Threshold-based insulin-pump interruption for reduction of hypoglycemia

Richard M. Bergensta, David C. Klonoff, Satish K. Garg, Bruce W. Bode, Melissa Meredith, Robert H. Slover, Andrew Ahmann, John B. Welsh, Scott W. Lee, Francine R. Kaufman

Research output: Contribution to journalArticle

386 Citations (Scopus)

Abstract

BACKGROUND: 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 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] x minutes vs. 1568±1995 mg per deciliter [87.0±110.7 mmol per liter] x minutes, P

Original languageEnglish (US)
Pages (from-to)224-232
Number of pages9
JournalNew England Journal of Medicine
Volume369
Issue number3
DOIs
StatePublished - 2013

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Hypoglycemia
Insulin
Glycosylated Hemoglobin A
Hypoglycemic Agents
Area Under Curve
Glucose
Control Groups
Therapeutics
Type 1 Diabetes Mellitus
Safety

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Bergensta, R. M., Klonoff, D. C., Garg, S. K., Bode, B. W., Meredith, M., Slover, R. H., ... Kaufman, F. R. (2013). Threshold-based insulin-pump interruption for reduction of hypoglycemia. New England Journal of Medicine, 369(3), 224-232. https://doi.org/10.1056/NEJMoa1303576

Threshold-based insulin-pump interruption for reduction of hypoglycemia. / Bergensta, Richard M.; Klonoff, David C.; Garg, Satish K.; Bode, Bruce W.; Meredith, Melissa; Slover, Robert H.; Ahmann, Andrew; Welsh, John B.; Lee, Scott W.; Kaufman, Francine R.

In: New England Journal of Medicine, Vol. 369, No. 3, 2013, p. 224-232.

Research output: Contribution to journalArticle

Bergensta, RM, Klonoff, DC, Garg, SK, Bode, BW, Meredith, M, Slover, RH, Ahmann, A, Welsh, JB, Lee, SW & Kaufman, FR 2013, 'Threshold-based insulin-pump interruption for reduction of hypoglycemia', New England Journal of Medicine, vol. 369, no. 3, pp. 224-232. https://doi.org/10.1056/NEJMoa1303576
Bergensta RM, Klonoff DC, Garg SK, Bode BW, Meredith M, Slover RH et al. Threshold-based insulin-pump interruption for reduction of hypoglycemia. New England Journal of Medicine. 2013;369(3):224-232. https://doi.org/10.1056/NEJMoa1303576
Bergensta, Richard M. ; Klonoff, David C. ; Garg, Satish K. ; Bode, Bruce W. ; Meredith, Melissa ; Slover, Robert H. ; Ahmann, Andrew ; Welsh, John B. ; Lee, Scott W. ; Kaufman, Francine R. / Threshold-based insulin-pump interruption for reduction of hypoglycemia. In: New England Journal of Medicine. 2013 ; Vol. 369, No. 3. pp. 224-232.
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