Twelve-Week 24/7 Ambulatory Artificial Pancreas With Weekly Adaptation of Insulin Delivery Settings: Effect on Hemoglobin A1c and Hypoglycemia

• DOI: 10.2337/dc17-1188
• Publication Date: 2017-10-14T00:40:15Z
• Authors: Eyal Dassau; Jordan E. Pinsker; Yogish C. Kudva; Sue A. Brown; Ravi Gondhalekar; Chiara Dalla Man; Steve Patek; Michele Schiavon; Vikash Dadlani; Isuru Dasanayake; Mei Mei Church; Rickey E. Carter; Wendy C. Bevier; Lauren M. Huyett; Jonathan Hughes; Stacey Anderson; Dayu Lv; Elaine Schertz; Emma Emory; Shelly K. McCrady...; Tyler Jean; Paige K. Bradley; Ling Hinshaw; Alejandro J. Lagu...; Ananda Basu; Boris Kovatchev; Claudio Cobelli; Francis J. Doyle
• Keywords: Artificial Pancreas; Insulin delivery; Blood Glucose Self-Monitoring

Artificial pancreas (AP) systems are best positioned for optimal treatment of type 1 diabetes (T1D) and currently being tested in outpatient clinical trials. Our consortium developed a novel adaptive AP an outpatient, single-arm, uncontrolled multicenter trial lasting 12 weeks.Thirty adults with T1D completed continuous glucose monitor (CGM)-augmented 1-week sensor-augmented pump (SAP) period. After the was started, basal insulin delivery settings used by initialization were adapted weekly, carbohydrate ratios every 4 weeks algorithm running on cloud-based server, automatic data upload from devices. Adaptations reviewed expert study clinicians patients. The primary end point change hemoglobin A1c (HbA1c). Outcomes reported adhering to consensus recommendations reporting trials.Twenty-nine patients trial. HbA1c, 7.0 ± 0.8% at start use, improved 6.7 0.6% after (-0.3, 95% CI -0.5 -0.2, P < 0.001). Compared SAP run-in, CGM time spent hypoglycemic range during day 5.0 1.9% (-3.1, -4.1 -2.1, 0.001) overnight 4.1 1.1% -4.2 -1.9, Whereas larger extent initially minimal changes thereafter, throughout. Approximately 10% adaptation manually overridden. There no protocol-related serious adverse events.Use our yielded significant reductions HbA1c hypoglycemia.