Randomized Outpatient Trial of Single- and Dual-Hormone Closed-Loop Systems That Adapt to Exercise Using Wearable Sensors

Jessica Castle, Joseph El Youssef, Leah M. Wilson, Ravi Reddy, Navid Resalat, Deborah Branigan, Katrina Ramsey, Joseph Leitschuh, Uma Rajhbeharrysingh, Brian Senf, Samuel M. Sugerman, Virginia Gabo, Peter Jacobs

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

RESEARCH DESIGN AND METHODS: Participants underwent four arms in randomized order: dual-hormone, single-hormone, predictive low glucose suspend, and continuation of current care over 4 outpatient days. Each arm included three moderate-intensity aerobic exercise sessions. The two primary outcomes were percentage of time in hypoglycemia (<70 mg/dL) and in a target range (70-180 mg/dL) assessed across the entire study and from the start of the in-clinic exercise until the next meal.

OBJECTIVE: Automated insulin delivery is the new standard for type 1 diabetes, but exercise-related hypoglycemia remains a challenge. Our aim was to determine whether a dual-hormone closed-loop system using wearable sensors to detect exercise and adjust dosing to reduce exercise-related hypoglycemia would outperform other forms of closed-loop and open-loop therapy.

RESULTS: The analysis included 20 adults with type 1 diabetes who completed all arms. The mean time (SD) in hypoglycemia was the lowest with dual-hormone during the exercise period: 3.4% (4.5) vs. 8.3% (12.6) single-hormone (P = 0.009) vs. 7.6% (8.0) predictive low glucose suspend (P < 0.001) vs. 4.3% (6.8) current care where pre-exercise insulin adjustments were allowed (P = 0.49). Time in hypoglycemia was also the lowest with dual-hormone during the entire 4-day study: 1.3% (1.0) vs. 2.8% (1.7) single-hormone (P < 0.001) vs. 2.0% (1.5) predictive low glucose suspend (P = 0.04) vs. 3.1% (3.2) current care (P = 0.007). Time in range during the entire study was the highest with single-hormone: 74.3% (8.0) vs. 72.0% (10.8) dual-hormone (P = 0.44).

CONCLUSIONS: The addition of glucagon delivery to a closed-loop system with automated exercise detection reduces hypoglycemia in physically active adults with type 1 diabetes.

Original languageEnglish (US)
Pages (from-to)1471-1477
Number of pages7
JournalDiabetes Care
Volume41
Issue number7
DOIs
StatePublished - Jul 1 2018

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Outpatients
Hormones
Exercise
Hypoglycemia
Type 1 Diabetes Mellitus
Glucose
Insulin
Glucagon
Meals

ASJC Scopus subject areas

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

Cite this

Randomized Outpatient Trial of Single- and Dual-Hormone Closed-Loop Systems That Adapt to Exercise Using Wearable Sensors. / Castle, Jessica; El Youssef, Joseph; Wilson, Leah M.; Reddy, Ravi; Resalat, Navid; Branigan, Deborah; Ramsey, Katrina; Leitschuh, Joseph; Rajhbeharrysingh, Uma; Senf, Brian; Sugerman, Samuel M.; Gabo, Virginia; Jacobs, Peter.

In: Diabetes Care, Vol. 41, No. 7, 01.07.2018, p. 1471-1477.

Research output: Contribution to journalArticle

Castle, J, El Youssef, J, Wilson, LM, Reddy, R, Resalat, N, Branigan, D, Ramsey, K, Leitschuh, J, Rajhbeharrysingh, U, Senf, B, Sugerman, SM, Gabo, V & Jacobs, P 2018, 'Randomized Outpatient Trial of Single- and Dual-Hormone Closed-Loop Systems That Adapt to Exercise Using Wearable Sensors', Diabetes Care, vol. 41, no. 7, pp. 1471-1477. https://doi.org/10.2337/dc18-0228
Castle, Jessica ; El Youssef, Joseph ; Wilson, Leah M. ; Reddy, Ravi ; Resalat, Navid ; Branigan, Deborah ; Ramsey, Katrina ; Leitschuh, Joseph ; Rajhbeharrysingh, Uma ; Senf, Brian ; Sugerman, Samuel M. ; Gabo, Virginia ; Jacobs, Peter. / Randomized Outpatient Trial of Single- and Dual-Hormone Closed-Loop Systems That Adapt to Exercise Using Wearable Sensors. In: Diabetes Care. 2018 ; Vol. 41, No. 7. pp. 1471-1477.
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AU - Resalat, Navid

AU - Branigan, Deborah

AU - Ramsey, Katrina

AU - Leitschuh, Joseph

AU - Rajhbeharrysingh, Uma

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N2 - RESEARCH DESIGN AND METHODS: Participants underwent four arms in randomized order: dual-hormone, single-hormone, predictive low glucose suspend, and continuation of current care over 4 outpatient days. Each arm included three moderate-intensity aerobic exercise sessions. The two primary outcomes were percentage of time in hypoglycemia (<70 mg/dL) and in a target range (70-180 mg/dL) assessed across the entire study and from the start of the in-clinic exercise until the next meal.OBJECTIVE: Automated insulin delivery is the new standard for type 1 diabetes, but exercise-related hypoglycemia remains a challenge. Our aim was to determine whether a dual-hormone closed-loop system using wearable sensors to detect exercise and adjust dosing to reduce exercise-related hypoglycemia would outperform other forms of closed-loop and open-loop therapy.RESULTS: The analysis included 20 adults with type 1 diabetes who completed all arms. The mean time (SD) in hypoglycemia was the lowest with dual-hormone during the exercise period: 3.4% (4.5) vs. 8.3% (12.6) single-hormone (P = 0.009) vs. 7.6% (8.0) predictive low glucose suspend (P < 0.001) vs. 4.3% (6.8) current care where pre-exercise insulin adjustments were allowed (P = 0.49). Time in hypoglycemia was also the lowest with dual-hormone during the entire 4-day study: 1.3% (1.0) vs. 2.8% (1.7) single-hormone (P < 0.001) vs. 2.0% (1.5) predictive low glucose suspend (P = 0.04) vs. 3.1% (3.2) current care (P = 0.007). Time in range during the entire study was the highest with single-hormone: 74.3% (8.0) vs. 72.0% (10.8) dual-hormone (P = 0.44).CONCLUSIONS: The addition of glucagon delivery to a closed-loop system with automated exercise detection reduces hypoglycemia in physically active adults with type 1 diabetes.

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