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Article ; Online: Therapy Settings Associated with Optimal Outcomes for t:slim X2 with Control-IQ Technology in Real-World Clinical Care.

Messer, Laurel H / Breton, Marc D

2023 Volume 25, Issue 12, Page(s) 877–882

Abstract: Objective: ...

Abstract	Objective:
MeSH term(s)	Humans ; Female ; Adult ; Male ; Hypoglycemic Agents/therapeutic use ; Blood Glucose ; Diabetes Mellitus, Type 1/drug therapy ; Diabetes Mellitus, Type 1/complications ; Retrospective Studies ; Blood Glucose Self-Monitoring ; Insulin Infusion Systems ; Hypoglycemia/drug therapy ; Insulin/therapeutic use ; Insulin, Regular, Human/therapeutic use ; Technology
Chemical Substances	Hypoglycemic Agents ; Blood Glucose ; Insulin ; Insulin, Regular, Human
Language	English
Publishing date	2023-10-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	1452816-2
ISSN	1557-8593 ; 1520-9156
ISSN (online)	1557-8593
ISSN	1520-9156
DOI	10.1089/dia.2023.0308
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Article ; Online: Integration of a Safety Module to Prevent Rebound Hypoglycemia in Closed-Loop Artificial Pancreas Systems.

Villa-Tamayo, María F / Colmegna, Patricio / Breton, Marc D

Journal of diabetes science and technology

2023 Volume 18, Issue 2, Page(s) 318–323

Abstract: Background: With automated insulin delivery (AID) systems becoming widely adopted in the management of type 1 diabetes, we have seen an increase in occurrences of rebound hypoglycemia or generated hypoglycemia induced by the controller's response to ... ...

Abstract	Background: With automated insulin delivery (AID) systems becoming widely adopted in the management of type 1 diabetes, we have seen an increase in occurrences of rebound hypoglycemia or generated hypoglycemia induced by the controller's response to rapid glucose rises following rescue carbohydrates. Furthermore, as AID systems aim to enable complete automation of prandial control, algorithms are designed to react even more strongly to glycemic rises. This work introduces a rebound hypoglycemia prevention layer (HypoSafe) that can be easily integrated into any AID system. Methods: HypoSafe constrains the maximum permissible insulin delivery dose based on the minimum glucose reading from the previous hour and the current glucose level. To demonstrate its efficacy, we integrated HypoSafe into the latest University of Virginia (UVA) AID system and simulated two scenarios using the 100-adult cohort of the UVA/Padova T1D simulator: a nominal case including three unannounced meals, and another case where hypoglycemia was purposely induced by an overestimated manual bolus. Results: In both simulation scenarios, rebound hypoglycemia events were reduced with HypoSafe (nominal: from 39 to 0, hypo-induced: from 55 to 7) by attenuating the commanded basal (nominal: 0.27U vs. 0.04U, hypo-induced: 0.27U vs. 0.03U) and bolus (nominal: 1.02U vs. 0.05U, hypo-induced: 0.43U vs. 0.02U) within the 30-minute interval after treating a hypoglycemia event. No clinically significant changes resulted for time in the range of 70 to 180 mg/dL or above 180 mg/dL. Conclusion: HypoSafe was shown to be effective in reducing rebound hypoglycemia events without affecting achieved time in range when combined with an advanced AID system.
MeSH term(s)	Adult ; Humans ; Hypoglycemic Agents/adverse effects ; Pancreas, Artificial/adverse effects ; Blood Glucose ; Blood Glucose Self-Monitoring/methods ; Insulin Infusion Systems/adverse effects ; Hypoglycemia/chemically induced ; Diabetes Mellitus, Type 1/drug therapy ; Insulin/adverse effects ; Glucose/adverse effects
Chemical Substances	Hypoglycemic Agents ; Blood Glucose ; Insulin ; Glucose (IY9XDZ35W2)
Language	English
Publishing date	2023-11-15
Publishing country	United States
Document type	Journal Article
ISSN	1932-2968
ISSN (online)	1932-2968
DOI	10.1177/19322968231212205
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Article ; Online: Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes. Reply.

Wadwa, R Paul / Beck, Roy W / Breton, Marc D

The New England journal of medicine

2023 Volume 388, Issue 23, Page(s) 2206–2207

MeSH term(s)	Child ; Humans ; Child, Preschool ; Diabetes Mellitus, Type 1/drug therapy ; Hypoglycemic Agents/therapeutic use ; Blood Glucose
Chemical Substances	Hypoglycemic Agents ; Blood Glucose
Language	English
Publishing date	2023-06-01
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc2304389
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Article ; Online: Performance Effect of Adjusting Insulin Sensitivity for Model-Based Automated Insulin Delivery Systems.

Moscoso-Vasquez, Marcela / Fabris, Chiara / Breton, Marc D

Journal of diabetes science and technology

2023 Volume 17, Issue 6, Page(s) 1470–1481

Abstract: Background: Model predictive control (MPC) has become one of the most popular control strategies for automated insulin delivery (AID) in type 1 diabetes (T1D). These algorithms rely on a prediction model to determine the best insulin dosing every ... ...

Abstract	Background: Model predictive control (MPC) has become one of the most popular control strategies for automated insulin delivery (AID) in type 1 diabetes (T1D). These algorithms rely on a prediction model to determine the best insulin dosing every sampling time. Although these algorithms have been shown to be safe and effective for glucose management through clinical trials, managing the ever-fluctuating relationship between insulin delivery and resulting glucose uptake (aka insulin sensitivity, IS) remains a challenge. We aim to evaluate the effect of informing an AID system with IS on the performance of the system. Method: The University of Virginia (UVA) MPC control-based hybrid closed-loop (HCL) and fully closed-loop (FCL) system was used. One-day simulations at varying levels of IS were run with the UVA/Padova T1D Simulator. The AID system was informed with an estimated value of IS obtained through a mixed meal glucose tolerance test. Relevant controller parameters are updated to inform insulin dosing of IS. Performance of the HCL/FCL system with and without information of the changing IS was assessed using a novel performance metric penalizing the time outside the target glucose range. Results: Feedback in AID systems provides a certain degree tolerance to changes in IS. However, IS-informed bolus and basal dosing improve glycemic outcomes, providing increased protection against hyperglycemia and hypoglycemia according to the individual's physiological state. Conclusions: The proof-of-concept analysis presented here shows the potentially beneficial effects on system performance of informing the AID system with accurate estimates of IS. In particular, when considering reduced IS, the informed controller provides increased protection against hyperglycemia compared with the naïve controller. Similarly, reduced hypoglycemia is obtained for situations with increased IS. Further tailoring of the adaptation schemes proposed in this work is needed to overcome the increased hypoglycemia observed in the more resistant cases and to optimize the performance of the adaptation method.
MeSH term(s)	Humans ; Diabetes Mellitus, Type 1/drug therapy ; Hypoglycemic Agents ; Blood Glucose/analysis ; Insulin Resistance ; Blood Glucose Self-Monitoring ; Insulin Infusion Systems ; Hypoglycemia/prevention & control ; Insulin ; Hyperglycemia/drug therapy ; Insulin, Regular, Human/therapeutic use ; Glucose ; Algorithms
Chemical Substances	Hypoglycemic Agents ; Blood Glucose ; Insulin ; Insulin, Regular, Human ; Glucose (IY9XDZ35W2)
Language	English
Publishing date	2023-10-20
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ISSN	1932-2968
ISSN (online)	1932-2968
DOI	10.1177/19322968231206798
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Article ; Online: Maximizing Glycemic Benefits of Using Faster Insulin Formulations in Type 1 Diabetes: In Silico Analysis Under Open- and Closed-Loop Conditions.

Diaz C, Jenny L / Colmegna, Patricio / Breton, Marc D

Diabetes technology & therapeutics

2023 Volume 25, Issue 4, Page(s) 219–230

Abstract: Background: ...

Abstract	Background:
MeSH term(s)	Adult ; Humans ; Blood Glucose ; Diabetes Mellitus, Type 1/drug therapy ; Hypoglycemic Agents/therapeutic use ; Insulin/therapeutic use ; Insulin Aspart/therapeutic use ; Insulin Infusion Systems ; Insulin, Regular, Human/therapeutic use ; Computer Simulation
Chemical Substances	Blood Glucose ; Hypoglycemic Agents ; Insulin ; Insulin Aspart (D933668QVX) ; Insulin, Regular, Human
Language	English
Publishing date	2023-01-19
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1452816-2
ISSN	1557-8593 ; 1520-9156
ISSN (online)	1557-8593
ISSN	1520-9156
DOI	10.1089/dia.2022.0468
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Zs.A 5269: Show issues

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Article ; Online: One Year Real-World Use of the Control-IQ Advanced Hybrid Closed-Loop Technology.

Breton, Marc D / Kovatchev, Boris P

Diabetes technology & therapeutics

2021 Volume 23, Issue 9, Page(s) 601–608

Abstract: Background: ...

Abstract	Background:
MeSH term(s)	Adolescent ; Adult ; Blood Glucose ; Blood Glucose Self-Monitoring/methods ; Child ; Diabetes Mellitus, Type 1/drug therapy ; Female ; Humans ; Hypoglycemic Agents/therapeutic use ; Insulin/therapeutic use ; Insulin Infusion Systems ; Male ; Middle Aged ; Retrospective Studies ; Technology ; Young Adult
Chemical Substances	Blood Glucose ; Hypoglycemic Agents ; Insulin
Language	English
Publishing date	2021-04-21
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1452816-2
ISSN	1557-8593 ; 1520-9156
ISSN (online)	1557-8593
ISSN	1520-9156
DOI	10.1089/dia.2021.0097
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Article ; Online: Handling Exercise During Closed Loop Control.

Breton, Marc D

Diabetes technology & therapeutics

2017 Volume 19, Issue 6, Page(s) 328–330

MeSH term(s)	Blood Glucose ; Diabetes Mellitus, Type 1/blood ; Diabetes Mellitus, Type 1/drug therapy ; Exercise/physiology ; Humans ; Hypoglycemic Agents/therapeutic use ; Insulin/therapeutic use ; Insulin Infusion Systems
Chemical Substances	Blood Glucose ; Hypoglycemic Agents ; Insulin
Language	English
Publishing date	2017-06-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	1452816-2
ISSN	1557-8593 ; 1520-9156
ISSN (online)	1557-8593
ISSN	1520-9156
DOI	10.1089/dia.2017.0191
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Zs.A 5269: Show issues

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Article: Titration of Long-Acting Insulin Using Continuous Glucose Monitoring and Smart Insulin Pens in Type 1 Diabetes: A Model-Based Carbohydrate-Free Approach.

El Fathi, Anas / Fabris, Chiara / Breton, Marc D

Frontiers in endocrinology

2022 Volume 12, Page(s) 795895

Abstract: Objective: Multiple daily injections (MDI) therapy is the most common treatment for type 1 diabetes (T1D), consisting of long-acting insulin to cover fasting conditions and rapid-acting insulin to cover meals. Titration of long-acting insulin is needed ... ...

Abstract	Objective: Multiple daily injections (MDI) therapy is the most common treatment for type 1 diabetes (T1D), consisting of long-acting insulin to cover fasting conditions and rapid-acting insulin to cover meals. Titration of long-acting insulin is needed to achieve satisfactory glycemia but is challenging due to inter-and intra-individual metabolic variability. In this work, a novel titration algorithm for long-acting insulin leveraging continuous glucose monitoring (CGM) and smart insulin pens (SIP) data is proposed. Methods: The algorithm is based on a glucoregulatory model that describes insulin and meal effects on blood glucose fluctuations. The model is individualized on patient's data and used to extract the theoretical glucose curve in fasting conditions; the individualization step does not require any carbohydrate records. A cost function is employed to search for the optimal long-acting insulin dose to achieve the desired glycemic target in the fasting state. The algorithm was tested in two virtual studies performed within a validated T1D simulation platform, deploying different levels of metabolic variability (nominal and variance). The performance of the method was compared to that achieved with two published titration algorithms based on self-measured blood glucose (SMBG) records. The sensitivity of the algorithm to carbohydrate records was also analyzed. Results: The proposed method outperformed SMBG-based methods in terms of reduction of exposure to hypoglycemia, especially during the night period (0 am-6 am). In the variance scenario, during the night, an improvement in the time in the target glycemic range (70-180 mg/dL) from 69.0% to 86.4% and a decrease in the time in hypoglycemia (<70 mg/dL) from 10.7% to 2.6% was observed. Robustness analysis showed that the method performance is non-sensitive to carbohydrate records. Conclusion: The use of CGM and SIP in people with T1D using MDI therapy has the potential to inform smart insulin titration algorithms that improve glycemic control. Clinical studies in real-world settings are warranted to further test the proposed titration algorithm. Significance: This algorithm is a step towards a decision support system that improves glycemic control and potentially the quality of life, in a population of individuals with T1D who cannot benefit from the artificial pancreas system.
MeSH term(s)	Algorithms ; Blood Glucose/metabolism ; Blood Glucose Self-Monitoring ; Computer Simulation ; Decision Support Techniques ; Diabetes Mellitus, Type 1/drug therapy ; Diabetes Mellitus, Type 1/metabolism ; Diet Records ; Dietary Carbohydrates ; Glycemic Control/methods ; Humans ; Hypoglycemia/chemically induced ; Hypoglycemia/prevention & control ; Hypoglycemic Agents/administration & dosage ; Injections, Subcutaneous/instrumentation ; Insulin, Long-Acting/administration & dosage ; Monitoring, Ambulatory
Chemical Substances	Blood Glucose ; Dietary Carbohydrates ; Hypoglycemic Agents ; Insulin, Long-Acting
Language	English
Publishing date	2022-01-10
Publishing country	Switzerland
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2592084-4
ISSN	1664-2392
ISSN	1664-2392
DOI	10.3389/fendo.2021.795895
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Article ; Online: Improvements in Parental Sleep, Fear of Hypoglycemia, and Diabetes Distress With Use of an Advanced Hybrid Closed-Loop System.

Cobry, Erin C / Bisio, Alessandro / Wadwa, R Paul / Breton, Marc D

Diabetes care

2022 Volume 45, Issue 5, Page(s) 1292–1295

Abstract: Objective: Parental sleep quality may contribute to glycemic control in youth with type 1 diabetes. In this article we present sleep analysis from a multicenter, randomized trial of children ages 6-13 years with type 1 diabetes evaluating the Tandem ... ...

Abstract	Objective: Parental sleep quality may contribute to glycemic control in youth with type 1 diabetes. In this article we present sleep analysis from a multicenter, randomized trial of children ages 6-13 years with type 1 diabetes evaluating the Tandem Control-IQ (CIQ) hybrid closed-loop (HCL) system. Research design and methods: Pittsburgh Sleep Quality Index (PSQI) scores were assessed at baseline to identify parents as "poor" sleepers (PSQI >5). Glycemic and psycho-behavioral outcomes before and after CIQ use were analyzed in poor sleepers (n = 49) and their children. Results: Nocturnal time in range (P < 0.001) and time hyperglycemic (P < 0.001), Hypoglycemia Fear Survey for Parents score (P < 0.001), Problem Areas in Diabetes scale score (P < 0.001), PSQI score (P < 0.001), and Hypoglycemia Fear Survey for Children score (P = 0.025) significantly improved. Of poor sleepers, 27 became good sleepers (PSQI score <5). Conclusions: Use of CIQ in youth with type 1 diabetes ages 6-13 years significantly improved sleep and psychosocial measures in parent poor sleepers, coinciding with improvements in child nocturnal glycemia, highlighting the relationship between HCL systems and parent sleep quality.
MeSH term(s)	Adolescent ; Blood Glucose ; Child ; Diabetes Mellitus, Type 1/complications ; Diabetes Mellitus, Type 1/psychology ; Fear ; Humans ; Hypoglycemia ; Parents/psychology ; Sleep
Chemical Substances	Blood Glucose
Language	English
Publishing date	2022-02-24
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	441231-x
ISSN	1935-5548 ; 0149-5992
ISSN (online)	1935-5548
ISSN	0149-5992
DOI	10.2337/dc21-1778
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Article ; Online: Insulin Replacement Across the Menstrual Cycle in Women with Type 1 Diabetes: An In Silico Assessment of the Need for Ad Hoc Technology.

Diaz C, Jenny L / Fabris, Chiara / Breton, Marc D / Cengiz, Eda

Diabetes technology & therapeutics

2022 Volume 24, Issue 11, Page(s) 832–841

Abstract: Background: ...

Abstract	Background:
MeSH term(s)	Female ; Humans ; Diabetes Mellitus, Type 1/drug therapy ; Insulin/therapeutic use ; Insulin Infusion Systems ; Blood Glucose ; Hypoglycemic Agents/therapeutic use ; Insulin, Regular, Human/therapeutic use ; Menstrual Cycle ; Insulin Resistance ; Technology
Chemical Substances	Insulin ; Blood Glucose ; Hypoglycemic Agents ; Insulin, Regular, Human
Language	English
Publishing date	2022-06-17
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1452816-2
ISSN	1557-8593 ; 1520-9156
ISSN (online)	1557-8593
ISSN	1520-9156
DOI	10.1089/dia.2022.0154
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