% at >250?mg/dL). RESULTS: Both the patch and pen groups achieved recommended targets in %TIR (74.1%?±?18.7%, 75.2?±?16.1%, respectively) and marked reductions in %TAR >180?mg/dL (21.1%?±?19.9%, 19.7%?±?17.5%, respectively) but with increased %TBR 70?mg/dL (4.7%?±?5.2%, 5.1?±?5.8, respectively), all .0001. No significant between-group differences in glycemic improvements or adverse events were observed. CONCLUSIONS: CGM confirmed that the patch or pen can be used to safely initiate and optimize basal-bolus therapy using a simple insulin adjustment algorithm with SMBG. Preference data suggest that use of the patch vs pen may enhance treatment adherence. |