Journal of Diabetes Science and Technology最新文献

Background: In people with type 1 diabetes (T1D) admitted to hospital, adverse glycemic events (AGE), both hypoglycemia and hyperglycemia, bestow risk for adverse outcomes. Continuous glucose monitoring (CGM) use is increasingly common amongst people with T1D. We investigated AGE frequency in hospital, based on CGM versus point-of-care (POC) blood glucose measures.

Methods: In this multi-center retrospective analysis of non-critically ill hospitalized adults with T1D who continued wearing their unmasked CGM (FreeStyle Libre 1/2, Dexcom G5/G6, Medtronic Guardian 3) during admission and received standard ward-based POC testing, we compared CGM- and POC-based AGE detection of hypoglycemia (<70 mg/dL) and hyperglycemia (>180 mg/dL).

Results: In 253 admissions, 127 837 CGM and 5508 POC glucose measures were analyzed, yielding 1391 CGM-detected hyperglycemia AGE and 317 CGM-detected hypoglycemia AGE. For CGM-detected AGE with a concurrent POC AGE evident, CGM detected hyperglycemia a median [interquartile range, IQR] of 70 minutes [22, 166] before POC and at lower glucose concentrations (187 vs 223 mg/dL, P < .0001) and detected hypoglycemia a median [IQR] of 38 minutes [14, 65] before POC and at higher glucose concentrations (67 vs 56 mg/dL, P < .0001). A quarter of CGM-detected AGE were not detected by POC. Only 3% of POC-detected AGE were not detected by CGM.

Conclusions: Almost all AGE in hospital were detected by CGM, with few detected by POC alone. Compared to POC, CGM detected AGE earlier, with a lesser glycemic extreme, although unmasked CGM use may have influenced these results. Detecting AGE in hospital appears superior with CGM compared to POC glucose alone in people with T1D.

There are a plethora of medical journals, also for the diabetes indication. Only a limited number of these journals are listed in databases like PubMed. A number of other diabetes journals approach potential authors and ask for submission of manuscripts. They promise rapid publication; however, one wonders what kind of impact these journals have and how serious they are at handling the review process and so on. One wonders what the economical basis (= business model) for these journals is, the publication fee might be considerable. Apparently, some journals pretend to publish manuscripts; however, this does not happen in reality, despite the fact that the authors have paid the publication fee. In the same line of thinking, the quality of the publications in these journals is at least questionable.

Importance and aims:Diabetes can lead to microvascular and macrovascular complications. Modeling the complex relationships between risk factors has motivated the use of Artificial Intelligence (AI) to develop predictive models. Recent advancements, including foundation models and generative AI, have significantly changed how this technology is applied across various contexts. In this review, we summarize the current state of research on AI for predictive diabetes complications, investigating the present and future implications of these innovations.

Methods: We conducted the literature search on PubMed, Scopus, Ovid MEDLINE, CINAHL, and IEEE databases. Our analysis focused on predicted complications, population characteristics, use of AI-based approaches, models' performance, predictor variables, and feature importance evaluation results.

Results: The 49 studies selected in our analysis considered different conditions as prediction outcomes. Eye-related complications were included in 29 studies (59%), emerging as the most frequent predicted diseases. Among the 48 studies employing AI algorithms specifically for the prediction task, 26 (54%) developed only Machine Learning models, 4 (8%) only Deep Learning models, and 18 (38%) applied both approaches. Foundation models and recent AI innovations included in the query were not used by any study. Moreover, only five studies (10%) dealt with unstructured data (signals and images). In the feature importance evaluation, age and glycated hemoglobin consistently emerged as important predictors.

Conclusions: Despite the extensive existing literature on AI for predicting diabetes complications, several emerging challenges persist. These include the effective utilization of unstructured data and the integration of recent advancements introduced by foundation models and generative AI.

The introduction of continuous glucose monitoring (CGM) has been considered a transformative monitoring tool in diabetes management. However, its adoption remains limited in the Gulf region, especially for patients with type 2 diabetes, due to cost, lack of reimbursement strategies, variability in healthcare infrastructure, and lack of trained health care providers (HCPs). The lack of regional guidelines tailored to the unique demographic, cultural, and health care needs of the Gulf population has resulted in low adoption and inconsistent use of CGM in clinical practice, leaving many patients without adequate advanced glucose monitoring options. This expert opinion statement evaluates the evidence for real-time CGM in the management of patients with type 2 diabetes and provides region-specific recommendations to guide HCPs in optimizing CGM use, improving patient outcomes, and addressing barriers to implementation in the Gulf region.

Background: Automated insulin delivery (AID) systems are limited by the short wear time of insulin infusion sets, which typically need replacement every 2 to 3 days, significantly shorter than the 14-day lifespan of continuous glucose monitoring (CGM) sensors. Infusion set failure remains a major obstacle to AID reliability and patient adherence. This study examined the roles of insertion trauma and biomaterial composition in causing acute inflammatory responses using both swine and mouse models.

Methodology: We evaluated three commercial CGM sensors (Abbott Libre 2, Dexcom G7, Medtronic Guardian 3) and two Teflon-based IIS catheters (Medtronic QuickSet and i-Port Advance). In swine, tissue was histologically analyzed one day after implantation to assess neutrophil extracellular trap (NET) formation. In a murine air pouch model, we isolated material-specific immune responses by reducing mechanical injury. Lavage fluids collected at 1 and 3 days postimplantation were examined for immune cell infiltration and cytokine expression using flow cytometry and MSD multiplex assays.

Results: NETs were observed at all insertion sites, indicating that tissue trauma, rather than the material itself, is the primary trigger of early NET formation. However, Teflon catheters caused a more prolonged inflammatory response, with increased recruitment of macrophages and mast cells, and higher levels of TNF-α and KC/GRO. In contrast, polyurethane-based sensors induced minimal immune activation, suggesting greater biocompatibility. The findings were consistent across models, although some species-specific differences were noted.

Conclusion: These findings underscore the importance of minimizing insertion trauma and selecting biocompatible materials to promote device-tissue integration, prolong wear time, and enhance AID system performance.

Background: This descriptive observational study reports on continuous glucose monitoring (CGM) data, using a novel glucose biosensor (Abbott Libre Sense Glucose Sport Biosensor), during professional game play and during daily life in elite European football players.

Methods: Eighteen healthy male elite football players (age: 27.5 ± 5.1 years; height 180.1 ± 7.2 cm, weight 74.2 ± 9.1 kg, UEFA Champions League club) participated, with a subset examined for a single game for active (n = 10) and reserve (n = 4) players. Group comparisons used unpaired t-tests or Wilcoxon rank-sum tests; within-group differences used repeated measures one-way analysis of variance or Friedman test. Descriptive statistics were summarized for 24-hour data for daytime (06:00 am-10:59 pm) and nighttime (11:00 pm-05:59 am).

Results: Higher mean CGM glucose was observed during-game in active compared with reserve players (159 ± 23 vs 133 ± 25 mg/dL, P = .09), with significantly higher time above range (TAR, 72.8 ± 32.02 vs 29.7 ± 37.9%, P = .04) and lower time in range (TIR, 26.7 ± 31.9 vs 70.3 ± 37.9%, P = .04). In the 90 minute pre- to 180 minute post-game period, TAR (57.3 ± 26.6% vs 16.1 ± 20.2%, P = .02) and mean iG (149 ± 19 vs 123 ± 14 mg/dL, P = .02) remained higher for active players. For all 18 players, TIR was 89.4 ± 11.7 and 91.6 ± 13.7%, TAR was 5.9 ± 6.7 and 2.9 ± 5.7%, and time below range was 4.5 ± 10.5 and 5.3 ± 13.2% for day and night, respectively.

Conclusions: This observational study suggests that elite European footballers may have significant increases in glycemia, as measured by CGM, supporting the notion that mild hyperglycemia can occur during and after active competition in healthy and metabolically normal athletes, perhaps because of competition stress.

Background: To evaluate a new fully closed-loop (FCL) system in people with type 1 diabetes (T1D) with high-carbohydrate and high-fat unannounced meals.

Methods: After a 1-week Control-IQ run-in period at home with mealtime insulin boluses, ten adults with T1D used the Tandem Freedom FCL System in the hotel setting for 72 hours without meal announcement or mealtime insulin boluses. Participants consumed high-carbohydrate and high-fat meals during their stay. Exercise challenges occurred each day. A Wilcoxon signed-rank test for nonparametric data compared outcomes between periods.

Results: Mean participant age was 38.6 years, duration of diabetes 15.9 years, total daily insulin 0.71 units/kg/d, and HbA_1c 7.3%. There were no diabetic ketoacidosis (DKA) or severe hypoglycemia events. During the hotel study, FCL was active 97.3% of the time, and median meal size was 70.8 g carbohydrate and 53.2 g fat for breakfast, 53.8 g carbohydrate and 40.0 g fat for lunch, and 96.1 g carbohydrate and 53.1 g fat for dinner. Median time in range (TIR) 70 to 180 mg/dL was 61.0% [58.9, 73.0] without any meal announcement or mealtime insulin boluses during the 72-hour FCL period, compared to 56.3% [50.9, 64.0] with their home pump with mealtime insulin boluses during the at-home run-in week (+9.0%, P = .23). Overnight TIR was 95.9% [83.8, 100.0] for FCL versus 69.6% [57.6, 77.8] for the run-in period (+26.1%, P = .01). Time <70 mg/dL was low at 0.4% during FCL.

Conclusions: FCL insulin delivery with the Tandem Freedom System was safe and effective in adults with T1D with high-carbohydrate, high-fat meals.

Presented is a series of narrative reviews that summarize published information regarding the effect or potential effect of interfering substances on the accuracy of continuous glucose monitoring (CGM) devices. While drawing together what is currently known regarding this topic, the future direction in this field and clinical implications posed by polypharmacy on CGM performance are considered. This first in a series of four review articles classifies commercially available CGMs by glucose measurement principle before reviewing what is currently known regarding substance interference mechanisms and design approaches that may serve to reduce interfering effects. Points covered include the following: minimally invasive electrochemical CGMs, which may be classified by first-, second-, or third-generational design (these models are at risk of interference from electroactive substances, or substances that can interfere with the enzymatic biorecognition process); non-invasive fluid sampling CGMs, which draw glucose across the skin barrier but are similarly reliant on the electrochemical measurement of an enzymatic reaction product; and minimally invasive implantable CGMs, which exhibit different interfering substance behaviors to other CGM classes, using a non-enzyme-based glucose-recognition agent coupled to optical detection. An understanding of substance-interfering mechanisms allows consideration of the potential impact on clinical accuracy of substances that are routinely prescribed, can be purchased over the counter, or are new to market.

Background: Technosphere insulin (TI) is an ultra-rapid-acting inhaled insulin approved for glucose management in adults with diabetes mellitus. Using a higher modified initial conversion dose than in the current United States Prescribing Information, this study assessed supplementing or replacing automated insulin delivery (AID) systems with TI.

Methods: Adult participants with type 1 diabetes (glycated hemoglobin [HbA1c], 7%-11%) using an AID system were randomized into TI + AID (TI for meals and AID for basal and corrections), TI + insulin degludec (TI for meals and corrections and insulin degludec for basal), or control group (remaining on AID) and treated for 90 days. HbA1c, forced expiratory volume in 1 second (FEV₁), hypoglycemic events, and adverse events (AEs) were assessed.

Results: Of 33 enrolled participants, 24 completed the study. All groups demonstrated comparable declines in HbA1c from baseline to end of treatment (statistically significant decline for control group). No within- or between-group statistical differences were observed in FEV₁. Incidence and event rate of hypoglycemia <70 mg/dL and <54 mg/dL were similar between groups, and no severe hypoglycemic events were reported. No treatment-related serious AEs were reported, and 2 participants experienced AEs of special interest related to TI (clinically relevant decline in pulmonary function and wheezing).

Conclusions: This proof-of-concept study demonstrated the safety and efficacy of TI, at a higher modified dose conversion, when added for mealtime control to an AID system or was used for glycemic control with basal insulin.

Individuals with a family history of type 1 diabetes (T1D) are at significantly higher risk of developing T1D compared to the general population. Before its clinical onset, individuals with T1D can be identified through islet autoantibody (IAb) testing which, if multiple IAbs are detected, justifies the diagnosis of early-stage T1D. Amid rising global T1D incidence, we outline Germany's strategy for early detection and management focused on individuals with a family history and, where informative, implementation lessons are illustrated using findings from the German Fr1da general-population study. Genetic risk factors for T1D development in individuals with family history are discussed, as well as impacts of positive screening results including influence on diabetic ketoacidosis (DKA) rates and psychological aspects. In parallel, recommendations and consensus guidelines from other national screening efforts are introduced. Building on this, we address challenges in nationwide T1D family-based screening integration and explore leveraging health care systems for cost-effective implementation. We also provide practical aspects to overcome barriers for family-based T1D screening and introduce monitoring strategies in individuals with early-stage T1D. With the advent of disease-modifying therapies (DMTs) for delaying T1D progression, there is now a rationale at hand that offers an IAb screening incentive. Collectively, we emphasize the critical role of early detection and monitoring among at-risk relatives in mitigating the burden of T1D on individuals, families, and health care systems.