Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes
Sue A Brown, Boris P Kovatchev, Dan Raghinaru, John W Lum, Bruce A Buckingham, Yogish C Kudva, Lori M Laffel, Carol J Levy, Jordan E Pinsker, R Paul Wadwa, Eyal Dassau, Francis J Doyle 3rd, Stacey M Anderson, Mei Mei Church, Vikash Dadlani, Laya Ekhlaspour, Gregory P Forlenza, Elvira Isganaitis, David W Lam, Craig Kollman, Roy W Beck, iDCL Trial Research Group, Sue Brown, Boris Kovatchev, Stacey Anderson, Emma Emory, Mary Voelmle, Katie Conshafter, Kim Morris, Mary Oliveri, Linda Gondor-Fredrick, Harry Mitchell, Kayla Calvo, Christian Wakeman, Marc Breton, Lori Laffel, Elvira Isganaitis, Louise Ambler-Osborn, Emily Flint, Kenny Kim, Lindsay Roethke, Jordan Pinsker, Mei Mei Church, Camille Andre, Molly Piper, Carol Levy, David Lam, Grenye O'Malley, Camilla Levister, Selassie Ogyaadu, Jessica Lovett, Yogish C Kudva, Vinaya Simha, Vikash Dadlani, Shelly McCrady-Spitzer, Corey Reid, Kanchan Kumari, R Paul Wadwa, Greg Forlenza, G Todd Alonso, Robert Slover, Emily Jost, Laurel Messer, Cari Berget, Lindsey Towers, Alex Rossick-Solis, Bruce Buckingham, Laya Ekhlaspour, Tali Jacobson, Marissa Town, Ideen Tabatabai, Jordan Keller, Evalina Salas, Francis Doyle 3rd, Eyal Dassau, John Lum, Roy Beck, Samantha Passman, Tiffany Campos, Dan Raghinaru, Craig Kollman, Carlos Murphy, Nandan Patibandla, Sarah Borgman, Guillermo Arreaza-Rubín, Neal Green, Eric Renard, Claudio Cobelli, Yves Reznik, Robert Janicek, Deanna Gabrielson, Sue A Brown, Boris P Kovatchev, Dan Raghinaru, John W Lum, Bruce A Buckingham, Yogish C Kudva, Lori M Laffel, Carol J Levy, Jordan E Pinsker, R Paul Wadwa, Eyal Dassau, Francis J Doyle 3rd, Stacey M Anderson, Mei Mei Church, Vikash Dadlani, Laya Ekhlaspour, Gregory P Forlenza, Elvira Isganaitis, David W Lam, Craig Kollman, Roy W Beck, iDCL Trial Research Group, Sue Brown, Boris Kovatchev, Stacey Anderson, Emma Emory, Mary Voelmle, Katie Conshafter, Kim Morris, Mary Oliveri, Linda Gondor-Fredrick, Harry Mitchell, Kayla Calvo, Christian Wakeman, Marc Breton, Lori Laffel, Elvira Isganaitis, Louise Ambler-Osborn, Emily Flint, Kenny Kim, Lindsay Roethke, Jordan Pinsker, Mei Mei Church, Camille Andre, Molly Piper, Carol Levy, David Lam, Grenye O'Malley, Camilla Levister, Selassie Ogyaadu, Jessica Lovett, Yogish C Kudva, Vinaya Simha, Vikash Dadlani, Shelly McCrady-Spitzer, Corey Reid, Kanchan Kumari, R Paul Wadwa, Greg Forlenza, G Todd Alonso, Robert Slover, Emily Jost, Laurel Messer, Cari Berget, Lindsey Towers, Alex Rossick-Solis, Bruce Buckingham, Laya Ekhlaspour, Tali Jacobson, Marissa Town, Ideen Tabatabai, Jordan Keller, Evalina Salas, Francis Doyle 3rd, Eyal Dassau, John Lum, Roy Beck, Samantha Passman, Tiffany Campos, Dan Raghinaru, Craig Kollman, Carlos Murphy, Nandan Patibandla, Sarah Borgman, Guillermo Arreaza-Rubín, Neal Green, Eric Renard, Claudio Cobelli, Yves Reznik, Robert Janicek, Deanna Gabrielson
Abstract
Background: Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes.
Methods: In this 6-month randomized, multicenter trial, patients with type 1 diabetes were assigned in a 2:1 ratio to receive treatment with a closed-loop system (closed-loop group) or a sensor-augmented pump (control group). The primary outcome was the percentage of time that the blood glucose level was within the target range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter), as measured by continuous glucose monitoring.
Results: A total of 168 patients underwent randomization; 112 were assigned to the closed-loop group, and 56 were assigned to the control group. The age range of the patients was 14 to 71 years, and the glycated hemoglobin level ranged from 5.4 to 10.6%. All 168 patients completed the trial. The mean (±SD) percentage of time that the glucose level was within the target range increased in the closed-loop group from 61±17% at baseline to 71±12% during the 6 months and remained unchanged at 59±14% in the control group (mean adjusted difference, 11 percentage points; 95% confidence interval [CI], 9 to 14; P<0.001). The results with regard to the main secondary outcomes (percentage of time that the glucose level was >180 mg per deciliter, mean glucose level, glycated hemoglobin level, and percentage of time that the glucose level was <70 mg per deciliter or <54 mg per deciliter [3.0 mmol per liter]) all met the prespecified hierarchical criterion for significance, favoring the closed-loop system. The mean difference (closed loop minus control) in the percentage of time that the blood glucose level was lower than 70 mg per deciliter was -0.88 percentage points (95% CI, -1.19 to -0.57; P<0.001). The mean adjusted difference in glycated hemoglobin level after 6 months was -0.33 percentage points (95% CI, -0.53 to -0.13; P = 0.001). In the closed-loop group, the median percentage of time that the system was in closed-loop mode was 90% over 6 months. No serious hypoglycemic events occurred in either group; one episode of diabetic ketoacidosis occurred in the closed-loop group.
Conclusions: In this 6-month trial involving patients with type 1 diabetes, the use of a closed-loop system was associated with a greater percentage of time spent in a target glycemic range than the use of a sensor-augmented insulin pump. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; iDCL ClinicalTrials.gov number, NCT03563313.).
Copyright © 2019 Massachusetts Medical Society.
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Source: PubMed