Evaluation of a Web-Based Simulation Tool for Self-Management Support in Type 1 Diabetes: A Pilot Study.

OBJECTIVE: To develop and evaluate a novel Web-based Simulation Tool (WST) that brings simulation technologies to people with Type 1 Diabetes (T1D), enabling unique patient-data interactions seamlessly on a daily basis. METHODS: A pilot clinical trial was conducted to assess system usability. The study consisted of one week of observation (Phase 1) and four weeks of interaction with WST (Phase 2). Responses to Technology Acceptance (TA) and Diabetes Distress Scale (DDS) questionnaires were collected, and follow-up interviews were conducted after Phase 2. RESULTS: Fifteen participants with T1D using Control-IQ technology (age: 36 ± 13 years, HbA1c: 6.5% ± 0.7%) completed all study procedures. Generated simulation models achieved a median Mean Absolute Relative Difference (MARD) of 6.8% [interquartile range, IQR: 5.1%, 9.1%]. A decrease in expected benefits (likely explained by issues with the third-party data collection system) and an increase in expected burdens were observed. On a 1-5 scale, ease of use, trust, and usefulness scores were 3 [3,4], 4 [3,4], and 4 [3,4], respectively. Time below 70 mg/dL decreased between Phases 1 and 2 (1.6% [0.7%,3.7%] vs 0.8% [0.5%,3.0%]). A reduction in mean emotional burden was also observed (2.5 ± 1.1 vs 2.1 ± 0.8). CONCLUSIONS: Results indicate that there was a learning curve to WST, but also that most participants trusted the system and found it useful in their diabetes care. SIGNIFICANCE: Simulation technologies like WST could be used by educators and patients to facilitate diabetes self-management, leading to better diabetes literacy and reducing associated distress.

Improvements in Parental Sleep, Fear of Hypoglycemia, and Diabetes Distress With Use of an Advanced Hybrid Closed-Loop System.

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.

The Impact of a Recently Approved Automated Insulin Delivery System on Glycemic, Sleep, and Psychosocial Outcomes in Older Adults With Type 1 Diabetes: A Pilot Study.

BACKGROUND: Older adults with type 1 diabetes (≥65 years) are often under-represented in clinical trials of automated insulin delivery (AID) systems. We sought to test the efficacy of a recently FDA-approved AID system in this population. METHODS: Participants with type 1 diabetes used sensor-augmented pump (SAP) therapy for four weeks and then used an AID system (Control-IQ) for four weeks. In addition to glucose control variables, patient-reported outcomes (PRO) were assessed with questionnaires and sleep parameters were assessed by actigraphy. RESULTS: Fifteen older adults (mean age 68.7 ± 3.3, HbA1c of 7.0 ± 0.8) completed the pilot trial. Glycemic outcomes improved during AID compared to SAP. During AID use, mean glucose was 146.0 mg/dL; mean percent time in range (TIR, 70-180 mg/dL) was 79.6%; median time below 70 mg/dL was 1.1%. The AID system was in use 92.6% ± 7.0% of the time. Compared to SAP, while participants were on AID the TIR increased significantly (+10%, P = .002) accompanied by a reduction in both time above 180 mg/dL (-6.9%, P = .005) and below 70 mg/dl (-0.4%, P = .053). Diabetes-related distress decreased significantly while using AID (P = .028), but sleep parameters remained unchanged. CONCLUSIONS: Use of this AID system in older adults improved glycemic control with high scores in ease of use, trust, and usability. Participants reported an improvement in diabetes distress with AID use. There were no significant changes in sleep.

Assessment for Predictors of Rise in Hemoglobin A1c During Extended Use of a Closed-Loop Control System.

We assessed predictors of rising hemoglobin A1c (HbA1c) during long-term use of closed-loop control (CLC) in children aged 6-13 years with type 1 diabetes. Participants used a CLC system during a 16-week randomization phase followed by a 12-week extension phase. We compared an "Increased-HbA1c" group (n = 17, ≥0.5% rise in HbA1c between randomization and extension phases) to a "Maintained-Improvement" group (n = 18, had stable or improved HbA1c). The Increased-HbA1c group had higher pre-CLC HbA1c (8.42% ± 0.80 vs. 7.45% ± 0.93, P = 0.002). Contrary to a-priori hypotheses, there were no differences in Δ-height-for-age z-score, a surrogate for a pubertal growth spurt (+0.16 vs. -0.15, P = 0.113), or number of carbohydrate boluses per day, a surrogate for missed boluses (4.4 ± 2.2 vs. 5.2 ± 2.1, P = 0.263). Both groups maintained high rates in closed-loop. Thus, some children exhibit meaningful rise in HbA1c after initial CLC use, likely from multiple contributing factors, and may benefit from added encouragement during ongoing use.

Impact of a Novel Diabetes Support System on a Cohort of Individuals With Type 1 Diabetes Treated With Multiple Daily Injections: A Multicenter Randomized Study.

OBJECTIVE: Achieving optimal glycemic control for many individuals with type 1 diabetes (T1D) remains challenging, even with the advent of newer management tools, including continuous glucose monitoring (CGM). Modern management of T1D generates a wealth of data; however, use of these data to optimize glycemic control remains limited. We evaluated the impact of a CGM-based decision support system (DSS) in patients with T1D using multiple daily injections (MDI). RESEARCH DESIGN AND METHODS: The studied DSS included real-time dosing advice and retrospective therapy optimization. Adults and adolescents (age >15 years) with T1D using MDI were enrolled at three sites in a 14-week randomized controlled trial of MDI + CGM + DSS versus MDI + CGM. All participants (N = 80) used degludec basal insulin and Dexcom G5 CGM. CGM-based and patient-reported outcomes were analyzed. Within the DSS group, ad hoc analysis further contrasted active versus nonactive DSS users. RESULTS: No significant differences were detected between experimental and control groups (e.g., time in range [TIR] +3.3% with CGM vs. +4.4% with DSS). Participants in both groups reported lower HbA1c (-0.3%; P = 0.001) with respect to baseline. While TIR may have improved in both groups, it was statistically significant only for DSS; the same was apparent for time spent <60 mg/dL. Active versus nonactive DSS users showed lower risk of and exposure to hypoglycemia with system use. CONCLUSIONS: Our DSS seems to be a feasible option for individuals using MDI, although the glycemic benefits associated with use need to be further investigated. System design, therapy requirements, and target population should be further refined prior to use in clinical care.

Scattering and Perturbation Theory for Discrete-Time Dynamics.

We present a systematic treatment of scattering processes for quantum systems whose time evolution is discrete. We define and show some general properties of the scattering operator, in particular the conservation of quasienergy which is defined only modulo 2π. Then we develop two perturbative techniques for the power series expansion of the scattering operator, the first one analogous to the iterative solution of the Lippmann-Schwinger equation, the second one to the Dyson series of perturbative quantum field theory. We use this formalism to compare the scattering amplitudes of a continuous-time model and of the corresponding discretized one. We give a rigorous assessment of the comparison for the case of bounded free Hamiltonian, as in a lattice theory with a bounded number of particles. Our framework can be applied to a wide class of quantum simulators, like quantum walks and quantum cellular automata. As a case study, we analyze the scattering properties of a one-dimensional cellular automaton with locally interacting fermions.

Sleep and diabetes-specific psycho-behavioral outcomes of a new automated insulin delivery system in young children with type 1 diabetes and their parents.

BACKGROUND: Data on the use of Control-IQ, the latest FDA-approved automated insulin delivery (AID) system for people with T1D 6 years of age or older is still scarce, particularly regarding nonglycemic outcomes. Children with T1D and their parents are at higher risk for sleep disturbances. This study assesses sleep, psycho-behavioral and glycemic outcomes of AID compared to sensor-augmented pump therapy (SAP) therapy in young children with T1D and their parents. METHODS: Thirteen parents and their young children (ages 7-10) on insulin pump therapy were enrolled. Children completed an initial 4-week study with SAP using their own pump and a study CGM followed by a 4-week phase of AID. Sleep outcomes for parents and children were evaluated through actigraphy watches. Several questionnaires were administered at baseline and at the end of each study phase. CGM data were used to assess glycemic outcomes. RESULTS: Actigraphy data did not show any significant change from SAP to AID, except a reduction of number of parental awakenings during the night (p = 0.036). Parents reported statistically significant improvements in Pittsburgh Sleep Quality Index total score (p = 0.009), Hypoglycemia Fear Survey total score (p = 0.011), diabetes-related distress (p = 0.032), and depression (p = 0.023). While on AID, time in range (70-180 mg/dL) significantly increased compared to SAP (p < 0.001), accompanied by a reduction in hyperglycemia (p = 0.001). CONCLUSIONS: These results suggest that use of AID has a positive impact on glycemic outcomes in young children as well as sleep and diabetes-specific quality of life outcomes in their parents.

Helicobacter pylori and diabetes mellitus: a controversial relationship.

Research on Helicobacter pylori (H. pylori), a pathogenic bacterium that is widespread among humans, is investigating the medical implications of the infection in many fields beyond gastroenterology. Because of the ubiquitous presence of the infection, there is an increasing interest in finding a relationship between this bacterium and diabetes mellitus (DM). It is not clear whether a significant relation between H. pylori and DM exists, whether the infection influences diabetes or vice versa, and the mechanisms underlying such a relationship. This review provides an analysis of new insights from studies published in more recent years. New research on this topic concentrated on the common pathogenic aspects between the bacterium and insulin resistance or autoimmunity, on the role of the bacterial infection in cardiovascular risk and whether the infection worsen glycemic outcomes in patients with DM. Research in this field still has to conclusively assess and explain the existence of a possible relationship between H. pylori and DM. Some studies have reached antithetic conclusions. Unless more robust data from studies using consistent research methods become available in the near future, people with diabetes should be compared to the general population when it comes to investigating and treating the presence of H. pylori.

Coping strategies in people with type 1 diabetes on insulin pump treatment.

BACKGROUND: In stressed people with diabetes (PWD) glycemia varies idiosyncratically. Coping is a relatively stable personality trait that assesses how individual deals with stress. Insulin pumps are considered the best insulin delivery system but require more attention from PWD, virtually increasing stress levels. Aim of our study was to evaluate the coping strategies adopted by a pool of participants with type 1 diabetes mellitus (T1DM) on continuous subcutaneous insulin infusion (CSII) therapy. METHODS: We collected data from 158 people with T1DM on CSII. COPE-NVI Test was administered and we also collected: hemoglobin A1c (HbA1c), 30 days of self-monitoring of blood glucose (SMBG) and continuous glucose monitoring (CGM) records (the most recent). From SMBG and CGM records we computed Kovatchev indexes. We investigated bivariate correlations between HbA1c, indexes and the results of the COPE-NVI Test; the analysis was performed on the total sample and on two sub-groups: men and women. The participants were then divided into clusters and non-parametric tests were performed. RESULTS: Regarding bivariate correlation, at a level of significance of 95%, several statistically significant correlations were found in the total sample and in both men and women sub-groups. Regarding non-parametric tests, we observed statistically significant results in clusters of the total sample and clusters of the sub-group formed by men, divided according to Low Blood Glucose Index (LBGI) risk, showing a different use of certain coping strategies. CONCLUSIONS: Assessing coping strategies preferably used by PWD is useful to select PWD in need of counseling and empowerment-oriented training in order to improve glycemic outcomes and decrease severe hypo/hyperglycemic events.

Theoretical framework for higher-order quantum theory.

Higher-order quantum theory is an extension of quantum theory where one introduces transformations whose input and output are transformations, thus generalizing the notion of channels and quantum operations. The generalization then goes recursively, with the construction of a full hierarchy of maps of increasingly higher order. The analysis of special cases already showed that higher-order quantum functions exhibit features that cannot be tracked down to the usual circuits, such as indefinite causal structures, providing provable advantages over circuital maps. The present treatment provides a general framework where this kind of analysis can be carried out in full generality. The hierarchy of higher-order quantum maps is introduced axiomatically with a formulation based on the language of types of transformations. Complete positivity of higher-order maps is derived from the general admissibility conditions instead of being postulated as in previous approaches. The recursive characterization of convex sets of maps of a given type is used to prove equivalence relations between different types. The axioms of the framework do not refer to the specific mathematical structure of quantum theory, and can therefore be exported in the context of any operational probabilistic theory.

Optimal Probabilistic Storage and Retrieval of Unitary Channels.

We address the question of quantum memory storage for quantum dynamics. In particular, we design an optimal protocol for N→1 probabilistic storage and retrieval of unitary channels on d-dimensional quantum systems. If we access the unknown unitary gate only N times, the optimal success probability of perfect single-use retrieval is N/(N-1+d^{2}). The derived size of the memory system exponentially improves the known upper bound on the size of the program register needed for probabilistic programmable quantum processors. Our results are closely related to probabilistic perfect alignment of reference frames and probabilistic port-based teleportation.

Solutions of a Two-Particle Interacting Quantum Walk.

We study the solutions of an interacting Fermionic cellular automaton which is the analogue of the Thirring model with both space and time discrete. We present a derivation of the two-particle solutions of the automaton recently in the literature, which exploits the symmetries of the evolution operator. In the two-particle sector, the evolution operator is given by the sequence of two steps, the first one corresponding to a unitary interaction activated by two-particle excitation at the same site, and the second one to two independent one-dimensional Dirac quantum walks. The interaction step can be regarded as the discrete-time version of the interacting term of some Hamiltonian integrable system, such as the Hubbard or the Thirring model. The present automaton exhibits scattering solutions with nontrivial momentum transfer, jumping between different regions of the Brillouin zone that can be interpreted as Fermion-doubled particles, in stark contrast with the customary momentum-exchange of the one-dimensional Hamiltonian systems. A further difference compared to the Hamiltonian model is that there exist bound states for every value of the total momentum and of the coupling constant. Even in the special case of vanishing coupling, the walk manifests bound states, for finitely many isolated values of the total momentum. As a complement to the analytical derivations we show numerical simulations of the interacting evolution.

Quantum walks, deformed relativity and Hopf algebra symmetries.

We show how the Weyl quantum walk derived from principles in D'Ariano & Perinotti (D'Ariano & Perinotti 2014Phys. Rev. A90, 062106. (doi:10.1103/PhysRevA.90.062106)), enjoying a nonlinear Lorentz symmetry of dynamics, allows one to introduce Hopf algebras for position and momentum of the emerging particle. We focus on two special models of Hopf algebras-the usual Poincaré and theκ-Poincaré algebras.