TY - JOUR
T1 - Implementation of Basal-Bolus Therapy in Type 2 Diabetes
T2 - A Randomized Controlled Trial Comparing Bolus Insulin Delivery Using an Insulin Patch with an Insulin Pen
AU - Calibra Study Group
AU - Bergenstal, Richard M.
AU - Peyrot, Mark
AU - Dreon, Darlene M.
AU - Aroda, Vanita R.
AU - Bailey, Timothy S.
AU - Brazg, Ronald L.
AU - Frias, Juan P.
AU - Johnson, Mary L.
AU - Klonoff, David C.
AU - Kruger, Davida F.
AU - Ramtoola, Shenaz
AU - Rosenstock, Julio
AU - Serusclat, Pierre
AU - Weinstock, Ruth S.
AU - Naik, Ramachandra G.
AU - Shearer, David M.
AU - Zraick, Vivien
AU - Levy, Brian L.
AU - McCrimmon, Rory
PY - 2019/5/7
Y1 - 2019/5/7
N2 - Background: Barriers to mealtime insulin include complexity, fear of injections, and lifestyle interference. This multicenter, randomized controlled trial evaluated efficacy, safety, and self-reported outcomes in adults with type 2 diabetes, inadequately controlled on basal insulin, initiating and managing mealtime insulin with a wearable patch versus an insulin pen.Methods: Adults with type 2 diabetes (n = 278, age: 59.2 ± 8.9 years), were randomized to patch (n = 139) versus pen (n = 139) for 48 weeks, with crossover at week 44. Baseline insulin was divided 1:1 basal: bolus. Using a pattern-control logbook, subjects adjusted basal and bolus insulin weekly using fasting and premeal glucose targets.Results: Glycated hemoglobin (HbA1c) change (least squares mean ± standard error) from baseline to week 24 (primary endpoint) improved (P < 0.0001) in both arms,-1.7% ± 0.1% and-1.6% ± 0.1% for patch and pen (-18.6 ± 1.1 and-17.5 ± 1.1 mmol/mol), and was maintained at 44 weeks. The coefficient of variation of 7-point self-monitoring blood glucose decreased more (P = 0.02) from baseline to week 44 for patch versus pen. There were no differences in adverse events, including hypoglycemia (three severe episodes per arm), and changes in weight and insulin doses. Subject-reported treatment satisfaction, quality of life, experience ratings at week 24, and device preferences at week 48 significantly favored the patch. Most health care providers preferred patch for mealtime insulin.Conclusions: Bolus insulin delivered by patch and pen using an algorithm-based weekly insulin dose titration significantly improved HbA1c in adults with type 2 diabetes, with improved subject and health care provider experience and preference for the patch.
AB - Background: Barriers to mealtime insulin include complexity, fear of injections, and lifestyle interference. This multicenter, randomized controlled trial evaluated efficacy, safety, and self-reported outcomes in adults with type 2 diabetes, inadequately controlled on basal insulin, initiating and managing mealtime insulin with a wearable patch versus an insulin pen.Methods: Adults with type 2 diabetes (n = 278, age: 59.2 ± 8.9 years), were randomized to patch (n = 139) versus pen (n = 139) for 48 weeks, with crossover at week 44. Baseline insulin was divided 1:1 basal: bolus. Using a pattern-control logbook, subjects adjusted basal and bolus insulin weekly using fasting and premeal glucose targets.Results: Glycated hemoglobin (HbA1c) change (least squares mean ± standard error) from baseline to week 24 (primary endpoint) improved (P < 0.0001) in both arms,-1.7% ± 0.1% and-1.6% ± 0.1% for patch and pen (-18.6 ± 1.1 and-17.5 ± 1.1 mmol/mol), and was maintained at 44 weeks. The coefficient of variation of 7-point self-monitoring blood glucose decreased more (P = 0.02) from baseline to week 44 for patch versus pen. There were no differences in adverse events, including hypoglycemia (three severe episodes per arm), and changes in weight and insulin doses. Subject-reported treatment satisfaction, quality of life, experience ratings at week 24, and device preferences at week 48 significantly favored the patch. Most health care providers preferred patch for mealtime insulin.Conclusions: Bolus insulin delivered by patch and pen using an algorithm-based weekly insulin dose titration significantly improved HbA1c in adults with type 2 diabetes, with improved subject and health care provider experience and preference for the patch.
KW - Mealtime insulin patch
KW - Type 2 diabetes
UR - http://www.scopus.com/inward/record.url?scp=85065517345&partnerID=8YFLogxK
U2 - 10.1089/dia.2018.0298
DO - 10.1089/dia.2018.0298
M3 - Article
C2 - 31025878
AN - SCOPUS:85065517345
SN - 1520-9156
VL - 21
SP - 273
EP - 285
JO - Diabetes Technology and Therapeutics
JF - Diabetes Technology and Therapeutics
IS - 5
ER -