Threshold-Based Insulin-Pump Interruption for Reduction of Hypoglycemia
| العنوان: | Threshold-Based Insulin-Pump Interruption for Reduction of Hypoglycemia |
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| المؤلفون: | Richard M, Bergenstal, David C, Klonoff, Satish K, Garg, Bruce W, Bode, Melissa, Meredith, Robert H, Slover, Andrew J, Ahmann, John B, Welsh, Scott W, Lee, Francine R, Kaufman, R, Weinstock |
| المصدر: | New England Journal of Medicine. 369:224-232 |
| بيانات النشر: | Massachusetts Medical Society, 2013. |
| سنة النشر: | 2013 |
| مصطلحات موضوعية: | Adult, Blood Glucose, Male, Insulin pump, medicine.medical_specialty, Adolescent, medicine.medical_treatment, Hypoglycemia, law.invention, Young Adult, chemistry.chemical_compound, Insulin Infusion Systems, Randomized controlled trial, law, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, Insulin, Aged, Glycated Hemoglobin, Type 1 diabetes, business.industry, Area under the curve, General Medicine, Middle Aged, medicine.disease, Surgery, Diabetes Mellitus, Type 1, chemistry, Area Under Curve, Anesthesia, Female, Glycated hemoglobin, business |
| الوصف: | 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.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.A total of 247 patients were randomly assigned to receive sensor-augmented insulin-pump 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 threshold-suspend 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, P0.001). 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 patient-week, P0.001). 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 (P0.001 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.This study showed that over a 3-month period the use of sensor-augmented insulin-pump therapy with the threshold-suspend feature reduced nocturnal hypoglycemia, without increasing glycated hemoglobin values. (Funded by Medtronic MiniMed; ASPIRE ClinicalTrials.gov number, NCT01497938.). |
| تدمد: | 1533-4406 0028-4793 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b799da21a070412fb3e5a834aae4c719Test https://doi.org/10.1056/nejmoa1303576Test |
| رقم الانضمام: | edsair.doi.dedup.....b799da21a070412fb3e5a834aae4c719 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15334406 00284793 |
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