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Adjustment of Open-Loop Settings to Improve Closed-Loop Results in Type 1 Diabetes: A Multicenter Randomized Trial

Dassau, Eyal ; Brown, Sue A ; Basu, Ananda ; Pinsker, Jordan E ; Kudva, Yogish C ; Gondhalekar, Ravi ; Patek, Steve ; Lv, Dayu ; Schiavon, Michele ; Lee, Joon Bok ; Dalla Man, Chiara ; Hinshaw, Ling ; Castorino, Kristin ; Mallad, Ashwini ; Dadlani, Vikash ; McCrady-Spitzer, Shelly K ; McElwee-Malloy, Molly ; Wakeman, Christian A ; Bevier, Wendy C ; Bradley, Paige K ; Kovatchev, Boris ; Cobelli, Claudio ; Zisser, Howard C ; Doyle, Francis J

The journal of clinical endocrinology and metabolism, 2015-10, Vol.100 (10), p.3878-3886 [Periódico revisado por pares]

United States: Endocrine Society

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Título:
Adjustment of Open-Loop Settings to Improve Closed-Loop Results in Type 1 Diabetes: A Multicenter Randomized Trial
Autor: Dassau, Eyal ; Brown, Sue A ; Basu, Ananda ; Pinsker, Jordan E ; Kudva, Yogish C ; Gondhalekar, Ravi ; Patek, Steve ; Lv, Dayu ; Schiavon, Michele ; Lee, Joon Bok ; Dalla Man, Chiara ; Hinshaw, Ling ; Castorino, Kristin ; Mallad, Ashwini ; Dadlani, Vikash ; McCrady-Spitzer, Shelly K ; McElwee-Malloy, Molly ; Wakeman, Christian A ; Bevier, Wendy C ; Bradley, Paige K ; Kovatchev, Boris ; Cobelli, Claudio ; Zisser, Howard C ; Doyle, Francis J
Assuntos: Adult ; Aged ; Blood Glucose - drug effects ; Blood Glucose Self-Monitoring ; Cross-Over Studies ; Diabetes Mellitus, Type 1 - blood ; Diabetes Mellitus, Type 1 - drug therapy ; Female ; Humans ; Hypoglycemic Agents - administration & dosage ; Hypoglycemic Agents - therapeutic use ; Insulin - administration & dosage ; Insulin - therapeutic use ; Insulin Infusion Systems ; Male ; Middle Aged ; Original ; Treatment Outcome ; Young Adult
É parte de: The journal of clinical endocrinology and metabolism, 2015-10, Vol.100 (10), p.3878-3886
Notas: This work was supported by the National Institutes of Health Grants DP3DK094331, R01DK085628 (to UCSB), and UL1 TR000135 from the National Center for Advancing Translational Science and the Urdang Family Foundation to Mayo Clinic. C.C., C.D.M., and M.S. are partially funded by Italian Ministero dell'Istruzione, dell'Università e della Ricerca (Progetto FIRB 2009).
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E.D., S.A.B., and A.B. contributed equally to this study.
Descrição: Context: Closed-loop control (CLC) relies on an individual's open-loop insulin pump settings to initialize the system. Optimizing open-loop settings before using CLC usually requires significant time and effort. Objective: The objective was to investigate the effects of a one-time algorithmic adjustment of basal rate and insulin to carbohydrate ratio open-loop settings on the performance of CLC. Design: This study reports a multicenter, outpatient, randomized, crossover clinical trial. Patients: Thirty-seven adults with type 1 diabetes were enrolled at three clinical sites. Interventions: Each subject's insulin pump settings were subject to a one-time algorithmic adjustment based on 1 week of open-loop (i.e., home care) data collection. Subjects then underwent two 27-hour periods of CLC in random order with either unchanged (control) or algorithmic adjusted basal rate and carbohydrate ratio settings (adjusted) used to initialize the zone-model predictive control artificial pancreas controller. Subject's followed their usual meal-plan and had an unannounced exercise session. Main Outcomes and Measures: Time in the glucose range was 80–140 mg/dL, compared between both arms. Results: Thirty-two subjects completed the protocol. Median time in CLC was 25.3 hours. The median time in the 80–140 mg/dl range was similar in both groups (39.7% control, 44.2% adjusted). Subjects in both arms of CLC showed minimal time spent less than 70 mg/dl (median 1.34% and 1.37%, respectively). There were no significant differences more than 140 mg/dL. Conclusions: A one-time algorithmic adjustment of open-loop settings did not alter glucose control in a relatively short duration outpatient closed-loop study. The CLC system proved very robust and adaptable, with minimal (<2%) time spent in the hypoglycemic range in either arm.
Editor: United States: Endocrine Society
Idioma: Inglês

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Adjustment of Open-Loop Settings to Improve Closed-Loop Results in Type 1 Diabetes: A Multicenter Randomized Trial

United States: Endocrine Society

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