000			03643nam a22004817a 4500
008			190521s20192019 xxu||||| |||| 00| 0 eng d
022			_a1520-9156
024			_a10.1089/dia.2018.0298 [doi]
040			_aOvid MEDLINE(R)
099			_a31025878
245			_aImplementation of Basal-Bolus Therapy in Type 2 Diabetes: A Randomized Controlled Trial Comparing Bolus Insulin Delivery Using an Insulin Patch with an Insulin Pen.
251			_aDiabetes Technology & Therapeutics. 21(5):273-285, 2019 May.
252			_aDiabetes Technol Ther. 21(5):273-285, 2019 May.
253			_aDiabetes technology & therapeutics
260			_c2019
260			_fFY2019
265			_sppublish
266			_d2019-05-21
520			_a<b>Background:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusions:</b> 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.
546			_aEnglish
650			_a*Diabetes Mellitus, Type 2/dt [Drug Therapy]
650			_a*Hypoglycemic Agents/ad [Administration & Dosage]
650			_a*Insulin Infusion Systems
650			_a*Insulin/ad [Administration & Dosage]
650			_aAged
650			_aBlood Glucose
650			_aDiabetes Mellitus, Type 2/bl [Blood]
650			_aFemale
650			_aHumans
650			_aHypoglycemic Agents/tu [Therapeutic Use]
650			_aInjections, Intramuscular
650			_aInsulin/tu [Therapeutic Use]
650			_aMale
650			_aMeals
650			_aMiddle Aged
650			_aTreatment Outcome
651			_aMedStar Health Research Institute
657			_aJournal Article
700			_aAroda, Vanita R
790			_aAroda VR, Bailey TS, Bergenstal RM, Brazg RL, Calibra Study Group, Dreon DM, Frias JP, Johnson ML, Klonoff DC, Kruger DF, Levy BL, Naik RG, Peyrot M, Ramtoola S, Rosenstock J, Serusclat P, Shearer DM, Weinstock RS, Zraick V
856			_uhttps://dx.doi.org/10.1089/dia.2018.0298 _zhttps://dx.doi.org/10.1089/dia.2018.0298
942			_cART _dArticle
999			_c4252 _d4252