The Experts below are selected from a list of 321 Experts worldwide ranked by ideXlab platform
Ahmad Haidar - One of the best experts on this subject based on the ideXlab platform.
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A Novel Dual-Hormone Insulin-and-Pramlintide Artificial Pancreas for Type 1 Diabetes: A Randomized Controlled Crossover Trial
Diabetes care, 2020Co-Authors: Ahmad Haidar, Michael Tsoukas, Jeanfrancois Yale, Joanna Rutkowski, Anne Bossy, Evelyne Pytka, Anas El Fathi, Natalia Strauss, Sarah Bernier-twardy, Laurent LegaultAbstract:The rapid insulin-alone Artificial Pancreas improves glycemia in type 1 diabetes but daytime control remains suboptimal. We propose two novel dual-hormone Artificial Pancreas systems. We conducted a randomized crossover trial comparing a rapid insulin-alone Artificial Pancreas with rapid insulin-and-pramlintide and with regular insulin-and-pramlintide Artificial Pancreas systems in adults with type 1 diabetes. Participants were assigned to the interventions in random order during three 24-h inpatient visits. Each visit was preceded by an outpatient hormonal open-loop run-in period of 10-14 days. The dual-hormone Artificial Pancreas delivered pramlintide in a basal-bolus manner, using a novel dosing algorithm, with a fixed ratio relative to insulin. The primary outcome was time in the range 3.9-10.0 mmol/L. Compared with the rapid insulin-alone Artificial Pancreas system, the rapid insulin-and-pramlintide system increased the time in range from 74% (SD 18%) to 84% (13%) (P = 0.0014), whereas the regular insulin-and-pramlintide system did not change the time in range (69% [19%]; P = 0.22). The increased time in range with the rapid insulin-and-pramlintide system was due to improved daytime control (daytime time in range increased from 63% [23%] to 78% [16%], P = 0.0004). There were 11 (1 per 2.5 days) hypoglycemic events (<3.3 mmol/L with symptoms or <3.0 mmol/L irrespective of symptoms) with the rapid insulin-alone system, compared with 12 (1 per 2.3 days) and 18 (1 per 1.4 days) with the rapid and regular insulin-and-pramlintide systems, respectively. Gastrointestinal symptoms were reported after 0% (0 of 112) of meals with the rapid insulin-alone system, compared with 6% (6 of 108) and 11% (11 of 104) with the rapid and regular insulin-and-pramlintide systems, respectively; none of the symptoms were severe. A novel rapid insulin-and-pramlintide Artificial Pancreas improves glucose control compared with a rapid insulin-alone Artificial Pancreas (ClinicalTrials.gov number NCT02814123). © 2020 by the American Diabetes Association.
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a novel dual hormone insulin and pramlintide Artificial Pancreas for type 1 diabetes a randomized controlled crossover trial
Diabetes Care, 2020Co-Authors: Ahmad Haidar, Michael Tsoukas, Sarah Berniertwardy, Jeanfrancois Yale, Joanna Rutkowski, Anne Bossy, Evelyne Pytka, Anas El Fathi, Natalia StraussAbstract:OBJECTIVE The rapid insulin-alone Artificial Pancreas improves glycemia in type 1 diabetes but daytime control remains suboptimal. We propose two novel dual-hormone Artificial Pancreas systems. RESEARCH DESIGN AND METHODS We conducted a randomized crossover trial comparing a rapid insulin-alone Artificial Pancreas with rapid insulin-and-pramlintide and with regular insulin-and-pramlintide Artificial Pancreas systems in adults with type 1 diabetes. Participants were assigned to the interventions in random order during three 24-h inpatient visits. Each visit was preceded by an outpatient hormonal open-loop run-in period of 10–14 days. The dual-hormone Artificial Pancreas delivered pramlintide in a basal-bolus manner, using a novel dosing algorithm, with a fixed ratio relative to insulin. The primary outcome was time in the range 3.9–10.0 mmol/L. RESULTS Compared with the rapid insulin-alone Artificial Pancreas system, the rapid insulin-and-pramlintide system increased the time in range from 74% (SD 18) to 84% (13; P = 0.0014), whereas the regular insulin-and-pramlintide system did not change the time in range (69% [19]; P = 0.22). The increased time in range with the rapid insulin-and-pramlintide system was due to improved daytime control (daytime in range increased from 63% [23] to 78% [16], P = 0.0004). There were 11 (1 per 2.5 days) hypoglycemic events ( CONCLUSIONS A novel rapid insulin-and-pramlintide Artificial Pancreas improves glucose control compared with a rapid insulin-alone Artificial Pancreas (ClinicalTrials.gov number NCT02814123).
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Insulin-and-Glucagon Artificial Pancreas Versus Insulin-Alone Artificial Pancreas: A Short Review.
Diabetes spectrum : a publication of the American Diabetes Association, 2019Co-Authors: Ahmad HaidarAbstract:IN BRIEF The advantage of the insulin-and-glucagon Artificial Pancreas is based on the rapid effect of subcutaneous glucagon delivery in preventing hypoglycemia compared to suspension of insulin delivery. In short-term studies, the dual-hormone Artificial Pancreas reduced daytime hypoglycemia, especially during exercise, compared to the insulin-alone Artificial Pancreas, but the insulin-alone system seemed sufficient in eliminating nocturnal hypoglycemia. The comparative benefits of the single- and dual-hormone systems for improving A1C and preventing severe hypoglycemia remain unknown.
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Dual-hormone Artificial Pancreas: benefits and limitations compared with single-hormone systems.
Diabetic medicine : a journal of the British Diabetic Association, 2018Co-Authors: Tricia M. Peters, Ahmad HaidarAbstract:Technological advances have made the Artificial Pancreas a reality. This has the potential to improve the lives of individuals with Type 1 diabetes by reducing the risk of hypoglycaemia, achieving better overall glucose control, and enhancing quality of life. Both single-hormone (insulin-only) and dual-hormone (insulin and glucagon) systems have been developed; however, a focused review of the relative benefits of each Artificial Pancreas system is needed. We reviewed studies that directly compared single- and dual-hormone systems to evaluate the efficacy of each system for preventing hypoglycaemia and maintaining glycaemic control, as well as their utility in specific situations including during exercise, overnight and during the prandial period. We observed additional benefits with the dual-hormone Artificial Pancreas for reducing the risk of hypoglycaemic events overall and during exercise over the study duration. The single-hormone Artificial Pancreas was sufficient for maintenance of euglycaemia in the overnight period and for preventing late-onset post-exercise hypoglycaemia. Future comparative studies of longer duration are required to determine whether one system is superior for improving mean glucose control, eliminating severe hypoglycaemia, or improving quality of life.
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Overnight Glucose Control with Dual- and Single-Hormone Artificial Pancreas in Type 1 Diabetes with Hypoglycemia Unawareness: A Randomized Controlled Trial.
Diabetes technology & therapeutics, 2018Co-Authors: Alexander Abitbol, Virginie Messier, Rémi Rabasa-lhoret, Laurent Legault, Mohamad Smaoui, Nathan Cohen, Ahmad HaidarAbstract:Abstract Background: The dual-hormone (insulin and glucagon) Artificial Pancreas may be justifiable in some, but not all, patients. We sought to compare dual- and single-hormone Artificial Pancreas systems in patients with hypoglycemia unawareness and documented nocturnal hypoglycemia. Methods: We conducted a randomized crossover trial comparing the efficacy of dual- and single-hormone Artificial Pancreas systems in controlling plasma glucose levels over the course of one night's sleep. We recruited 18 adult participants with hypoglycemia unawareness and 17 participants with hypoglycemia awareness, all of whom had documented nocturnal hypoglycemia during 2 weeks of screening. Outcomes were calculated using plasma glucose. Results: In participants with hypoglycemia unawareness, the median (interquartile range [IQR]) percentage of time that plasma glucose was below 4.0 mmol/L was 0% (0–0) on dual-hormone Artificial Pancreas nights and 0% (0–10) on single-hormone Artificial Pancreas nights (P = 0.20). Additi...
Laurent Legault - One of the best experts on this subject based on the ideXlab platform.
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A Novel Dual-Hormone Insulin-and-Pramlintide Artificial Pancreas for Type 1 Diabetes: A Randomized Controlled Crossover Trial
Diabetes care, 2020Co-Authors: Ahmad Haidar, Michael Tsoukas, Jeanfrancois Yale, Joanna Rutkowski, Anne Bossy, Evelyne Pytka, Anas El Fathi, Natalia Strauss, Sarah Bernier-twardy, Laurent LegaultAbstract:The rapid insulin-alone Artificial Pancreas improves glycemia in type 1 diabetes but daytime control remains suboptimal. We propose two novel dual-hormone Artificial Pancreas systems. We conducted a randomized crossover trial comparing a rapid insulin-alone Artificial Pancreas with rapid insulin-and-pramlintide and with regular insulin-and-pramlintide Artificial Pancreas systems in adults with type 1 diabetes. Participants were assigned to the interventions in random order during three 24-h inpatient visits. Each visit was preceded by an outpatient hormonal open-loop run-in period of 10-14 days. The dual-hormone Artificial Pancreas delivered pramlintide in a basal-bolus manner, using a novel dosing algorithm, with a fixed ratio relative to insulin. The primary outcome was time in the range 3.9-10.0 mmol/L. Compared with the rapid insulin-alone Artificial Pancreas system, the rapid insulin-and-pramlintide system increased the time in range from 74% (SD 18%) to 84% (13%) (P = 0.0014), whereas the regular insulin-and-pramlintide system did not change the time in range (69% [19%]; P = 0.22). The increased time in range with the rapid insulin-and-pramlintide system was due to improved daytime control (daytime time in range increased from 63% [23%] to 78% [16%], P = 0.0004). There were 11 (1 per 2.5 days) hypoglycemic events (<3.3 mmol/L with symptoms or <3.0 mmol/L irrespective of symptoms) with the rapid insulin-alone system, compared with 12 (1 per 2.3 days) and 18 (1 per 1.4 days) with the rapid and regular insulin-and-pramlintide systems, respectively. Gastrointestinal symptoms were reported after 0% (0 of 112) of meals with the rapid insulin-alone system, compared with 6% (6 of 108) and 11% (11 of 104) with the rapid and regular insulin-and-pramlintide systems, respectively; none of the symptoms were severe. A novel rapid insulin-and-pramlintide Artificial Pancreas improves glucose control compared with a rapid insulin-alone Artificial Pancreas (ClinicalTrials.gov number NCT02814123). © 2020 by the American Diabetes Association.
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Overnight Glucose Control with Dual- and Single-Hormone Artificial Pancreas in Type 1 Diabetes with Hypoglycemia Unawareness: A Randomized Controlled Trial.
Diabetes technology & therapeutics, 2018Co-Authors: Alexander Abitbol, Virginie Messier, Rémi Rabasa-lhoret, Laurent Legault, Mohamad Smaoui, Nathan Cohen, Ahmad HaidarAbstract:Abstract Background: The dual-hormone (insulin and glucagon) Artificial Pancreas may be justifiable in some, but not all, patients. We sought to compare dual- and single-hormone Artificial Pancreas systems in patients with hypoglycemia unawareness and documented nocturnal hypoglycemia. Methods: We conducted a randomized crossover trial comparing the efficacy of dual- and single-hormone Artificial Pancreas systems in controlling plasma glucose levels over the course of one night's sleep. We recruited 18 adult participants with hypoglycemia unawareness and 17 participants with hypoglycemia awareness, all of whom had documented nocturnal hypoglycemia during 2 weeks of screening. Outcomes were calculated using plasma glucose. Results: In participants with hypoglycemia unawareness, the median (interquartile range [IQR]) percentage of time that plasma glucose was below 4.0 mmol/L was 0% (0–0) on dual-hormone Artificial Pancreas nights and 0% (0–10) on single-hormone Artificial Pancreas nights (P = 0.20). Additi...
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outpatient 60 hour day and night glucose control with dual hormone Artificial Pancreas single hormone Artificial Pancreas or sensor augmented pump therapy in adults with type 1 diabetes an open label randomised crossover controlled trial
Diabetes Obesity and Metabolism, 2017Co-Authors: Ahmad Haidar, Virginie Messier, Laurent Legault, Martin Ladouceur, Remi RabasalhoretAbstract:Aims To assess whether the dual-hormone (insulin and glucagon) Artificial Pancreas reduces hypoglycemia compared to the single-hormone (insulin alone) Artificial Pancreas in outpatient settings during the day and night. Material and Methods In a randomized, three-way, crossover trial, we compared the dual-hormone Artificial Pancreas, the single-hormone Artificial Pancreas, and sensor-augmented pump therapy (control) in 23 adults with type 1 diabetes. Each intervention was applied from 08 h00 Day 1 to 20 h00 Day 3 (60 hours) in outpatient free-living conditions. The primary outcome was time spent with sensor glucose levels below 4.0 mmol/L. A P value of less than 0.017 was regarded as significant. This trial is registered, NCT01966393. Results The median difference between the dual-hormone system compared to the single-hormone system was -2.3% (P = 0.072) for time spent below 4.0 mmol/L, -1.3% (P = 0.017) for time below 3.5 mmol/L, and −0.7% (P = 0.031) for time below 3.3 mmol/L. Both systems reduced (P < 0.017) hypoglycemia below 4.0, 3.5, and 3.3 mmol/L compared to control therapy but the reductions were larger with the dual-hormone system than with the single-hormone system (medians −4.0% vs −3.4% for 4.0 mmol/L; -2.7% vs -2.2% for 3.5 mmol/L; and −2.2% vs −1.2% for 3.3 mmol/L). There were 34 hypoglycemic events (<3.0 mmol/L for 20 minutes) with control therapy, 14 with the single-hormone system, and 6 with the dual-hormone system. These differences in hypoglycemia were observed while mean glucose level was low and comparable in all interventions (P=NS). Conclusions The dual-hormone Artificial Pancreas had the lowest risk of hypoglycemia, but the differences were not statistically significant. Larger studies are needed.
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glucagon in Artificial Pancreas systems potential benefits and safety profile of future chronic use
Diabetes Obesity and Metabolism, 2017Co-Authors: Nadine Taleb, Ahmad Haidar, Virginie Messier, Véronique Gingras, Laurent Legault, Remi RabasalhoretAbstract:The role of glucagon in the pathophysiology of diabetes has long been recognized, although its approved clinical use has so far been limited to the emergency treatment of severe hypoglycaemia. A novel use of glucagon as intermittent mini-boluses is proposed in the dual-hormone version (insulin and glucagon) of the external Artificial Pancreas. Short-term studies suggest that the incorporation of glucagon into Artificial Pancreas systems has the potential to further decrease hypoglycaemic risk and improve overall glucose control; however, the potential long-term safety and benefits also need to be investigated given the recognized systemic effects of glucagon. In the present report, we review the available animal and human data on the physiological functions of glucagon, as well as its pharmacological use, according to dosing and duration (acute and chronic). Along with its main role in hepatic glucose metabolism, glucagon affects the cardiovascular, renal, pulmonary and gastrointestinal systems. It has a potential role in weight reduction through its central satiety function and its role in increasing energy expenditure. Most of the pharmacological studies investigating the effects of glucagon have used doses exceeding 1 mg, in contrast to the mini-boluses used in the Artificial Pancreas. The available data are reassuring but comprehensive human studies using small but chronic glucagon doses that are close to the physiological ranges are lacking. We propose a list of variables that could be monitored during long-term trials of the Artificial Pancreas. Such trials should address the questions about the risk-benefit ratio of chronic glucagon use.
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Single- and Dual-Hormone Artificial Pancreas for Overnight Glucose Control in Type 1 Diabetes.
The Journal of clinical endocrinology and metabolism, 2015Co-Authors: Ahmad Haidar, Virginie Messier, Rémi Rabasa-lhoret, Laurent Legault, Leif E. Lovblom, Rohan Rakheja, Émilie D'aoust, C. Marcelo Falappa, Tara Justice, Andrej OrszagAbstract:Context: The added benefit of glucagon in Artificial Pancreas systems for overnight glucose control in type 1 diabetes has not been fully explored. Objective: The objective of the study was to compare the efficacy of dual-hormone (insulin and glucagon) Artificial Pancreas, single-hormone (insulin alone) Artificial Pancreas, and conventional insulin pump therapy. Design: This study was a three-center, three-arm, open-label, randomized, crossover controlled trial involving three interventions, each applied over a night after a high carbohydrate/high fat meal and a second after exercise to mimic real-life glycemic excursions. Setting: The study was conducted in a home setting. Patients: Twenty-eight type 1 diabetes participants (21 adults and seven adolescents) participated in the study. Interventions: Dual-hormone Artificial Pancreas, single-hormone Artificial Pancreas, and conventional pump therapy was activated from 9:00 pm to 7:00 am. Main Outcome: The main outcome was a proportion of time in target (4–8...
Virginie Messier - One of the best experts on this subject based on the ideXlab platform.
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A critical review and analysis of ethical issues associated with the Artificial Pancreas.
Diabetes & metabolism, 2018Co-Authors: Ariane Quintal, Virginie Messier, Rémi Rabasa-lhoret, Eric RacineAbstract:The Artificial Pancreas combines a hormone infusion pump with a continuous glucose monitoring device, supported by a dosing algorithm currently installed on the pump. It allows for dynamic infusions of insulin (and possibly other hormones such as glucagon) tailored to patient needs. For patients with type 1 diabetes the Artificial Pancreas has been shown to prevent more effectively hypoglycaemic events and hyperglycaemia than insulin pump therapy and has the potential to simplify care. However, the potential ethical issues associated with the upcoming integration of the Artificial Pancreas into clinical practice have not yet been discussed. Our objective was to identify and articulate ethical issues associated with Artificial Pancreas use for patients, healthcare professionals, industry and policymakers. We performed a literature review to identify clinical, psychosocial and technical issues raised by the Artificial Pancreas and subsequently analysed them through a common bioethics framework. We identified five sensitive domains of ethical issues. Patient confidentiality and safety can be jeopardized by the Artificial Pancreas' vulnerability to security breaches or unauthorized data sharing. Public and private coverage of the Artificial Pancreas could be cost-effective and warranted. Patient selection criteria need to ensure equitable access and sensitivity to patient-reported outcomes. Patient coaching and support by healthcare professionals or industry representatives could help foster realistic expectations in patients. Finally, the Artificial Pancreas increases the visibility of diabetes and could generate issues related to personal identity and patient agency. The timely consideration of these issues will optimize the technological development and clinical uptake of the Artificial Pancreas.
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Overnight Glucose Control with Dual- and Single-Hormone Artificial Pancreas in Type 1 Diabetes with Hypoglycemia Unawareness: A Randomized Controlled Trial.
Diabetes technology & therapeutics, 2018Co-Authors: Alexander Abitbol, Virginie Messier, Rémi Rabasa-lhoret, Laurent Legault, Mohamad Smaoui, Nathan Cohen, Ahmad HaidarAbstract:Abstract Background: The dual-hormone (insulin and glucagon) Artificial Pancreas may be justifiable in some, but not all, patients. We sought to compare dual- and single-hormone Artificial Pancreas systems in patients with hypoglycemia unawareness and documented nocturnal hypoglycemia. Methods: We conducted a randomized crossover trial comparing the efficacy of dual- and single-hormone Artificial Pancreas systems in controlling plasma glucose levels over the course of one night's sleep. We recruited 18 adult participants with hypoglycemia unawareness and 17 participants with hypoglycemia awareness, all of whom had documented nocturnal hypoglycemia during 2 weeks of screening. Outcomes were calculated using plasma glucose. Results: In participants with hypoglycemia unawareness, the median (interquartile range [IQR]) percentage of time that plasma glucose was below 4.0 mmol/L was 0% (0–0) on dual-hormone Artificial Pancreas nights and 0% (0–10) on single-hormone Artificial Pancreas nights (P = 0.20). Additi...
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outpatient 60 hour day and night glucose control with dual hormone Artificial Pancreas single hormone Artificial Pancreas or sensor augmented pump therapy in adults with type 1 diabetes an open label randomised crossover controlled trial
Diabetes Obesity and Metabolism, 2017Co-Authors: Ahmad Haidar, Virginie Messier, Laurent Legault, Martin Ladouceur, Remi RabasalhoretAbstract:Aims To assess whether the dual-hormone (insulin and glucagon) Artificial Pancreas reduces hypoglycemia compared to the single-hormone (insulin alone) Artificial Pancreas in outpatient settings during the day and night. Material and Methods In a randomized, three-way, crossover trial, we compared the dual-hormone Artificial Pancreas, the single-hormone Artificial Pancreas, and sensor-augmented pump therapy (control) in 23 adults with type 1 diabetes. Each intervention was applied from 08 h00 Day 1 to 20 h00 Day 3 (60 hours) in outpatient free-living conditions. The primary outcome was time spent with sensor glucose levels below 4.0 mmol/L. A P value of less than 0.017 was regarded as significant. This trial is registered, NCT01966393. Results The median difference between the dual-hormone system compared to the single-hormone system was -2.3% (P = 0.072) for time spent below 4.0 mmol/L, -1.3% (P = 0.017) for time below 3.5 mmol/L, and −0.7% (P = 0.031) for time below 3.3 mmol/L. Both systems reduced (P < 0.017) hypoglycemia below 4.0, 3.5, and 3.3 mmol/L compared to control therapy but the reductions were larger with the dual-hormone system than with the single-hormone system (medians −4.0% vs −3.4% for 4.0 mmol/L; -2.7% vs -2.2% for 3.5 mmol/L; and −2.2% vs −1.2% for 3.3 mmol/L). There were 34 hypoglycemic events (<3.0 mmol/L for 20 minutes) with control therapy, 14 with the single-hormone system, and 6 with the dual-hormone system. These differences in hypoglycemia were observed while mean glucose level was low and comparable in all interventions (P=NS). Conclusions The dual-hormone Artificial Pancreas had the lowest risk of hypoglycemia, but the differences were not statistically significant. Larger studies are needed.
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glucagon in Artificial Pancreas systems potential benefits and safety profile of future chronic use
Diabetes Obesity and Metabolism, 2017Co-Authors: Nadine Taleb, Ahmad Haidar, Virginie Messier, Véronique Gingras, Laurent Legault, Remi RabasalhoretAbstract:The role of glucagon in the pathophysiology of diabetes has long been recognized, although its approved clinical use has so far been limited to the emergency treatment of severe hypoglycaemia. A novel use of glucagon as intermittent mini-boluses is proposed in the dual-hormone version (insulin and glucagon) of the external Artificial Pancreas. Short-term studies suggest that the incorporation of glucagon into Artificial Pancreas systems has the potential to further decrease hypoglycaemic risk and improve overall glucose control; however, the potential long-term safety and benefits also need to be investigated given the recognized systemic effects of glucagon. In the present report, we review the available animal and human data on the physiological functions of glucagon, as well as its pharmacological use, according to dosing and duration (acute and chronic). Along with its main role in hepatic glucose metabolism, glucagon affects the cardiovascular, renal, pulmonary and gastrointestinal systems. It has a potential role in weight reduction through its central satiety function and its role in increasing energy expenditure. Most of the pharmacological studies investigating the effects of glucagon have used doses exceeding 1 mg, in contrast to the mini-boluses used in the Artificial Pancreas. The available data are reassuring but comprehensive human studies using small but chronic glucagon doses that are close to the physiological ranges are lacking. We propose a list of variables that could be monitored during long-term trials of the Artificial Pancreas. Such trials should address the questions about the risk-benefit ratio of chronic glucagon use.
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Single- and Dual-Hormone Artificial Pancreas for Overnight Glucose Control in Type 1 Diabetes.
The Journal of clinical endocrinology and metabolism, 2015Co-Authors: Ahmad Haidar, Virginie Messier, Rémi Rabasa-lhoret, Laurent Legault, Leif E. Lovblom, Rohan Rakheja, Émilie D'aoust, C. Marcelo Falappa, Tara Justice, Andrej OrszagAbstract:Context: The added benefit of glucagon in Artificial Pancreas systems for overnight glucose control in type 1 diabetes has not been fully explored. Objective: The objective of the study was to compare the efficacy of dual-hormone (insulin and glucagon) Artificial Pancreas, single-hormone (insulin alone) Artificial Pancreas, and conventional insulin pump therapy. Design: This study was a three-center, three-arm, open-label, randomized, crossover controlled trial involving three interventions, each applied over a night after a high carbohydrate/high fat meal and a second after exercise to mimic real-life glycemic excursions. Setting: The study was conducted in a home setting. Patients: Twenty-eight type 1 diabetes participants (21 adults and seven adolescents) participated in the study. Interventions: Dual-hormone Artificial Pancreas, single-hormone Artificial Pancreas, and conventional pump therapy was activated from 9:00 pm to 7:00 am. Main Outcome: The main outcome was a proportion of time in target (4–8...
Rémi Rabasa-lhoret - One of the best experts on this subject based on the ideXlab platform.
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Insulin Pumps and Artificial Pancreas
Encyclopedia of Endocrine Diseases, 2019Co-Authors: Nadine Taleb, Véronique Gingras, Rémi Rabasa-lhoretAbstract:Several technologies have recently been implemented to advance the management of insulin replacement in diabetes. The aim of these technologies is to provide the patients with better tools to meet the glycemic targets and to improve treatment flexibility and quality of life. Continuous subcutaneous insulin infusion using insulin pumps allowed a more flexible insulin delivery and continuous glucose monitoring by subcutaneous sensors improved glucose profiling to guide, in real-time, diabetes management. Different combinations of insulin pumps and glucose sensors have been made available over the years with the most advanced and promising being their integration in the external Artificial Pancreas. Better glucose control with a reduced risk of hypoglycemia has marked the clinical studies testing the Artificial Pancreas across different ages and conditions. This article sheds the light on these various technologies displaying their mode of action, clinical efficacy and limitations and discusses the challenges that still need to be overcome in the future of diabetes management.
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A critical review and analysis of ethical issues associated with the Artificial Pancreas.
Diabetes & metabolism, 2018Co-Authors: Ariane Quintal, Virginie Messier, Rémi Rabasa-lhoret, Eric RacineAbstract:The Artificial Pancreas combines a hormone infusion pump with a continuous glucose monitoring device, supported by a dosing algorithm currently installed on the pump. It allows for dynamic infusions of insulin (and possibly other hormones such as glucagon) tailored to patient needs. For patients with type 1 diabetes the Artificial Pancreas has been shown to prevent more effectively hypoglycaemic events and hyperglycaemia than insulin pump therapy and has the potential to simplify care. However, the potential ethical issues associated with the upcoming integration of the Artificial Pancreas into clinical practice have not yet been discussed. Our objective was to identify and articulate ethical issues associated with Artificial Pancreas use for patients, healthcare professionals, industry and policymakers. We performed a literature review to identify clinical, psychosocial and technical issues raised by the Artificial Pancreas and subsequently analysed them through a common bioethics framework. We identified five sensitive domains of ethical issues. Patient confidentiality and safety can be jeopardized by the Artificial Pancreas' vulnerability to security breaches or unauthorized data sharing. Public and private coverage of the Artificial Pancreas could be cost-effective and warranted. Patient selection criteria need to ensure equitable access and sensitivity to patient-reported outcomes. Patient coaching and support by healthcare professionals or industry representatives could help foster realistic expectations in patients. Finally, the Artificial Pancreas increases the visibility of diabetes and could generate issues related to personal identity and patient agency. The timely consideration of these issues will optimize the technological development and clinical uptake of the Artificial Pancreas.
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Overnight Glucose Control with Dual- and Single-Hormone Artificial Pancreas in Type 1 Diabetes with Hypoglycemia Unawareness: A Randomized Controlled Trial.
Diabetes technology & therapeutics, 2018Co-Authors: Alexander Abitbol, Virginie Messier, Rémi Rabasa-lhoret, Laurent Legault, Mohamad Smaoui, Nathan Cohen, Ahmad HaidarAbstract:Abstract Background: The dual-hormone (insulin and glucagon) Artificial Pancreas may be justifiable in some, but not all, patients. We sought to compare dual- and single-hormone Artificial Pancreas systems in patients with hypoglycemia unawareness and documented nocturnal hypoglycemia. Methods: We conducted a randomized crossover trial comparing the efficacy of dual- and single-hormone Artificial Pancreas systems in controlling plasma glucose levels over the course of one night's sleep. We recruited 18 adult participants with hypoglycemia unawareness and 17 participants with hypoglycemia awareness, all of whom had documented nocturnal hypoglycemia during 2 weeks of screening. Outcomes were calculated using plasma glucose. Results: In participants with hypoglycemia unawareness, the median (interquartile range [IQR]) percentage of time that plasma glucose was below 4.0 mmol/L was 0% (0–0) on dual-hormone Artificial Pancreas nights and 0% (0–10) on single-hormone Artificial Pancreas nights (P = 0.20). Additi...
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Single- and Dual-Hormone Artificial Pancreas for Overnight Glucose Control in Type 1 Diabetes.
The Journal of clinical endocrinology and metabolism, 2015Co-Authors: Ahmad Haidar, Virginie Messier, Rémi Rabasa-lhoret, Laurent Legault, Leif E. Lovblom, Rohan Rakheja, Émilie D'aoust, C. Marcelo Falappa, Tara Justice, Andrej OrszagAbstract:Context: The added benefit of glucagon in Artificial Pancreas systems for overnight glucose control in type 1 diabetes has not been fully explored. Objective: The objective of the study was to compare the efficacy of dual-hormone (insulin and glucagon) Artificial Pancreas, single-hormone (insulin alone) Artificial Pancreas, and conventional insulin pump therapy. Design: This study was a three-center, three-arm, open-label, randomized, crossover controlled trial involving three interventions, each applied over a night after a high carbohydrate/high fat meal and a second after exercise to mimic real-life glycemic excursions. Setting: The study was conducted in a home setting. Patients: Twenty-eight type 1 diabetes participants (21 adults and seven adolescents) participated in the study. Interventions: Dual-hormone Artificial Pancreas, single-hormone Artificial Pancreas, and conventional pump therapy was activated from 9:00 pm to 7:00 am. Main Outcome: The main outcome was a proportion of time in target (4–8...
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Outpatient overnight glucose control with dual-hormone Artificial Pancreas, single-hormone Artificial Pancreas, or conventional insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, randomised controlled trial
The lancet. Diabetes & endocrinology, 2015Co-Authors: Ahmad Haidar, Virginie Messier, Laurent Legault, Laurence Matteau-pelletier, Maryse Dallaire, Martin Ladouceur, Rémi Rabasa-lhoretAbstract:Summary Background Additional benefits of the dual-hormone (insulin and glucagon) Artificial Pancreas compared with the single-hormone (insulin alone) Artificial Pancreas have not been assessed in young people in outpatient unrestricted conditions. We evaluated the efficacy of three systems for nocturnal glucose control in children and adolescents with type 1 diabetes. Methods We did a randomised, three-way, crossover trial in children aged 9–17 years with type 1 diabetes attending a diabetes camp in Canada. With use of sealed envelopes, children were randomly assigned in a 1:1:1:1:1:1 ratio with blocks of six to different sequences of the three interventions (single-hormone Artificial Pancreas, dual-hormone Artificial Pancreas, and conventional continuous subcutaneous insulin pump therapy). Each intervention was applied for 3 consecutive nights. Participants, study staff, and endpoint assessors were not masked. The primary outcome was the percentage of time spent with glucose concentrations lower than 4·0 mmol/L from 2300 h to 0700 h. Analysis was by intention to treat. A p value of less than 0·0167 was regarded as significant. This study is registered with ClinicalTrials.gov, number NCT02189694. Findings Between June 30, 2014, and Aug 9, 2014, we enrolled 33 children of mean age 13·3 years (SD 2·3; range 9–17). The time spent at a glucose concentration lower than 4·0 mmol/L was median 0% (IQR 0·0–2·4) during nights with the dual-hormone Artificial Pancreas, 3·1% (0·0–6·9) during nights with the single-hormone Artificial Pancreas (p=0·032), and 3·4% (0–11·0) during nights with conventional pump therapy (p=0·0048 compared with dual-hormone Artificial Pancreas and p=0·32 compared with single-hormone Artificial Pancreas). 15 hypoglycaemic events ( Interpretation The dual-hormone Artificial Pancreas could improve nocturnal glucose control in children and adolescents with type 1 diabetes. Longer and larger outpatient studies are now needed. Funding Canadian Diabetes Association, Fondation J A De Seve.
Remi Rabasalhoret - One of the best experts on this subject based on the ideXlab platform.
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outpatient 60 hour day and night glucose control with dual hormone Artificial Pancreas single hormone Artificial Pancreas or sensor augmented pump therapy in adults with type 1 diabetes an open label randomised crossover controlled trial
Diabetes Obesity and Metabolism, 2017Co-Authors: Ahmad Haidar, Virginie Messier, Laurent Legault, Martin Ladouceur, Remi RabasalhoretAbstract:Aims To assess whether the dual-hormone (insulin and glucagon) Artificial Pancreas reduces hypoglycemia compared to the single-hormone (insulin alone) Artificial Pancreas in outpatient settings during the day and night. Material and Methods In a randomized, three-way, crossover trial, we compared the dual-hormone Artificial Pancreas, the single-hormone Artificial Pancreas, and sensor-augmented pump therapy (control) in 23 adults with type 1 diabetes. Each intervention was applied from 08 h00 Day 1 to 20 h00 Day 3 (60 hours) in outpatient free-living conditions. The primary outcome was time spent with sensor glucose levels below 4.0 mmol/L. A P value of less than 0.017 was regarded as significant. This trial is registered, NCT01966393. Results The median difference between the dual-hormone system compared to the single-hormone system was -2.3% (P = 0.072) for time spent below 4.0 mmol/L, -1.3% (P = 0.017) for time below 3.5 mmol/L, and −0.7% (P = 0.031) for time below 3.3 mmol/L. Both systems reduced (P < 0.017) hypoglycemia below 4.0, 3.5, and 3.3 mmol/L compared to control therapy but the reductions were larger with the dual-hormone system than with the single-hormone system (medians −4.0% vs −3.4% for 4.0 mmol/L; -2.7% vs -2.2% for 3.5 mmol/L; and −2.2% vs −1.2% for 3.3 mmol/L). There were 34 hypoglycemic events (<3.0 mmol/L for 20 minutes) with control therapy, 14 with the single-hormone system, and 6 with the dual-hormone system. These differences in hypoglycemia were observed while mean glucose level was low and comparable in all interventions (P=NS). Conclusions The dual-hormone Artificial Pancreas had the lowest risk of hypoglycemia, but the differences were not statistically significant. Larger studies are needed.
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glucagon in Artificial Pancreas systems potential benefits and safety profile of future chronic use
Diabetes Obesity and Metabolism, 2017Co-Authors: Nadine Taleb, Ahmad Haidar, Virginie Messier, Véronique Gingras, Laurent Legault, Remi RabasalhoretAbstract:The role of glucagon in the pathophysiology of diabetes has long been recognized, although its approved clinical use has so far been limited to the emergency treatment of severe hypoglycaemia. A novel use of glucagon as intermittent mini-boluses is proposed in the dual-hormone version (insulin and glucagon) of the external Artificial Pancreas. Short-term studies suggest that the incorporation of glucagon into Artificial Pancreas systems has the potential to further decrease hypoglycaemic risk and improve overall glucose control; however, the potential long-term safety and benefits also need to be investigated given the recognized systemic effects of glucagon. In the present report, we review the available animal and human data on the physiological functions of glucagon, as well as its pharmacological use, according to dosing and duration (acute and chronic). Along with its main role in hepatic glucose metabolism, glucagon affects the cardiovascular, renal, pulmonary and gastrointestinal systems. It has a potential role in weight reduction through its central satiety function and its role in increasing energy expenditure. Most of the pharmacological studies investigating the effects of glucagon have used doses exceeding 1 mg, in contrast to the mini-boluses used in the Artificial Pancreas. The available data are reassuring but comprehensive human studies using small but chronic glucagon doses that are close to the physiological ranges are lacking. We propose a list of variables that could be monitored during long-term trials of the Artificial Pancreas. Such trials should address the questions about the risk-benefit ratio of chronic glucagon use.
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comparison of dual hormone Artificial Pancreas single hormone Artificial Pancreas and conventional insulin pump therapy for glycaemic control in patients with type 1 diabetes an open label randomised controlled crossover trial
The Lancet Diabetes & Endocrinology, 2015Co-Authors: Ahmad Haidar, Virginie Messier, Laurent Legault, Tina Maria Mitre, Catherine Leroux, Remi RabasalhoretAbstract:Summary Background The Artificial Pancreas is an emerging technology for the treatment of type 1 diabetes and two configurations have been proposed: single-hormone (insulin alone) and dual-hormone (insulin and glucagon). We aimed to delineate the usefulness of glucagon in the Artificial Pancreas system. Methods We did a randomised crossover trial of dual-hormone Artificial Pancreas, single-hormone Artificial Pancreas, and conventional insulin pump therapy (continuous subcutaneous insulin infusion) in participants aged 12 years or older with type 1 diabetes. Participants were assigned in a 1:1:1:1:1:1 ratio with blocked randomisation to the three interventions and attended a research facility for three 24-h study visits. During visits when the patient used the single-hormone Artificial Pancreas, insulin was delivered based on glucose sensor readings and a predictive dosing algorithm. During dual-hormone Artificial Pancreas visits, glucagon was also delivered during low or falling glucose. During conventional insulin pump therapy visits, patients received continuous subcutaneous insulin infusion. The study was not masked. The primary outcome was the time for which plasma glucose concentrations were in the target range (4·0–10·0 mmol/L for 2 h postprandially and 4·0–8·0 mmol/L otherwise). Hypoglycaemic events were defined as plasma glucose concentration of less than 3·3 mmol/L with symptoms or less than 3·0 mmol/L irrespective of symptoms. Analysis was by modified intention to treat, in which we included data for all patients who completed at least two visits. A p value of less than 0·0167 (0·05/3) was regarded as significant. This trial is registered with ClinicalTrials.gov, number NCT01754337. Findings The mean proportion of time spent in the plasma glucose target range over 24 h was 62% (SD 18), 63% (18), and 51% (19) with single-hormone Artificial Pancreas, dual-hormone Artificial Pancreas, and conventional insulin pump therapy, respectively. The mean difference in time spent in the target range between single-hormone Artificial Pancreas and conventional insulin pump therapy was 11% (17; p=0·002) and between dual-hormone Artificial Pancreas and conventional insulin pump therapy was 12% (21; p=0·00011). There was no difference (15; p=0·75) in the proportion of time spent in the target range between the single-hormone and dual-hormone Artificial Pancreas systems. There were 52 hypoglycaemic events with conventional insulin pump therapy (12 of which were symptomatic), 13 with the single-hormone Artificial Pancreas (five of which were symptomatic), and nine with the dual-hormone Artificial Pancreas (0 of which were symptomatic); the number of nocturnal hypoglycaemic events was 13 (0 symptomatic), 0, and 0, respectively. Interpretation Single-hormone and dual-hormone Artificial Pancreas systems both provided better glycaemic control than did conventional insulin pump therapy. The single-hormone Artificial Pancreas might be sufficient for hypoglycaemia-free overnight glycaemic control. Funding Canadian Diabetes Association; Fondation J A De Seve; Juvenile Diabetes Research Foundation; and Medtronic.
