The Importance of Expanding Medicare Continuous Glucose Monitoring Coverage for High-Risk Hypoglycemia.

Background: There is limited evidence of continuous glucose monitoring (CGM) in patients with type 2 diabetes (T2D) . CGM use improves HbA1c and quality of life, however scant evidence exists on the effect of CGM use on hypoglycemia awareness in patients with T2D. Selecting patients with T2D at high risk and low risk for hypoglycemia, we hypothesized that CGM use would improve hypoglycemia awareness. Methods: We conducted a 16 week, single center, randomized study on patients [n=40, 50% females, mean (SD) age 59 years (12.5) , BMI 34.kg/m2 (8.1) ] with T2D [screening HbA1c 7.6% (1.2) ] who were deemed to be either high risk (n=22) or low risk (n=18) for hypoglycemia over 5 years using our previously established scoring system. Each participant wore 2 CGM sensors. Within each risk category, participants were randomized to wearing either 1 unblinded+1 blinded sensor (Freestyle Libre/Freestyle Libre Pro) or 2 blinded sensors (2 Freestyle Libre Pro) . Every 2 weeks was an in-person visit for CGM replacement. Clarke and Gold questionnaires were performed at the screening visit (week 0) , visit 4 (week 8) and visit 8 (week 16) . Participants in the unblinded CGM group were instructed to use the CGM as they wished. Participants in the blinded CGM group were instructed to continue with their usual finger stick program. Result: At baseline, there were no differences in the Gold or Clark questionnaires between participants at high or low risk for hypoglycemia over 5 years. At end-intervention, no differences were noted in the Gold or Clark questionnaires regardless of CGM assignment or baseline hypoglycemia risk category. The trajectory of Gold or Clark scores over the study were also not significantly different between groups regardless of CGM assignment or baseline hypoglycemia risk category. Conclusion: In patients with T2D, the use of an unblinded CGM did not affect the awareness of hypoglycemia, even in patients at high risk for hypoglycemia, as assessed by Gold and Clark scores. Disclosure A.Mehfooz: None. Y.Lee: None. Q.Wang: None. L.S.Chow: Other Relationship; Dexcom, Inc.

Abstracts from ATTD 2016 9th International Conference on Advanced Technologies & Treatments for Diabetes Milan, Italy-February 3-6, 2016.

This report represents the conclusions of 15 experts in nephrology and endocrinology, based on their knowledge of key studies and evidence in the field, on the role of continuous glucose monitors (CGMs) in patients with diabetes and chronic kidney disease (CKD), including those receiving dialysis. The experts discussed issues related to CGM accuracy, indications, education, clinical outcomes, quality of life, research gaps, and barriers to dissemination. Three main goals of management for patients with CKD and diabetes were identified: (1) greater use of CGMs for better glycemic monitoring and management, (2) further research evaluating the accuracy, feasibility, outcomes, and potential value of CGMs in patients with end-stage kidney disease (ESKD) on hemodialysis, and (3) equitable access to CGM technology for patients with CKD. The experts also developed 15 conclusions regarding the use of CGMs in this population related to CGMs' unique delivery of both real-time information that can guide monitoring and management of glycemia and continuous and predictive data in this population, which is at higher risk for hypoglycemia and hyperglycemia. The group noted three major clinical gaps: (1) CGMs are not routinely prescribed for patients with diabetes and CKD; (2) CGMs are not approved by the United States Food and Drug Administration (FDA) for patients with diabetes who are on dialysis; and (3) CGMs are not routinely available to all of those who need them because of structural barriers in the health care system. These gaps can be improved with greater stakeholder collaboration, education, and awareness brought to the use of CGM technology in CKD.

The Future of Glucose Monitoring.

Objective: Continuous glucose monitoring (CGM) is beneficial in individuals at high risk of hypoglycemia or hypoglycemic events. Cognitive impairment can affect diabetes management and lead to poor health outcomes. We aimed to (1) assess the association between CGM use and all-cause mortality among diabetes patients with cognitive impairment and dementia, and (2) determine disparities in the use of CGM in this population. Methods: We used 2016-2020 electronic health records data from the University of Florida Health System and identified patients who (1) had diagnoses of both diabetes and cognitive impairment (i.e., mild cognitive impairment or Alzheimer's disease and related dementias) and (2) were insulin users. We examined CGM use by race/ethnicity and insurance status; and applied multiple logistic regression to examine the association of CGM use with all-cause mortality. Results: Of 1995 eligible patients (mean age 70.5±9.9 years, 56.9% non-Hispanic White (NHW), 37.5% non-Hispanic Black (NHB), and 5.6% others), 51 (2.6%) were CGM users and 566 (28.9%) died in a median follow up of 697 days. Black patients were less likely to use CGM compared to White patients (29.4% vs. 37.7% were Black among CGM users vs. non-users, respectively). Medicaid/uninsured patients were less likely to use CGM compared to Medicare/private insurance patients (1.9% vs. 11% were Medicaid/uninsured patients among CGM users vs. non-users, respectively). After adjusting for demographic and clinical characteristics in insulin users, CGM users were associated with a significantly lower risk of all-cause mortality compared to non-CGM users (adjusted OR (95% CI):0.2 (0.1-0.6)). Conclusion: The use of CGM was associated with improved survival among diabetes patients who were insulin users and had cognitive impairment. However, racial and socioeconomic disparities in the use of CGM were observed, which may exacerbate existing inequities in diabetes care and outcomes. Disclosure P.Kotecha: Employee; Novo Nordisk Global Business Services. W.Chen: None. Y.Li: None. W.T.Donahoo: None. J.Bian: None. J.Guo: Consultant; Pfizer Inc., Research Support; PhRMA Foundation, NIH - National Institutes of Health.

T he past year saw marked advances in research in pediatric diabetes with numerous studies investigating the use of closed-loop systems in the pediatric population. While such technologies are on the horizon for clinical use in pediatrics, other studies in the past year have highlighted the challenges with clinical implementation of insulin pump therapy, a technology that has been available for decades. The hope for an automatedor initially a semiautomated or hybrid closed-loop system requiring the user to give premeal boluses of insulinis well deserved. These systems aim to improve glucose control and lower the burden of care for children with type 1 diabetes (T1D) and their families. However, initial systems will continue to require significant user involvement as well as experienced and informed pediatric diabetes teams for successful adoption of these diabetes technologies. In addition, advances were seen in the use of a novel intranasal formulation of glucagon to treat hypoglycemia that simplifies the current injectable version of this potentially lifesaving medication. A randomized trial on the benefits of metformin in overweight adolescents with T1D found no benefit on HbA1c, but other potential metabolic improvements. Technology was also studied using telehealth to improve diabetes outcomes by delivering care to rural populations and in pediatric patients struggling to achieve treatment goals. Research in diabetes technology in pediatrics has accelerated in the past few years and with the advent of clinical availability of closed-loop technology promises to remain a rich field of investigation for years to come. Pediatric patients and their families should begin to reap the benefits of decades of work on these diabetes technologies to improve glucose control and lower the burden of care for diabetes. We conducted a Medline search for articles on the following topics: diabetes technology, insulin pump therapy (continuous subcutaneous insulin infusion [CSII]), continuous glucose monitoring (CGM), closed-loop systems, and new therapies in T1D relating to the pediatric age group (0-18 years). This article focuses on key articles that were published between July 1, 2015 and June 30, 2016. Use of insulin pump therapy in children and adolescents with type 1 diabetes and its impact on metabolic control: comparison of results from three large, transatlantic paediatric registries

BackgroundCohort data on continuous glucose monitoring (CGM) metrics are scarce for liver glycogen storage diseases (GSDs) and idiopathic ketotic hypoglycemia (IKH). The aim of this study was to retrospectively describe CGM metrics for people with liver GSDs and IKH. Patients and methodsCGM metrics (descriptive, glycemic variation and glycemic control parameters) were calculated for 47 liver GSD and 14 IKH patients, categorized in cohorts by disease subtype, age and treatment status, and compared to published age-matched CGM metrics from healthy individuals. Glycemic control was assessed as time-in-range (TIR; ≥3.9 - ≤7.8 and ≥3.9 - ≤10.0 mmol/L), time-below-range (TBR; <3.0 mmol/L and ≥3.0 - ≤3.9 mmol/L), and time-above-range (TAR; >7.8 and >10.0 mmol/L). ResultsDespite all patients receiving dietary treatment, GSD cohorts displayed significantly different CGM metrics compared to healthy individuals. Decreased TIR together with increased TAR were noted in GSD I, GSD III, and GSD XI (Fanconi-Bickel syndrome) cohorts (all p < 0.05). In addition, all GSD I cohorts showed increased TBR (all p < 0.05). In GSD IV an increased TBR (p < 0.05) and decreased TAR were noted (p < 0.05). In GSD IX only increased TAR was observed (p < 0.05). IKH patient cohorts, both with and without treatment, presented CGM metrics similar to healthy individuals. ConclusionDespite dietary treatment, most liver GSD cohorts do not achieve CGM metrics comparable to healthy individuals. International recommendations on the use of CGM and clinical targets for CGM metrics in liver GSD patients are warranted, both for patient care and clinical trials.

BackgroundHyperinsulinism (HI) due to excess and dysregulated insulin secretion is the most common cause of severe and recurrent hypoglycemia in childhood. High cerebral glucose use in the early hours results in a high risk of hypoglycemia in people with diabetes and carries a significant risk of brain injury. Prevention of hypoglycemia is the cornerstone of the management of HI, but the risk of hypoglycemia at night or the timing of hypoglycemia in children with HI has not been studied; thus, the digital phenotype remains incomplete and management suboptimal.ObjectiveThis study aims to quantify the timing of hypoglycemia in patients with HI to describe glycemic variability and to extend the digital phenotype. This will facilitate future work using computational modeling to enable behavior change and reduce exposure of patients with HI to injurious hypoglycemic events.MethodsPatients underwent continuous glucose monitoring (CGM) with a Dexcom G4 or G6 CGM device as part of their clinical assessment for either HI (N=23) or idiopathic ketotic hypoglycemia (IKH; N=24). The CGM data were analyzed for temporal trends. Hypoglycemia was defined as glucose levels <3.5 mmol/L.ResultsA total of 449 hypoglycemic events totaling 15,610 minutes were captured over 237 days from 47 patients (29 males; mean age 70 months, SD 53). The mean length of hypoglycemic events was 35 minutes. There was a clear tendency for hypoglycemia in the early hours (3-7 AM), particularly for patients with HI older than 10 months who experienced hypoglycemia 7.6% (1480/19,370 minutes) of time in this period compared with 2.6% (2405/92,840 minutes) of time outside this period (P<.001). This tendency was less pronounced in patients with HI who were younger than 10 months, patients with a negative genetic test result, and patients with IKH. Despite real-time CGM, there were 42 hypoglycemic events from 13 separate patients with HI lasting >30 minutes.ConclusionsThis is the first study to have taken the first step in extending the digital phenotype of HI by describing the glycemic trends and identifying the timing of hypoglycemia measured by CGM. We have identified the early hours as a time of high hypoglycemia risk for patients with HI and demonstrated that simple provision of CGM data to patients is not sufficient to eliminate hypoglycemia. Future work in HI should concentrate on the early hours as a period of high risk for hypoglycemia and must target personalized hypoglycemia predictions. Focus must move to the human-computer interaction as an aspect of the digital phenotype that is susceptible to change rather than simple mathematical modeling to produce small improvements in hypoglycemia prediction accuracy.

Time at high risk of hypoglycemia (THRH), 3.9 to 5.6 mmol/L, is a continuous glucose monitoring (CGM)-based metric recommended for reporting in hospitalized patients. This study aims to validate THRH as a predictor of hypoglycemia. The CGM data from 166 non-intensive care unit (non-ICU) inpatients with type 2 diabetes from the DIATEC trial were analyzed. All participants received basal-bolus insulin therapy. Of these, 82 were monitored with point-of-care glucose testing and blinded CGM, while 84 had open CGM. Linear and negative binomial regression analyses assessed the relationship between THRH and time below range (TBR) (<3.0 mmol/L, 3.0-3.9 mmol/L, and <3.9 mmol/L) and hypoglycemic events. Analyses were conducted for day (07:00-23:00), night (23:01-06:59), and 24-hour periods. For CGM-monitored patients, every 10%-point increase in THRH was associated with a 0.13%-point increase in TBR (<3.0 mmol/L) (95% confidence interval [CI] = 0.06-0.21), 0.66%-point increase in TBR (3.0-3.9 mmol/L) (95% CI = 0.47-0.86), and 0.74%-point increase in TBR (<3.9 mmol/L) (95% CI = 0.51-0.97), all P < .001. A THRH threshold below 50% was linked to a TBR <3.9 mmol/L of less than 4%, as recommended. Similar results were observed during both day and night analyses and for point-of-care monitored patients, also for hypoglycemic events. The THRH is strongly associated with hypoglycemia in non-ICU hospitalized patients with type 2 diabetes on basal-bolus insulin. Aiming for THRH below 50% aligns with the recommended TBR target of <3.9 mmol/L below 4%, supporting THRH's role in guiding hypoglycemia prevention strategies.

California Children’s Services (CCS) is a supplemental state medical insurance for low income children with chronic medical conditions. Until June 2016, continuous glucose monitors (CGM) were rarely covered by CCS for children with type 1 diabetes (T1D). Current CCS criteria for CGM includes: checking blood sugar 4 times/day and concerns that interfere with T1D management (such as fear of hypoglycemia). Ongoing approval requires CGM use for 5/7 days/week. We evaluated 6 months of CGM use by the first 41 children approved by CCS attending our clinics (age= 11.1 ± 4.7 years [range 3-21 years], T1D duration=4.8 ± 3.7 years, 59% male, 66% on pumps, 63% ethnic minorities and 15% non-English speakers). Most patients used the Dexcom receiver (73%). Thirty-three (81%) remained on CGM for ≥6 months. Of the 8 who stopped, 2 were due to lapses in insurance coverage. The other 6 stopped due to personal preference (5 within 3 months). All who stopped CGM use were English speakers. Among those who continued CGM with complete data (n=29, 71%), the mean percentage time worn at 6 months was 97±8% based on review of the CGM download. HbA1c remained stable over 6 months of CGM use (8.2±1.2%). Blinded CGM use was not available prior to initiation of personal CGM, so we cannot assess if hypoglycemia decreased. However, many of these children with CCS started CGM due to hypoglycemia and/or fear of hypoglycemia. Time in hypoglycemia as low at 6 months (4.3±4.8%). The number of fingersticks remained stable with 6.3/d at initiation and 5.6/d at 6 months. Our clinic data from the first 41 CCS patients approved for CGM demonstrates sustained CGM use for 6 months, even among non-English speakers. In this initial chart review, the incidence of hypoglycemia is low while on CGM. These data on sustained usability of CGM support CCS coverage of CGM. Given FDA approval of CGM use for insulin dosing decisions, expansion of CCS coverage of CGM should be considered to improve bolus adherence. Further studies are needed to promote improved clinical use and outcomes with CGM in this population. Disclosure P. Prahalad: None. B. Buckingham: Advisory Panel; Self; Novo Nordisk Inc., ConvaTec Inc.. Research Support; Self; Medtronic, Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc.. Consultant; Self; Tandem Diabetes Care, Inc., Becton, Dickinson and Company. D. Wilson: Research Support; Self; T1D Exchange, Medtronic MiniMed, Inc., Dexcom, Inc., National Institute of Diabetes and Digestive and Kidney Diseases, Insulet Corporation. Advisory Panel; Self; Tolerion. D.M. Maahs: Advisory Panel; Self; Insulet Corporation. Consultant; Self; Abbott. Research Support; Self; Medtronic, Bigfoot Biomedical, Dexcom, Inc., Insulet Corporation, Roche Diabetes Care Health and Digital Solutions.

Continuous glucose monitoring (CGM) is increasingly used although not officially registered for the management of people living with liver glycogen storage diseases (GSDs). The aims of this study were twofold: (a) to investigate the current experiences of healthcare providers (HCPs), patients, and caregivers using CGM to monitor glucose concentrations in liver GSDs, and (b) to formulate consensus statements. Two web-based questionnaires were distributed, one for HCPs and one for patients and/or their caregivers. The questionnaires collected data on demographics and epidemiology, current use of CGM, and opinions and statements about CGM in GSDs. For the statements, respondents rated their agreement on a 5-point Likert scale, and the consensus level was set at 75%. One Hundred Fourteen HCPs (including 87 physicians and 26 dietitians) from 28 countries responded, representing care of approximately 3800 liver GSD patients. Additionally, 148 GSD patients and/or their caregivers from 21 countries responded, mainly representing GSD Ia (n = 50), GSD Ib (n = 56), GSD III (n = 14), and GSD IX (n = 18). The median age to consider starting to use CGM was 6 and 2 months for HCPs and GSD families, respectively. Out of 16 statements common to the two questionnaires, HCPs and patients/caregivers reached consensus on 12 statements in both groups. Use of CGM is considered standard of care by both HCPs and GSD families, but reimbursement of CGM devices is challenging. Compared to diabetes mellitus, CGM should be applied differently in liver GSDs. Consensus guidelines are warranted on the use of CGM in liver GSDs, both in routine healthcare and in clinical trials.

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INTRODUCTION: The rising incidence of pediatric diabetes underscores the need for accurate glucose monitoring tools to facilitate early detection. Although both Blood Glucose Meters (BGM) and Continuous Glucose Monitoring (CGM) are widely used, their comparative effectiveness in predicting diabetes onset in children remains contested. This study evaluated and compared the predictive utility of BGM and CGM in high-risk pediatric populations. METHODS: A nine-month prospective observational study (January–September 2024) was conducted at the Health Polytechnic of the Ministry of Health, Sorong, involving 76 children aged 10–18 years diagnosed with Acanthosis Nigricans and positive FINDRISC scores. Participants were allocated to either BGM (every 3 days) or CGM (15-minute intervals). Key outcome measures included Time in Range (TIR), mean glucose levels, frequencies of hypo- and hyperglycaemic episodes, adherence rates, and Mean Absolute Relative Difference (MARD). RESULTS: CGM significantly outperformed BGM across all parameters: higher TIR (78.9% vs. 63.4%, p&lt;0.001), lower average glucose levels (145.3 vs. 162.7 mg/dL, p=0.003), fewer hypoglycaemic (1.1 vs. 2.8, p=0.015) and hyperglycaemic events (2.6 vs. 4.5, p=0.002), and superior adherence (88.7% vs. 71.3%, p&lt;0.001). CGM also showed a lower MARD (7.2% vs. 10.8%, p=0.004), indicating greater accuracy. CONCLUSIONS: CGM offers more reliable and comprehensive glucose monitoring than BGM for predicting diabetes onset in children at risk, supported by better glycaemic control, higher adherence, and improved accuracy. These findings endorse CGM as the preferred approach for early diabetes detection in pediatric populations.

Inpatient use of CGM results in higher detection of hypoglycemic and hyperglycemic events compared to point of care testing (POC) but its efficacy and safety in adjusting insulin therapy has not been evaluated. This randomized controlled trial included 181 general medicine and surgery patients with type 1 (n= 18) and type 2 (n= 155) diabetes treated with a basal bolus insulin regimen. All patients underwent POC testing AC &amp; HS. Patients in the POC group wore a blinded Dexcom G6 CGM with insulin dose adjusted based on POC results; while in the CGM group, insulin adjustment was based on daily Dexcom G6 CGM profile review. Hypoglycemia alarms were set at 80 mg/dl in the CGM group. Primary endpoints were differences in time in range (70-180 mg/dl) and hypoglycemia (&amp;lt;70 mg/dl and &amp;lt;54 mg/dl) . Results: There were no differences on admission clinical characteristics, HbA1c or diabetes type between POC and CGM groups. There were no differences in mean daily glucose (186.8±39 mg/dl vs. 183.2±40 mg/dl, p=0.36) , total daily insulin dose (36.1±28 U/day vs. 40.7±29 U/day, p=0.33) , % patients with CGM values &amp;lt;70 mg/dl (39% vs. 36%, p=0.68) or &amp;lt;54mg/dl (24% vs. 14%, p=0.12) between the two groups. Among patients with ≥ 1 hypoglycemic event, compared to POC, CGM use resulted in significant reduction in hypoglycemia recurrence with an incidence-ratio for glucose &amp;lt;70mg/dl (0.53, 95% CI:0.31-0.92) and incidence-ratio for glucose &amp;lt;54mg/dl (0.37 (95% CI:0.17-0.83) . The percent time &amp;lt;70 mg/dl among those with hypoglycemia was smaller in the CGM (1.9±3.3% vs. 5.5±8.5, p=0.024) compared to the POC group, with group difference in hypoglycemia confirmed by zero-inflated Beta Regression analysis (p&amp;lt;0.001) . Conclusion: Our results indicates that the inpatient use of Dexcom G6 CGM is safe and effective in guiding insulin adjustment resulting in similar improvement in glucose control and in significant reduction of recurrent hypoglycemic events compared to POC testing. Disclosure I. Spanakis: Other Relationship; Dexcom, Inc. L. G. Singh: None. C. Gothong: None. I. Marcano: None. S. Lizama: None. K. M. Munir: None. C. Chesney: None. R. D. Maguire: None. W. H. Scott: None. L. Peng: None. G. E. Umpierrez: Research Support; AstraZeneca, Dexcom, Inc., Novo Nordisk. M. A. Urrutia: None. M. F. Scioscia: None. R. J. Galindo: Advisory Panel; Sanofi, WW International, Inc., Research Support; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk. P. Vellanki: n/a. A. L. Migdal: None. G. Davis: Consultant; Medscape, Research Support; Insulet Corporation. T. Idrees: None. F. J. Pasquel: Consultant; AI Health LLC, Boehringer Ingelheim International GmbH, Dexcom, Inc., Research Support; Dexcom, Inc., Insulet Corporation, Merck &amp; Co., Inc.

The National Institute for Clinical Excellence updated guidance for continuous glucose monitoring (CGM) in 2022, recommending that CGM be available to all people living with type 1 diabetes. Manufacturers can trade in the UK with Conformité Européenne (CE) marking without an initial national assessment. The regulatory process for CGM CE marking, in contrast to the Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA) process, is described. Manufacturers operating in the UK provided clinical accuracy studies submitted for CE marking. Critical appraisal of the studies shows several CGM devices have CE marking for wide-ranging indications beyond available data, unlike FDA and TGA approval. The FDA and TGA use tighter controls, requiring comprehensive product-specific clinical data evaluation. In 2018, the FDA published the integrated CGM (iCGM) criteria permitting interoperability. Applying the iCGM criteria to clinical data provided by manufacturers trading in the UK identified several study protocols that minimized glucose variability, thereby improving CGM accuracy on all metrics. These results do not translate into real-life performance. Furthermore, for many CGM devices available in the UK, accuracy reported in the hypoglycaemic range is below iCGM standards, or measurement is absent. We offer a framework to evaluate CGM accuracy studies critically. The review concludes that FDA- and TGA-approved indications match the available clinical data, whereas CE marking indications can have discrepancies. The UK can bolster regulation with UK Conformity Assessed marking from January 2025. However, balanced regulation is needed to ensure innovation and timely technological access are not hindered.