1. 996-P: A Randomized Study to Evaluate the Efficacy of Insulclock Pen Device in Insulin-Treated Patients with Uncontrolled Type 2 Diabetes
- Author
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Priyathama Vellanki, Bonnie S. Albury, Maya Fayfman, Saumeth Cardona, Rodolfo J. Galindo, Georgia Davis, Clementina Ramos, Alexandra Migdal, Francisco J. Pasquel, Muhammad M. Alam, Omolade Oladejo, Guillermo E. Umpierrez, and Jeehea Sonya Haw
- Subjects
medicine.medical_specialty ,business.industry ,Endocrinology, Diabetes and Metabolism ,Insulin ,medicine.medical_treatment ,Repeated measures design ,Insulin pen ,Type 2 diabetes ,medicine.disease ,law.invention ,Patient satisfaction ,Randomized controlled trial ,law ,Internal medicine ,Diabetes mellitus ,Internal Medicine ,medicine ,business ,Glycemic - 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 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.
- Published
- 2020
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