996-P: A Randomized Study to Evaluate the Efficacy of Insulclock Pen Device in Insulin-Treated Patients with Uncontrolled Type 2 Diabetes

Abstract

Insulin pen devices have been reported to improve patient satisfaction and treatment adherence compared to the traditional vial/syringe. Insulclock® is a small electronic device plugged onto insulin pen to track information via Bluetooth to smart-phone technology on date, time and dosage of injections and with an alarm system to reduce insulin omissions. We performed a randomized, cross-over design study in patients with type 2 diabetes (T2D) on basal insulin to assess the efficacy and satisfaction of Insulclock device. Eighty T2D patients on basal insulin ± oral agents with HbA1c between 7.0% and 12.0% were randomized to a 12-week ’intervention’ phase receiving reminders or to a 12-week ’control’ phase with device without feedback. Basal insulin was titrated every 2 weeks to a target fasting and premeal glucose between 70-130 mg/dl. Study outcomes included differences between groups on glycemic control, treatment adherence and satisfaction (DTSQc survey). Baseline characteristics were similar between groups (56±11 years, HbA1c 9.2%±1.5). HbA1c improved significantly from baseline, with reduction of 0.9 % in the intervention and 0.7% in the control group. Insulclock improved glycemic control with an estimated reduction in average mean daily blood glucose (BG), fasting BG, and pre-meal BG of 6.03 (95% CI: [-3.21, 15.3]), 6.66 (95% CI: [-1.72, 15.04]), and 5.57 (95% CI: [-6.15, 17.31]) mg/dl, respectively. Repeated measures analyses based on linear mixed models suggest significant effects of insulclock on the trajectory of mean daily BG, fasting BG, pre-meal BG (p<0.01, p=0.03, p=0.01). There were no differences in treatment adherence or on the rate of hypoglycemia, and patients were equally satisfied with the device during intervention and control phase (DTSQc 15.5±3.7 and 15.2±3.1, respectively). In conclusion, the use of Insulclock resulted in improved glycemic control and treatment satisfaction in insulin treated patients with T2D. Disclosure C. Ramos: None. R.J. Galindo: Advisory Panel; Self; Lilly Diabetes. Consultant; Self; Valeritas, Inc. Research Support; Self; Novo Nordisk Inc. Other Relationship; Self; UpToDate. M.M. Alam: None. S. Cardona: None. B.S. Albury: None. O. Oladejo: None. F.J. Pasquel: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. Research Support; Self; Dexcom, Inc., Merck Sharp & Dohme Corp., National Institutes of Health. P. Vellanki: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. M. Fayfman: None. A. Migdal: None. G. Davis: None. J. Haw: None. G.E. Umpierrez: None.