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

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

SUBMITTER: Castle JR

PROVIDER: S-EPMC6014543 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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

Castle Jessica R JR El Youssef Joseph J Wilson Leah M LM Reddy Ravi R Resalat Navid N Branigan Deborah D Ramsey Katrina K Leitschuh Joseph J Rajhbeharrysingh Uma U Senf Brian B Sugerman Samuel M SM Gabo Virginia V Jacobs Peter G PG

Diabetes care 20180511 7

<h4>Objective</h4>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.<h4>Research design and methods</h4>Participants underwent four arms in randomized order: dual-hormone, single-hormone, predic ...[more]

PMID: 29752345

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Project description:BACKGROUND:Over the past several decades, naturally occurring and man-made mass casualty incidents (MCIs) have increased in frequency and number worldwide. To test the impact of such events on medical resources, simulations can provide a safe, controlled setting while replicating the chaotic environment typical of an actual disaster. A standardized method to collect and analyze data from mass casualty exercises is needed to assess preparedness and performance of the health care staff involved. OBJECTIVE:In this study, we aimed to assess the feasibility of using wearable proximity sensors to measure proximity events during an MCI simulation. In the first instance, our objective was to demonstrate how proximity sensors can collect spatial and temporal information about the interactions between medical staff and patients during an MCI exercise in a quasi-autonomous way. In addition, we assessed how the deployment of this technology could help improve future simulations by analyzing the flow of patients in the hospital. METHODS:Data were obtained and collected through the deployment of wearable proximity sensors during an MCI functional exercise. The scenario included 2 areas: the accident site and the Advanced Medical Post, and the exercise lasted 3 hours. A total of 238 participants were involved in the exercise and classified in categories according to their role: 14 medical doctors, 16 nurses, 134 victims, 47 Emergency Medical Services staff members, and 27 health care assistants and other hospital support staff. Each victim was assigned a score related to the severity of his/her injury. Each participant wore a proximity sensor, and in addition, 30 fixed devices were placed in the field hospital. RESULTS:The contact networks show a heterogeneous distribution of the cumulative time spent in proximity by the participants. We obtained contact matrices based on the cumulative time spent in proximity between the victims and rescuers. Our results showed that the time spent in proximity by the health care teams with the victims is related to the severity of the patient's injury. The analysis of patients' flow showed that the presence of patients in the rooms of the hospital is consistent with the triage code and diagnosis, and no obvious bottlenecks were found. CONCLUSIONS:Our study shows the feasibility of the use of wearable sensors for tracking close contacts among individuals during an MCI simulation. It represents, to our knowledge, the first example of unsupervised data collection-ie, without the need for the involvement of observers, which could compromise the realism of the exercise-of face-to-face contacts during an MCI exercise. Moreover, by permitting detailed data collection about the simulation, such as data related to the flow of patients in the hospital, such deployment provides highly relevant input for the improvement of MCI resource allocation and management.

Dataset Information

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

Publications

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

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