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

• Published in: Diabetes (New York, N.Y.) Vol. 69; no. Supplement_1
• Main Authors: RAMOS, CLEMENTINA, GALINDO, RODOLFO J., ALAM, MUHAMMAD M., CARDONA, SAUMETH, ALBURY, BONNIE S., OLADEJO, OMOLADE, PASQUEL, FRANCISCO J., VELLANKI, PRIYATHAMA, FAYFMAN, MAYA, MIGDAL, ALEXANDRA, DAVIS, GEORGIA, HAW, JEEHEA SONYA, UMPIERREZ, GUILLERMO E.
• Format: Journal Article
• Language: English
• Published: New York American Diabetes Association 01-06-2020
• Subjects: Blood glucose; Diabetes; Diabetes mellitus (non-insulin dependent); Fasting; Glucose monitoring; Hypoglycemia; Insulin; Patient satisfaction
• ISSN: 0012-1797; 1939-327X
• DOI: 10.2337/db20-996-P

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.