bims-glumda Biomed News
on CGM data in management of diabetes
Issue of 2025–11–09
nineteen papers selected by
Mott Given



  1. J Matern Fetal Neonatal Med. 2025 Dec;38(1): 2582947
       BACKGROUND: Pregnancy in women with type 1 diabetes (T1D) is associated with increased risk of adverse outcomes, including preeclampsia and macrosomia. Normalizing glycated hemoglobin (A1C) helps minimize these risks. Previous evidence suggests that continuous glucose monitoring (CGM) improves treatment decisions and glycemic control. However, no synthesized evidence currently assesses whether CGM use is associated with improved A1C levels in this population.
    OBJECTIVE: The aim of this integrative review is to compare A1C levels during pregnancy between women with T1D who use CGM and those who do not use CGM (e.g. intermittent blood glucose monitoring only).
    METHODS: An integrative review was conducted in accordance with Whittemore and Knafl's guidelines. Three databases (CINAHL, PubMed, and Web of Science) were searched on 5 June 2024. Studies were included if they involved pregnant women with T1D and reported pregnancy A1C levels for both CGM users and non-users, enabling pooled analysis using sample size as a weighting factor. Study quality was assessed using the Mixed Methods Appraisal Tool (version 2018).
    RESULTS: Of 300 screened articles, nine met the inclusion criteria. CGM users consistently demonstrated lower pooled mean A1C levels than non-users across all trimesters: first trimester (6.55% vs. 6.82%; SD = 0.72 vs. 0.93), second trimester (5.89% vs. 6.11%; SD = 0.55 vs. 0.63), and third trimester (6.07% vs. 6.24%; SD = 0.53 vs. 0.61). Overall, CGM users had a lower average pooled mean A1C throughout pregnancy (6.19% vs. 6.40%; SD = 0.61 vs. 0.74).
    CONCLUSIONS: CGM use in pregnant women with T1D may support better glycemic target achievement by providing real-time glucose data that informs insulin dosing and dietary adjustment. These findings support further investigation in larger controlled studies.
    Keywords:  Continuous glucose monitoring; blood glucose self-monitoring; diabetes type 1; glycated hemoglobin; pregnancy
    DOI:  https://doi.org/10.1080/14767058.2025.2582947
  2. BMJ Open Diabetes Res Care. 2025 Nov 04. pii: e005469. [Epub ahead of print]13(6):
       INTRODUCTION: This analysis investigated whether use of real-time continuous glucose monitoring (CGM) compared with blood glucose monitoring (BGM) results in rapidly improved glycemic management in adults with type 2 diabetes (T2D) treated with basal insulin.
    RESEARCH DESIGN AND METHODS: Using data from the MOBILE study where adults (n=175) with T2D treated with basal insulin without prandial insulin were randomized (2:1) to either CGM (n=116) or BGM (n=59), the treatment effect on glycemic management was determined over 3 months. The main outcome was a between-group difference in hemoglobin A1c (HbA1c) at 3 months adjusted for baseline value. Other outcomes included changes in CGM-derived glucose metrics and hypoglycemic events.
    RESULTS: After 3 months, there was a greater reduction from baseline in mean HbA1c in the CGM group compared with the BGM group, from 9.1±1.0% (76±11 mmol/mol) to 8.0±1.2% (64±13 mmol/mol) in the CGM group and from 9.0±0.9% (75±10 mmol/mol) to 8.5±1.5% (69±16 mmol/mol) in the BGM group (adjusted difference, -0.6% (95% CI -0.9% to -0.3%); -6.6 mmol/mol (95% CI -10.2 to -2.9), p<0.001). Mean time spent in range 70-180 mg/dL (3.9-10.0 mmol/L) increased significantly more in the CGM group than the BGM group (adjusted difference, +9.3% (95% CI 2.1% to 16.4%), p<0.001). There also was a greater reduction in mean time >250 mg/dL (>13.9 mmol/L) with CGM (adjusted difference, -5.8% (95% CI -10.4% to -1.2%), p<0.001) without an increase in time <70 mg/dL (<3.9 mmol/L). Mean weekly hypoglycemic event rate was lower with CGM than BGM (adjusted difference, -0.2 events per week (95% CI -0.4 to -0.1), p<0.001). Further, in the CGM group, significant improvements in CGM metrics were observed during the first 7 days of CGM use.
    CONCLUSIONS: In adults with basal insulin-treated T2D, use of CGM compared with BGM resulted in rapidly improved glycemic management, with a substantial reduction in HbA1c over 3 months.
    TRIAL REGISTRATION NUMBER: NCT03566693.
    Keywords:  Blood Glucose Self-Monitoring; Diabetes Mellitus, Type 2; Glycated Hemoglobin A
    DOI:  https://doi.org/10.1136/bmjdrc-2025-005469
  3. Expert Rev Pharmacoecon Outcomes Res. 2025 Nov 06.
       BACKGROUND: One of the novel methods of blood glucose monitoring is continuous glucose monitoring (CGM). This study aims to evaluate the cost-effectiveness of CGM versus self-monitoring of blood glucose (SMBG) in patients with type 2 diabetes (T2D) in Iran.
    METHODS: A cost-effectiveness analysis with a lifetime horizon was conducted to compare the two monitoring strategies. The patient-level United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model was employed, and clinical and demographic data from Iranian patients enrolled in the Diabetes Care study were extracted for the analysis. Cost-effectiveness was evaluated by calculating incremental cost-effectiveness ratios (ICERs), expressed as cost per QALY gained. Uncertainty in the model was addressed through probabilistic sensitivity analysis using 100 bootstrap iterations.
    RESULTS: The cost-effectiveness analysis showed that the expected cost of CGM compared to SMBG was $40,444.2. The incremental gain in QALYs was 0.096, resulting in an ICER of $397,644.7 per QALY gained. Based on bootstrap analysis, the 95% CI for the ICER ranged from $271,157.3 to $600,185.2.
    CONCLUSION: CGM does not represent a cost-effective alternative to SMBG for patients with T2D in Iran. This finding was supported by bootstrap analysis, which demonstrated a lack of cost-effectiveness across all simulated scenarios.
    Keywords:  Cost-effectiveness analysis; Iran; Self-monitoring of blood glucose; continuous glucose monitoring; type 2 diabetes
    DOI:  https://doi.org/10.1080/14737167.2025.2586670
  4. Diabetes Ther. 2025 Nov 01.
       INTRODUCTION: This study aimed to examine glucose metrics and insulin delivery patterns in children, adolescents, and adults with type 1 (T1D) or 2 (T2D) diabetes in France using the tubeless Omnipod DASH® pump with and a continuous glucose monitoring (CGM) sensor connected to myDiabby Healthcare® Data Management Platform (DMP).
    METHODS: Time-stamped CGM and insulin data were extracted from the DMP on December 6, 2023 for 17,344 users whose first data point from the tubeless pump occurred after January 1, 2020. The study population included users with sufficient pump and CGM data (≥ 90 days of use) and ≥ 15.5% of CGM use days reaching > 70% coverage. Analyses were performed by type of diabetes and age group.
    RESULTS: Among 14,757 users included in this analysis, most reported having T1D (93.7%), the median age was 33 years (Q1-Q3, 16-51), and the median duration of pump use was 545 days for people with T1D and 505 days for people with T2D (1.49 and 1.38 years, respectively). People with T1D spent a median of 52.5% (Q1-Q3, 43.4-62.5) of time in range (70-180 mg/dL, TIR) and a TIR ≥ 70% was attained by 12.6% of users. The median time below range (TBR, < 70 mg/dL) was 3.7% (Q1-Q3, 2.1-6.1). For users with T2D, median TIR was 66.9% (Q1-Q3, 54.0-77.8), with 42.8% of users achieving a TIR ≥ 70%. Over 90% of all users consumed less than 60 UI/day.
    CONCLUSION: This robust and scalable analysis of a database of substantial quantity, density, and quality found that tubeless pump users achieved moderate glycemic outcomes overall with favorablesafety outcomes in particular, and used the pump consistently. Such databases could be useful for research and patient care, and further work will show how best to use them.
    Keywords:  CGM; Data management platform; Insulin pump; Real-world data; Type 1 diabetes; Type 2 diabetes
    DOI:  https://doi.org/10.1007/s13300-025-01814-8
  5. Ther Innov Regul Sci. 2025 Nov 07.
       BACKGROUND: A continuous glucose monitoring system (CGM) is a digital health technology (DHT) device that measures interstitial glucose. CGMs are used in the management of diabetes. The purpose of this study was to retrospectively assess the quality of CGM data in a clinical trial involving patients with type 1 diabetes.
    METHODS: CGM data were collected from 461 patients with type 1 diabetes who participated in a 16-week, double-blind phase 3 trial designed to examine the efficacy of prandial (mealtime) insulins. CGM data were collected at three 2 week study time points. The patterns of missing CGM data (due to non-wear, user- and device-related causes) and the relationship between CGM metrics and hemoglobin A1C (HbA1c) were examined using data visualization approaches.
    RESULTS: Across the three observation periods, 4.7-6% of CGM observations were missing. Approximately 16% of daily values were missing on days when a new CGM sensor was inserted. For many patients, high glucose variability was associated with low time in range (TIR) and HbA1c >7%. Conversely, low glucose variability was associated with higher TIR.
    CONCLUSIONS: Our analysis identified the need for adequate documentation indicating the presence of patient- and device-related events (e.g., sensor changes, non-wear time) to address causes of missing CGM data. These causes need to be considered prior to the statistical assessment of such data for research and regulatory purposes. Accurate documentation of post-baseline events is important for the development of research and regulatory standards for the collection and analysis of data acquired from DHTs.
    Keywords:  Clinical trials; Continuous glucose monitoring; Digital health technology; Type 1 diabetes
    DOI:  https://doi.org/10.1007/s43441-025-00880-1
  6. Clin Med Insights Endocrinol Diabetes. 2025 ;18 11795514251389034
       Background: The 2025 American Diabetes Association guidelines emphasize the benefits of continuous glucose monitoring (CGM) for patients with diabetes receiving insulin therapy. CGM measures interstitial fluid glucose levels, offering an alternative to capillary (finger-stick) devices. This study aimed to evaluate the real-world impact of CGM devices on patients with uncontrolled type 2 diabetes (T2D) compared to traditional blood glucose monitoring (BGM) in a resource-limited population.
    Methods: This is a retrospective study of patients 18 years or older, with T2D, with a glycated hemoglobin (HbA1c) > 9% at enrollment during the study period of December 1, 2021, to February 12, 2023, at an inner-city hospital. Patients with T2D using CGM devices were compared to a historical cohort of patients from the same population using BGM devices in the same period. The primary outcome was the HbA1c at 3 months. In total, 64 patients were included in the analysis after screening: 27 in the CGM group and 37 in the non-CGM group.
    Results: For the primary end point of HbA1c at 3-months, the study found no significant difference between groups. After adjustment for baseline differences (age, HbA1c, creatinine, point-of-care glucose, and number of patients on injectables), average treatment effect (ATE) was -0.48% (SE = 0.27) in favor of the non-CGM group (P = .07). Potential outcome means were 8.8% (SE = 0.17) and 8.3% (SE = 0.2) for CGM and non-CGM groups respectively. Both groups achieved clinically meaningful reduction in HbA1c.
    Conclusion: Our study did not find that CGM titrated regimens resulted in a statistically significant difference in HbA1c change at 3 months compared to non-CGM based treatment. This may indicate that while diabetes technology can help achieve glucose goals in more controlled settings, optimal results in the real world is influenced by many factors, such as insurance coverage, patient adoption, and provider training. More research can be done on identifying factors that yield optimal results in CGM utilization in outpatient settings.
    Keywords:  BGM; CGM; HbA1c; T2D; Type 2 diabetes; continuous glucose monitoring; traditional blood glucose monitoring
    DOI:  https://doi.org/10.1177/11795514251389034
  7. Diabetes Obes Metab. 2025 Nov 03.
       AIMS: Early detection and management of gestational diabetes mellitus (GDM) benefits both mother and infants. We aimed to compare continuous glucose monitoring (CGM) to routine self-monitoring of blood glucose (SMBG) in a randomised controlled trial on glycaemic management and pregnancy outcomes in women with GDM diagnosed in gestational Weeks 8-26.
    MATERIALS AND METHODS: From October 2021 to December 2023, 128 women with GDM were enrolled and 120 completed the trial after 2:1 randomisation to either the intervention (Dexcom G6 CGM, n = 80) or the control group (SMBG 4×/day and monthly blinded CGM [Dexcom G6 Pro], n = 40). Both groups received lifestyle and medication advice based on the CGM interpretation, clinical follow-up and glucose monitoring until delivery. CGM metrics were evaluated with the automated glucose data analysis (AGATA) toolbox (https://github.com/gcappon/agata) and maternal and neonatal outcomes were collected from medical records. Participants completed the CGM Satisfaction survey prior to delivery.
    RESULTS: While no significant differences between groups in time spent in the glucose target range (TIR) 63-140 mg/dL (primary outcome) were found (p = 0.37), the intervention group experienced significantly lower unscheduled caesarean section rates (20.0% vs. 44.4%, p = 0.046, V = 0.19) and preterm deliveries (6.8% vs. 18.4%, p = 0.041, V = 0.19). Neonates experienced lower large-for-gestational-age rates (5.0% vs. 18.4%, p = 0.019, V = 0.22) and neonatal intensive care unit admissions (22.5% vs. 44.7%, p = 0.013, V = 0.23) compared to the control group. Participants in the intervention group reported high CGM satisfaction and endorsed the behavioural and psychosocial benefits.
    CONCLUSIONS: For women with early GDM, despite no improvement in TIR, CGM improved maternal and neonatal outcomes versus SMBG. The effect may be mediated by improved awareness of glycaemic excursions and by facilitation of treatment regimen adjustments.
    Keywords:  continuous glucose monitoring (CGM); gestational diabetes; patient reported outcomes; randomised trial
    DOI:  https://doi.org/10.1111/dom.70254
  8. Obstet Gynecol Surv. 2025 Nov 01. 80(11): 679-681
      (Abstracted from Lancet Diabetes Endocrinol 2025;13:591-599) The incidence rate for gestational diabetes mellitus (GDM) is as high as 14%, making it one of the more common complications of pregnancy. Glycemic control is an important factor in the treatment of GDM and includes self-monitoring of blood glucose (SMBG).
    DOI:  https://doi.org/10.1097/01.ogx.0001172276.61602.22
  9. Diabetes Care. 2025 Nov 03. pii: dc251494. [Epub ahead of print]
       OBJECTIVE: Continuous glucose monitoring (CGM) is widely used to monitor glucose levels in patients with diabetes and guide insulin dosing in outpatients. In inpatient care, special regulatory requirements necessitate CGM accuracy as a prerequisite for its integration into clinical decision support.
    RESEARCH DESIGN AND METHODS: To meet the specific demands of in-hospital care, CGM accuracy was retrospectively evaluated in 226 patients using paired CGM and point-of-care glucose measurements, assessed via mean absolute relative difference (MARD), Clarke Error Grid (CEG) analysis, and a modified version of the U.S. Food and Drug Administration agreement rule. A dynamic, patient-specific algorithm incorporating time lag correction and linear modeling was developed to minimize MARD and applied in a second cohort of 24 patients within the clinical workflow.
    RESULTS: Data analysis showed an initial MARD of 10.30%, with 99.02% of data points located in zones A and B of the CEG. The application of the patient-specific optimization algorithm improved the MARD by 4.33%. Evaluation of the patient-specific algorithm on the second inpatient cohort demonstrated a 5.58% reduction in intrapersonal MARD, indicating its potential applicability within clinical workflows.
    CONCLUSIONS: Patient-specific algorithmic refinements of CGM data demonstrate the potential to adequately address the unique demands of inpatient diabetes care by reducing intrapersonal MARD, paving the way for the adoption of CGM systems into hospital environments.
    DOI:  https://doi.org/10.2337/dc25-1494
  10. Diabetes Ther. 2025 Nov 01.
       INTRODUCTION: The aim of this study was to investigate the cost-utility of real-time continuous glucose monitoring (rt-CGM) versus self-monitoring of blood glucose (SMBG) in people with insulin-treated type 2 diabetes (T2D) in Sweden.
    METHODS: The CORE Diabetes Model (CDM v10) was used for the analysis. Clinical effectiveness data were obtained from the Steno2Tech trial, an investigator-initiated, 12-month, single center randomized controlled trial based in Denmark. Adverse event rates were sourced from a large-scale observational study based in the USA. Costs were obtained from Swedish and European studies and inflated to 2023 Swedish Krona (SEK). The analysis adopted the perspective of the Swedish payer, and a remaining lifetime horizon was used in the base case. A discount rate of 3% was applied to future costs and outcomes on an annual basis. A commonly cited willingness-to-pay (WTP) threshold of SEK 500,000 was used.
    RESULTS: rt-CGM led to a gain in mean incremental survival by 0.082 years (11.529 life years for rt-CGM versus 11.447 life years for SMBG). Total mean incremental costs were SEK 138,448 higher with rt-CGM compared with SMBG (SEK 1,151,049 for rt-CGM versus SEK 1,012,601 for SMBG). However, rt-CGM incurred fewer overall diabetes-related complication costs than SMBG over the remaining lifetime horizon. Rt-CGM also yielded a gain in mean incremental quality-adjusted life years (QALYs) of 0.632 (8.608 QALYs for rt-CGM versus 7.976 QALYs for SMBG). The mean incremental cost-utility ratio (ICUR) for rt-CGM was SEK 219,063 per QALY gained, which showed rt-CGM to be cost-effective when compared with the WTP threshold of SEK 500,000. When various indirect cost estimates were incorporated, rt-CGM was consistently more cost-effective than in the base case analysis.
    CONCLUSIONS: For individuals living in Sweden with T2D requiring insulin treatment, rt-CGM is a cost-effective management option relative to SMBG.
    Keywords:  Continuous glucose monitoring; Cost-utility; Health economics; Quality of life; Self-monitoring of blood glucose; Type 2 diabetes
    DOI:  https://doi.org/10.1007/s13300-025-01811-x
  11. Lancet Digit Health. 2025 Nov 03. pii: S2589-7500(25)00086-X. [Epub ahead of print] 100904
      Digital health feedback technologies are expected to help address the projected 630 million individuals with prediabetes worldwide by 2045. This Viewpoint article characterises the historical use of continuous glucose monitoring (CGM) systems in behavioural research with a focus on the prediabetic population. We identified 19 peer-reviewed studies through a pragmatic literature review and reported key methodological features, including study design, sensor wear protocols, data masking strategies, the role of CGM in behavioural interventions, and approaches to generate CGM metrics. Based on our literature review, we propose four directions to advance CGM in behavioural intervention research in prediabetes: refining sampling strategies to focus recruitment on individuals with prediabetes to better understand metrics in this population; improving transparency in CGM feedback delivery protocols; reporting a comprehensive and targeted set of CGM metrics; and articulating principles that account for the effects of CGM use within behavioural interventions. This methodological characterisation of CGM is a starting point to enhance research quality and behavioural intervention effectiveness, particularly when integrating CGM systems aimed at supporting dietary, physical activity, or lifestyle modifications among people with prediabetes.
    DOI:  https://doi.org/10.1016/j.landig.2025.100904
  12. J Diabetes Sci Technol. 2025 Nov 04. 19322968251388119
       INTRODUCTION: Prior studies have not identified if continuous glucose monitoring (CGM) metrics at a critical gestational age window can discriminate risk of adverse pregnancy outcomes. We evaluated late second- and third-trimester CGM metrics by gestational age associated with pregnancy outcomes in gravidas with type 1 diabetes (T1DM).
    METHODS: Dexcom G6 CGM data from a retrospective cohort of singleton gestations with T1DM (2018-2022) at an academic medical center were analyzed. Time in, above, and below range 63 to 140 mg/dL (TIR, TAR, TBR), glycemic variability, and mean glucose concentration were computed in two-week CGM intervals from 240 to 396 weeksdays. Adverse pregnancy outcomes were hypertensive disorders of pregnancy (HDP), large-for-gestational age (LGA), and neonatal hypoglycemia. Linear mixed-effects models were fitted on CGM metrics computed from two-week CGM intervals, with gestational age, adverse pregnancy outcomes (i.e. presence/absence of HDP, LGA, and/or neonatal hypoglycemia), and their interaction as fixed effects.
    RESULTS: In 87 gravidas with preconception median hemoglobin A1c 6.5% (IQR 6.0, 7.1) and maternal body mass index 24.8 kg/m2 (IQR 21.9, 27.1), 71% had at least one adverse pregnancy outcome. Between weeks 240 and 376, gravidas with HDP had higher TAR and mean glucose and lower TIR (P < .05). Gravidas with LGA had lower TBR between weeks 240 and 356. TIR, TAR, and mean glucose evolution differed by HDP status, with greatest divergence between groups at 280 to 296 weeks' gestation (P ≤ .001).
    CONCLUSION: CGM metrics in the late second to early third trimester, a period of peak insulin resistance, may help to distinguish risk of HDP and LGA in gravidas with T1DM.
    Keywords:  continuous glucose monitoring; obstetric morbidity; pregnancy; type 1 diabetes
    DOI:  https://doi.org/10.1177/19322968251388119
  13. Sci Rep. 2025 Nov 03. 15(1): 38376
      Continuous glucose monitoring (CGM) devices allow real-time glucose readings leading to improved glycemic control. However, glucose predictions in the lower (hypoglycemia) and higher (hyperglycemia) extremes, referred as glycemic excursions, remain challenging due to their rarity. Moreover, limited access to sensitive patient data hampers the development of robust machine learning models even with advanced deep learning algorithms available. We propose to simultaneously provide accurate glucose predictions in the excursion regions while addressing data privacy concerns. To tackle excursion prediction, we propose a novel Hypo-Hyper (HH) loss function that penalizes errors based on the underlying glycemic range with a higher penalty at the extremes over the normal glucose range. On the other hand, to address privacy concerns, we propose FedGlu, a machine learning model trained in a federated learning (FL) framework. FL allows collaborative learning without sharing sensitive data by training models locally and sharing only model parameters across other patients. The HH loss combined within FedGlu addresses both the challenges at the same time. The HH loss function demonstrates a 46% improvement over mean-squared error (MSE) loss across 125 patients. Compared to local models, FedGlu improved glycemic excursion detection by 35% compared to local models. This improvement translates to enhanced performance in predicting both, hypoglycemia and hyperglycemia, for 105 out of 125 patients. These results underscore the effectiveness of the proposed HH loss function in augmenting the predictive capabilities of glucose predictions. Moreover, implementing models within a federated learning framework not only ensures better predictive capabilities but also safeguards sensitive data concurrently.
    Keywords:  Continuous glucose monitoring; Diabetes; Federated learning; Glucose prediction; Hyperglycemia; Hypoglycemia
    DOI:  https://doi.org/10.1038/s41598-025-22316-4
  14. Health Care Sci. 2025 Oct;4(5): 350-354
      We report the case of a newly diagnosed overweight patient with type 2 diabetes mellitus who achieved diabetes remission using continuous glucose monitoring (CGM), which promotes patient engagement in self-management. Key measures included selection of a patient newly diagnosed with type 2 diabetes mellitus, use of CGM, analysis of glucose trends and contributing factors, and patient guidance in maintaining a health diary and developing personalized self-management strategies (e.g., dietary modification and exercise regimens). Following 6-month CGM-guided self-management, the patient's glycated hemoglobin level decreased from 7.3% at baseline to 6.0% and his body weight decreased from 83 to 77 kg, a 7% reduction; thus, the patient met the criteria for diabetes remission.
    Keywords:  continuous glucose monitoring; diabetes remission; overweight; type 2 diabetes mellitus
    DOI:  https://doi.org/10.1002/hcs2.70035
  15. Diabetes Technol Ther. 2025 Nov 07.
      The Dexcom G7 continuous glucose monitor is labeled for 10 days of wear. We assessed the real-world duration of Dexcom G7 sensor wear in youth with type 1 diabetes (T1D) in this single-center retrospective cohort study. Median duration of sensor wear was calculated for youth using ≥3 sensors over a 93-day period (May 13, 2024, to August 13, 2024). Overall, 643 unique individuals (15.1 years, 45.1% female, 66.3% non-Hispanic White, 60.2% privately insured, 4.9 years T1D duration) wore 5055 sensors over the 93 days. The median sensor wear time was 8.6 days (interquartile range 7.3, 9.6). Wear time was <7.0 days for 24.8% of sensors, and just 39.9% of sensors were worn for ≥10.0 days. In summary, the real-world duration of Dexcom G7 sensor wear is <10 days for most youth with T1D. Whereas people with diabetes typically receive 36 sensors per year, with a median wear time of 8.6 days, youth would require 43 sensors or more to allow for continuous use.
    Keywords:  Dexcom G7; continuous glucose monitoring; duration of CGM wear; pediatrics; real-world; type 1 diabetes
    DOI:  https://doi.org/10.1177/15209156251390821
  16. Sleep Med. 2025 Oct 30. pii: S1389-9457(25)00563-5. [Epub ahead of print]137 106888
       BACKGROUND: The impact of nocturnal hypoglycemia (NH) on subjective sleep quality in type 1 diabetes (T1D) is unclear. Awareness to stimuli varies across sleep stages-lower during early slow-wave sleep and higher during late sleep-which may influence the impact of NH on perceived sleep quality. This study examines whether NH timing affects subjective sleep quality in T1D.
    METHODS: Adults with T1D using multiple daily injections or basic insulin pumps (excluding real-time continuous glucose monitoring [CGM] users) wore a blinded CGM (Freestyle Libre Pro) for 14-28 days and rated sleep quality each morning using a single-item Likert scale (1 = very poor; 5 = very well). Sleep time was defined as 0000-0600 h, split into early (0000-0300) and late (0300-0600) periods. NH was categorized as Time-Below-Range, TBR1 (<70 mg/dL) and TBR2 (<54 mg/dL). A cumulative link mixed model assessed the impact of NH during early (TBR-E) and late (TBR-L) sleep on sleep quality, with participant as a random effect.
    RESULTS: Among 27 participants (18 women), median age was 30.6 years, mean BMI 24 kg/m2, median diabetes duration 16 years, and median HbA1c 7.6 %. Over half used insulin pumps, all used insulin analogs. NH during late sleep significantly reduced the odds of reporting better sleep quality (OR 0.90, 95 % CI: 0.86-0.94, p < 0.001). TBR1-E and TBR2 showed no association. Adjusting for age, gender, BMI, HbA1c, and diabetes duration did not change these findings.
    CONCLUSION: NH timing may be a key determinant of subjective sleep quality in T1D.
    Keywords:  Continuous glucose monitoring; Nocturnal hypoglycemia; Sleep quality; Type 1 diabetes
    DOI:  https://doi.org/10.1016/j.sleep.2025.106888
  17. Arch Endocrinol Metab. 2025 Nov 06. 69(6): e250034
       OBJECTIVE: The relationship between liver health and glycaemic control in elderly patients with diabetes remains poorly understood. In this study, the value of liver elastography in identifying associations with poor glycaemic control among elderly patients with type 2 diabetes mellitus was investigated.
    SUBJECTS AND METHODS: In total, 90 elderly patients (aged ≥ 60 years) with type 2 diabetes mellitus were enrolled in this prospective observational study. All participants underwent liver elastography using FibroScan® and continuous glucose monitoring (CGM). Liver stiffness measurements (LSMs) and the controlled attenuation parameter (CAP) were obtained. Glycaemic control was assessed through multiple parameters, including the time in range (TIR), time above range (TAR), glycaemic variability, and mean glucose levels. Poor glycaemic control was defined as a TIR < 70%. The mean age of the participants was 64.0 ± 10.5 years, with 65.6% being female. The mean liver stiffness was 6.1 ± 7.8 kPa, and the mean CAP was 266.0 ± 54.7 dB/m.
    RESULTS: Patients with higher liver stiffness (>8.0 kPa) had a significantly lower TIR (68.7% versus 83.5%, p<0.001) than those with normal liver stiffness (<5.5 kPa). LSMs were strongly negatively correlated with the TIR (r = -0.42, p < 0.001) and positively correlated with the mean glucose level (r = 0.38, p < 0.001). Multivariate analysis revealed that increased liver stiffness was independently associated with poor glycaemic control (adjusted OR = 1.28, 95% CI: 1.14-1.44; p < 0.001).
    CONCLUSION: ROC analysis revealed an exploratory LSM cut-off value of 6.8 kPa for association with poor glycaemic control (AUC = 0.76; sensitivity = 71.2%; specificity = 78.9%). LSMs via transient elastography are independently associated with poor glycaemic control in elderly patients with type 2 diabetes. An LSM threshold of 6.8 kPa may help identify patients who are more likely to present with poor glycaemic control.
    Keywords:  Type 2 diabetes mellitus; continuous glucose monitoring; elderly patients; glycaemic control; liver elastography
    DOI:  https://doi.org/10.20945/2359-4292-2025-0034
  18. Diabetes Ther. 2025 Nov 07.
       INTRODUCTION: FreeStyle Libre (FSL) systems are effective and user-friendly glucose monitoring devices. This cost-effectiveness analysis compared FSL vs. self-blood glucose monitoring (SBGM) in patients with poorly controlled [hemoglobin A1c (HbA1c) > 8%] type 2 diabetes (T2DM) on basal insulin, from the Spanish National Health System perspective.
    METHODS: The DEDUCE model, which simulated 10,000 patients with T2DM over a 50 years' time horizon (annual discount rate = 3.00%), was adapted to the Spanish setting. The population characteristics, frequency of acute and chronic diabetic complications, costs (€, 2025) and utilities/disutilities proceeded from scientific literature and were validated by national multidisciplinary experts. The annual probabilities of acute events associated with SBGM were 17.02% for non-severe hypoglycemia (SHE) (€3.92; disutility = - 0.0016), 2.50% for SHE (€1031.69; disutility = - 0.0470) and 0.25% for ketoacidosis (DKA) (€2523.93; disutility = - 0.0470). The RECODe risk engine was used to model chronic diabetic complications (myocardial infarction [€1248.44-€31,013.22; disutility = - 0.0550]; heart failure [€1523.14-6505.08; disutility = - 0.1080]; stroke [€3187.92-7849.48; disutility = - 0.1640]; blindness [€2943.37; disutility = - 0.0740]; renal failure [€4057.05-42,757.39; disutility = - 0.2040]). According to the Spanish recommendations, a patient with SBGM required 2.5 reactive strips/day and 2.5 lancets/day (€0.57/strip; €0.14/lancet; VAT included). FSL (26 sensors/year; €3.00/day; VAT included) was associated with reductions of 58% in hypoglycemia, 68% in DKA, 83% in the use of strips/lancets, and an absolute decrease of 1.1% in HbA1c. Deterministic and probabilistic sensitivity analyses (SAs) were conducted.
    RESULTS: While SBGM yielded 9.18 quality-adjusted life years (QALYs) and total costs of €77,092 (glucose monitoring = €17,080; diabetic complications = €68,272), FSL yielded 9.98 QALYs and total costs of €61,447 (glucose monitoring = €8820; diabetic complications = €44,367). Compared with SBGM, FSL produced total cost savings of €15,645 and 0.80 additional QALYs per patient, being a dominant alternative compared to SBGM. FSL was found to be dominant in all SAs.
    CONCLUSIONS: This analysis suggests that FSL, which provides better clinical outcomes at a lower overall cost, is a preferable alternative to SBGM among people with poorly controlled T2DM on basal insulin.
    Keywords:  Basal insulin therapy; Cost-effectiveness analysis; Cost–utility analysis; FreeStyle Libre systems; Glucose monitoring; Poor glycemic control; Self-blood glucose monitoring; Spain; Type 2 diabetes mellitus
    DOI:  https://doi.org/10.1007/s13300-025-01816-6
  19. Rom J Ophthalmol. 2025 Jul-Sep;69(3):69(3): 460-463
       Objectives: To present the case of a premenopausal woman with long-standing type 1 diabetes mellitus and diabetic retinopathy, in whom severe vitamin D deficiency was associated with poor metabolic control and depressive symptoms, and whose ocular and systemic condition spectacularly improved after vitamin D supplementation.
    Material and methods: We describe the clinical history, laboratory findings, and ophthalmological assessments of a 42-year-old woman from an urban area of Dobrogea, Romania. The patient had a 28-year history of type 1 diabetes mellitus complicated with proliferative diabetic retinopathy, early-stage chronic kidney disease, and diabetic polyneuropathy. Initial laboratory evaluation indicated severe vitamin D deficiency (8 ng/mL), marked glycemic variability (documented by continuous glucose monitoring), and microalbuminuria.
    Results: Following six months of vitamin D supplementation, serum levels increased to 40 ng/mL, depressive symptoms improved, and the patient became more adherent to nutritional therapy. Ophthalmological follow-up: Optical Coherence Tomography (OCT) retinal findings showed stabilization of retinal neovascularization.
    Discussion: The distinctiveness of this case arises from the coexistence of multiple risk factors, including long-duration type 1 diabetes with microvascular involvement, pronounced vitamin D deficiency despite favorable sun exposure conditions, premenopausal status under HRT, and retinal changes objectively documented before and after supplementation.
    Conclusions: This case supports the hypothesis that vitamin D may have a protective role against retinal neovascularization in diabetic retinopathy, possibly by reducing inflammation and angiogenesis trend, and indirectly by improving metabolic control.
    Keywords:  CGM = Continuous Glucose Monitoring; DR = Diabetic Retinopathy; HIF = Hypoxia-Inducible Factor; HbA1c = Hemoglobin A1c; OCT = Optical Coherence Tomography; PDR = Proliferative Diabetic Retinopathy; PRN = Pro re nata (as needed); PRP = Panretinal Photocoagulation; VA = Visual Acuity; VD = Vitamin D; VEGF = Vascular Endothelial Growth Factor; Vitamin D; diabetic retinopathy; retinal neovascularization; type 1 diabetes
    DOI:  https://doi.org/10.22336/rjo.2025.72