Richard M Bergenstal1, Mary L Johnson1, Vanita R Aroda2, Ronald L Brazg3, Darlene M Dreon4, Juan P Frias5, Davida F Kruger6, Mark E Molitch7, Deborah M Mullen1, Mark Peyrot8, Sara Richter9, Julio Rosenstock10, Pierre Serusclat11, Carl Vance12, Ruth S Weinstock13, Brian L Levy4. 1. International Diabetes Center, Park Nicollet, Minneapolis, MN, USA. 2. Medstar Health Research Institute, Hyattsville, MD, USA. 3. Rainier Clinical Research Center, Renton, WA, USA. 4. Calibra Medical, Johnson & Johnson Diabetes Care Companies, Wayne, PA, USA. 5. National Research Institute, Los Angeles, CA, USA. 6. Division of Endocrinology, Diabetes, Bone and Mineral Disease, Henry Ford Health System, Detroit, MI, USA. 7. Division of Endocrinology, Metabolism and Molecular Medicine at the Northwestern University Feinberg School of Medicine, Chicago, IL, USA. 8. Loyola University Maryland, Department of Sociology, Baltimore, MD, USA. 9. Professional Data Analysts, GBC, Minneapolis, MN, USA. 10. Dallas Diabetes Research Center at Medical City, Dallas, TX, USA. 11. Groupe Hospitalier Mutualiste Les Portes du Sud, Ve'nissieux, France. 12. Rocky Mountain Diabetes Center, Idaho Falls, Idaho, USA. 13. Department of Endocrinology, Diabetes and Metabolism, SUNY Upstate Medical University, Syracuse, NY, USA.
Abstract
OBJECTIVE: CeQur Simplicity™ (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, n = 49; pen, n = 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 P < .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.
OBJECTIVE: CeQur Simplicity™ (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, n = 49; pen, n = 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 P < .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.
Entities:
Keywords:
CGM; SMBG; T2D; TIR; algorithm; mealtime insulin; patch; time in range; type 2 diabetes
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