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BackgroundA composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data.MethodsWe assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low-glucose and low-glucose hypoglycemia; very high-glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation.ResultsThe analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals.ConclusionThe GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.

Ongoing innovation in diabetes technologies has led to the development of advanced tools such as automated insulin delivery (AID) systems that adjust insulin delivery in response to current and predicted glucose levels, residual insulin action, and other inputs (eg, meal and exercise announcements). However, infusion sets continue to be the "Achilles heel" of accurate and precise insulin delivery and continued device use. A recent study by Kalus et al (DERMIS Study) revealed higher vessel density and signals of inflammation by optical coherence tomography (OCT), in addition to increased inflammation, fat necrosis, fibrosis, and eosinophilic infiltration by histopathology. Although the study provided a comprehensive description of what was happening, the results raise important questions that require additional research. On February 29, 2024, the Leona M. and Harry B. Helmsley Charitable Trust sponsored a conference to begin addressing these issues. This article summarizes the DERMIS study findings and testing methodologies discussed at the conference and proposes the next steps for developing insulin infusion sets that reduce the variability in insulin delivery and extend wear., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Interventional studies investigating blood glucose (BG) management in intensive care units (ICU) have been inconclusive. New insights are needed. We assessed the ability of a new metric, the Glycemic Ratio (GR), to determine the relationship of ICU glucose control relative to preadmission glycemia and mortality., Methods: Retrospective cohort investigation (n = 4790) in an adult medical-surgical ICU included patients with minimum four BGs, hemoglobin (Hgb), and hemoglobin A1c (HbA1c). The GR is the quotient of mean ICU BGs (mBG) and estimated preadmission BG, derived from HbA1c., Results: Mortality displayed a J-shaped curve with GR (nadir GR 0.9), independent of background glycemia, consistent for HbA1c <6.5% vs >6.5%, and Hgb >10 g/dL vs <10 g/dL and medical versus surgical. An optimal range of GR 0.80 to 0.99 was associated with decreased mortality compared with GR above and below this range. The mBG displayed a linear relationship with mortality at lower HbA1c but diminished for HbA1c >6.5%, and dependent on preadmission glycemia. In adjusted analysis, GR remained associated with mortality (odds ratio = 2.61, 95% confidence interval = 1.48-4.62, P = .0012), but mBG did not (1.004, 1.000-1.009, .059). A single value on admission was not independently associated with mortality., Conclusions: The GR provided new insight into malglycemia that was not apparent using mBG, or an admission value. Mortality was associated with acute change from preadmission glycemia (GR). Further assessment of the impact of GR deviations from the nadir in mortality at GR 0.80 to 0.99, as both relative hypo- and hyperglycemia, and as duration of exposure and intensity, may further define the multifaceted nature of malglycemia., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: JSK and J-CP disclosed that they are advisory board members and consultants for Edwards Life Sciences, OptiScan Biomedical, and Roche Diagnostics. IBH’s institution received funding from Insulet and Beta Bionics; he disclosed that he is a consultant for Abbott, Roche, LifeScan, and GWave. GEU’s institution received funding from Dexcom, Abbott, and Baxter. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Background: People with type 1 diabetes generally view it easier to exercise when having continuous information of the glucose levels. We evaluated whether patients with type 1 diabetes managed with multiple daily insulin injections (MDI) exercised more after initiating continuous glucose monitoring (CGM) and whether the improved glycemic control and well-being associated with CGM translates into improved blood lipids and markers of inflammation., Method: The GOLD trial was a randomized cross-over trial over 16 months where patients used either CGM or capillary self-monitoring of blood glucose (SMBG) over six months, with a four-month wash-out period between the two treatment periods. We compared grade of physical activity, blood lipids, apolipoproteins, and high-sensitivity C-reactive protein (hsCRP) levels during CGM and SMBG., Results: There were 116 patients with information of physical activity estimated by the International Physical Activity Questionnaire (IPAQ) during both CGM and SMBG. No changes were found during CGM or SMBG, IPAQ scores 3305 versus 3878 ( P = .16). In 136 participants with information of blood lipid levels with no change in lipid-lowering medication during the two treatment periods, HbA1c differed by 4.2 mmol/mol (NGSP 0.39%) between SMBG and CGM treatment ( P < .001). No significant changes existed in low-density lipoprotein, high-density lipoprotein, triglycerides, total cholesterol, apolipoprotein A1, apolipoprotein B1, or hsCRP, during CGM and SMBG., Conclusion: Although many patients experience it easier to perform physical activity when monitoring glucose levels with CGM, it does not influence the amount of physical activity in persons with type 1 diabetes. Blood lipids, apolipoprotein, and hsCRP levels were similar during CGM and SMBG., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: TN has received unrestricted grants from AstraZeneca and NovoNordisk and has served on national advisory boards of Abbot, Amgen, Novo Nordisk, Sanofi-Aventis, Eli Lilly, MSD, and Boehringer Ingelheim. ML has received research grants from Eli Lilly and Novo Nordisk and been consultant or received honoraria from Astra Zeneca, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. JH has served on advisory boards or lectured for Novo Nordisk, Sanofi, Lilly, Abbot, Rubin Medical, MSD, and Boehringer Ingelheim. MW has served on advisory boards or lectured for MSD, Lilly, Novo Nordisk, and Sanofi and has organized a professional regional meeting sponsored by Lilly, Rubin Medical, Sanofi, Novartis, and Novo Nordisk. JB has received honoraria for consulting and/or lecture fees from Abbott Diabetes Care, Novo Nordisk, and Sanofi.

Background: Emerging data highlight the interactions of preadmission glycemia, reflected by admission HbA1c levels, glycemic control during critical illness, and mortality. The association of preadmission insulin treatment with outcomes is unknown., Methods: This observational cohort study includes 5245 patients admitted to the medical-surgical intensive care unit of a university-affiliated teaching hospital. Three groups were analyzed: patients with diabetes with prior insulin treatment (DM-INS, n  = 538); patients with diabetes with no prior insulin treatment (DM-No-INS, n  = 986); no history of diabetes (NO-DM, n  = 3721). Groups were stratified by HbA1c level: <6.5%; 6.5%-7.9% and >8.0%., Results: Among the three strata of HbA1c, mean blood glucose (BG), coefficient of variation (CV), and hypoglycemia increased with increasing HbA1c, and were higher for DM-INS than for DM-No-INS. Among patients with HbA1c < 6.5%, mean BG ≥ 180 mg/dL and CV > 30% were associated with lower severity-adjusted mortality in DM-INS compared to patients with mean BG 80-140 mg/dL and CV < 15%, ( P  = .0058 and < .0001, respectively), but higher severity-adjusted mortality among DM-No-INS ( P  = .0001 and < .0001, respectively) and NON-DM ( P  < .0001 and < .0001, respectively). Among patients with HbA1c ≥ 8.0%, mean BG ≥ 180 mg/dL was associated with lower severity-adjusted mortality for both DM-INS and DM-No-INS than was mean BG 80-140 mg/dL ( p  < 0.0001 for both comparisons)., Conclusions: Significant differences in mortality were found among patients with diabetes based on insulin treatment and HbA1c at home and post-admission glycemic control. Prospective studies need to confirm an individualized approach to glycemic control in the critically ill.

Aims: Continuous glucose monitoring (CGM) has the potential to promote diabetes self-management at home with a better glycemic control as outcome. Investigation of the effect of CGM has typically been carried out based on randomized controlled trials with prespecified CGM devices on CGM-naïve participants. The aim of this study was to investigate the effect on glycemic control in people using their personal CGM before and during the trial., Materials and Methods: Data from the Onset 5 trial of 472 people with type 1 diabetes using either their personal CGM ( n  = 117) or no CGM ( n  = 355) and continuous subcutaneous insulin infusion in a 16-week treatment period were extracted. Change from baseline in glycated hemoglobin A1c (HbA 1c ), number of hypoglycemic episodes, and CGM metrics at the end of treatment were analyzed with analysis of variance repeated-measures models., Results: Use of personal CGM compared with no CGM was associated with a reduction in risk of documented symptomatic hypoglycemia (event rate ratio: 0.82; 95% CI: 0.69-0.97) and asymptomatic hypoglycemia (event rate ratio: 0.72; 95% CI: 0.53-0.97), reduced time spent in hypoglycemia ( P  = .0070), and less glycemic variability ( P  = .0043) without a statistically significant increase in HbA 1c ( P  = .2028)., Conclusions: Results indicate that use of personal CGM compared with no CGM in a population of type 1 diabetes is associated with a safer glycemic control without a statistically significantly deteriorated effect on HbA 1c , which adds to the evidence about the real-world use of CGM, where device type is not prespecified, and users are not CGM naïve.

Background: The prevalence of smoking and diabetes is increasing in many developing countries. The aim of this study was to investigate the association of smoking with inadequate glycemic control and glycemic variability with continuous glucose monitoring (CGM) data in people with type 1 diabetes., Methods: Forty-nine smokers and 320 nonsmokers were obtained from the Novo Nordisk Onset 5 trial. After 16 weeks of treatment with continuous subcutaneous insulin infusion, risk of not achieving glycemic target and glycemic variability from six CGM measures was investigated. Analyzes were carried out with logistic regression models (glycemic target) and general linear models (glycemic variability). Finally, CGM median profiles were examined for the identification of daily glucose excursions., Results: A 4.7-fold (95% confidence interval: 1.5-15.4) increased risk of not achieving glycemic target was observed for smokers compared with nonsmokers. Increased time in hyperglycemia, decreased time in range, increased time in hypoglycemia (very low interstitial glucose), and increased fluctuation were observed for smokers compared with nonsmokers from CGM measures. CGM measures of coefficient of variation and time in hypoglycemia were not statistically significantly different. Examination of CGM median profiles revealed that risk of morning hypoglycemia is increased for smokers., Conclusions: In conclusion, smoking is associated with inadequate glycemic control and increased glycemic variability for people with type 1 diabetes with especially risk of morning hypoglycemia. It is important for clinicians to know that if the patient has type 1 diabetes and is smoking, a preemptive action to treat high glycated hemoglobin levels should not necessarily be treatment intensification due to the risk of hypoglycemia.

Background: The use of near-continuous blood glucose (BG) monitoring has the potential to improve glycemic control in critically ill patients. The MANAGE IDE trial evaluated the performance of the OptiScanner (OS) 5000 in a multicenter cohort of 200 critically ill patients., Methods: An Independent Group reviewed the BG run charts of all 200 patients and voted whether unblinded use of the OS, with alarms set at 90 and 130 to 150 mg/dL to alert the clinical team to impending hypoglycemia and hyperglycemia, respectively, would have eliminated episodes of dysglycemia: hypoglycemia, defined as a single BG <70 mg/dL; hyperglycemia, defined as >4 hours of BG >150 mg/dL; severe hyperglycemia, defined as >4 hours of BG >200 mg/dL and increased glucose variability (GV), defined as coefficient of variation (CV) >20%., Results: At least one episode of dysglycemia occurred in 103 (51.5%) of the patients, including 6 (3.0%) with hypoglycemia, 83 (41.5%) with hyperglycemia, 18 (9.0%) with severe hyperglycemia, and 40 (20.0%) with increased GV. Unblinded use of the OS with appropriate alarms would likely have averted 97.1% of the episodes of dysglycemia: hypoglycemia (100.0%), hyperglycemia (96.4%), severe hyperglycemia (100.0%), and increased GV (97.5%). Point accuracy of the OS was very similar to that of the point of care BG monitoring devices used in the trial., Conclusion: Unblinded use of the OS would have eliminated nearly every episode of dysglycemia in this cohort of critically ill patients, thereby markedly improving the quality and safety of glucose control.