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

Castle, Jessica R.; 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 G.

doi:10.2337/dc18-0228

Cited by 152Diabetes Management and ResearchDiabetes Management and EducationDiabetes and associated disorders

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

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Castle, Jessica R., El Youssef, Joseph, Wilson, Leah M., Reddy, Ravi, Resalat, Navid, Branigan, Deborah, Ramsey, Katrina, Leitschuh, Joseph +5 more·2018·Diabetes Care

DOI 10.2337/dc18-0228PMC PMC6014543

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Abstract

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. 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. 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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The two T1D virtual patient populations were validated against clinical data from real-world patients with T1D.
“These virtual populations were validated against clinical data acquired from real-world patients with T1D [12].”
From A statistical virtual patient population for the glucoregulatory system in type 1 diabetes with integrated exercise model (2019) · cites this paper as [12]
The Participants and Study Design and Procedures sections describe a trial involving adults with type 1 diabetes, not two virtual patient populations. A search for virtual populations, simulation, and validation against clinical data found no passage addressing the claimed validation. (LLM, conf=0.75)
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A Comprehensive Review of Continuous Glucose Monitoring Accuracy during Exercise Periods
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Case series of a hybrid closed‐loop system used in pregnancies in clinical practice
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Predicting and Preventing Nocturnal Hypoglycemia in Type 1 Diabetes Using Big Data Analytics and Decision Theoretic Analysis
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The Type 1 Diabetes and EXercise Initiative: Predicting Hypoglycemia Risk During Exercise for Participants with Type 1 Diabetes Using Repeated Measures Random Forest
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Integrating metabolic expenditure information from wearable fitness sensors into an AI-augmented automated insulin delivery system: a randomised clinical trial
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Artificial Pancreas: Current Progress and Future Outlook in the Treatment of Type 1 Diabetes
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Empagliflozin add-on therapy to closed-loop insulin delivery in type 1 diabetes: a 2 × 2 factorial randomized crossover trial
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A single-blind, randomised, crossover study to reduce hypoglycaemia risk during postprandial exercise with closed-loop insulin delivery in adults with type 1 diabetes: Announced (with or without bolus reduction) vs unannounced exercise strategies
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Performance of Omnipod Personalized Model Predictive Control Algorithm with Moderate Intensity Exercise in Adults with Type 1 Diabetes
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A Randomized Crossover Trial to Compare Automated Insulin Delivery (the Artificial Pancreas) With Carbohydrate Counting or Simplified Qualitative Meal-Size Estimation in Type 1 Diabetes
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Adaptive Control of an Artificial Pancreas Using Model Identification, Adaptive Postprandial Insulin Delivery, and Heart Rate and Accelerometry as Control Inputs
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Incorporating Glucose Variability into Glucose Forecasting Accuracy Assessment Using the New Glucose Variability Impact Index and the Prediction Consistency Index: An LSTM Case Example
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Modeling risk of hypoglycemia during and following physical activity in people with type 1 diabetes using explainable mixed-effects machine learning
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Technological advances shaping diabetes care
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The automated pancreas: A review of technologies and clinical practice
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Current Technologies for Managing Type 1 Diabetes Mellitus and Their Impact on Quality of Life—A Narrative Review
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Strengths and Challenges of Closed-Loop Insulin Delivery During Exercise in People With Type 1 Diabetes: Potential Future Directions
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Advances in Closed-Loop Insulin Delivery Systems in Patients with Type 1 Diabetes
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Comparison Between Closed-Loop Insulin Delivery System (the Artificial Pancreas) and Sensor-Augmented Pump Therapy: A Randomized-Controlled Crossover Trial
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Separating insulin-mediated and non-insulin-mediated glucose uptake during and after aerobic exercise in type 1 diabetes
Nguyen, T.-T. P., Jacobs, P. G., Castle, J. R., Wilson, L. M., Kuehl, K. S., Branigan, D. L., Gabo, V. B., Guillot, F. H., Riddell, M. C., Haidar, A., et al. (2020) · American Journal of Physiology-Endocrinology and Metabolism · doi:10.1152/ajpendo.00534.2020 · Cited by 30 · see citing works
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Dual‐hormone artificial pancreas for glucose control in type 1 diabetes: A meta‐analysis
Zeng, B., Jia, H., Gao, L., Yang, Q., Yu, K., & Sun, F. (2022) · Diabetes Obesity and Metabolism · doi:10.1111/dom.14781 · Cited by 30 · see citing works
Chronic Care in a Life Transition: Challenges and Opportunities for Artificial Intelligence to Support Young Adults With Type 1 Diabetes Moving to University
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Low doses of dasiglucagon consistently increase plasma glucose levels from hypoglycaemia and euglycaemia in people with type 1 diabetes mellitus
Hövelmann, U., Olsen, M. B., Mouritzen, U., Lamers, D., Kronshage, B., & Heise, T. (2019) · Diabetes, Obesity and Metabolism · doi:10.1111/dom.13562 · Cited by 28 · see citing works
A Review of Predictive Low Glucose Suspend and Its Effectiveness in Preventing Nocturnal Hypoglycemia
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Insulin-and-Glucagon Artificial Pancreas Versus Insulin-Alone Artificial Pancreas: A Short Review
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Low-Dose Empagliflozin as Adjunct to Hybrid Closed-Loop Insulin Therapy in Adults With Suboptimally Controlled Type 1 Diabetes: A Randomized Crossover Controlled Trial
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The closed‐loop artificial pancreas in 2020
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Nocturnal hypoglycemia in type 1 and type 2 diabetes: an update on prevalence, prevention, pathophysiology and patient awareness
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A Randomized Crossover Pilot Study Evaluating Glucose Control During Exercise Initiated 1 or 2 h After a Meal in Adults with Type 1 Diabetes Treated with an Automated Insulin Delivery System
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Time spent outside of target glucose range for young children with type 1 diabetes: a continuous glucose monitor study
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The Potential of Current Noninvasive Wearable Technology for the Monitoring of Physiological Signals in the Management of Type 1 Diabetes: Literature Survey
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Applying technologies to simplify strategies for exercise in type 1 diabetes
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Role of Glucagon in Automated Insulin Delivery
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Performance of a dual-hormone closed-loop system versus insulin-only closed-loop system in adolescents with type 1 diabetes. A single-blind, randomized, controlled, crossover trial
Lindkvist, E. B., Laugesen, C., Reenberg, A. T., Ritschel, T. K. S., Svensson, J., Jørgensen, J. B., Nørgaard, K., & Ranjan, A. G. (2023) · Frontiers in Endocrinology · doi:10.3389/fendo.2023.1073388 · Cited by 21 · see citing works
Exercising Safely with the MiniMed™ 780G Automated Insulin Delivery System
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Artificial Pancreas With Carbohydrate Suggestion Performance for Unannounced and Announced Exercise in Type 1 Diabetes
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Alleviating carbohydrate counting with a FiASP‐plus‐pramlintide closed‐loop delivery system (artificial pancreas): Feasibility and pilot studies
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Combining uncertainty-aware predictive modeling and a bedtimeSmart Snackintervention to prevent nocturnal hypoglycemia in people with type 1 diabetes on multiple daily injections
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Translational aspects of glucagon: current use and future prospects
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Long-Term Safety and Tolerability of Dasiglucagon, a Stable-in-Solution Glucagon Analogue
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Felix dies natalis, insulin… ceterum autem censeo “beta is better”
Piemonti, L. (2021) · Acta Diabetologica · doi:10.1007/s00592-021-01737-3 · Cited by 18 · see citing works
Adaptive tuning of basal and bolus insulin to reduce postprandial hypoglycemia in a hybrid artificial pancreas
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Diabetes Technology and Exercise
Riddell, M. C., Pooni, R., Fontana, F. Y., & Scott, S. N. (2019) · Endocrinology and Metabolism Clinics of North America · doi:10.1016/j.ecl.2019.10.011 · Cited by 17 · see citing works
Online Classification of Unstructured Free-Living Exercise Sessions in People with Type 1 Diabetes
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Research Gaps, Challenges, and Opportunities in Automated Insulin Delivery Systems
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(Hybrid) Closed-Loop Systems: From Announced to Unannounced Exercise
Zimmer, R. T., Auth, A., Schierbauer, J., Haupt, S., Wachsmuth, N. B., Zimmermann, P., Voit, T., Battelino, T., Sourij, H., & Moser, O. (2023) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2023.0293 · Cited by 15 · see citing works
Parallel Control of an Artificial Pancreas with Coordinated Insulin, Glucagon, and Rescue Carbohydrate Control Actions
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Automated Insulin Delivery: The Artificial Pancreas Technical Challenges
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Coordinated dual-hormone artificial pancreas with parallel control structure
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The Bio-inspired Artificial Pancreas for Type 1 Diabetes Control in the Home: System Architecture and Preliminary Results
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Improved glycaemic variability and basal insulin dose reduction during a running competition in recreationally active adults with type 1 diabetes—A single-centre, prospective, controlled observational study
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Closed-loop insulin delivery systems in children and adolescents with type 1 diabetes
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Decision Support Systems and Closed Loop
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Patient Input for Design of a Decision Support Smartphone Application for Type 1 Diabetes
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Impact of Temporary Glycemic Target Use in the Hybrid and Advanced Hybrid Closed-Loop Systems
Dovč, K., Battelino, T., Beck, R. W., Sibayan, J., Bailey, R. J., Calhoun, P. M., Turcotte, C., WEINZIMER, S. A., Schweiger, D. Š., Nimri, R., et al. (2022) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2022.0153 · Cited by 12 · see citing works
How Well Do Continuous Glucose Monitoring Systems Perform During Exercise?
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Artificial Pancreas Technology Offers Hope for Childhood Diabetes
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A Dual-Hormone Multicontroller for Artificial Pancreas Systems
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Getting IoT-ready
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Where Do We Stand with Closed-Loop Systems and Their Challenges?
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Glucagon for hypoglycaemia treatment in type 1 diabetes
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Measuring glucose at the site of insulin delivery with a redox-mediated sensor
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A Brief Review on the Evolution of Technology in Exercise and Sport in Type 1 Diabetes: Past, Present, and Future
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Integrating Multiple Inputs Into an Artificial Pancreas System: Narrative Literature Review
Hettiarachchi, C., Daskalaki, E., Desborough, J., Nolan, C. J., O'Neal, D. N., & Suominen, H. (2022) · JMIR Diabetes · doi:10.2196/28861 · Cited by 13 · see citing works
Evaluating dasiglucagon as a treatment option for hypoglycemia in diabetes
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A Single Load of Fructose Attenuates the Risk of Exercise-Induced Hypoglycemia in Adults With Type 1 Diabetes on Ultra-Long-Acting Basal Insulin: A Randomized, Open-Label, Crossover Proof-of-Principle Study
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Glycemic Management Around Postprandial Exercise in People With Type 1 Diabetes: Challenge Accepted
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Dual-Hormone Closed-Loop System Using a Liquid Stable Glucagon Formulation Versus Insulin-Only Closed-Loop System Compared With a Predictive Low Glucose Suspend System: An Open-Label, Outpatient, Single-Center, Crossover, Randomized Controlled Trial
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Randomized trial of a dual‐hormone artificial pancreas with dosing adjustment during exercise compared with no adjustment and sensor‐augmented pump therapy
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A single-blind, randomised, crossover study to reduce hypoglycaemia risk during postprandial exercise with closed-loop insulin delivery in adults with type 1 diabetes: Announced (with or without bolus reduction) vs unannounced exercise strategies
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Haidar, A., Legault, L., Dallaire, M., Alkhateeb, A., Coriati, A., Messier, V., Cheng, P., Millette, M., Boulet, B., & Rabasa-Lhoret, R. (2013) · Canadian Medical Association Journal · doi:10.1503/cmaj.121265 · Cited by 167 · see citing works
1038-P: Results of Interim Analysis of a Randomized Crossover Study in Type 1 Diabetes (T1D) of a Dual-Hormone Closed-Loop System with Xerisol™ Glucagon vs. Insulin-Only Closed-Loop System vs. a Predictive Low Glucose Suspend System
Wilson, L. M., Jacobs, P. G., Resalat, N., Reddy, R. K. K., Youssef, J. E., Branigan, D. L., LEITSCHUH, J. A., Senf, B., Gabo, V. B., & Castle, J. R. (2019) · Diabetes · doi:10.2337/db19-1038-p · Cited by 4 · see citing works
Self-citation

Authors: Castle, J. R., El Youssef, J., Wilson, L. M., Reddy, R., Resalat, N., Branigan, D., Ramsey, K., Leitschuh, J., Rajhbeharrysingh, U., Senf, B., Sugerman, S. M., Gabo, V., & Jacobs, P. G.
Affiliations: Oregon Health & Science University (US)
Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR
Corresponding author: Castle, Jessica R.
ORCID: Castle, Jessica R.
Wilson, Leah M.
Reddy, Ravi
Resalat, Navid
Branigan, Deborah
Ramsey, Katrina
Leitschuh, Joseph
Senf, Brian
Sugerman, Samuel M.
Gabo, Virginia
Jacobs, Peter G.
Venue: Diabetes Care
Publisher: American Diabetes Association
Published: 2018-05-11
Volume: 41
Issue: 7
Pages: 1471-1477
ISSN: 0149-5992 (ISSN-L)
1935-5548
DOI: 10.2337/dc18-0228
PMC: PMC6014543
OpenAlex: W2799357239
Cited by: 152
References: 36
Citations by year: 2026: 4 · 2025: 12 · 2024: 10 · 2023: 19 · 2022: 16 · 2021: 22 · 2020: 27 · 2019: 33 · 2018: 9
FWCI: 18.11
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.diabetesjournals.org/content/license (vor, 42 d)
Locations: Diabetes Care (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: National Institute of Diabetes and Digestive and Kidney Diseases (1DP3-DK-101044)
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
Keywords: type 1 diabetes, artificial pancreas, wearable sensors, exercise detection, predictive low glucose suspend, time in range
MeSH terms: Wearable Electronic Devices, Adult, Blood Glucose, Diabetes Mellitus, Type 1, Female, Glucagon, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Male, Middle Aged, Outpatients, Blood Glucose Self-Monitoring, Exercise, Cross-Over Studies, Pancreas, Artificial, Young Adult, Meals

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

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