Journal of Diabetes Science and Technology最新文献

Background: Continuous glucose monitoring (CGM) has come a long way and is standard for patients with type 1 diabetes and many with type 2 diabetes. Several attempts to establish noninvasive glucose monitoring, that is, measuring glucose without puncturing the skin, have not been successful yet.

Method: A different approach is the monitoring of volatile organic compounds in breath.

Results: This addresses a number of limitations of current invasive glucose monitoring techniques. This should enhance compliance, adherence, clinical outcomes, and quality of life. It might also reduce costs associated with CGM.

Conclusions: A recent publication in this journal indicates the clinical value of this approach by presenting data from a clinical study. The respective pros and cons will be discussed briefly.

Introduction: Type 1 diabetes mellitus (T1D) requires precise carbohydrate estimation to manage blood glucose and prevent chronic and acute complications to hyperglycemia or hypoglycemia. This study evaluates the accuracy of ChatGPT in estimating carbohydrate content in images of meals, compared with the considered gold standard of manually counting carbohydrates.

Method: Carbohydrate content of 60 fruits and vegetables (F&V) and 60 composite meals was manually counted as the reference standard. Images (n = 240), with and without a size reference, were uploaded to ChatGPT-4o with a standardized prompt in separate sessions. ChatGPT's estimates were then compared with the manual counts to assess accuracy.

Results: The performance of ChatGPT-4o compared with the manual calculation was assessed primarily using mean absolute error, percentage of agreement (PoA), and Bland-Altman analysis. ChatGPT-4o achieved a PoA of 93.3% for F&V's estimates, increasing to 95% with a size reference, while composite meal estimates yielded a PoA of 46.7%, reducing to 43.3% with a size reference, based on a ±10 g carbohydrates limit. Bland-Altman analysis showed a slight bias tendency in both ChatGPT-4o's estimates of F&V and composite meals with a size reference. ChatGPT-4o's estimate for F&V and composite meals without a size reference exhibited a systematic bias, with both overestimation and underestimation of the carbohydrate content.

Conclusion: This study suggests that adolescents living with T1D should employ ChatGPT-4o for carbohydrate estimating with caution. ChatGPT-4o showed inaccuracies in its application to composite meals, increasing the risk of inaccurate insulin administration and potentially causing postprandial hyperglycemia or hypoglycemia.

Background: The hemoglobin glycation index (HGI), defined as the difference between HbA1c and the glucose management indicator (GMI) derived from continuous glucose monitoring (CGM), has emerged as a tool to evaluate discordance between laboratory and sensor-based measures. The impact of sodium-glucose cotransporter 2 inhibitors (SGLT2i) on these markers remains unclear.

Methods: We retrospectively analyzed CGM data from 143 individuals with type 2 diabetes, stratified by SGLT2i use. Both HGI and glycated albumin-to-HbA1c (GA/HbA1c) ratio were compared. A restricted dataset (n = 117) excluding individuals with anemia or advanced renal dysfunction was also examined.

Results: SGLT2i users exhibited higher hematologic parameters and significantly greater HGI (full dataset: 0.3 vs 0.1, P = .0297; restricted: 0.4 vs 0.1, P = .0206), whereas the GA/HbA1c ratio was significantly lower (full: 2.27 vs 2.54, P = .0117; restricted: 2.18 vs 2.38, P = .0178). The HbA1c-GMI relationship showed significantly different slopes between SGLT2i users and non-users, while the GA-GMI relationship was consistent across groups. Multivariate analyses identified SGLT2i use as an independent determinant of both higher HGI and lower GA/HbA1c ratio, even after adjustment for age, sex, body mass index (BMI), hemoglobin, albumin, renal function, mean glucose, and glycemic variability.

Conclusion: SGLT2i therapy alters the interpretation of glycemic markers by elevating HGI and lowering GA/HbA1c, independent of hematologic and renal factors. These findings emphasize the need for individualized assessment of glycemic control using CGM-derived metrics and complementary biomarkers.

Background: Type 2 diabetes (T2D) is a growing global health concern, with self-monitoring of blood glucose (SMBG) being essential for optimal management. Current SMBG methods are invasive and often underutilized due to discomfort and inconvenience. Non-invasive alternatives, such as breath-based glucose estimation using volatile organic compounds (VOC), could improve compliance and quality of life.

Methods: A prospective, cross-sectional, single-center clinical study enrolled 130 adults with T2D not requiring prandial insulin. The study was conducted in two phases: algorithm training (n = 100) and validation (n = 30). Participants underwent a standardized meal test with venous, capillary, and breath VOC measurements at seven time points. A portable VOC analyzer prototype (MIB) was used, and algorithm performance was assessed using Parkes error grid analysis, calibration indicators, and reproducibility measures. User feedback was collected via a questionnaire.

Results: The VOC-based device demonstrated high reliability and safety, with 99% of measurements valid on the first breath. In the validation phase, 98.7% of blood glucose estimates fell within clinically acceptable Parkes grid zones A or B (T2D grid: 99.7%). Best accuracy was observed in fasting and early post-meal states, with lower performance at higher glucose levels. User feedback indicated strong enthusiasm for a non-invasive device, with most participants expressing willingness to use it regularly.

Conclusion: This study validates the potential of breath-based VOC analysis for non-invasive SMBG in T2D, demonstrating reliability, usability, and patient acceptance. Further optimization is needed to improve accuracy, particularly at high glucose levels, but the technology shows promise for enhancing diabetes management and screening.

Background: Multiday fasting is practiced globally for various health or religious reasons which can cause marked declines in circulating glucose levels. Yet, the extent of hypoglycemia exposure (ie, blood glucose <70 mg/dL), as measured by continuous glucose monitoring (CGM) during a prolonged fast is unclear. We aimed to determine the distribution of interstitial glucose data as measured by CGM, during a seven-day water-only fast in healthy men and women.

Methods: This study used interstitial glucose levels from CGM (Dexcom G4 Platinum) to profile hypoglycemic exposure during a seven-day water-only fast in 12 healthy adults (seven men; age 29.7 ± 6.1 years; body mass index [BMI] 25.0 ± 3.3 kg/m²) that also included physical performance tests (day 6) and an oral glucose tolerance test (day 7).

Results: Time <70 mg/dL increased from 3.0% ± 7.1% at baseline to 66.0% ± 25.7% by day 5 (P < .001). Minimum daily glucose levels also declined from 76 ± 14 mg/dL at baseline to 50 ± 7 mg/dL by day 5 (P < .001). The performance tests and the oral glucose tolerance test markedly increased glycemia. No symptoms of hypoglycemia were reported.

Conclusions: This research demonstrated considerable hypoglycemia exposure occurs without symptoms in heathy men and women who undertake multiday fasting.

Safety aspects play a major role in air travel, including the safety of passengers with chronic illnesses. Due to atmospheric pressure changes inside passenger aircraft during flight, the question arises as to whether the therapeutically important delivery accuracy of insulin pumps is affected. An in vitro study simulated the pressure conditions during a flight in a pressure chamber. Pressure changes cause air bubbles to form in the insulin reservoir in the pump, displacing insulin, which would lead to additional insulin delivery. However, such in vitro experiments do not answer the question of whether they adequately reflect the in vivo situation. This article aims to examine the physical and physiological aspects of insulin delivery from insulin pumps under real-life conditions during flight.

Background: The use of Continuous Glucose Monitoring (CGM) devices has significantly improved diabetes management. However, several limitations persist, including the great variation in accuracy, inconsistent study designs, and variations in regulatory approval standards. Therefore, the need for regulatory harmonization, robust validation, and transparent data reporting is crucial.

Methods: The current consensus report was developed through a structured, multi-phase process to comprehensively assess these challenges. A literature review of databases such as PubMed, Scopus, and the Saudi Digital Library, focusing on publications from 2016 to 2024, evaluated evidence on CGM devices in terms of performance and clinical outcome, with priority given to regional data, randomized controlled trials (RCTs), and systematic reviews. A multidisciplinary panel reviewed the literature, engaging in structured discussions. Recommendations were formulated using the Delphi method, ensuring consensus and alignment with global standards while addressing regional challenges.

Results and recommendations: The resulting recommendations advocate for aligning Saudi regulatory standards with international frameworks like Food and Drug Administration iCGM criteria, Medical Device Regulation (MDR)-aligned criteria, establishing and enforcing minimum performance criteria, including dynamic testing for glucose fluctuations, strengthening local post-market surveillance capacity, mandating transparent data reporting by manufacturers, and facilitating comprehensive clinical education and cross-sector collaboration.

Background: Diabetes summer camp is a demanding, although joyful, setting with many unpredictable activities affecting glycemic control. Recent technological advances, such as automated insulin delivery (AID) systems, offer promising real-world benefits. Our aim was to evaluate the efficacy and safety of continuous subcutaneous insulin infusion (CSII) systems during a diabetes summer camp and compare the performance of the MiniMed 780G (AID) system with the sensor-augmented MiniMed 640G system.

Methods: This is a retrospective, observational study collecting data from six summer camp weeks organized from 2019 to 2025 in Northern Greece. Children, adolescents, and adult staff with type 1 diabetes (T1D) using MiniMed insulin pumps and continuous glucose monitoring were included. Glycemic metrics (time in range, glucose coefficient of variation, time in hypoglycemia/hyperglycemia, glycemia risk index) were collected from CareLink platform across three weekly periods: during camp, pre-camp, and post-camp.

Results: Data from 93 participants/year (67 females,72.04%) were included. Mean time in range (TIR) during camp was 72.72%, with best outcomes in years 2023 to 2025 (TIR > 77%). Across all periods, MiniMed 780G users demonstrated markedly superior outcomes compared to 640G users: during the camp week, TIR was 78.68% vs 62.83% (P < .001), and post-camp TIR remained higher (70.02% vs 55.43%, P < .001), with lower time in hyperglycemia >180 mg/dL (22.67% vs 30.71%, P < .001). Camp weeks were associated with improved TIR and reduced hyperglycemia overall without increased hypoglycemia rates.

Conclusion: Diabetes camps promote satisfactory glycemic control in youth with T1D, particularly when using AID systems. MiniMed 780G users maintained better outcomes even the week after camp compared to MiniMed 640G users.