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Threshold-based insulin-pump interruption for reduction of hypoglycemia

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dc.contributor.authorBergenstal, Richard M.
dc.contributor.authorKlonoff, David C. K
dc.contributor.authorGarg, Satish K.
dc.contributor.authorBode, Bruce W.
dc.contributor.authorMeredith, Melissa
dc.contributor.authorSlover, Robert H.
dc.contributor.authorAhmann, Andrew J.
dc.contributor.authorWelsh, John B.
dc.contributor.authorLee, Scott W.
dc.contributor.authorKaufman, Francine R.
dc.contributor.corporatenamePontificia Universidad Javeriana. Facultad de Medicina. Departamento de Medicina Interna. Grupo de Investigación de Enfermedades Crónicas del Adulto
dc.date.accessioned2020-06-01T23:32:55Z
dc.date.available2020-06-01T23:32:55Z
dc.date.created2013-06-22
dc.description.abstract*spa
dc.description.abstractenglishBackground The threshold-suspend feature of sensor-augmented insulin pumps is designed to minimize the risk of hypoglycemia by interrupting insulin delivery at a preset sensor glucose value. We evaluated sensor-augmented insulin-pump therapy with and without the threshold-suspend feature in patients with nocturnal hypoglycemia. Methods We randomly assigned patients with type 1 diabetes and documented nocturnal hypoglycemia to receive sensor-augmented insulin-pump therapy with or without the threshold-suspend feature for 3 months. The primary safety outcome was the change in the glycated hemoglobin level. The primary efficacy outcome was the area under the curve (AUC) for nocturnal hypoglycemic events. Two-hour threshold-suspend events were analyzed with respect to subsequent sensor glucose values. Results A total of 247 patients were randomly assigned to receive sensor-augmented insulinpump therapy with the threshold-suspend feature (threshold-suspend group, 121 patients) or standard sensor-augmented insulin-pump therapy (control group, 126 patients). The changes in glycated hemoglobin values were similar in the two groups. The mean AUC for nocturnal hypoglycemic events was 37.5% lower in the thresholdsuspend group than in the control group (980±1200 mg per deciliter [54.4±66.6 mmol per liter]×minutes vs. 1568±1995 mg per deciliter [87.0±110.7 mmol per liter]×minutes, P<0.001). Nocturnal hypoglycemic events occurred 31.8% less frequently in the threshold-suspend group than in the control group (1.5±1.0 vs. 2.2±1.3 per patientweek, P<0.001). The percentages of nocturnal sensor glucose values of less than 50 mg per deciliter (2.8 mmol per liter), 50 to less than 60 mg per deciliter (3.3 mmol per liter), and 60 to less than 70 mg per deciliter (3.9 mmol per liter) were significantly reduced in the threshold-suspend group (P<0.001 for each range). After 1438 instances at night in which the pump was stopped for 2 hours, the mean sensor glucose value was 92.6±40.7 mg per deciliter (5.1±2.3 mmol per liter). Four patients (all in the control group) had a severe hypoglycemic event; no patients had diabetic ketoacidosis. Conclusions This study showed that over a 3-month period the use of sensor-augmented insulinpump therapy with the threshold-suspend feature reduced nocturnal hypoglycemia, without increasing glycated hemoglobin values. (Funded by Medtronic MiniMed; ASPIRE ClinicalTrials.gov number, NCT01497938.)spa
dc.description.paginas224-232spa
dc.description.quartilescopusQ1spa
dc.description.tipoarticuloArtículo originalspa
dc.formatPDFspa
dc.format.mimetypeapplication/pdfspa
dc.format.soportePapel / Electrónicospa
dc.identifierhttps://www.nejm.org/doi/pdf/10.1056/NEJMoa1303576spa
dc.identifier.doihttps:// doi.org/ 10.1056/NEJMoa1303576spa
dc.identifier.issn0028-4793 / 1533-4406 (Electrónico)spa
dc.identifier.urihttp://hdl.handle.net/10554/49546
dc.languagespaspa
dc.rights.licenceAtribución-NoComercial 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/*
dc.sourceNew England Journal of Medicine; Vol. 369 Núm. 3 (2013)spa
dc.titleThreshold-based insulin-pump interruption for reduction of hypoglycemiaspa
dc.typeinfo:eu-repo/semantics/article
dc.type.hasversionhttp://purl.org/coar/version/c_ab4af688f83e57aa
dc.type.localArtículo de revistaspa

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