Glucose Monitoring Research Articles

Development of a Diabetes Navigator Toolkit to Support Diabetes Technology Uptake: The IMPACT Toolkit

Advanced diabetes technologies (ADTs), including continuous glucose monitoring devices, insulin pumps, and automated insulin delivery systems, improve glycemic control in type 1 diabetes but are underutilized, particularly in minority and underserved populations. This article reports on a qualitative study to develop a diabetes toolkit. Participants identified barriers to the use of ADTs and proposed solutions to these barriers, which were then incorporated into a diabetes toolkit designed for use by a diabetes navigator or other diabetes care team members seeking to improve the uptake and sustained use of ADTs.

Initiating continuous glucose monitoring is associated with improvements in glycemic control and reduced health care resource utilization for people with diabetes in a large US-insured population: A real-world evidence study.

To examine the real-world impact of continuous glucose monitoring (CGM) use on glycemic management and health care resource utilization (HCRU) in people with diabetes in a large US-insured population. This retrospective observational study used Aetna administrative claims data from a cohort of fully insured commercial and Medicare Advantage beneficiaries with diabetes and with coverage for medical and pharmacy benefits. The index date was the first CGM pharmacy or medical claim observed between January 1, 2019, and December 31, 2021. Change in hemoglobin A1c was calculated using values from 3 months before and the latest values 10-12 months after the index date. HCRU was measured 12 months before and after the index date. Data were analyzed by the following patient groups: type 1 diabetes, type 2 diabetes (T2D) on intensive insulin therapy, T2D on basal-only insulin therapy, and T2D not on insulin therapy. Data from 7,336 patients (74% T2D, mean age 57 years, 42% Medicare-insured, 54% male, 56% White) were analyzed. Beneficiaries with available A1c data (n = 1,063) showed a significant improvement in A1c after CGM initiation (-0.7%, P < 0.0001), including -0.9% change in the T2D not on insulin group (n = 264). For the overall cohort, the number of patients with diabetes-related hospitalizations and emergency department visits decreased significantly by 67% and 40%, respectively (P < 0.0001 for both). This study showed that CGM use was associated with clinically meaningful improvements in A1c and reduced HCRU, suggesting potential for population-level clinical benefits, especially for patients not using insulin.

What is the Relationship Between Time in Range, Time in Tight Range, and HbA1c in Youth and Young Adults With Type 1 Diabetes? Results From the German/Austrian/Luxembourgian/Swiss Diabetes Prospective Follow-Up Registry.

Time in range (TIR, 70-180 mg/dL) is an established marker of glycemic control. More recently, time in tight range (TTR, 70-140 mg/dL) has been proposed as well. The aim of this study was to examine the relationship between TIR, TTR, and HbA1c in youth and young adults with type 1 diabetes (T1D) in the German/Austrian/Luxembourgian/Swiss Diabetes Prospective Follow-up (DPV) registry. Data of youth and young adults aged ≤25 years with T1D for >3 months, documented in the DPV registry between 2019 and 2022 were analyzed. The most recent available HbA1c and corresponding continuous glucose monitoring (CGM) profiles in the 12 preceding weeks with at least 80% completeness were included. Associations were investigated using correlation and adjusted regression models. 1901 individuals (median age 14.0 years [IQR 10.4-16.9]) were included in the analysis. TIR and TTR correlated strongly, r = 0.965 (95% CI [0.962, 0.968]), P < .001. TTR estimates predicted from TIR were significantly higher in the group with high coefficient of variation (CV group ≥ 36%), P < .001. Correlations between TIR or TTR and HbA1c were both strong, r = -0.764 (95% CI [-0.782, -0.745]) and r = -0.777 (95% CI [-0.795, -0.759]), both P < .001, with no significant difference (P = .312) However, adjusted regression models indicated a slightly better fit for the prediction of HbA1c from TIR compared with TTR. Based on large, real-world data from a multinational registry, TIR and TTR correlated strongly, and both showed a good prediction of HbA1c. TTR estimates predicted from TIR were significantly higher in people with high glucose variability (CV).

Glucagon-like peptide-1 agonists: Role of the gut in hypoglycemia unawareness, and the rationale in type 1 diabetes

Type 1 diabetes is increasing and the majority of patients have poor glycemic control. Although advanced technology and nanoparticle use have greatly enhanced insulin delivery and glucose monitoring, weight gain and hypo-glycemia remain major challenges and a constant source of concern for patients with type 1 diabetes. Type 1 diabetes shares some pathophysiology with type 2 diabetes, and an overlap has been reported. The above observation created great interest in glucagon-like peptide-1 receptor agonists (GLP-1) as adjuvants for type 1 diabetes. Previous trials confirmed the positive influence of GLP-1 agonists on β cell function. However, hypoglycemia unawareness and dysregulated glucagon response have been previously reported in patients with recurrent hypoglycemia using GLP-1 agonists. Jin et al found that the source of glucagon dysregulation due to GLP-1 agonists resides in the gut. Plausible explanations could be gut nervous system dysregulation or gut microbiota disruption. This review evaluates the potential of GLP-1 agonists in managing type 1 diabetes, particularly focusing on their impact on glycemic control, weight management, and glucagon dysregulation. We provide a broader insight into the problem of type 1 diabetes mellitus management in the light of recent findings and provide future research directions.

Simultaneous and Rapid Detection of Glucose and Insulin: Coupling Enzymatic and Aptamer-Based Assays.

Diabetes management demands precise monitoring of key biomarkers, particularly insulin (I) and glucose (G). Herein, we present a bioelectronic chip device that enables the simultaneous detection of I and G in biofluids within 2 min. This dual biosensor chip integrates aptamer-based insulin sensing with enzymatic glucose detection on a single platform, employing a four-electrode sensor chip. The insulin voltammetric sensor employs a G-quadraplex methylene-blue-modified aptamer, while the amperometric biocatalytic glucose sensor utilizes a second-generation mediator-based approach. Simultaneous reagent-less sensing of I and G has been achieved by addressing key challenges. These include combining different surface chemistries, assay formats, and detection principles at closely spaced working electrodes and the substantially different concentration levels of the I and G targets. An attractive analytical performance, with no apparent crosstalk, is demonstrated for the simultaneous detection of millimolar G concentrations and picomolar I concentrations in single microliter serum or saliva sample droplets. This dual biosensor offers rapid, cost-effective, and reliable monitoring, addressing the unmet need for integrated multiplexed diabetes biomarker detection in decentralized settings. Such integration of enzymatic and aptamer-based bioassays could greatly expand the scope of decentralized testing in healthcare beyond diabetes care.

Observed Glycemic and Psychosocial Benefits in the Prospective Bigfoot Unity Real World Study: A Six-Month Analysis.

The Bigfoot Unity Diabetes Management System integrates Abbott FreeStyle Libre 2 continuous glucose monitoring (CGM) data into a smart pen cap and mobile app enabling clinician-directed insulin dose recommendations and real-time alerts. The objective was to analyze real world 6-month glycemic control in a prospective study for individuals using the System for multiple daily insulin injections (MDI). We conducted a 6-month analysis from the BURST study (NCT05088265) of individuals with type 1 or type 2 diabetes (T2D). Participants reported baseline demographics, adverse event and other surveys electronically. Either at-home kit or electronic medical record glycated hemoglobin A1c (HbA1c) data were collected. Of 102 participants in the per-protocol cohort, median age was 59 years, 87% had T2D, 42% used CGM previously, 62% were White non-Hispanic and 59% female. Mean HbA1c decreased from 9.1 ± 1.7% at baseline to 8.0 ± 1.2% at 6 months (mean difference -1.1%, 95% confidence interval -1.4 to -0.8, P < 0.001). At 6 months, time in range 70-180 mg/dL, time <70 mg/dL and <54 mg/dL were 56 ± 23%, 1.0 ± 1.4% and 0.04 ± 0.14%, respectively. Six severe hypoglycemia events occurred in 4 participants (none system related) and no diabetic ketoacidosis events occurred in the per-protocol cohort. In this study primarily of older adults with T2D using MDI, durable glycemic improvement occurred using the System at 6 months, with the frequency of hypoglycemia being substantially below established targets of <4% and <1% for time below 70 and 54 mg/dL, respectively.

Using Time in Tight Glucose Range as a Health-Promoting Strategy in Preschoolers With Type 1 Diabetes.

Children who develop diabetes in their first years of life risk being exposed to many decades of hyperglycemia, hence having a high risk of early complications and premature death. An additional age-dependent risk is that dysglycemia, especially hyperglycemia, negatively affects the developing brain. In evaluating the outcome of insulin treatment at an individual and group level, cutoff thresholds for glucose values are needed. Time in tight range (TITR) was defined as a measurement of time spent in a state of normoglycemia. The International Society of Pediatric and Adolescent Diabetes recommended that for preschoolers with type 1 diabetes (T1D), either >70% of time with glucose in range 70-180 mg/dL (3.9-10 mmol/L) or >50% of time in a tighter range 70-140 mg/dL (TITR) can be used as continuous glucose monitoring targets. In Sweden, over the past two decades, pediatric diabetes teams set glycemic targets to 70-140 mg/dL (3.9-7.8 mmol/L). Swedish registry data show that >50% of children <7 years old have >50% TITR. The purpose of this review is to share and discuss international knowledge and experiences of working with TITR as a health-promoting strategy in preschoolers with T1D on a structural and individual level. We conclude that as insulin treatment improves, a reasonable goal is to strive for as much time in a state of normoglycemia as possible, and this can easily be explained to families of children with diabetes. For children with access to an experienced health care team and diabetes technologies a currently realistic target can be at least half of the time in normoglycemic range, i.e., TITR >50%.

Type 1 Diabetes Mellitus in Movies: The Hollywood Effect

Introduction. Type 1 diabetes mellitus (T1D) is one of the most common chronic diseases with childhood onset. Cinematic films and movies have the capability to reach populations worldwide and effect their concept of this disease. This research examined the accuracy of these movies depicting T1D from childhood into adulthood. Methods. We conducted an internet search of several databases that resulted in a list of 39 movies from 2000 to 2022 with characters that had diabetes. We ultimately assessed 13 fictional movies that dealt with management of disease, character development, access to care, and complications. Results. Movies portray severe but rare diabetes manifestations such as comas. They emphasize access to basic diabetes supplies and cost of care. Only starting in 2020, a continuous glucose monitor (CGM) and insulin pumps are shown. Female characters are presented as resilient and unaffected by the struggles of their T1D. Conclusions. This sample of fictional movies portrays extreme T1D symptoms and mostly outdated technology for monitoring and treatment. It would be beneficial if future movies reflected the advances in closed-loop CGM/insulin pumps. It is important for clinicians to be aware of how the movie industry is presenting the disease to their patients. Clinicians can use popular movies to start difficult discussions with their patients about topics pertinent to the comprehensive care of T1D.

Continuous Glucose Monitoring for the Diagnosis of Post-Transplantation Diabetes Mellitus and Impaired Glucose Tolerance From Years One to Five After Kidney Transplantation—A Prospective Pilot Study

Post-transplantation diabetes mellitus (PTDM) and prediabetes are associated with increased cardiovascular morbidity and mortality in kidney transplant recipients (KTR), when diagnosed by an oral glucose tolerance test (oGTT). Hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) display low concordance with the oGTT in the early phase posttransplant. For this prospective cross-sectional pilot study, 41 KTR from years one to five after transplantation without known preexisting PTDM (defined by HbA1c ≥ 6.5% (NGSP) or 48 mmol/mol (IFCC) at last visit or glucose-lowering therapy) were recruited at the Charité Transplant Outpatient Clinic. For each study participant HbA1c, FPG and an oGTT were followed by CGM. 38 of the 41 patients recruited had sufficient CGM-recordings (≥10 days). PTDM and impaired glucose tolerance (IGT), as defined by the gold standard oral glucose tolerance test (oGTT)-derived 2-h plasma glucose (2hPG), were diagnosed in one (3%) and twelve (32%) patients, respectively. HbA1c exhibited good test characteristics regarding IGT (ROC-AUC: 0.87); sensitivity/specificity of HbA1c-threshold 5.7% (NGSP) or 39 mmol/mol (IFCC) were 1.0/0.64, respectively. Best performing CGM-readouts mean sensor glucose and percent of time &amp;gt;140 mg/dL (%TAR (140 mg/dL)) displayed acceptable diagnostic performance (ROC-AUC: 0.78 for both). Thus, HbA1c can aid in timely diagnosis of IGT in the stable phase after kidney transplantation.

Cutting-edge technology in medicine: preparation for colonoscopy in a patient with type 1 diabetes mellitus treated with a hybrid closed-loop insulin pump-continuous glucose monitor - case report and framework recommendations

Cutting-edge technology in medicine: preparation for colonoscopy in a patient with type 1 diabetes mellitus treated with a hybrid closed-loop insulin pump-continuous glucose monitor - case report and framework recommendations

Early continuous glucose monitoring-derived glycemic patterns are associated with subsequent insulin resistance and gestational diabetes mellitus development during pregnancy.

Gestational diabetes mellitus (GDM) and insulin resistance (IR) increase the risk of adverse pregnancy outcomes. We aimed to examine the relationship of interstitial glucose assessed by continuous glucose monitoring (CGM) at early gestation, and the subsequent development of IR and GDM, and to determine 24-h interstitial glucose centile distributions in women with normal (non-IR and non-GDM) and suboptimal glycemic status (IR and/or GDM). CGM measurements were taken for 3-10days at 18-24weeks' gestation, followed by fasting serum insulin and oral glucose tolerance testing at 24-28weeks' gestation. IR and GDM were determined by the updated Homeostasis Model Assessment of IR score of ≥ 1.22 and 2013 World Health Organization criteria, respectively. Risks of IR and GDM were estimated using modified Poisson models, and hourly interstitial glucose centiles determined using Generalized Additive Models for Location, Scale and Shape. This prospective cohort study involved 167 pregnant women in Singapore, with a mean age of 31.7years, body mass index of 22.9kg/m2, and gestation of 20.3weeks. 25% of women exhibited IR and 18% developed GDM. After confounders adjustment, women with suboptimal glycemic control, indicated by higher mean daily glucose (risk ratio 1.42; 95% confidence interval 1.16, 1.73), glucose management indicator (1.08; 1.03, 1.12), and J-index (1.04; 1.02, 1.06), as well as those with greater glycemic variability, indicated by higher standard deviation (1.69; 1.37, 2.09), coefficient of variation (1.03; 1.00, 1.06), and mean amplitude of glycemic excursions (1.4; 1.14, 1.35) derived from CGM in early gestation were associated with higher risks of developing IR in later gestation. These associations were similarly observed for the development of GDM. Centile curves showed that, compared to those with normal glycemic status, women with suboptimal glycemic status had higher glucose levels, with greater fluctuations throughout 24h. In pregnant women who subsequently developed IR and GDM, interstitial glucose levels assessed by CGM were elevated and varied greatly. This supports the potential use of CGM to screen for glycemic changes early in pregnancy.

The Need for Standardization of Continuous Glucose Monitoring Performance Evaluation: An Opinion by the International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Continuous Glucose Monitoring.

Metrics derived from continuous glucose monitoring (CGM) systems are often discordant between systems. A major cause is that CGM systems are not standardized; they use various algorithms and calibration methods, leading to discordant CGM readings across systems. This discordance can be addressed by standardizing CGM performance assessments: If manufacturers aim their CGM systems at the same target, then CGM readings will align across systems. This standardization should include the comparator device, sample origin, and study procedures. With better aligned CGM readings, CGM-derived metrics will subsequently also align better between systems.

Intermittently scanned continuous glucose monitoring (isCGM) in hospitalized elderly patients

Intermittently scanned continuous glucose monitoring (isCGM) in hospitalized elderly patients

Phase angle and body composition in long-term type 1 diabetes in adults: a comparative study in a Brazilian public reference outpatient clinic.

Type 1 Diabetes Mellitus (DM1) affects a small percentage of the population. Nevertheless, its prevalence is currently growing with alarming data on uncontrolled cases. The importance of body composition and Phase Angle (PA), assessed by Bioelectrical Impedance (BIA), in long- term DM1 patients lies in the fact that alterations in cellular integrity and body compartments may affect risk profiles and metabolic control. The objective of this study was to compare PA and body composition parameters between adults with DM1 and healthy controls. A comparative study was carried out in a public university outpatient clinic including a cohort of adult patients of both sexes diagnosed with DM1 and healthy controls matched by age and sex in a 2:1 ratio. Anthropometric measurements included weight, height and BMI. Using the raw BIA data of Resistance and Reactance, fat-free mass (FFM), fat mass (FM), fat-free mass index (FFMI), fat mass index (FMI), PA and standardized PA (SPA) were calculated. Means or medians were compared between the groups. Regression models were used to identify distinguishing characteristics of the groups and associations within the DM1 group (i.e. glycated hemoglobin (HbA1c), disease duration, presence of microvascular complications, capillary blood glucose, BMI and FMI). 88 patients with DM1and 46 healthy controls were evaluated. PA (6.05 vs. 6.85, p = 0.000) and SPA (-1.47 vs. -0,37, p = 0.000) were lower in patients with DM1 compared to healthy controls. People with DM1 displayed higher adiposity (%FM = 29.6 vs. 27.6, p = 0.016; FMI = 7.00 vs. 6.33, p = 0.016) and lower %FFM compared to healthy controls. Most of the differences were maintained after sex stratification; however, men with DM1 showed a lower FFMI than male controls (18.2 vs. 20.16, p = 0.029). Patients with DM1 present lower PA than healthy controls, which may be related to worse cell membrane integrity. Significant body composition differences between the groups and between sexes were identified, with data showing greater adiposity in women with DM1 and men displaying lower muscle mass. These findings suggest the importance of including PA and body composition evaluations in the follow-up of patients with DM1. The ultimate goal is to obtain a better metabolic control and, consequently, a better prognosis.

Glucose measurements in sheep using a long-term continuous glucose monitor designed for humans

This study evaluated the feasibility of utilizing a continuous glucose monitors (CGM) designed for use in humans to measure glucose levels in sheep. Four Suffolk x Dorset sheep were fitted with jugular catheters and FreeStyle Libre 2 (Abbott®) glucose monitors. Glucose concentration from the CGM were compared with those from a glucometer and traditional assays during a hyperglycemic clamp, aiming to explore a broader range of physiological glucose concentrations in a controlled manner. Measurements were taken every five minutes during the infusion and every ten minutes post-infusion until baseline levels were restored. Relationships were analyzed using a linear mixed-effects model with glucometer readings as the response variables, GCM reading as fixed effects, and animal as random effect with significant level of p &amp;lt; 0.05. The results demonstrated a significant linear correlation between the CGM and glucometer readings both during the infusion (p = 0.0003) and afterward (p = 0.006). A glucose calorimetric test was used to confirm glucose concentrations on samples and used as gold standard. Although the glucometer and CGM did not differ from the assay method, they did differ from one another (p = 0.045). Upon more in-depth analysis, the random intercepts for animal were highly significant and one CGM showed values numerically much higher than other CGM and other glucose analysis methods. No difference among methods was observed (p = 0.715) when the outlier animal was omitted. While promising, CGM demands confirmation of initial readings and standardization against established methods before wider adoption in research or clinical applications.

Development of a high-performance Cu–Ni decorated laser-induced graphene sensor for nonenzymatic glucose monitoring in sweat

Development of a high-performance Cu–Ni decorated laser-induced graphene sensor for nonenzymatic glucose monitoring in sweat

Flash glucose monitoring system help reduce the frequency of hypoglycemia and hypoglycemic fear behavior in type 1 diabetes patients

ObjectiveHypoglycemia represents a serious acute complication in individuals with type 1 diabetes mellitus (T1DM). In order to more effectively identify and discriminate the occurrence of hypoglycemic events in patients with T1DM, this study aims to evaluate the impact of two distinct glucose monitoring systems—Flash Glucose Monitoring (FGM) and Continuous Glucose Monitoring (CGM)—on the management of blood glucose levels and the emotional responses associated with hypoglycemic episodes in individuals with T1DM.MethodIn this study, a total of 113 patients with type 1 diabetes mellitus were enrolled and allocated to two groups for the implementation of Glucose Monitoring Systems (GMS). The groups consisted of the FreeStyle Libre group (FGM, n=56) and the ipro2 group (CGM, n=57). Participants in both groups utilized GMS at least biannually and completed a set of three questionnaires: the Diabetes Monitoring and Treatment Satisfaction Questionnaire (DMTSQ), the Diabetes Specific Quality of Life (DQOL), and the Chinese Version of the Hypoglycemia Fear Survey II (CFHSII). Clinical data, CGM metrics, and questionnaire scores were collected at the initial visit and after a one-year follow-up period.ResultsThe glucose coefficient of variation (GCV) and the standard deviation of blood glucose (SDBG) were independently associated with Time Below Range (TBR). Specifically, GCV could predict TBR ≥12%, with a cut-off point of 40.55. This yielded a specificity of 88.10% and a sensitivity of 68.18% in the overall patient population. For the FreeStyle Libre group and the iPro2 group, the cut-off points were 38.69 and 40.55, respectively, with specificities of 0.74 and 0.92, and sensitivities of 0.73 and 0.86, respectively. In the FreeStyle Libre group, where the frequency of use was greater than or equal to five times per year, the hypoglycemic episodes (time/month) and CHFSII-B scores were significantly reduced at follow-up compared to baseline (7.80 ± 10.25 vs 13.95 ± 14.87; 27.37 ± 11.05 vs 38.90 ± 21.61, respectively, all P &amp;lt;0.05).ConclusionThe utilization of multiple Flash Glucose Monitoring (FGM) implementations proved to be valuable in discriminating the occurrence of hypoglycemia and mitigating the fear of hypoglycemic episodes in patients with type 1 diabetes. Within the parameters of Glucose Monitoring Systems (GMS), the glucose glycemic variability (GCV) was identified as a predictive factor for the risk of severe hypoglycemia (TBR &amp;gt; 12%). The optimal cut-off point for GCV was determined to be 40.55.

Evaluating Various Methods Used by Direct-to-Consumer Products Promising Personalized Nutrition

The increasing availability of direct-to-consumer personalized nutrition products has raised questions about their scope of personalization and added value compared to general dietary guidelines. This study evaluated eleven personalized nutrition products across six distinct methodologies, including DNA analysis, blood marker analysis, microbiome testing, blood glucose monitoring, questionnaire-based personalization, and consultation with a dietitian, comparatively evaluating their consistency and added value compared to general dietary guidelines. A 24-year-old obese male with no pre-existing illnesses was chosen as the case participant to represent a typical individual seeking personalized nutrition advice for weight loss. Significant variability and inconsistency were observed across and within the different methodologies, particularly in recommendations for energy intake and macronutrient distribution. Most advice was generic and aligned closely with existing dietary guidelines, with a notable lack of behavioral change strategies. This study underscores the challenges in personalized nutrition, highlighting the problem that current practices often fall short of delivering truly tailored recommendations. There is a critical need for clearer definitions, evidence-based guidelines, and more comprehensive approaches to fully realize the potential of personalized nutrition in improving individual health.

Abstract 4138815: Prognostic Implications of Glycemic Variability Assessed by Continuous Glucose Monitoring-derived Coefficient of Variation among Patients Hospitalized for Acute Heart Failure

Background: Recent findings indicate that high glycemic variability (GV) could increase the risk of adverse outcomes in patients with cardiovascular disease. With the advances in technology, the utility of continuous glucose monitoring (CGM) has grown during recent years, which can provide valuable information that is not captured by HbA1c. We used the glucose coefficient of variation (CV, calculated as the ratio of standard deviation divided by the mean glucose level) of the obtained CGM data to analyze GV. Aims: We aimed to analyze CGM-derived CV as an indicator of GV and to evaluate prognostic implications of CGM-derived CV in patients hospitalized for acute heart failure (HF). Methods: Patients hospitalized for HF who had not been diagnosed diabetes were performed 75g-oral glucose tolerance test (OGTT). CV was evaluated using CGM system for at least 72 consecutive hours after being able to have meals stably during hospitalization. The primary outcome was a composite of cardiovascular death or re-hospitalization for HF. Patients were divided into two groups based on the median value of CV. Results: We prospectively analyzed 130 patients (mean age: 76±10 years, male 56%) admitted for acute HF. Following the 75g-OGTT, only 21% of the entire cohort exhibited normal glucose tolerance. During the median follow up period of 905 days, Kaplan–Meier curve analysis revealed that the cumulative incidence of the primary outcome event was significantly higher in patients with CV above median than in those with CV less than median (51.7% versus 24.4%, Log-rank P=0.01)(Figure). Multivariate Cox proportional analysis demonstrated that the risk of CV per 1% increment for the primary outcome was significant adjusted for history of diabetes, CGM-derived mean glucose level, and HbA1c level (hazard ratio: 1.06, 95% confidence interval 1.03–1.09). Conclusions: CGM-derived CV was associated with long term prognosis of patients hospitalized for HF with or without diabetes.

Impact of Continuous Glucose Monitoring Versus Blood Glucose Monitoring to Support a Carbohydrate-Restricted Nutrition Intervention in People with Type 2 Diabetes.

Introduction: Low- and very-low-carbohydrate eating patterns, including ketogenic eating, can reduce glycated hemoglobin (HbA1c) in people with type 2 diabetes (T2D). Continuous glucose monitoring (CGM) has also been shown to improve glycemic outcomes, such as time in range (TIR; % time with glucose 70-180 mg/dL), more than blood glucose monitoring (BGM). CGM-guided nutrition interventions are sparse. The primary objective of this study was to compare differences in change in TIR when people with T2D used either CGM or BGM to guide dietary intake and medication management during a medically supervised ketogenic diet program (MSKDP) delivered via continuous remote care. Methods: IGNITE (Impact of Glucose moNitoring and nutrItion on Time in rangE) study participants were randomized to use CGM (n = 81) or BGM (n = 82) as part of a MSKDP. Participants and their care team used CGM and BGM data to support dietary choices and medication management. Glycemia, medication use, ketones, dietary intake, and weight were assessed at baseline (Base), month 1 (M1), and month 3 (M3); differences between arms and timepoints were evaluated. Results: Adults (n = 163) with a mean (standard deviation) T2D duration of 9.7 (7.7) years and HbA1c of 8.1% (1.2%) participated. TIR improved from Base to M3, 61-89% for CGM and 63%-85% for BGM (P < 0.001), with no difference in change between arms (P = 0.26). Additional CGM metrics also improved by M1, and improvements were sustained through M3. HbA1c decreased by ≥1.5% from Base to M3 for both CGM and BGM arms (P < 0.001). Diabetes medications were de-intensified based on change in medication effect scores from Base to M3 (P < 0.001). Total energy and carbohydrate intake decreased (P < 0.001), and participants in both arms lost clinically significant weight (P < 0.001). Conclusion: Both the CGM and BGM arms saw similar and significant improvements in glycemia and other diabetes-related outcomes during this MSKDP. Additional CGM-guided nutrition intervention research is needed.