title: Performance and acceptability of a combined device for insulin infusion and glucose sensing in the home setting.
abstract: The use of sensor-augmented insulin pump (SAP) therapy is increasing. Currently, glucose sensors and insulin infusion cannulas are inserted separately. A new device, MiniMed Duo, combines sensing and infusion capabilities on the same platform and is intended to simplify device insertion and site management. We evaluated the device's performance with respect to insulin delivery and glucose sensing, and its acceptability with patients. Forty-five patients (mean ± SD age, 45.5 ± 10.9 years, 48% female) with type 1 diabetes and previous use of SAP participated. Each subject was to wear 5 devices connected to insulin pumps over 15 days (3 days/device) and test capillary blood glucose (SMBG) 7 times/day. The primary endpoint was the percentage of sensor-SMBG paired values within 20% of one another. Subject experiences were assessed via questionnaires. Overall, 74.8% of sensor-SMBG paired values were within 20%, meeting the primary accuracy endpoint, and the mean absolute relative difference was 15.5 ± 17.1%. Consensus error grid analysis showed that >95% of points were within the A+B zones, exceeding the threshold for adequate clinical accuracy. Insulin dosage and SMBG values did not change significantly compared to prestudy values. The functional survival of the device entering day 3 was 90.5%. There were no serious adverse events. Mean questionnaire results indicated overall satisfaction with the device. Duo provided insulin infusion and glucose sensing capabilities in a single device, which provided accurate glucose readings during routine use, was safe to wear, and was acceptable to most patients. It may improve satisfaction and convenience for patients using sensor-augmented insulin pumps.
authors.affiliation: Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Nørgaard
authors.affiliation: Medtronic, Inc., Northridge, CA, USA.
authors.forename: John
authors.initials: J
authors.lastname: Shin
authors.affiliation: Medtronic, Inc., Northridge, CA, USA john.b.welsh@medtronic.com.
authors.forename: John B
authors.initials: JB
authors.lastname: Welsh
authors.affiliation: Department of Internal Medicine, Fredericia Hospital, Fredericia, Denmark.
authors.forename: Hans
authors.initials: H
authors.lastname: Gjessing
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D007328:Insulin / Q000008:administration & dosage; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: accuracy; combo-set; continuous glucose monitoring; duo; insulin infusion