Continuous Glucose Monitor: Reclaiming Type 2 Diabetes Self-efficacy and Mitigating Disparities.

Context: The rise in continuous glucose monitor (CGM) use has been characterized by widening disparities between the least and most socially marginalized. Given access barriers, there is limited CGM patient experience information that is inclusive of those with type 2 diabetes mellitus from socially marginalized backgrounds. Objective: To understand the CGM usage experience in the primary care setting across a US Medicaid population with type 2 diabetes at federally qualified health centers. Methods: This qualitative study used semi-structured phone interviews with 28 English- or Spanish-speaking participants prescribed the CGM who were enrolled in a US Medicaid program that subsidized CGMs. Audio recordings of interviews were transcribed and analyzed by reflective thematic analysis. Results: Twenty-eight participants (75% female, median age 56 years with interquartile-range 48-60 years) were interviewed. Participants were from different racial/ethnic backgrounds: 21% non-Hispanic White, 57% Hispanic, and 18% non-Hispanic Black. Participants primarily spoke English (68%) or Spanish (32%), and 53% reported 9 or fewer years of formal education. We identified 6 major themes: initial expectations and overcoming initiation barriers, convenience and ease promote daily use, increased knowledge leads to improved self-management, collaboration with provider and clinical team, improved self-reported outcomes, and barriers and burdens are generally tolerated. Conclusion: CGM use was experienced as easy to understand and viewed as a tool for diabetes self-efficacy. Expanded CGM access for socially marginalized patients with type 2 diabetes can enhance diabetes self-management to help mitigate diabetes outcome disparities.

Using Continuous Glucose Monitoring to Passively Classify Naturalistic Binge Eating and Vomiting Among Adults With Binge-Spectrum Eating Disorders: A Preliminary Investigation.

OBJECTIVE: Binge eating and self-induced vomiting are common, transdiagnostic eating disorder (ED) symptoms. Efforts to understand these behaviors in research and clinical settings have historically relied on self-report measures, which may be biased and have limited ecological validity. It may be possible to passively detect binge eating and vomiting using data collected by continuous glucose monitors (CGMs; minimally invasive sensors that measure blood glucose levels), as these behaviors yield characteristic glucose responses. METHOD: This study developed machine learning classification algorithms to classify binge eating and vomiting among 22 adults with binge-spectrum EDs using CGM data. Participants wore Dexcom G6 CGMs and reported eating episodes and disordered eating symptoms using ecological momentary assessment for 2 weeks. Group-level random forest models were generated to distinguish binge eating from typical eating episodes and to classify instances of vomiting. RESULTS: The binge eating model had accuracy of 0.88 (95% CI: 0.83, 0.92), sensitivity of 0.56, and specificity of 0.90. The vomiting model demonstrated accuracy of 0.79 (95% CI: 0.62, 0.91), sensitivity of 0.88, and specificity of 0.71. DISCUSSION: Results suggest that CGM may be a promising avenue for passively classifying binge eating and vomiting, with implications for innovative research and clinical applications.

Accuracy of FreeStyle Libre flash glucose monitoring in patients with type 2 diabetes who migrated from highlands to plains.

BACKGROUND: The FreeStyle Libre flash glucose monitoring (FGM) system entered the Chinese market in 2017 to complement the self-monitoring of blood glucose. Due to its increased usage in clinics, the number of studies investigating its accuracy has increased. However, its accuracy has not been investigated in highland popu-lations in China. AIM: To evaluate measurements recorded using the FreeStyle Libre FGM system compared with capillary blood glucose measured using the enzyme electrode method in patients with type 2 diabetes (T2D) who had migrated within 3 mo from highlands to plains. METHODS: Overall, 68 patients with T2D, selected from those who had recently migrated from highlands to plains (within 3 mo), were hospitalized at the Department of Endocrinology from August to October 2017 and underwent continuous glucose monitoring (CGM) with the FreeStyle Libre FGM system for 14 d. Throughout the study period, fingertip capillary blood glucose was measured daily using the enzyme electrode method (Super GL, China), and blood glucose levels were read from the scanning probe during fasting and 2 h after all three meals. Moreover, the time interval between reading the data from the scanning probe and collecting fingertip capillary blood was controlled to < 5 min. The accuracy of the FGM system was evaluated according to the CGM guidelines. Subsequently, the factors influencing the mean absolute relative difference (MARD) of this system were analyzed by a multiple linear regression method. RESULTS: Pearson's correlation analysis showed that the fingertip and scanned glucose levels were positively correlated (R = 0.86, P = 0.00). The aggregated MARD of scanned glucose was 14.28 ± 13.40%. Parker's error analysis showed that 99.30% of the data pairs were located in areas A and B. According to the probe wear time of the FreeStyle Libre FGM system, MARD1 d and MARD2-14 d were 16.55% and 14.35%, respectively (t = 1.23, P = 0.22). Multiple stepwise regression analysis showed that MARD did not correlate with blood glucose when the largest amplitude of glycemic excursion (LAGE) was < 5.80 mmol/L but negatively correlated with blood glucose when the LAGE was ≥ 5.80 mmol/L. CONCLUSION: The FreeStyle Libre FGM system has good accuracy in patients with T2D who had recently migrated from highlands to plains. This system might be ideal for avoiding the effects of high hematocrit on blood glucose monitoring in populations that recently migrated to plains. MARD is mainly influenced by glucose levels and fluctuations, and the accuracy of the system is higher when the blood glucose fluctuation is small. In case of higher blood glucose level fluctuations, deviation in the scanned glucose levels is the highest at extremely low blood glucose levels.

Neuropathy of diabetes following initiation of a low-carbohydrate diet: Case report.

Introduction: This case study portrays an unusual case of treatment-induced neuropathy of diabetes (TIND) in a patient with uncontrolled type 2 diabetes (T2D) who achieved rapid improvement in glucose control primarily with dietary intervention. Initial presentation was 50-year-old white male with a long-standing history of obesity and a family history of T2D with a screening glucose level >500mg/dL by glucometer, HbA1c of 14.9%, and initial weight 213 lbs. Methods: The initial intervention included a low-carbohydrate diet, metformin, and a continuous glucose monitor (CGM). Semaglutide was added after seven days. Results: His glycemia was within the target range within three weeks. Four weeks after initiation of therapy, he developed TIND symptoms consisting of burning, tightness, and numbness of bilateral feet along with 10/10 pain. At three months, his HbA1c dropped to 6.9% and his weight to 195 lbs. Treatment of his TIND reduced his pain from 10/10 to 2/10. Conclusion: Whereas TIND is commonly associated with the use of insulin or sulfonylureas, this study adds evidence to the paucity of literature regarding TIND precipitated by dietary intervention.

Continuous Glucose Monitoring Captures Glycemic Variability After Roux-en-Y Gastric Bypass in Patients with and Without Type 2 Diabetes Mellitus: A Prospective Cohort Study.

PURPOSE: To evaluate glycemic variability (GV) using continuous glucose monitoring (CGM) in individuals with and without type 2 diabetes mellitus (T2DM) undergoing Roux-en-Y gastric bypass (RYGB). METHODS: This prospective cohort study compared the CGM data of fourteen patients with T2DM (n = 7) and without T2DM (n = 7) undergoing RYGB. After 6 months, these patients were compared to a non-operative control group (n = 7) matched by BMI, sex, and age to the T2DM group. RESULTS: Fourteen patients underwent RYGB, with a mean BMI of 46.9 ± 5.3 kg/m2 and an average age of 47.9 ± 8.9 years; 85% were female. After 6 months post-surgery, the total weight loss (TWL) was 27.1 ± 6.3%, with no significant differences between the groups. Patients without diabetes had lower mean interstitial glucose levels (81 vs. 94 and 98 mg/dl, p < 0.01) and lower glucose management indicator (GMI) (5.2 vs. 5.6 and 5.65%, p = 0.01) compared to the control and T2DM groups, respectively. The coefficient of variation (CV) significantly increased only in patients with diabetes (17% vs. 26.7%, p < 0.01). Both groups with (0% vs. 2%, p = 0.03) and without (3% vs. 22%, p = 0.03) T2DM experienced an increased time below range with low glucose (54-69 mg/dL). However, patients without T2DM had significantly less time in rage (70-180 mg/dL) (97% vs. 78%, p = 0.04). CONCLUSION: Significant differences in CGM metrics among RYGB patients suggest an increase in glycemic variability after surgery, with a longer duration of hypoglycemia, especially in patients without T2DM.

Innovative solution or cause for concern? The use of continuous glucose monitors in people not living with diabetes: A narrative review.

AIMS: Continuous glucose monitors (CGMs) have expanded their scope beyond indicated uses for diabetes management and are gaining traction among people not living with diabetes (PNLD). CGMs track in time glucose levels and are proposed as tools for the early detection of abnormal glucose and a potential solution for its normalisation through behavioural change, particularly, diet personalisation and motivation of physical activity. This becomes relevance given the growing incidence of metabolic conditions, such as type 2 diabetes mellitus (T2DM). Clinical guidelines, however, do not recommend CGMs in contexts outside type 1 diabetes (T1DM) or insulin-treated T2DM. Therefore, there is a visible disconnect between the indicated and real-world usage of these medical devices. While the commercial market for CGMs in PNLD is expanding rapidly, a comprehensive and evidence-based evaluation of the devices' utility in this population has not been done. Therefore, this review aims to formulate a working model for CGM utility in PNLD as proposed by the 'health and wellness' market that advertises and distributes it to these individuals. METHODS: We aim to critically analyse the available research addressing components of the working model, that is (1) detection of abnormal glucose; (2) behavioural change, and (3) metabolic health improvement. RESULTS: We find a lack of consistent and high-quality evidence to support the utility of CGMs for these purposes. We identify significantly under-reserved areas including clinical benchmarks and scoring procedures for CGM measures, device acceptability, and potential adverse effects of CGMs on eating habits in PNLD. We also raise concerns about the robustness of available CGM research. CONCLUSION: In the face of these research gaps, we urge for the commercial claims suggesting the utility of the device in PNLD to be labelled as misleading. We argue that there is a regulatory inadequacy that fuels 'off-label' CGM distribution and calls for the strengthening of post-market clinical follow-up oversight for CGMs. We hope this will help to avert the continued misinformation risk to PNLD and 'off-label' exacerbation of health disparities.

Continuous Glucose Monitoring Using the Dexcom G6 in Cardiac Surgery During the Postoperative Period.

OBJECTIVE: Cardiac surgery is associated with hyperglycemia, which in turn is associated with adverse postsurgical outcomes such as wound infections, acute renal failure, and mortality. This pilot study seeks to determine if Dexcom G6Pro continuous glucose monitor (Dexcom G6Pro CGM) is accurate during the postoperative cardiac surgery period when fluid shifts, systemic inflammatory response syndrome, and vasoactive medications are frequently encountered, compared to standard glucose monitoring techniques. METHODS: This study received institutional review board approval. In this prospective study, correlation between clinical and Dexcom glucose readings was evaluated. Clinical glucose (blood gas, metabolic panel, and point of care) data set included 1428 readings from 29 patients, while the Dexcom G6Pro CGM data included 45 645 data points following placement to upper arm. Additionally, average clinical measurements of day and overnight temperatures and hemodynamics were evaluated. Clinical and Dexcom data were restricted to being at least 1 hour after prior clinical reading Matching Dexcom G6Pro CGM data were required within 5 minutes of clinical measure. Data included only if taken at least 2 hours after Dexcom G6Pro CGM insertion (warm-up time) and analyzed only following intensive care unit (ICU) admission. Finally, a data set excluding the first 24 hours after ICU admission was created to explore stability of the device. Patients remained on Dexcom G6Pro CGM until discharge or 10 days postoperatively. RESULTS: The population was 71% male, 14% with known diabetes; 66% required intravenous insulin infusion. The Clarke error grid plot of all measures post-ICU admission showed 53.5% in zone A, 45.9% in zone B, and 0.6% (n = 5) in zones D or E. The restricted dataset that excluded the first 24 hours post-ICU admission showed 55.9% in zone A, 43.9% in zone B, and 0.2% in zone D. Mean absolute relative difference between clinical and Dexcom G6Pro CGM measures was 20.6% and 21.6% in the entire post-ICU admission data set, and the data set excluding the first 24 hours after ICU admission, respectively. In the subanalysis of the 12 patients who did not have more than a 5-minute tap in the operating room, a consensus error grid, demonstrated that after ICU admission, percentage in zone A was 53.9%, zone B 45.4%, and zone C 0.7%. Similar percentages were obtained removing the first 24 hours post-ICU admission. These numbers are very similar to the entire cohort. A consensus error grid created post-ICU admission demonstrated: (zone A) 54%, (zone B) 45%, (zone C) 0.9%, and the following for the dataset created excluding the first 24 hours: (zone A) 56%, (zone B) 44%, (zone C) 0.4%, which demonstrated very close agreement with the original Clarke error grid. No adverse events were reported. CONCLUSIONS: Almost 100% of Dexcom G6Pro CGM and clinical data matching points fell within areas considered as giving clinically correct decisions (zone A) and clinically uncritical decisions (zone B). However, the relatively high mean absolute relative difference precludes its use for both monitoring and treatment in the clinical context. As technology evolves, interstitial glucose monitoring may become an important tool to limit iatrogenic anemia and mitigate glycemic fluctuations.

Exploring the Impact of Device Sourcing on Real-World Adherence and Cost Implications of Continuous Glucose Monitoring in Patients With Diabetes: Retrospective Claims Analysis.

BACKGROUND: Insurance benefit design influences whether individuals with diabetes who require a continuous glucose monitor (CGM) to provide real-time feedback on their blood glucose levels can obtain the CGM device from either a pharmacy or a durable medical equipment supplier. The impact of the acquisition channel on device adherence and health care costs has not been systematically evaluated. OBJECTIVE: This study aims to compare the adherence rates for patients new to CGM therapy and the costs of care for individuals who obtained CGM devices from a pharmacy versus acquisition through a durable medical equipment supplier using retrospective claims analysis. METHODS: Using the Mariner commercial claims database, individuals aged >18 years with documented diabetes and an initial CGM claim during the first quarter of 2021 (2021 Q1, index date) were identified. Patients had to maintain uninterrupted enrollment for a duration of 15 months but file no CGM claim during the 6 months preceding the index date. We used direct matching to establish comparable pharmacy and durable medical equipment cohorts. Outcomes included quarterly adherence, reinitiation, and costs for the period from 2021 Q1 to the third quarter of 2022 (2022 Q3). Between-cohort differences in adherence rates and reinitiation rates were analyzed using z tests, and cost differences were analyzed using 2-tailed t tests. RESULTS: Direct matching was used to establish comparable pharmacy and durable medical equipment cohorts. A total of 2356 patients were identified, with 1178 in the pharmacy cohort and 1178 in the durable medical equipment cohorts. Although adherence declined over time in both cohorts, the durable medical equipment cohort exhibited significantly superior adherence compared to the pharmacy cohort at 6 months (pharmacy n=615, 52% and durable medical equipment n=761, 65%; P<.001), 9 months (pharmacy n=579, 49% and durable medical equipment cohorts n=714, 61%; P<.001), and 12 months (pharmacy 48% and durable medical equipment n=714, 59%; P<.001). Mean annual total medical costs for adherent patients in the pharmacy cohort were 53% higher than the durable medical equipment cohort (pharmacy US $10,635 and durable medical equipment US $6967; P<.001). In nonadherent patients, the durable medical equipment cohort exhibited a significantly higher rate of therapy reinitiation during the period compared to the pharmacy cohort (pharmacy 61/613, 10% and durable medical equipment 108/485, 22%; P<.001). CONCLUSIONS: The results from this real-world claims analysis demonstrate that, in a matched set, individuals who received their CGM through a durable medical equipment supplier were more adherent to their device. For individuals who experienced a lapse in therapy, those whose supplies were provided through the durable medical equipment channel were more likely to resume use after an interruption than those who received their supplies from a pharmacy. In the matched cohort analysis, those who received their CGM equipment through a durable medical equipment supplier demonstrated a lower total cost of care.

Development of a Continuous Glucose Monitoring Service by Clinical Pharmacists in a Medically Underserved Population.

Background: Continuous glucose monitoring (CGM) is an evolving technology that provides a wealth of information to aid in managing diabetes. Professional CGM (ProCGM) is recommended when personal CGM is not desired or available. Patients in medically underserved areas may have limited access to personal CGM devices, thus ProCGM devices can be used for short-term monitoring and medication adjustment. Clinical pharmacists are well-positioned to help set up and establish personal and professional CGM management services. Objectives: To determine the effect of ProCGM in patients with persistently uncontrolled type 2 diabetes in a medically underserved population (MUP). Methods: Pre-post intervention analysis of a single cohort of patients in a public health center. Patients with persistently uncontrolled (A1c > 9%) and taking at least one daily dose of insulin were included. Included participants wore a ProCGM sensor and met with the clinical pharmacist at least once for ProCGM data interpretation and education. The primary analysis evaluated patients who achieved an A1c <9% 1-6 months after intervention. The change in A1c was also evaluated. Participants completed a pre- and post-survey about their experience. Results: Twenty-two patients were included in the final analysis. Ten patients achieved an A1c <9% (45%). The mean A1c pre- and post-ProCGM was 11.0% and 9.8% respectively, with a decrease of -1.2% (p=0.055) overall and a decrease of -1.7% for patients who wore the sensor for at least 10 days (p=0.012; n=15). Using the CGM data 91% of participants had a change to their medication regimen and 45% achieved an A1c <9%. Six participants experienced hypoglycemia per the CGM report, but only two were aware of it. After reviewing their glucose report with the pharmacist, 95% of the respondents agreed or strongly agreed to feeling more knowledgeable about blood sugar patterns after reviewing the report with a pharmacist. Conclusion: Almost half of the patients in the study achieved an A1c <9%. This study demonstrated glycemic benefit in patients in a MUP who wore a ProCGM for at least 10 days and met with a clinical pharmacist. Data from ProCGM enabled patients to better understand glucose patterns in those with persistently uncontrolled type 2 diabetes.

Continuous Glucose Monitoring in Older Adults: What We Know and What We Have Yet to Learn.

OBJECTIVE: To assess the growing use of continuous glucose monitoring (CGM) systems by older adults and explore additional areas integration that could benefit adults with frailty. BACKGROUND: The use of CGM devices has expanded rapidly in the last decade. This has been supported by substantial data showing significant benefit in glycemic metrics: hemoglobin A1c improvements, less hypoglycemia, and improved quality of life. However, sub-populations, such as older persons, exist where available data are limited. Furthermore, frail older adults represent a heterogeneous population with their own unique challenges to the management of diabetes. This group has some of the poorest outcomes related to the sequela of diabetes. For example, hypoglycemia resulting in significant morbidity and mortality is more frequent in older person with diabetes than in younger persons with diabetes. METHOD: We present a concise literature review on CGM use in the older adult as well as expand upon glycemic and nonglycemic benefits of CGM for patients, caregivers, and providers. Retrospective analysis of inpatient glycemic data of 16,935 older adults with Type 2 diabetes mellitus at Atrium Health Wake Forest Baptist indicated those with fraility managed with insulin or sulfonylurea had the highest rates of delirium (4.8%), hypoglycemia (3.5%), cardiovascular complications (20.2%) and ED visits/hospitalizatoins (49%). In addition, we address special consideration of specific situations including inpatient, palliative and long term care settings. CONCLUSION: This review article summarizes the available data for CGM use in older adults, discusses the benefits and obstacles with CGM use in this population, and identifies areas of future research needed for improved delivery of care to older persons with diabetes.

Glycemic Management Among Adults With Type 1 Diabetes During Passover: A Pre-Post Single-center Study.

OBJECTIVES: No data are available regarding glycemic management of individuals with type 1 diabetes (T1D) during Passover. Our aim in this study was to assess the effect of Passover on diabetes management and glycemic management in adults with T1D with nutritional changes during Passover (observant) compared with those who did not change their dietary habits during Passover (nonobservant). METHODS: We conducted an observational pre-post study of adults with T1D, followed in a diabetes clinic in Israel. Data were downloaded from insulin pumps and continuous glucose monitoring for 37 days: 2 weeks before Passover, 9 days of Passover, and 2 weeks thereafter. Differences in percentage of time spent above target (>10.0 to >13.9 mmol/L), at target (3.9 to 10.0 mmol/L), and below target (<3.9 to <3.0 mmol/L) were compared using paired t tests or paired signed rank tests. RESULTS: The study cohort included 43 individuals with T1D (23 observant, 20 nonobservant). The average blood glucose was significantly higher during Passover compared with the period before Passover---in nonobservant patients 8.2±1.5 mmol/L and 7.9±1.3 mmol/L (p=0.043), respectively, and in observant patients 8.7±1.6 mmol/L and 8.4±1.6 mmol/L (p=0.048), respectively. Time above range 10 to 13.9 mmol/L was increased in observant individuals during Passover, as compared with the period before Passover, at 24.9±16.2% and 20.6±12.4% (p=0.04), respectively. The dose of bolus insulin had increased significantly in observant individuals: 27.4±13.9 units during Passover, as compared with 24.2±11.2 units before Passover (p=0.02). CONCLUSIONS: Passover alters glycemic management and insulin needs in Jewish adults with T1D. It is advisable to make specific adjustments to maintain the recommended glycemic management.

ROUTE-T1D: A behavioral intervention to promote optimal continuous glucose monitor use among racially minoritized youth with type 1 diabetes: Design and development.

BACKGROUND: Type 1 diabetes management is often challenging during adolescence, and many youth with type 1 diabetes struggle with sustained and optimal continuous glucose monitor (CGM) use. Due to racial oppression and racially discriminatory policies leading to inequitable access to quality healthcare and life necessities, racially minoritized youth are significantly less likely to use CGM. METHODS: ROUTE-T1D: Research on Optimizing the Use of Technology with Education is a pilot behavioral intervention designed to promote optimal CGM use among racially minoritized youth with type 1 diabetes. Intervention strategies include problem solving CGM challenges and promoting positive caregiver-youth communication related to CGM data. RESULTS: This randomized waitlist intervention provides participants with access to three telemedicine sessions with a Certified Diabetes Care and Education Specialist. Caregiver participants are also connected with a peer-parent coach. CONCLUSION: Hypothesized findings and anticipated challenges are discussed. Future directions regarding sustaining and optimizing the use of diabetes technology among racially minoritized pediatric populations are reviewed.

Combining an Electrochemical Continuous Glucose Sensor With an Insulin Delivery Cannula: A Feasibility Study.

BACKGROUND: Combining a continuous glucose monitor with an insulin delivery cannula (CGM-IS) could benefit clinical outcomes. We evaluated the feasibility of a single-needle insertion electrochemical investigational CGM-IS (Pacific Diabetes Technologies, Portland, Oregon) in type 1 diabetes adults. METHODS: Following 48 hours run-in using a Medtronic 780G in manual mode with a commercial insulin set, 12 participants commenced insulin delivery using the CGM-IS. A standardized test meal was eaten on the mornings of days 1 and 4. Venous samples were collected every 10 minutes one hour prior to and 15 minutes post-meal for four hours. CGM-IS glucose measurements were post-processed with a single capillary blood calibration during warm-up and benchmarked against YSI. A Dexcom G6 sensor was worn post-consent to study end. RESULTS: Mean absolute relative difference (MARD) for the CGM-IS glucose measurements was 9.2% (484 paired data points). Consensus error grid revealed 88.6% within zone A and 100% in A + B. Mean (SD) % bias was -3.5 (11.7) %. There were 35 paired YSI readings <100 mg/dL cutoff and 449 ≥100 mg/dL with 81.4% within ±15 mg/dL or ±15%, and 89.9% within ±20 mg/dL or ±20%. Two cannula occlusions required discontinuation of insulin delivery: one at 70 hours post insertion and another during the day 4 meal test. Mean (SD) Dexcom glucose measurements during run-in and between meal tests was respectively 161.3 ± 27.3 mg/dL versus 158.0 ± 25.6 mg/dL; P = .39 and corresponding mean total daily insulin delivered by the pump was 58.0 ± 25.4 Units versus 57.1 ± 28.8 Units; P = .47. CONCLUSIONS: Insulin delivery and glucose sensing with the investigational CGM-IS was feasible. Longer duration studies are needed.

Partnering for Better Health: Using Continuous Glucose Monitoring and Clinical Pharmacist Collaboration to Improve Glycemic Control in Underserved Patients With Type 2 Diabetes.

PURPOSE: The purpose of this study was to examine the effect of initiating use of a continuous glucose monitor (CGM) in patients being treated for type 2 diabetes mellitus, specifically those who face barriers to obtaining this device because of its cost. METHODS: This retrospective medical record review compared diabetes control of patients before and after use of a CGM device within a single primary care office. Patient medical records were reviewed 18 months after initial CGM was provided, and only those who received a CGM directly from the clinic were included in the review. Statistical analysis comparing the difference in mean baseline glycosylated hemoglobin (HbA1c) level with the first HbA1c level after CGM placement was completed using the paired t test for the primary outcome. FINDINGS: A total of 41 patients who obtained at least 1 CGM reader and a minimum of a 30-day supply of sensors from the clinic were included in the review. The primary outcome resulted in a significant reduction in the mean (SD) first HbA1c level after CGM placements of -1.9% (2.5%) (P < .001) with a total of 10 and 22 patients with an HbA1c level <7% and 8%, respectively. This mean (SD) reduction in HbA1c level was also seen in both insulin-treated patients (-1.8% [2.8%], n = 30) and non-insulin-treated patients (-2% [2.8%], n=11). The largest reduction in the first HbA1c level after CGM placement was seen in those patients provided a CGM along with collaborative care with a clinical pharmacist. These patients saw a mean (SD) decrease of -2.5% [2.7%] (n = 26) in their HbA1c level with a mean (SD) decrease of -0.8% (1.6%) (n = 15) for those not comanaged by the clinical pharmacist. IMPLICATIONS: The results of this study suggest that the use of CGM in the underserved population can lead to a significant improvement in glycemic control in patients with diabetes, regardless of treatment therapies used. Involving a multidisciplinary team in diabetes management, including clinical pharmacists, may further improve outcomes. Access to these devices in the underserved population may be crucial in reducing the risk of developing complications related to uncontrolled diabetes.

Real-world glycaemic outcomes in patients with type 1 diabetes using glucose sensors-Experience from a single centre in Dublin.

AIMS: To evaluate changes in glycated haemoglobin (HbA1 c) and sensor-based glycaemic metrics after glucose sensor commencement in adults with T1D. METHODS: We performed a retrospective observational single-centre study on HbA1 c, and sensor-based glycaemic data following the initiation of continuous glucose monitoring (CGM) in adults with T1D (n = 209). RESULTS: We observed an overall improvement in HbA1 c from 66 (59-78) mmol/mol [8.2 (7.5-9.3)%] pre-sensor to 60 (53-71) mmol/mol [7.6 (7.0-8.6)%] on-sensor (p < .001). The pre-sensor HbA1 c improved from 66 (57-74) mmol/mol [8.2 (7.4-8.9)%] to 62 (54-71) mmol/mol [7.8 (7.1-8.7)%] within the first year of usage to 60 (53-69) mmol/mol [7.6 (7.0-8.4)%] in the following year (n = 121, p < .001). RT-CGM-user had a significant improvement in HbA1 c (Dexcom G6; p < .001, r = 0.33 and Guardian 3; p < .001, r = 0.59) while a non-significant reduction was seen in FGM-user (Libre 1; p = .279). Both MDI (p < .001, r = 0.33) and CSII group (p < .001, r = 0.41) also demonstrated significant HbA1 c improvement. Patients with pre-sensor HbA1 c of ≥64 mmol/mol [8.0%] (n = 125), had attenuation of pre-sensor HbA1 c from 75 (68-83) mmol/mol [9.0 (8.4-9.7)%] to 67 (59-75) mmol/mol [8.2 (7.6-9.0)%] (p < .001, r = 0.44). Altogether, 25.8% of patients achieved the recommended HbA1 c goal of ≤53 mmol/mol and 16.7% attained the recommended ≥70% time in range (3.9-10.0 mmol/L). CONCLUSIONS: Our study demonstrated that minimally invasive glucose sensor technology in adults with T1D is associated with improvement in glycaemic outcomes. However, despite significant improvements in HbA1 c, achieving the recommended goals for all glycaemic metrics remained challenging.

Wearable Devices Beyond Activity Trackers in Youth With Obesity: Summary of Options.

Background: Current treatment protocols to prevent and treat pediatric obesity focus on prescriptive lifestyle interventions. However, treatment outcomes are modest due to poor adherence and heterogeneity in responses. Wearable technologies offer a unique solution as they provide real-time biofeedback that could improve adherence to and sustainability of lifestyle interventions. To date, all reviews on wearable devices in pediatric obesity cohorts have only explored biofeedback from physical activity trackers. Hence, we conducted a scoping review to (1) catalog other biofeedback wearable devices available in this cohort, (2) document various metrics collected from these devices, and (3) assess safety and adherence to these devices. Methods: This scoping review was conducted adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. Fifteen eligible studies examined the use of biofeedback wearable devices beyond activity trackers in pediatric cohorts, with an emphasis on feasibility of these devices. Results: Included studies varied in sample sizes (15-203) and in ages 6-21 years. Wearable devices are being used to capture various metrics of multicomponent weight loss interventions to provide more insights about glycemic variability, cardiometabolic function, sleep, nutrition, and body fat percentage. High safety and adherence rates were reported among these devices. Conclusions: Available evidence suggests that wearable devices have several applications aside from activity tracking, which could modify health behaviors through real-time biofeedback. Overall, these devices appear to be safe and feasible so as to be employed in various settings in the pediatric age group to prevent and treat obesity.

A review of CONCEPTT study findings including subanalyses in pregnant women using continuous glucose monitoring with type 1 diabetes and their offspring.

The main objective of this article is to provide a comprehensive review of continuous glucose monitor (CGM) use in pregnant women with type 1 diabetes (T1D) from the CONCEPTT study including subanalyses. Literature search was accessed through MEDLINE (1966-September 2023) using the key terms: CONCEPTT, pregnancy, women, T1D, and CGM with limitations set to distinguish human subjects written in English. A total of 17 publications including one main clinical trial and 15 subanalyses have been published to date regarding the use of CGM in pregnant women with T1D which were conducted by a research group identified as the CONCEPTT Collaborative Group. While advances in maternal care have resulted in safer pregnancy for both the mother and child, women with preexisting T1D and pregnancy still experience higher rates of complications both in the short and long term. The use of CGM in pregnancy has not been studied extensively until more recently. The CONCEPTT clinical trial was a landmark study that involved several subanalyses. The main trial proved that CGM use in T1D pregnancy resulted in less hyperglycemia in the third trimester, reduced large for gestational age (LGA, >90th percentile), reduced neonatal intensive care unit admissions lasting longer than 24 h, and reduced neonatal hypoglycemia. Although subanalyses showed a variety of results including 'inconclusive' due to lack of prespecification, it is believed that CGM in T1D during pregnancy is to be recommended and used for overall improved outcomes.

Effectiveness of Continuous Glucose Monitoring on Metrics of Glycemic Control in Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

PURPOSE: To provide a systematic review and meta-analysis synthesizing the findings of randomized controlled trials (RCTs) of continuous glucose monitors (CGMs) in the management of adults with type 2 diabetes mellitus (T2DM) on glucose control and clinical outcomes. METHODS: MEDLINE, Embase, and Cochrane were searched for RCTs that assessed the effectiveness of real-time CGM (rt-CGM) or flash CGM (FGM) in adults (≥18 years) with T2DM that reported on at least 1 of the following outcomes: hemoglobin A1c (HbA1c), time in range, time in hyperglycemia, or time in hypoglycemia. The GRADE approach was used to assess certainty of evidence for primary outcomes. RESULTS: Fourteen RCTs assessing CGM were included, with 825 patients in 9 RCTs using rt-CGM and 822 in 5 RCTs using FGM. Moderate certainty of evidence indicated that use of CGM had a modest but statistically significant reduction in HbA1c levels of about 0.32%. Our analyses of each device type separately showed similar reductions in HbA1c (0.34% and 0.33%, respectively, for rt-CGM and FGM), with trends for improvement in other glucose metrics favoring rt-CGM over self-monitored blood glucose. CONCLUSION: Both rt-CGM and flash CGM led to modest but statistically significant declines in HbA1c among individuals with T2DM, with little heterogeneity in the results. However, the duration of the included RCTs was relatively short and few studies reported on important clinical outcomes, such as adverse events, emergency department use, or hospitalization. Longer term studies are needed to determine if the short-term improvements in glucose control leads to improvements in clinically important outcomes.