bims-glumda Biomed News
on CGM data in management of diabetes
Issue of 2025–05–11
twenty papers selected by
Mott Given
  1. Recommendations on the Collection of Comparator Measurement Data in the Performance Evaluation of Continuous Glucose Monitoring Systems.
  2. Accuracy of a novel calibratable real-time continuous glucose monitoring device based on FreeStyle libre in- and out-of-hospital.
  3. Accuracy of Factory-Calibrated Continuous Glucose Monitors in Critically Ill Patients Receiving Intravenous Insulin: A Prospective Clinical Trial of Two Leading Systems.
  4. How to take action beyond ambulatory glucose profile: Latin American expert recommendations on CGM data interpretation.
  5. Clinical Accuracy of Continuous Glucose Monitoring Immediately after Kidney Transplant in Patients with Type 2 Diabetes.
  6. Continuous Glucose Monitoring in the Management of Medication in Care Home Residents with Type 2 Diabetes (eDMED): A Protocol for a Feasibility Study.
  7. Time in tight range and time in range for predicting the achievement of typical glucose management indicator and HbA1c targets.
  8. Time-divided hypoglycemia management derived by continuous glucose monitoring may reduce microvascular diseases in type 2 diabetes patients.
  9. Hypoglycaemic Unawareness in a Glycogen Storage Disorder Patient: A Case Report and Review of the Literature.
  10. Continuous Glucose Monitoring in Type 2 Diabetes: A Systematic Review of Barriers and Opportunities for Care Improvement.
  11. Glucose Management Indicator: Do We Need Device-Specific Equations?
  12. Noninvasive blood glucose monitoring using a dual band microwave sensor with machine learning.
  13. Challenges in diagnosing gestational diabetes after Roux-en-Y gastric bypass: a comparative analysis of OGTT, SMBG, and CGM.
  14. Hypoglycemic timeslots after hospital discharge in patients with diabetes on multiple daily insulin injection: Dose of Insulin CHanged According to the Reported Glucose by Libre Pro (DISCHARGe study).
  15. Use of technology in prediabetes and precision prevention.
  16. Real-World Effectiveness of Glucose-Guided Eating Using the Data-Driven Fasting App Among Adults Interested in Weight and Glucose Management: Observational Study.
  17. A Cross-Sectional Study Demonstrating a High Prevalence of Skin Rash to Diabetes Medical Devices: An Underestimated Problem.
  18. Periodontal disease in adolescents with type 1 diabetes mellitus: A cross link between continuous glucose monitoring-derived metrics, caspase-3 levels, diabetic nephropathy and subclinical atherosclerosis.
  19. Optoacousto-fluidics Based Optical Rotation Measure for Blood Glucose Sensing.
  20. Wearable MXene-enhanced organic Bio-FET paper patch for glucose detection in sweat with pH and temperature calibration.
  1. J Diabetes Sci Technol. 2025 May 06. 19322968251336221
    Recommendations on the Collection of Comparator Measurement Data in the Performance Evaluation of Continuous Glucose Monitoring Systems.
    Guido Freckmann, Stefan Pleus, Manuel Eichenlaub, Elisabet Eriksson Boija, Marion Fokkert, Rolf Hinzmann, Johan Jendle, David C Klonoff, Konstantinos Makris, James H Nichols, John Pemberton, Elizabeth Selvin, Nam K Tran, Lilian Witthauer, Robbert J Slingerland.
      While current systems for continuous glucose monitoring (CGM) are safe and effective, there is a high degree of variability between readings within and across CGM systems. In current CGM performance studies, device readings are compared with glucose concentrations obtained with a comparator ("reference") measurement procedure (usually capillary or venous glucose). However, glucose concentrations from capillary and venous samples can systematically differ, often by as much as 5 to 10%. Different comparator methods have shown biases of up to 8%, and comparator devices of the same brand can systematically differ by more than 5%. To address these issues, the Working Group on CGM of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC WG-CGM) recommends standardizing study procedures and the comparator measurement process in CGM performance studies. The majority of IFCC WG-CGM members recommend the use of capillary samples as reference, mainly because CGM readings will then be aligned better with results from self-monitoring of blood glucose (SMBG). Even with factory-calibrated CGM systems, manufacturers require CGM users to perform SMBG in some situations, eg, manual calibration, confirmation of extreme readings, discordance between CGM readings and symptoms of hyper- or hypoglycemia, or intermittent signal loss. Comparator devices should meet defined analytical performance specifications for bias and imprecision. Comparator bias can be reduced by retrospective correction of comparator values based on measurements with a method or materials of higher metrological order. Once manufacturers align CGM readings of their systems with comparator results using standardized procedures, variability across CGM systems will be reduced.
    Keywords:  clinical performance evaluation; comparator data requirements; continuous glucose monitoring; standardization; traceability
    DOI:  https://doi.org/10.1177/19322968251336221
  2. Front Endocrinol (Lausanne). 2025 ;16 1466358
    Accuracy of a novel calibratable real-time continuous glucose monitoring device based on FreeStyle libre in- and out-of-hospital.
    Zhenghao Wu, Zhaoxiang Liu, Wenhui Zhao, Shaocheng Wang, Liangbiao Gu, Jianzhong Xiao.
       Objectives: Based on FreeStyle Libre, we designed QT AIR, an advanced real-time, calibrated Continuous Glucose Monitoring (CGM) device. This study aim to validate the consistency and clinical accuracy of the product by comparing the capillary blood glucose (CBG) with CGM data in both in-hospital and outpatient scenarios.
    Methods: Results of CGM devices were compared with random capillary glucose values from users in both in-hospital and outpatient settings. The accuracy of CGMs was assessed through consistency analysis, Bland-Altman analysis, calculation of MARD and MAD, Consensus Error Grids, as well as analysis using the Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA).
    Results: In outpatient setting, 1907 values from 138 users were analyzed. FreeStyle Libre data, QT AIR calibrated and uncalibrated data showed strong positive correlations with capillary blood glucose values. The MARD values for the FreeStyle Libre, uncalibrated QT AIR, and calibrated QT AIR groups were 18.33%, 20.63%, and 12.39%, respectively. Consensus Error Grid, reference values in Zone A: FreeStyle Libre: 69.75%, QT AIR uncalibrated: 67.80%, QT AIR calibrated: 87.62%. The Bland-Altman analysis results suggest that FreeStyle Libre exhibitsed a systematic underestimation of blood glucose levels, while QT AIR almost rectified the differences. In the in-Hospital setting, the MARD of QT AIR after calibration was reduced to 7.24%. The Consensus error grid analyses of the in-Hospital data revealed that 95% of the calibrated QT AIR values fell within Zone A, a significantly higher proportion than that of other two group. The CG-DIVA analysis of the calibrated QT AIR device showed a median bias of -0.49% and a between-sensor variability of 26.65%, both of which are significantly lower than the corresponding values observed for the FreeStyle Libre device.
    Conclusions: We successfully transformed a retrospective CGM system into a real-time monitoring device. The monitoring accuracy of the device could be improved by calibration.
    Keywords:  FreeStyle libre; accuracy; calibrate; continuous glucose monitoring; rtCGM
    DOI:  https://doi.org/10.3389/fendo.2025.1466358
  3. J Diabetes Sci Technol. 2025 May 08. 19322968251338865
    Accuracy of Factory-Calibrated Continuous Glucose Monitors in Critically Ill Patients Receiving Intravenous Insulin: A Prospective Clinical Trial of Two Leading Systems.
    Gautam Ramesh, Emily Kobayashi, Navyaa Sharma, Amit R Majithia, Kristen Kulasa, Schafer C Boeder.
       BACKGROUND: Continuous glucose monitors (CGMs) are increasingly being used to guide glucose management in the hospital. However, uncertainty regarding their accuracy in this setting remains.
    METHODS: We conducted a nonrandomized, open-label, clinically blinded prospective trial of the Dexcom G6 Pro (G6P) and FreeStyle Libre Pro (FLP) in the inpatient setting among critically ill hospitalized patients (n = 40) requiring continuous intravenous insulin infusion. In parallel with CGM data, reference serum (Lab) glucose and point-of-care (POC) glucose values were obtained. On completion of the study, CGM and reference values were analyzed to assess CGM accuracy.
    RESULTS: A total of 1015 matched G6P-Lab pairs had a mean absolute relative difference (MARD) of 22.7%, 2369 G6P-POC pairs had an MARD of 22.9%, 1006 matched FLP-Lab pairs had an MARD of 25.2%, and 2353 FLP-POC pairs had an MARD of 27.0%. Both CGM systems demonstrated considerable inter-patient variability in sensor accuracy and tended to underestimate glucose in comparison with the reference values. Rarely were low reference values overestimated by either sensor.
    CONCLUSIONS: Factory-calibrated continuous glucose monitors may require accuracy validation and per-patient calibration for inpatient use in critically ill patients.
    Keywords:  Abbott FreeStyle Libre Pro; Dexcom G6 Pro; continuous glucose monitor (CGM); critical care; mean absolute relative difference (MARD)
    DOI:  https://doi.org/10.1177/19322968251338865
  4. Diabetol Metab Syndr. 2025 May 08. 17(1): 149
    How to take action beyond ambulatory glucose profile: Latin American expert recommendations on CGM data interpretation.
    Luis Eduardo Calliari, Álvaro Contreras Sepúlveda, Nicolás Coronel-Restrepo, Laura Kabakian, Rodrigo N Lamounier, Emma Picasso, Adrian Proietti, Alex Ramírez-Rincón, Alicia E Yépez-Rodriguez.
       PURPOSE: This expert consensus provides a standardized methodology for interpreting continuous glucose monitoring (CGM) data to optimize diabetes management. It aims to help healthcare professionals recognize glycemic patterns and apply targeted interventions based on real-time glucose metrics.
    METHODS: A systematic literature review informed expert panel discussions. Specialists from Latin America assessed CGM interpretation challenges, reviewed key metrics, and reached consensus through an anonymous voting process. The recommendations align with international guidelines while addressing regional limitations in technology access and healthcare infrastructure.
    RESULTS: Reliable CGM data interpretation requires at least 70% sensor use over 14 days. The Ambulatory Glucose Profile (AGP) report serves as the primary tool, offering essential metrics such as time in range (TIR), time below range (TBR), time above range (TAR), coefficient of variation (CV), and glucose management indicator (GMI). Identifying hyperglycemia, hypoglycemia, and glucose variability allows for personalized treatment adjustments. The panel adopted international glycemic targets, adapting them to Latin American settings. The time in tight range (TITR) was considered but not included due to limited supporting evidence and regional barriers to advanced CGM technology.
    CONCLUSIONS: Standardized CGM interpretation improves glycemic control and treatment decisions. These recommendations provide a structured approach to diabetes care, aiming to enhance clinical outcomes and address healthcare disparities in Latin America.
    Keywords:  Ambulatory glucose profile; Continuous glucose monitoring; Diabetes mellitus; Digital ecosystem; Recommendations
    DOI:  https://doi.org/10.1186/s13098-025-01702-y
  5. Endocr Pract. 2025 May 07. pii: S1530-891X(25)00142-9. [Epub ahead of print]
    Clinical Accuracy of Continuous Glucose Monitoring Immediately after Kidney Transplant in Patients with Type 2 Diabetes.
    Qurrat-Ul-Ain Aziz, Kavita Batra, Sanna Fatima, Jared Splinter, Amber Laurel Champion, Ajay M Kumar, Kenneth E Izuora.
       OBJECTIVE: To evaluate the accuracy of a blinded continuous glucose monitoring (CGM) device compared to point-of-care testing (POCT) and serum glucose measurements in the immediate post-operative period among kidney transplant recipients with type 2 diabetes mellitus.
    METHODS: In this prospective study, we enrolled 22 participants aged ≥ 18 years, with type 2 diabetes, immediately after kidney transplant. We applied a blinded CGM device that sampled interstitial glucose every 15 minutes and collected POCT and serum glucose values. Using matched pairs of glucose readings between CGM and POCT; and between CGM and serum glucose, we calculated bias, Absolute Relative Difference and conducted a Clarke Error Grid analysis.
    RESULTS: Participants included 82% male, average age 58±9.69 years, mean body mass index 30±6.41 kg/m2, baseline mean A1c 6.7 ± 1.07%. The mean duration of type 2 diabetes and End Stage Kidney Disease were 19±10.6 and 3±2.27 years, respectively. There were 327 and 72 matched pairs of CGM/POCT and CGM/serum glucose data respectively. Clarke Error Grid analysis comparing CGM/POCT showed 83.79% of values in zone A, and 15.29% in zone B (combined 99.08%), with Mean Absolute Relative Difference (MARD) of 13.24%. For CGM/serum glucose, 83.1% values were in zone A, and 16.9% in zone B (combined 100%) with MARD of 13.10%.
    CONCLUSION: CGM provided accurate blood glucose measurements compared to POCT and serum glucose values in patients with type 2 diabetes after kidney transplant. When used in this patient population, CGM devices have the potential to improve clinical outcomes through earlier detection and intervention for glycemic excursions.
    Keywords:  Continuous Glucose Monitor; Kidney Transplant; Type 2 Diabetes
    DOI:  https://doi.org/10.1016/j.eprac.2025.04.022
  6. Diabetes Ther. 2025 May 08.
    Continuous Glucose Monitoring in the Management of Medication in Care Home Residents with Type 2 Diabetes (eDMED): A Protocol for a Feasibility Study.
    Anneka E Welford, James Ridgeway, Clare Gillies, Pratik Choudhary, Vidya Hegde, Kamlesh Khunti, Samuel Seidu.
       AIMS: Overprescribing is common in older adults with diabetes, potentially leading to hospitalisation and reduced quality of life. Additionally, diabetes care in older adults is often complicated by multiple interacting conditions and cognitive impairment, resulting in challenging self-management. Although evidence suggests that de-intensification of medications is safe in older adults, there are no data evaluating glucose ranges during this process.
    METHODS: eDMED is a 12-week feasibility study including 49 adults, aged ≥ 65 years with type 2 diabetes and residing in care homes. All eligible participants will receive medication de-intensification and continuous glucose monitoring (CGM). Primary healthcare professionals (HCPs) will undergo structured training on a de-intensification algorithm and CGM, while care home staff will receive tailored education on diabetes management and CGM application to ensure safe and effective implementation.
    PLANNED OUTCOMES: The primary outcome is the percentage of participants achieving a composite of > 50% time in range and < 1% time below range at 12 weeks, measured via CGM. Secondary outcomes include trends in time above and below range (quantified by level of hyper- or hypoglycaemia), change in quality of life (EQ-5D-5L), percentage of data captured to indicate adherence to the CGM and the acceptability of the intervention to participants, their consultees and carers (Theoretical Framework of Acceptability questionnaire).
    TRIAL REGISTRATION: International Clinical Trials Registry Platform (ID: ISRCTN 69024008).
    Keywords:  Care home; Continuous glucose monitoring; De-intensification of medications; Frailty; Hypoglycaemia; Primary care; Type 2 diabetes
    DOI:  https://doi.org/10.1007/s13300-025-01740-9
  7. Diabetologia. 2025 May 07.
    Time in tight range and time in range for predicting the achievement of typical glucose management indicator and HbA1c targets.
    Seohyun Kim, Sang Ho Park, Jin A Lee, So Hyun Cho, Rosa Oh, Ji Yoon Kim, You-Bin Lee, Gyuri Kim, Kyu Yeon Hur, Jae Hyeon Kim, Sang-Man Jin.
       AIMS/HYPOTHESIS: This study aimed to compare the ability of time in tight range (TITR) and time in range (TIR) to predict the achievement of typical glucose management indicator (GMI) and HbA1c targets.
    METHODS: This cross-sectional analysis included 773 adults with diabetes receiving insulin therapy who visited Samsung Medical Center between June 2019 and December 2023 and wore a Dexcom G6 or FreeStyle Libre continuous glucose monitor for at least 90 days (sensor wear time, ≥70%). A receiver operating characteristic analysis was used to compare the ability of TITR and TIR to predict GMI and HbA1c targets.
    RESULTS: TITR had significantly greater AUC values than TIR for predicting GMIs of <53 mmol/mol (7.0%) and <48 mmol/mol (6.5%) among participants using a Dexcom G6 or FreeStyle Libre continuous glucose monitor. TITR also had significantly greater AUC values than TIR for predicting HbA1c levels of <53 mmol/mol (7.0%) (95% CI for difference: 0.006, 0.03) and <48 mmol/mol (6.5%) (95% CI for difference: 0.001, 0.03) among participants using the FreeStyle Libre. In the HbA1c range of 48-53 mmol/mol (6.5-7.0%), TIR exhibited broader variations than TITR across CV groups. The modifying effect of CV on the association between TITR and GMI or HbA1c was minimised around a GMI and HbA1c level of 53 mmol/mol (7.0%).
    CONCLUSIONS/INTERPRETATION: TITR might be a more useful indicator than TIR of the achievement of typical GMI and HbA1c targets among adults with diabetes on insulin therapy.
    Keywords:  Continuous glucose monitoring; Glucose management indicator; HbA1c ; Time in range; Time in tight range
    DOI:  https://doi.org/10.1007/s00125-025-06442-2
  8. Endocrine. 2025 May 09.
    Time-divided hypoglycemia management derived by continuous glucose monitoring may reduce microvascular diseases in type 2 diabetes patients.
    Yuqiong Li, Liwei Cai, Qinkang Lu, Weikun Gong, Penghao Wang, Tao Chen, Wen Ye, Bingqi Li, Hui Zhu, Zhifeng Xu, Jin Xu, Lindan Ji.
       PURPOSE: To assess the association between hypoglycemia exposure and the risk of developing microvascular diseases (MVDs) in type 2 diabetes patients via continuous glucose monitoring (CGM), aiming to identify optimal hypoglycemia thresholds for improved glucose management.
    METHODS: A total of 174 type 2 diabetes patients underwent 2 weeks of CGM. Binary multivariate logistic regression assessed the association between hypoglycemia exposure and MVDs prevalence at thresholds of 3.0-3.9 mmol/L.
    RESULTS: After 14 days of monitoring, 79.9% of patients experienced hypoglycemia. The MVDs group had a significantly greater percentage of participants with hypoglycemia (glucose < 3.4 mmol/L: 57.6 vs. 39.8%, P = 0.023) and nocturnal hypoglycemia (glucose < 3.9 mmol/L: 62.1 vs. 46.3%, P = 0.043), with no significant difference in daytime hypoglycemia. After adjustment for confounders, only nocturnal hypoglycemia was independently associated with the risk of developing MVDs, and the prevalence of MVDs was positively associated with hypoglycemia severity. When the hypoglycemia threshold was reduced from 3.4-3.0 mmol/L, the odds ratio increased from 1.342 (1.026, 1.798) to 1.855 (1.141, 3.457). Further subgroup analysis revealed that nocturnal hypoglycemia below 3.4 mmol/L was a risk factor for the development of retinopathy and neuropathy (P < 0.05) but not for nephropathy.
    CONCLUSION: Nighttime glucose levels below 3.4 mmol/L are strongly associated with a greater risk of developing retinopathy and neuropathy in type 2 diabetes patients. Thus, blood glucose management should be time-specific, with daytime levels maintained above 3.9 mmol/L and nighttime levels maintained above 3.4 mmol/L.
    Keywords:  Continuous glucose monitoring; Hypoglycaemia; Microvascular diseases.; Type 2 diabetes
    DOI:  https://doi.org/10.1007/s12020-025-04250-7
  9. Cureus. 2025 Apr;17(4): e81805
    Hypoglycaemic Unawareness in a Glycogen Storage Disorder Patient: A Case Report and Review of the Literature.
    Alamin Alkundi, Rabiu Momoh.
      The concept of hypoglycaemic unawareness is often discussed in the literature in relation to diabetics on insulin treatment. Hypoglycaemic unawareness is a state in which patients fail to recognize neuroglycopenic symptoms and signs that could prompt the need to seek measures to reverse or treat low blood sugar readings. This can lead to serious dangers, as immediate action is vital to avert potentially life-threatening consequences. We present a finding of hypoglycaemic unawareness in a 27-year-old female with a long-term diagnosis of Von Gierke disease (a glycogen storage disorder (GSD)) who went on to be fitted with a continuous glucose monitoring (CGM) device to prevent the harmful effects of unrecognised hypoglycaemia. We have reviewed the burden and probable mechanism for the development of hypoglycaemic unawareness in this disorder and in other infrequently reported disorders for the education of health professionals and patients.
    Keywords:  continuous glucose monitoring (cgm); glucose; gycogen; hypoglycaemia; hypoglycaemic unawareness; metabolic disorder; neuroglycopaenic symptoms; patient education; uncooked cornstarch therapy; von gierke disease
    DOI:  https://doi.org/10.7759/cureus.81805
  10. Int J Qual Health Care. 2025 May 08. pii: mzaf046. [Epub ahead of print]
    Continuous Glucose Monitoring in Type 2 Diabetes: A Systematic Review of Barriers and Opportunities for Care Improvement.
    Maria Assunta Barchiesi, Armando Calabrese, Roberta Costa, Francesca Di Pillo, Antonio D'Uffizi, Luigi Tiburzi, Erum Zahid.
       BACKGROUND: Diabetes mellitus, particularly type 2 diabetes (T2DM), is a chronic disease associated with serious complications, such as heart disease, kidney failure, and blindness. Continuous glucose monitoring (CGM) systems have emerged as a more effective alternative to traditional fingerstick testing, offering patients greater control over their condition. Despite their potential benefits, several barriers to CGM sensor use persist, limiting their widespread adoption among patients with T2DM. This review explores the barriers to CGM sensor use, particularly from the patient's perspective.
    METHODS: A systematic literature review is conducted following PRISMA guidelines. The search focuses on studies published between January 2018 and June 2024 and is performed in two primary databases, PubMed and Scopus, selected for their relevance to Type 2 diabetes research. Studies are included if they explore challenges and barriers to CGM adoption, report patient perspectives, or provide insights into the usability and accessibility of technology. The data is analysed using deductive content analysis, applying Wilson et al.'s thematic categories as a predefined framework to systematically classify and interpret barriers to CGM adoption. This approach ensures methodological consistency and alignment with existing research on eHealth adoption challenges.
    RESULTS: The review identifies several key barriers to CGM sensor use despite the benefits, such as improved glucose control and reduced hypoglycaemic events. Major challenges include the high cost of sensors, wearability issues, discomfort from adhesive materials, and concerns about the visibility of the sensors. Additionally, patients report difficulties in interpreting the large volumes of data generated by CGMs, as well as discomfort or fear related to sensor insertion. Lack of technological support, low health literacy, and insufficient social support are also identified as factors contributing to non-adoption.
    CONCLUSIONS: Policymakers and healthcare providers are encouraged to address these barriers by developing patient-centred strategies that support the adoption of CGM sensors. Successfully overcoming these challenges can further support integrating CGM sensors with the Chronic Care Model (CCM) and Automated Insulin Delivery (AID) systems. As an implication, this integration has the potential to enhance glycemic control and improve patient quality of life in the management of Type 2 diabetes. Furthermore, addressing these barriers may drive advancements in sensor design, improve accessibility, and minimize the environmental impact of CGM sensor use.
    Keywords:  Barriers to adoption; CGM sensors; Patient perspective; Self-management; Type 2 Diabetes Mellitus (T2DM)
    DOI:  https://doi.org/10.1093/intqhc/mzaf046
  11. Diabetes Metab. 2025 May 06. pii: S1262-3636(25)00056-4. [Epub ahead of print] 101661
    Glucose Management Indicator: Do We Need Device-Specific Equations?
    Tamás Jávorfi, Győző Kocsis, Márk M Svébis, Viktória Ferencz, Beatrix A Domján, Árpád Kézdi, Hanna Hankó, Zsuzsanna Putz, ÁdámG Tabák.
       AIM: Glucose management indicator (GMI) may not perform equally well for different continuous glucose monitoring (CGM) systems. Thus, we aimed to develop device-specific GMI for the Guardian 3 and 4 sensors, compare them to the original GMI, and investigate the association between the glycaemic gap (=HbA1c-GMI) and HbA1c.
    METHODS: In a single-centre, observational study of adult type 1 diabetes patients using Guardian Sensor 3 (G3) and 4 (G4) CGM devices, we estimated HbA1c using CGM-derived mean glucose for both CGMs using linear mixed models. We compared the estimates and their residuals (G3-gap and G4-gap) to the original GMI and its residuals (Bergenstal-gap) using regression and Bland-Altman plots.
    RESULTS: We included 120 adult type 1 diabetes patients (90 with G3 and 30 with G4) and 194 measurement points. We found that for G3 and G4 sensors, GMI significantly underestimated glycaemia in high HbA1c ranges, reaching the clinically significant 0.5%[4.4 mmol/mol] difference at 7.6% [60 mmol/mol] for G3 and 8.3% [67 mmol/mol] for G4 sensors. For G4, GMI significantly overestimated glycaemia in the lower HbA1c range. We found a strong relationship between all 3 gaps and HbA1c, and the slope was steeper for the Bergenstal-gap versus the sensor-specific G3 and G4 gaps. The G3-gap was approximately half as large as the Bergenstal-gap for HbA1c > 7% [53 mmol/mol], and the G4-gap is approximately half of the Bergenstal-gap for the whole HbA1c range.
    CONCLUSION: Device-specific GMI equations could reduce the risk of clinically significant under- and overestimation of HbA1c, improving clinical decision-making.
    Keywords:  Continuous Glucose Monitoring; Diabetes Mellitus; Glucose Management Indicator; Glycaemic Control; Glycated; Haemoglobin; Retrospective Studies; Type 1
    DOI:  https://doi.org/10.1016/j.diabet.2025.101661
  12. Sci Rep. 2025 May 09. 15(1): 16271
    Noninvasive blood glucose monitoring using a dual band microwave sensor with machine learning.
    Mariam Farouk, Anwer S Abd El-Hameed, Angie R Eldamak, Dalia N Elsheakh.
      The potential for continuous non-invasive blood glucose monitoring has attracted a lot of interest in the field of medical diagnostics. This paper provides a new shape of a dual-band bandpass filter (DBBPF) acting as a microwave transmission line sensor for continuous non-invasive blood glucose monitoring operating at 2.45 and 5.2 GHz. The proposed system uses the interaction between biological tissues and microwave signals to correctly assess blood glucose levels. The proposed dual-band bandpass filter (DBBPF), comprises three split ring resonator (SRR) cells with different dimensions. It is designed to operate as a sensor with improved sensitivity, compact dimensions, and a high-quality factor. It also ensures a reasonable bandwidth for lower and higher bands of 8.6 and 2%, respectively in the industrial, scientific, medical band, and the wireless local area network (ISM and WLAN) Bands. A dual-band filter enhances measurement sensitivity and specificity by targeting specific frequency ranges where glucose exhibits distinctive dielectric responses, thereby providing redundant data points for accurate glucose level determination. Glucose concentrations can be evaluated by measuring the changes in the dielectric properties of blood by sending microwave waves through the body and assessing the collected S-parameter signals. The measurement parameters encompass the reflection, phase, magnitude, as well as transmission parameters. This yields multiple evaluations of the glucose-induced alterations. Simulations are validated through laboratory measurements incorporating a phantom finger model for capturing realistic outcomes. Machine learning models are employed to analyze the sensor data, improving the accuracy of diabetes detection. Simulations are validated through laboratory measurements incorporating a phantom finger model for capturing realistic outcomes. A Cole-Cole model, implemented using MATLAB, is utilized for the phantom finger model. The main results reveal the success of the proposed transmission-based microwave glucose sensing, with a remarkable sensitivity of 1 ~ 1.5 dB for glucose level change up to 200 mg/dL.
    DOI:  https://doi.org/10.1038/s41598-025-94367-6
  13. Surg Obes Relat Dis. 2025 Apr 08. pii: S1550-7289(25)00138-8. [Epub ahead of print]
    Challenges in diagnosing gestational diabetes after Roux-en-Y gastric bypass: a comparative analysis of OGTT, SMBG, and CGM.
    Chiara Ferrario, Sara Santini, Nathalie Vionnet, Jerôme Pasquier, Jardena J Puder, Styliani Mantziari, Lucie Favre.
       BACKGROUND: Gestational diabetes mellitus (GDM) is a common complication of pregnancy, and the oral glucose tolerance test (OGTT) is the standard diagnostic tool. However, in women after Roux-en-Y gastric bypass (RYGB), OGTT is less reliable and potentially unsafe due to the risk of hypoglycemia.
    OBJECTIVES: This study compares 3 methods of GDM diagnosis-OGTT, self-monitoring of blood glucose (SMBG), and continuous glucose monitoring (CGM)-in post-RYGB pregnant women to assess and compare their diagnostic performance.
    SETTING: University Hospital, Switzerland.
    METHODS: A cohort of 15 pregnant women with a history of RYGB was evaluated between 24 and 28 weeks of gestation. Each participant underwent OGTT, SMBG, and CGM. We assessed the sensitivity, specificity, and concordance of OGTT and SMBG against CGM, which served as the reference test. The incidence of hypoglycemia during OGTT was examined.
    RESULTS: Using OGTT, 7 of the 15 participants were diagnosed with GDM, and 8 participants experienced hypoglycemia (glucose levels below 3.0 mmol/L). SMBG diagnosed GDM in 7 participants and CGM identified GDM in 11 participants. There was no significant concordance among OGTT, SMBG, and CGM (φ .26 (-.26 to .67) between OGTT and CGM (P = .57); φ -.07 (-.58 to .44) between OGTT and SMBG (P = 1), φ .26 (-.21 to .67), and between CGM and SMBG (P = .57). OGTT and SMBG demonstrated similar sensitivity and specificity, when compared to CGM (sensitivity of 54.40% and specificity of 75%) even though the patients diagnosed differed between the methods.
    CONCLUSIONS: In this exploratory study, CGM appears to be a possible approach for diagnosing GDM in post-RYGB patients. SMBG is a commonly available method. OGTT poses risks of severe hypoglycemia. These findings support the need for tailored GDM screening approaches in postbariatric surgery pregnancies and highlight the importance of further research to establish specific guidelines for this population.
    Keywords:  Bariatric surgery; CGM; Gestational diabetes; Roux-en-Y gastric bypass
    DOI:  https://doi.org/10.1016/j.soard.2025.03.008
  14. J Diabetes Investig. 2025 May 08.
    Hypoglycemic timeslots after hospital discharge in patients with diabetes on multiple daily insulin injection: Dose of Insulin CHanged According to the Reported Glucose by Libre Pro (DISCHARGe study).
    Manabu Saito, Hiroshi Uchino, Ayako Fuchigami, Genki Sato, Masahiko Miyagi, Takahisa Hirose.
       INTRODUCTION: Insulin improves clinical outcomes in hospitalized patients; however, hypoglycemia hinders discharge transition in patients with insulin-treated diabetes. Studies on hypoglycemic timeslots, rates, and risk factors during discharge transition are lacking.
    MATERIALS AND METHODS: Fifteen patients with type 2 diabetes (T2D) receiving multiple daily insulin (MDI) injections participated. Glucose variability metrics and hypoglycemia were monitored using a continuous glucose monitoring system starting a day pre-discharge through 13 days of discharge transition. Hypoglycemia was analyzed chronobiologically using Cosinor analysis. Anthropometric measurements, C-peptide, insulin dose, and glucagon were assessed.
    RESULTS: The mean patient age was 52.7 ± 12.6 years; 13/15 were male; body mass index was 28.1 ± 5.9 kg/m2, T2D duration was 8.6 ± 8.8 years, HbA1c was 12.4 ± 2.5%, and total daily insulin dose averaged 36.6 ± 15.1 units and hospitalization lasted 13.1 ± 2.3 days. Time in range decreased post-discharge. Time below range increased from 7.0% at discharge to 17.6% by the study end (manova, P < 0.001). Hypoglycemic events peaked post-breakfast, with the highest amplitude (42 points) recorded at 12:00. The highest and lowest numbers of hypoglycemia occurred at 12:00 and 17:30, respectively. However, the highest hypoglycemic timeslot (11:00-12:00) was not significantly associated with clinical and biochemical parameters.
    CONCLUSIONS: The chronobiology of hypoglycemia exists during the discharge transition in patients with MDI-treated T2D. Hypoglycemia frequency and severity peaked pre-lunch, reached a nadir at 17:30, and exaggerated post-discharge, emphasizing the need for pre-breakfast insulin dose reductions on the discharge day.
    Keywords:  Hypoglycemia; Insulin; Outpatient Care
    DOI:  https://doi.org/10.1111/jdi.70065
  15. J Diabetes Investig. 2025 May 02.
    Use of technology in prediabetes and precision prevention.
    Jie He, Natural Chu, Heng Wan, James Ling, Yincong Xue, Kathy Leung, Aimin Yang, Jie Shen, Elaine Chow.
      Controlling the epidemic of diabetes is an urgent global healthcare challenge. The low uptake of diabetes prevention programs highlights difficulties in scalability, partly due to the need for intensive face-to-face contact and its impact on healthcare resource utilization. In this narrative review, we will summarize the latest evidence in technology-assisted lifestyle interventions. We will appraise evidence of digital diabetes prevention programs that use internet platforms or text messaging tools to support information delivery, lifestyle coaching, or peer support. We will also discuss the use of wearables, including physical activity trackers and continuous glucose monitoring (CGM) as part of lifestyle intervention. Experience from diabetes highlights the potential for CGM as a motivational tool to promote lifestyle change. The integration of digital data may facilitate earlier detection of prediabetes, sub-phenotyping, and personalized nutritional predictions. We will highlight major gaps in research and the need for rigorous clinical trials to evaluate the acceptability and cost-effectiveness of integrating technologies as part of a multicomponent strategy in diabetes prevention.
    Keywords:  Continuous glucose monitoring; Prediabetes; Wearables
    DOI:  https://doi.org/10.1111/jdi.70057
  16. JMIR Form Res. 2025 May 08. 9 e65368
    Real-World Effectiveness of Glucose-Guided Eating Using the Data-Driven Fasting App Among Adults Interested in Weight and Glucose Management: Observational Study.
    Michelle R Jospe, Martin Kendall, Susan M Schembre, Melyssa Roy.
       Background: The Data-Driven Fasting (DDF) app implements glucose-guided eating (GGE), an innovative dietary intervention that encourages individuals to eat when their glucose level, measured via glucometer or continuous glucose monitor, falls below a personalized threshold to improve metabolic health. Clinical trials using GGE, facilitated by paper logging of glucose and hunger symptoms, have shown promising results.
    Objective: This study aimed to describe user demographics, app engagement, adherence to glucose monitoring, and the resulting impact on weight and glucose levels.
    Methods: Data from 6197 users who logged at least 2 days of preprandial glucose readings were analyzed over their first 30 days of app use. App engagement and changes in body weight and fasting glucose levels by baseline weight and diabetes status were examined. Users rated their preprandial hunger on a 5-point scale.
    Results: Participants used the app for a median of 19 (IQR 9-28) days, with a median of 7 (IQR 3-13) weight entries and 52 (IQR 25-82) glucose entries. On days when the app was used, it was used a median of 1.8 (IQR 1.4-2.1) times. A significant inverse association was observed between perceived hunger and preprandial glucose concentrations, with hunger decreasing by 0.22 units for every 1 mmol/L increase in glucose (95% CI -0.23 to -0.21; P<.001). Last observation carried forward analysis resulted in weight loss of 0.7 (95% CI -0.8 to -0.6) kg in the normal weight category, 1 (95% CI -1.1 to -0.9) kg in the overweight category, and 1.2 (95% CI -1.3 to -1.1) kg in the obese category. All weight changes nearly doubled when analyzed using a per-protocol (completers) analysis. Fasting glucose levels increased by 0.11 (95% CI 0.09-0.12) mmol/L in the normal range and decreased by 0.14 (95% CI -0.16 to -0.12) mmol/L in the prediabetes range and by 0.5 (95% CI -0.58 to -0.42) mmol/L in the diabetes range. Per-protocol analysis showed fasting glucose reductions of 0.26 (SD 4.7) mg/dL in the prediabetes range and 0.94 (16.9) mg/dL in the diabetes range.
    Conclusions: The implementation of GGE through the DDF app in a real-world setting led to consistent weight loss across all weight categories and significant improvements in fasting glucose levels for users with prediabetes and diabetes. This study underscores the potential of the GGE to facilitate improved metabolic health.
    Keywords:   app engagement; blood glucose; biological feedback; blood glucose self-monitoring; diet; dietary intervention; digital health; glucose; glucose monitoring; metabolic health; monitoring; personalized nutrition; precision health; self monitoring
    DOI:  https://doi.org/10.2196/65368
  17. J Diabetes Sci Technol. 2025 May 07. 19322968251336261
    A Cross-Sectional Study Demonstrating a High Prevalence of Skin Rash to Diabetes Medical Devices: An Underestimated Problem.
    Josefin Ulriksdotter, Thanisorn Sukakul, Magnus Bruze, Nils Hamnerius, Martin Mowitz, Cecilia Svedman.
       BACKGROUND: Adverse skin reactions to continuous glucose monitors (CGMs) and devices for continuous subcutaneous insulin infusions (CSIIs) ("diabetes medical devices" (MDs)) are well known. However, epidemiological studies on prevalence and skin rash details are lacking. The objective of this study was to describe the prevalence and details of skin rash to diabetes MDs in adults with type 1 diabetes.
    METHOD: All adult individuals (≥18 years) with type 1 diabetes attending outpatient diabetes clinics at two hospitals in southern Sweden were invited to participate (n = 1943) in a questionnaire study.
    RESULTS: The questionnaire was completed by 667. Of the respondents 95.1% had used CGM and 36.7% had used CSII. Skin rash to the devices was reported by 42.1% of CGM users and 44.9% of CSII users. Skin rash was reported with use of all types of diabetes MDs. For diabetes MDs with ≥50 users, 18.0% to 56.5% of the participants with skin rash had to change the device more often than recommended and 4.0% to 18.0% had to stop using the device due to skin rash. In multivariable analyses, the odds for skin rash to diabetes MDs were higher among younger individuals and individuals with childhood atopic dermatitis. Odds increased with use of higher numbers of devices. Of the participants with skin rash, 13 of the 289 (4.5%) had been investigated for contact allergy.
    CONCLUSIONS: Skin rash to diabetes MDs is common. The problem is underdiagnosed in clinical practice. With use of diabetes MDs expected to increase, an increasing prevalence of skin rash is to be expected.
    Keywords:  contact dermatitis; continuous glucose monitoring; insulin infusion systems; medical device; type 1 diabetes
    DOI:  https://doi.org/10.1177/19322968251336261
  18. Diabetes Res Clin Pract. 2025 May 08. pii: S0168-8227(25)00248-7. [Epub ahead of print]224 112234
    Periodontal disease in adolescents with type 1 diabetes mellitus: A cross link between continuous glucose monitoring-derived metrics, caspase-3 levels, diabetic nephropathy and subclinical atherosclerosis.
    Nancy Samir Elbarbary, Doaa Adel Khattab, Basma Mohamed Sultan, Eman Abdel Rahman Ismail.
       BACKGROUND: Periodontitis can lead to the development of atherosclerotic heart disease.
    AIM: To assess the relation between periodontal disease and continuous glucose monitoring (CGM)-derived metrics, caspase-3 and carotid intima media thickness (CIMT) in adolescents with type 1 diabetes mellitus (T1DM).
    METHODS: This cross-sectional study included 115 participants with T1DM (15.91 ± 2.14 years). CIMT, CGM-derived metrics, periodontal probing depths (PPD) and amount of loss clinical attachment (CAL) were assessed. Serum caspase-3 levels were measured in T1DM participants compared with 40 healthy controls.
    RESULTS: Periodontitis was found in 69.6 % of T1DM group. Serum caspase-3 levels were significantly elevated in T1DM participants compared with controls (median 8.4 versus 1.2 ng/mL; p < 0.001. Participants with periodontitis had higher percentage of nephropathy with elevated CIMT, caspase-3 levels, glucose management indicator (GMI) (7.5 ± 0.58 versus 7.1 ± 0.51 %; p = 0.047), coefficient of variation (CV) (36.4 ± 5.6 versus 33.2 ± 5.9 %; p = 0.008) and glycemic risk index while time in range (TIR) was significantly lower (58.5 ± 14.1 versus 69.7 ± 11.5 %; p = 0.002) compared with those without periodontitis. Participants using advanced hybrid close loop system had lower caspase 3 levels and CIMT compared with those on multiple daily injections. There were positive correlations between caspase-3 and GMI (r = 0.587), CV (r = 0.434), CIMT (r = 0.425), PPD (r = 0.952) and CAL (r = 0.739) while caspase-3 was negatively correlated to TIR(r = -0.481; p < 0.001 for all).
    CONCLUSION: Periodontitis is prevalent among adolescents with T1DM and is linked to glycemic variability and poor metabolic control while associated with diabetic nephropathy and subclinical atherosclerosis. Elevated caspase-3 highlights the involvement of apoptosis in periodontal disease and subclinical atherosclerosis in T1DM.
    Keywords:  Carotid intima media thickness; Caspase-3; Diabetic nephropathy; Glycemic variability; Periodontal disease; Subclinical atherosclerosis; Type 1 diabetes
    DOI:  https://doi.org/10.1016/j.diabres.2025.112234
  19. IEEE Trans Biomed Eng. 2025 May 05. PP
    Optoacousto-fluidics Based Optical Rotation Measure for Blood Glucose Sensing.
    Swathi Padmanabhan, Sarikonda Aryan Shashank, Rajesh Srinivasan, Jaya Prakash.
       SIGNIFICANCE: Glucose sensing in deep tissue is challenging due to high light scattering and the optical properties of tissue constituents.
    OBJECTIVE: We present a novel approach that integrates polarized light with optoacousto-fluidics based glucose sensing.
    METHODS: A custom microfluidic chip mimicking blood vessel dimensions was developed to measure optical rotation via optoacoustic detection using polarized light (vertical and circular) at 1560 nm (near-infrared). The system reduces sample volume requirements while maintaining high sensitivity and accuracy. Experiments were performed using serum-like and human blood samples at a depth of 2 mm through whole blood. Flow dynamics was varied to assess their impact on measurement accuracy. Proof-of-concept studies included samples from diabetic and healthy volunteers.
    RESULTS: Depth-resolved optoacoustic signals enabled accurate optical rotation quantification for glucose detection. Variations in flow velocity showed no significant effect, confirming system reliability under dynamic conditions. The system achieved a detection limit of 50 mg/dL in serum samples. Classification of diabetic and healthy samples reached an 88% prediction accuracy.
    CONCLUSION: This work demonstrates a low-volume, high-sensitivity method for glucose detection using polarized light and optoacousto-fluidics, with potential for real-time, non-invasive monitoring at tissue depths of 2-3 mm. It lays the foundation for advancing optical rotation-based glucose detection methodologies with significant implications for in-vivo sensing (at depths of 2-3 mm in skin).
    DOI:  https://doi.org/10.1109/TBME.2025.3566940
  20. Sci Rep. 2025 May 09. 15(1): 16219
    Wearable MXene-enhanced organic Bio-FET paper patch for glucose detection in sweat with pH and temperature calibration.
    Milad Farahmandpour, Zoheir Kordrostami.
      This paper proposes the design of organic Bio-FET sensors using paper as a substrate. Three different wearable biosensors have been engineered for the non-invasive monitoring of sweat biomarkers. The proposed sensors, which have a field-effect transistor (FET) structure, contribute to an array that is flexible, bendable, affordable, disposable, and biocompatible. The approach of drawing Organic FETs (OFETs) on paper using a paintbrush could successfully make cost-effective sweat biochemical sensors (glucose and pH Sensors) and biophysical sensors (temperature-sensor) which are versatile and sensors for real-time health monitoring. PDMS, PEDOT: PSS, and sensitive materials have been used as the oxide layer, source/drain electrodes, and the FET channel, respectively. The wearable glucose sensor utilizes a composite of copper oxide (CuO), carboxyl-functionalized multiwall carbon nanotubes (MWCNT-COOH), and Ti₃C₂ MXene (Ti₃C₂ MXene/CuO/MWCNT) as the channel material in its FET structure, enhancing its sensitivity and performance. Additionally, Ti3C2 MXene/MWCNT and Ti₃C₂ MXene/rGO/MWCNT composites were employed in the pH and temperature sensors, respectively, to enhance their functionality and performance. The proposed Bio-FETs are fabricated in three different designs: resistive, side-gated and back-gated structures, and their responses are compared and discussed. Continuous health monitoring is achieved through a fully integrated, disposable wireless device that combines glucose, pH, and temperature sensing. The fabricated Bio-FET exhibits high sensitivity and promising reproducibility, stability, and repeatability. To enhance precision, the proposed glucose sensor has been calibrated using real-time temperature and pH measurements.
    Keywords:  BioFETs; Drawing on paper; Non-invasive; Sweat; Wearable sensors
    DOI:  https://doi.org/10.1038/s41598-025-00533-1
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