Twelve-week 24/7 ambulatory artificial pancreas with weekly adaptation of insulin delivery settings: Effect on hemoglobin A1c and hypoglycemia

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-SpitzerTyler Jean, Paige K. Bradley, Ling Hinshaw, Alejandro J. Laguna Sanz, Ananda Basu, Boris Kovatchev, Claudio Cobelli, Francis J. Doyle

Research output: Contribution to journalArticle

33 Scopus citations

Abstract

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

Original languageEnglish (US)
Pages (from-to)1719-1726
Number of pages8
JournalDiabetes care
Volume40
Issue number12
DOIs
StatePublished - Dec 1 2017

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

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    Dassau, E., Pinsker, J. E., Kudva, Y. C., Brown, S. A., Gondhalekar, R., Man, C. D., Patek, S., Schiavon, M., Dadlani, V., Dasanayake, I., Church, M. M., Carter, R. E., Bevier, W. C., Huyett, L. M., Hughes, J., Anderson, S., Lv, D., Schertz, E., Emory, E., ... Doyle, F. J. (2017). Twelve-week 24/7 ambulatory artificial pancreas with weekly adaptation of insulin delivery settings: Effect on hemoglobin A1c and hypoglycemia. Diabetes care, 40(12), 1719-1726. https://doi.org/10.2337/dc17-1188