Use Of Real-time Continuous Glucose Monitoring Research Articles

Reduction in Diabetes-Related Hospitalizations and Medical Costs After Dexcom G6 Continuous Glucose Monitor Initiation in People with Type 2 Diabetes Using Intensive Insulin Therapy.

Some people with type 2 diabetes (T2D) require intensive insulin therapy to manage their diabetes. This can increase the risk of diabetes-related hospitalizations. We hypothesize that initiation of real-time continuous glucose monitoring (RT-CGM), which continuously measures a user's glucose values and provides threshold- and trend-based alerts, will reduce diabetes-related emergency department (ED) and inpatient hospitalizations and concomitant costs. A retrospective analysis of US healthcare claims data using Optum's de-identified Clinformatics® Data Mart database was performed. The cohort consisted of commercially insured, CGM-naïve individuals with T2D who initiated Dexcom G6 RT-CGM system between August 1, 2018, and March 31, 2021. Twelve months of continuous health plan enrollment before and after RT-CGM initiation was required to capture baseline and follow-up rates of diabetes-related hospitalizations and associated healthcare resource utilization (HCRU) costs. Analyses were performed for claims with a diabetes-related diagnosis code in either (1) any position or (2) first or second position on the claim. A total of 790 individuals met the inclusion criteria. The average age was 52.8 (10.5) [mean (SD)], 53.3% were male, and 76.3% were white. For claims with a diabetes-related diagnosis code in any position, the number of individuals with ≥ 1 ED visit decreased by 30.0% (p = 0.01) and with ≥ 1 inpatient visit decreased by 41.5% (p < 0.0001). The number of diabetes-related visits and average number of visits per person similarly decreased by at least 31.4%. Larger relative decreases were observed for claims with a diabetes-related diagnosis code in the first or second position on the claim. Total diabetes-related costs expressed as per-person-per-month (PPPM) decreased by $341 PPPM for any position and $330 PPPM for first or second position. Initiation of Dexcom G6 among people with T2D using intensive insulin therapy was associated with a significant reduction in diabetes-related ED and inpatient visits and related HCRU costs. Expanded use of RT-CGM could augment these benefits and result in further cost reductions.

2023 Clinical Practice Guidelines for Diabetes: Continuous Glucose Monitoring and Insulin Pumps

With the expanding use of continuous glucose monitoring (CGM) and insulin pumps worldwide, several international guidelines dedicated to diabetes technology have been developed. Recently, the Korean Diabetes Association released a new version of their clinical practice guidelines including substantial changes in recommendations on the use of CGM and insulin pumps. Of note, continuous use of real-time CGM is now recommended to all people with diabetes using insulin, including people with type 2 diabetes using once daily basal insulin. Convincing evidence from recent automated insulin delivery (AID) trials supports the recommendation of AID as standard therapy in type 1 diabetes. This review summarizes the results of recent clinical studies on CGM and AID and their influence on the new clinical recommendations.

The impact of real-time sensor technology on quality of life for adults with type 1 diabetes: A Dutch national survey

AimsTo examine the impact of real-time continuous glucose monitoring (RT-CGM) on quality of life in Dutch adults with type 1 diabetes, inside/outside automated insulin delivery (AID) systems. MethodsIn this cross-sectional retrospective observational study, RT-CGM users completed an online survey including (adapted) validated questionnaires, study-specific items and open-ended questions. ResultsOf 893 participating adults, 69% used the RT-CGM as part of AID. The overall sample reported improvements in quality of life related to RT-CGM use (irrespective of initial indication), particularly with respect to physical health, emotional wellbeing and energy. Merits for sleep, intimacy and cognitive diabetes load lagged somewhat behind, mostly when RT-CGM was not integrated in AID. Users of AID had significantly larger improvements in overall quality of life, fatigue and diabetes-specific distress than users of sensor-augmented pump or Open Loop treatment. In regression analyses, user evaluations were associated with perceptions of benefit and burden. In qualitative content analysis, benefits (e.g. life ‘normalization’, increased perceptions of control) outweighed burdens (e.g. technology frustrations, confrontation with diabetes). ConclusionsRT-CGM positively impacted the quality of life of adults with type 1 diabetes. This justifies a (re-)consideration of broader access. Increased support to maximize device benefits and minimize burdens is also warranted.

538-P: Use of Real-Time Continuous Glucose Monitoring Supports Behavior Modification in Gestational Diabetes Mellitus—Results from an Ongoing Pilot Study

Gestational diabetes mellitus (GDM) is common, with 14% of women developing GDM. Although real-time continuous glucose monitoring (RT-CGM) has been shown to support behavioral/lifestyle modifications in patients living with type 1 and type 2 diabetes, no studies to date have assessed RT-CGM as a behavior modification tool for patients with GDM. Participants diagnosed with GDM [prior to gestational age 24 weeks (early) or between 24-30 weeks (typical)] were randomized to use RT-CGM or continue self-monitoring of blood glucose (SMBG) using finger-sticks and wore 3 serial blinded CGM over the remainder of the pregnancy. Both groups continued their routine obstetric care. After delivery, RT-CGM participants completed a 44-question survey adapted from the Joslin Diabetes Center CGM questionnaire plus our published 8-question survey on behavior modification and CGM use. To date, 70 participants have enrolled; 31 were randomized to RT-CGM. Twenty-four (4 early and 20 typical) have completed the post-delivery surveys. Demographics: 42% were Caucasian, 63% reported annual incomes of &amp;gt;$50,000, and 79% had achieved at least a bachelor’s degree. From RT-CGM use: 71% excluded or limited sugared beverages (29% never drank sugared beverages), 78% excluded or limited white rice (13% never ate white rice), 67% started reading labels for fiber content (17% of participants already read labels for fiber content), and 92% would walk or increase activity after a meal if they saw their glucose rising. Overall, 92% of participants felt like RT-CGM contributed to a healthier lifestyle during pregnancy. Sixty-three percent wanted to continue using RT-CGM. Our study suggests that women with GDM perceive that RT-CGM supports improved lifestyle choices during pregnancy. Studies are ongoing to assess whether RT-CGM improves maternal and/or fetal outcomes, but advocacy is needed now to improve accessibility of RT-CGM in GDM. Disclosure B.Cedeno: None. E.Fay: None. N.M.Ehrhardt: Advisory Panel; Novo Nordisk, Dexcom, Inc., Consultant; Nestlé Health Science. S.J.Fonda: Research Support; Dexcom, Inc. Funding Dexcom, Inc. (IIS-2019-101)

230-OR: Hybrid Continuous Glucose Monitoring Protocols in the Intensive Care Unit—Multicenter Experience

There is limited experience with continuous glucose monitoring (CGM) in intensive care units (ICUs). We assessed the effectiveness, safety, and accuracy of real-time CGM use in COVID-19 ICUs. We pooled data from three academic centers using hybrid protocols combining point of care (POC) blood glucose (BG) with non-adjunctive CGM. At hospitals A and B, CGM was used non-adjunctively with POC at least every 6 hours. At hospital C, POC BG was performed every two hours. We also examined CGM performance during lowest pAO2, oxygen saturation, pH, and mean arterial pressure. Of 169 patients, mean age was 60.9±12.2 years, and 82%, 93%, and 62% received corticosteroids, mechanical ventilation, and vasopressors respectively. Median duration of IV insulin was 118, 156, and 50 hours at hospitals A, B, and C respectively. Mean POC BG frequency was 10.2±6.1, 7.0±5.2, and 16±6.5 times/day on day 1 of IV insulin and 6.7±3.1, 6.0±3.5, and 12.2±5.8 times/day thereafter. The median percent CGM time in range (TIR, 70-180mg/dl) was 72%, 70% and 46% during IV insulin. Median time &amp;lt;70mg/dl was &amp;lt;0.1% for all hospitals. The absolute relative difference between CGM and POC did not correlate with hemodynamic instability, Figure. This data indicates hybrid monitoring can reduce POC frequency while safely maintaining glucose. Sensor-meter agreement was not associated with abnormal physiologic parameters and requires further study. Disclosure E.R.Faulds: Advisory Panel; Dexcom, Inc., Other Relationship; A1Control, LLC, Research Support; Dexcom, Inc., Speaker's Bureau; Dexcom, Inc., Medscape. M.Garcia: None. S.Chandra: None. F.J.Pasquel: Consultant; Dexcom, Inc., Medscape, Research Support; Dexcom, Inc., Ideal Medical Technologies. K.M.Dungan: Board Member; Elsevier, Consultant; Eli Lilly and Company, Dexcom, Inc., Other Relationship; UpToDate, Research Support; Dexcom, Inc., Abbott, ViaCyte, Inc., Sanofi, Speaker's Bureau; Academy for Continued Healthcare Learning, Cardiometabolic Health Congress, Medscape, Integritas. Y.Badakhshi: None. A.Boutsicaris: None. M.C.Exline: Other Relationship; Abbott Nutrition. J.Hester: None. L.G.Jones: None. M.Mcnett: Research Support; Dexcom, Inc., National Institutes of Health. J.D.Miller: Advisory Panel; MannKind Corporation, Employee; Medtronic, Research Support; Dexcom, Inc. R.Shah: None.

A primary care delivered, technology supported lifestyle program for Type 2 Diabetes Management: An evaluation of changes in metabolic health, feasibility, and acceptability – A pilot interventional study protocol

BackgroundType 2 Diabetes (T2D) is associated with significant health complications and socioeconomic costs. Previous research conducted through an outpatient research facility demonstrated use of a low carbohydrate (LC) diet and exercise plan delivered in the format of an education book combined with use of real-time continuous glucose monitoring (RT-CGM) is an effective self-management intervention to improve weight and blood glucose management in patients with T2D. Primary health care remains the central access point for patient management of T2D, but General Practitioners (GPs) lack access to effective evidenced-based, self-management programs that can be prescribed to improve patient outcomes. MethodsA single-arm, within-participant pilot intervention study will be conducted to evaluate the changes in metabolic health, acceptability and feasibility of a prescriptive LC diet and lifestyle program combined with RT-CGM (LC-RTC) delivered via GP practices. Forty adults with T2D will be recruited from GP practices and prescribed the LC-RTC intervention for 12 weeks. Outcomes will be assessed at baseline and 12-weeks post intervention. Changes in metabolic health will be assessed by changes in glycosylated hemoglobin (primary outcome), body weight, blood pressure, blood lipids, and medication usage. Post-intervention, participants will complete questionnaires and participate in focus groups to explore their experience of the LC-RTC program including acceptance, perceived benefits/barriers, limitations, financial feasibility, intervention drop-out rates, participant and GP engagement with the program (clinic attendance and contacts made to clinic for program support) and RT-CGM use and wear time acceptance. GPs and clinical staff involved will participate focus groups to evaluate the perceived value and feasibility of the LC-RTC program. DiscussionThis trial will provide a powered evaluation of the changes in metabolic health, acceptability, and feasibility of the LC-RTC program for patients with T2D delivered via GP practices. Trial registrationANZCTR: 12622000635763 (Website Link to full registration: ANZCTR - Registration). Registered 29th April 2022. Overall trial status: Commenced; Recruitment Status: Commenced 1st May 2022, with 40 participants recruited as of 2nd May 2023 using a rolling recruitment approach.

Continuous Glucose Monitoring-Derived Metrics and Capillary Vessel Density in Subjects with Type 1 Diabetes without Diabetic Retinopathy.

Optical coherence tomography angiography (OCTA) is an innovative and reliable technique detecting the early preclinical retinal vascular change in patients with diabetes. We have designed our study to evaluate whether an independent relationship exists between continuous glucose monitoring (CGM)-derived glucose metrics and OCTA parameters in young adult patients with type 1 diabetes without diabetic retinopathy (DR). Inclusion criteria were age ≥ 18 years, diagnosis of type 1 diabetes from ≥ 1 year, stable insulin treatment in the last three months, use of real-time CGM, and CGM wear time ≥ 70%. Each patient underwent dilated slit lamp fundus biomicroscopy to exclude the presence of DR. A skilled operator performed OCTA scans in the morning to avoid possible diurnal variation. CGM-derived glucose metrics from the last 2 weeks were collected through the dedicated software during OCTA. Forty-nine patients with type 1 diabetes (age 29 [18; 39] years, HbA1c 7.7 ± 1.0%) and 34 control subjects participated in the study. Vessel density (VD) of the whole image and parafoveal retina in the superficial (SCP) and deep capillary plexus (DCP) was significantly lower in patients with type 1 diabetes compared to controls. The coefficient of variation of average daily glucose, evaluated by CGM, significantly correlated with foveal and parafoveal VD in SCP and with foveal VD in DCP. High glucose variability might be responsible for the early increase of VD in these areas. Prospective studies may help understand if this pattern precedes DR. The difference we detected between patients with and without diabetes confirms that OCTA is a reliable tool for detecting early retinal abnormalities.

Management of Individuals With Diabetes at High Risk for Hypoglycemia: An Endocrine Society Clinical Practice Guideline.

Hypoglycemia in people with diabetes is common, especially in those taking medications such as insulin and sulfonylureas (SU) that place them at higher risk. Hypoglycemia is associated with distress in those with diabetes and their families, medication nonadherence, and disruption of life and work, and it leads to costly emergency department visits and hospitalizations, morbidity, and mortality. To review and update the diabetes-specific parts of the 2009 Evaluation and Management of Adult Hypoglycemic Disorders: Endocrine Society Clinical Practice Guideline and to address developing issues surrounding hypoglycemia in both adults and children living with diabetes. The overriding objectives are to reduce and prevent hypoglycemia. A multidisciplinary panel of clinician experts, together with a patient representative, and methodologists with expertise in evidence synthesis and guideline development, identified and prioritized 10 clinical questions related to hypoglycemia in people living with diabetes. Systematic reviews were conducted to address all the questions. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make recommendations. The panel agreed on 10 questions specific to hypoglycemia risk and prevention in people with diabetes for which 10 recommendations were made. The guideline includes conditional recommendations for use of real-time continuous glucose monitoring (CGM) and algorithm-driven insulin pumps in people with type 1 diabetes (T1D), use of CGM for outpatients with type 2 diabetes at high risk for hypoglycemia, use of long-acting and rapid-acting insulin analogs, and initiation of and continuation of CGM for select inpatient populations at high risk for hypoglycemia. Strong recommendations were made for structured diabetes education programs for those at high risk for hypoglycemia, use of glucagon preparations that do not require reconstitution vs those that do for managing severe outpatient hypoglycemia for adults and children, use of real-time CGM for individuals with T1D receiving multiple daily injections, and the use of inpatient glycemic management programs leveraging electronic health record data to reduce the risk of hypoglycemia. The recommendations are based on the consideration of critical outcomes as well as implementation factors such as feasibility and values and preferences of people with diabetes. These recommendations can be used to inform clinical practice and health care system improvement for this important complication for people living with diabetes.

Continuous glucose monitoring metrics (Mean Glucose, time above range and time in range) are superior to glycated haemoglobin for assessment of therapeutic efficacy.

To evaluate continuous glucose monitoring (CGM) metrics for use as alternatives to glycated haemoglobin (HbA1c) to evaluate therapeutic efficacy. We re-analysed correlations among CGM metrics from studies involving 545 people with type 1 diabetes (T1D), 5910 people with type 2 diabetes (T2D) and 98 people with T1D during pregnancy and the postpartum period. Three CGM metrics, interstitial fluid Mean Glucose level, proportion of time above range (%TAR) and proportion of time in range (%TIR), were correlated with HbA1c and provided metrics that can be used to evaluate therapeutic efficacy. Mean Glucose showed the highest correlation with %TAR (r= 0.98 in T1D, 0.97 in T2D) but weaker correlations with %TIR (r= -0.92 in T1D, -0.83 in T2D) or with HbA1c (r= 0.78 in T1D). %TAR and %TIR were highly correlated changes in (r= -0.96 in T1D, -0.91 in T2D). After 6 months of use of real-time CGM by people with T1D, changes in Mean Glucose level were more highly correlated with changes in %TAR (r= 0.95) than with changes in %TIR (r= -0.85) or with changes in HbA1c level (r= 0.52). These metrics can be combined with metrics of hypoglycaemia and/or glycaemic variability to provide a more comprehensive assessment of overall quality of glycaemic control. The CGM metrics %TAR and %TIR show much higher correlations with Mean Glucose than with HbA1c and provide sensitive indicators of efficacy. Mean glucose may be the best metric and shows consistently higher correlations with %TAR than with %TIR.

Real-Time Continuous Glucose Monitoring in Adolescents and Young Adults With Type 2 Diabetes Can Improve Quality of Life.

Real-time continuous glucose monitoring (CGM) is effective for diabetes management in cases of type 1 diabetes and adults with type 2 diabetes (T2D) but has not been assessed in adolescents and young adults (AYAs) with T2D. The objective of this pilot interventional study was to assess the feasibility and acceptability of real-time CGM use in AYAs with T2D. Adolescents and young adults (13-21 years old) with T2D for six months or more and hemoglobin A1c (A1c) greater than 7%, on any Food and Drug Administration-approved treatment regimen, were included. After a blinded run-in period, participants were given access to a real-time CGM system for 12 weeks. The use and acceptability of the real-time CGM were evaluated by sensor usage, surveys, and focus group qualitative data. Participants' (n = 9) median age was 19.1 (interquartile range [IQR] 16.8-20.5) years, 78% were female, 100% were people of color, and 67% were publicly insured. Baseline A1c was 11.9% (standard deviation ±2.8%), with median diabetes duration of 2.5 (IQR 1.4-6) years, and 67% were using insulin. Seven participants completed the study and demonstrated statistically significant improvement in diabetes-related quality of life, with the mean Pediatric Quality of Life inventory (PedsQL) diabetes score increasing from 70 to 75 after using CGM (P = .026). Focus group results supported survey results that CGM use among AYAs with T2D is feasible, can improve quality of life, and has the potential to modify behavior. Real-time CGM is feasible and acceptable for AYAs with T2D and may improve the quality of life of patients with diabetes. Larger randomized controlled trials are needed to assess the effects on glycemic control and healthy lifestyle changes.

Comparison Between Continuous Versus Flash Glucose Monitoring in Children, Adolescents, and Young Adults with Type 1 Diabetes: An 8-Week Prospective Randomized Trial.

IntroductionTo assess the impact of real-time continuous glucose monitoring (RT-CGM) instead of first-generation flash glucose monitoring (FGM) on hypoglycaemia in children and adolescents with type 1 diabetes.MethodsIn this randomized controlled interventional study, young individuals with type 1 diabetes used RT-CGM or FGM for 8 weeks. We evaluated changes in time below range (TBR), severe hypoglycaemia (SH), HbA1c, glycaemic variability, and impaired awareness of hypoglycaemia with RT-CGM (intervention group) in comparison with FGM.ResultsWe randomly assigned 37 participants to either the intervention group (n = 19) or the control group (n = 18). At 8 weeks, we did not find a decrease in TBR in either group, but there was a significant reduction in SH in the intervention group. For participants with TBR ≥ 5% at baseline, we observed significant reductions in 24-h TBR, wake TBR, sleep TBR, and glucose variability at 8 weeks in the intervention group.ConclusionsThe use of RT-CGM versus FGM decreased SH in young individuals with type 1 diabetes, and TBR and glucose variability in patients with a higher TBR at baseline. The patient's history should be taken into account when advising on the method of blood glucose monitoring, as RT-CGM could be more effective in younger patients at high risk for SH.Trial registrationClinicalTrials.gov NCT04249102.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01297-x.

649-P: Real-Time Continuous Glucose Monitoring in the Hospital Identifies and Prompts Treatment for Hypoglycemia

Reliance on point-of-care (POC) blood glucose measurements for inpatient diabetes management can result in long between-measurement intervals, which contribute to undetected and untreated dysglycemia. The G6 real-time continuous glucose monitoring (RT-CGM) system (Dexcom) allows for remote monitoring. In the hospital, this may reduce the need for close interactions and infectious disease transmission between patients and hospital staff. A man in his mid-60s was admitted to a non-intensive care unit in an acute care facility with a diagnosis of COVID-19. His preadmission type 2 diabetes was managed with twice-daily intermediate-acting insulin and prandial rapid-acting insulin; steroids and POC glucose testing (prandial and bedtime with a FreeStyle Precision Pro meter [Abbott]) were added to this regimen. A G6 was placed on the abdomen and was set to alert the staff to glucose values ≤85 mg/dL or predicted to be &amp;lt;55 mg/dL within 20 minutes. Two hypoglycemic events occurred which triggered three G6 alerts (Figure) . The G6 alerts prompted ad hoc POC measurements that confirmed the hypoglycemic events, prompted appropriate interventions, and documented the patient’s return to euglycemia. All seven G6 readings were within 20 mg/dL or 20% of POC values ≤100 or &amp;gt;100 mg/dL, respectively. Inpatient RT-CGM use can detect existing or impending hypoglycemia and assist in diabetes management. Disclosure M.Baker: Other Relationship; Dexcom, Inc. J.Welsh: Employee; Dexcom, Inc. Funding Dexcom, Inc.

Real-World Outcomes of Glucose Sensor Use in Type 1 Diabetes-Findings from a Large UK Centre.

Flash glucose monitoring (FGM) and real-time continuous glucose monitoring (RT-CGM) are increasingly used in clinical practice, with improvements in HbA1c and time in range (TIR) reported in clinical studies. We aimed to evaluate the impact of FGM and RT-CGM use on glycaemic outcomes in adults with type 1 diabetes (T1DM) under routine clinical care. We performed a retrospective data analysis from electronic outpatient records and proprietary web-based glucose monitoring platforms. We measured HbA1c (pre-sensor vs. on-sensor data) and sensor-based outcomes from the previous three months as per the international consensus on RT-CGM reporting guidelines. Amongst the 789 adults with T1DM, HbA1c level decreased from 61.0 (54.0, 71.0) mmol/mol to 57 (49, 65.8) mmol/mol in 561 people using FGM, and from 60.0 (50.0, 70.0) mmol/mol to 58.8 (50.3, 66.8) mmol/mol in 198 using RT-CGM (p < 0.001 for both). We found that 23% of FGM users and 32% of RT-CGM users achieved a time-in-range (TIR) (3.9 to 10 mmol/L) of >70%. For time-below-range (TBR) < 4 mmol/L, 70% of RT-CGM users and 58% of FGM users met international recommendations of <4%. Our data add to the growing body of evidence supporting the use of FGM and RT-CGM in T1DM.

Use of Connected Pen as a Diagnostic Tool to Evaluate Missed Bolus Dosing Behavior in People with Type 1 and Type 2 Diabetes.

Objective: This study used connected pen to determine missed bolus dose (MBD) frequency during masked and unmasked continuous glucose monitoring (CGM) periods and examined its link with time-in-range (TIR), time-above-range (TAR), time-below-range (TBR), and key participant characteristics in people with diabetes.Methods: This was a 12-week, single-arm, exploratory, two-period study for people with type 1 diabetes (T1D) or type 2 diabetes (T2D). The primary objective was to estimate the average number of MBD during masked and real-time CGM use. The secondary objective was to estimate the average percent TIR and its relationship to MBD. An exploratory objective was to investigate the participant characteristics that were associated with MBD. Data were analyzed for differences in MBD by diabetes type and other participant characteristics, by CGM period, and by hypoglycemic fear scores.Results: Participants (n = 64; T1D, n = 38; T2D, n = 26) were 48 ± 11.9 years old and 44% were female. From the masked to the unmasked period, MBD, %TAR, %TBR, and glycated hemoglobin decreased significantly (0.74 MBD/day to 0.62 MBD/day, P = 0.008; 53.6%–48.1%, P = 0.004; 4.49%–2.93%, P < 0.001; mean 8.8%–8.4%, P < 0.001, respectively), while %TIR increased significantly (41.9%–49.0%, P < 0.001). MBD/day was negatively associated with TIR (P = 0.016) and positively associated with TAR (P = 0.015) for T1D and positively associated with TBR (P = 0.024) for T2D in the masked period only. MBD was significantly associated with fear of hypoglycemia for T2D, but not T1D.Conclusions: MBD is associated with reduced TIR when CGM is masked and tailored therapeutic approaches are needed for T1D and T2D populations.

Continuous Glucose Monitoring in the Management of Neonates With Persistent Hypoglycemia and Congenital Hyperinsulinism.

BackgroundPersistent hypoglycemia is common in the newborn and is associated with poor neurodevelopmental outcome. Adequate monitoring is critical in prevention, but is dependent on frequent, often hourly blood sampling. Continuous glucose monitoring (CGM) is increasingly being used in children with type 1 diabetes mellitus, but use in neonatology remains limited. We aimed to introduce real-time CGM to provide insights into patterns of dysglycemia and to support the management of persistent neonatal hypoglycemia.MethodsThis is a single-center retrospective study of real-time CGM use over a 4-year period in babies with persistent hypoglycemia.ResultsCGMs were inserted in 14 babies: 8 term and 6 preterm infants, 9 with evidence of congenital hyperinsulinism (CHI). A total of 224 days of data was collected demonstrating marked fluctuations in glucose levels in babies with CHI, with a higher sensor glucose SD (1.52 ± 0.79 mmol/L vs 0.77 ± 0.22 mmol/L) in infants with CHI compared with preterm infants. A total of 1254 paired glucose values (CGM and blood) were compared and gave a mean absolute relative difference of 11%.ConclusionCGM highlighted the challenges of preventing hypoglycemia in these babies when using intermittent blood glucose levels alone, and the potential application of CGM as an adjunct to clinical care.

61-LB: Continuous Glucose Monitoring (CGM) in ICU Patients during COVID-19: A Pilot Study

Objective: During the COVID 19 pandemic, the FDA approved emergency authorization of Real Time Continuous Glucose Monitoring (RT-CGM) for inpatient use. The objective of this study was to evaluate the safety of RT-CGM use. Methods: Blood Glucose (BG) data were collected from the electronic medical record and the Dexcom system on 165 patients treated on DEXCOM CGM from June to December using a preapproved protocol. Retrospective chart review was performed on 60 patients on vasopressors and dialysis. Analysis included glycemic control, hypoglycemia rate, and correlation between finger stick (FS) and RT-CGM BG. Pearson's correlation coefficients (PCC) and MARD were calculated. Strong correlation was defined as a PCC value of > 0.7. Results: Of the > 300,000 BG readings from DEXCOM, 81 % were between 70-180 mg/dl;12 % between 180-250mg/dl;and 5% were > 250 mg/dl. The incidence of hypoglycemia was low, 0.8% values being between 55 - 69 mg/dL and 0.5% being < 55 mg/dL. Of the 2016 readings used for correlation, the PCC between FS and RT-CGM glucose was 0.838 with a MARD of 14%. PCC was 0.798 for patients on vasopressors and 0.79 for dialysis Patients. Conclusions: In this preliminary study, Dexcom CGM utilization was safe with a low incidence of hypoglycemia and good correlation to FS blood glucose. CGM utilization decreased the frequency of FS for most patients, and was well accepted by the clinical team.

592-P: Patient Perception of RT-CGM for Lifestyle Change Six Months after Two Sessions of RT-CGM

Background: Real-time continuous glucose monitoring (RT-CGM) provides glucose readings to patients with diabetes, potentially supporting self-care. Preliminary data suggests efficacy of these devices influencing behavior change but data are limited on the sustainability of this change following short term use. Methods: Following completion of a 14 week intervention involving use of RT-CGM as a behavior modification tool, a 6 month follow up survey was conducted. The survey included ten questions evaluating the impact of the subject's participation in the study on their continued lifestyle and health. The final question of the survey inquired if the subject had a significant other available to answer questions regarding their awareness of the subject's participation and impact on their own lifestyle choices. Results: Twenty-two participants with diabetes participated in the initial intervention, of which sixteen responded to the survey. In the six months since their participation, 100% of respondents reported that CGM continues to contribute to a healthier lifestyle. 75% reported that they have excluded or limited certain foods as a result of participating and participation has motivated them to increase activity level. If available, 88% reported that they would you like to wear a CGM device on a regular basis. 68.8 % reported subjective weight loss since participating in the study with 7 (63.7%) of those participants reporting a weight loss of 10lbs or greater. Of the 16 participants, 3 subjects had a significant other that lived with the subject throughout the study and was able to be contacted. Of these three, 1 reported feeling healthier and changing their food choices as a result of their partner wearing a CGM. Conclusion: In patients with diabetes, RT-CGM creates a sustainable lifestyle impact 6 months following use and is a desired tool for self care. However, longer prospective studies need to be completed. Further evaluation of RT-CGM contribution to the “health” of the household is also needed. Disclosure M. W. Porter: None. L. Needleman: None. S. Ramhmdani: None. N. M. Ehrhardt: Advisory Panel; Self; Novo Nordisk, Research Support; Self; Dexcom, Inc., Merck &amp; Co., Inc., Novo Nordisk.

Change in Hemoglobin A1c and Quality of Life with Real-Time Continuous Glucose Monitoring Use by People with Insulin-Treated Diabetes in the Landmark Study.

Background: Initiating continuous glucose monitoring (CGM) can affect hemoglobin A1c (HbA1c) levels and patients' relationship with their diabetes. We used real-world HbA1c data to quantify short-term changes in glycemia and validated psychosocial questionnaires to assess changes in quality-of-life indicators in people during their first few months of CGM use.Methods: Eligibility was assessed during calls to Dexcom sales regarding its G6 CGM System. Eligibility criteria included ages 25–65 years, type 1 (T1D) or type 2 diabetes (T2D) on intensive insulin therapy (IIT), and no prior CGM use. Participants used a web-based portal to complete the 17-item Diabetes Distress Scale (DDS) and the 14-item Hypoglycemia Attitudes and Behavior Scale (HABS); provided validated HbA1c measurements; and shared their CGM data pre- and 3–5 months post-CGM initiation. Satisfaction and ease of use with the G6 System were also assessed.Results: Data were available from 248 patients (182 with T1D, 66 with T2D; 57% male, 88% non-Hispanic white). Mean (standard deviation) HbA1c fell significantly from 8.2% (1.9%) at baseline to 7.1% (1.1%) at the end of the study (P < 0.001); more than half (54.4%) of those with initial HbA1c values >7% experienced absolute HbA1c reductions of >1%. Significant reductions in diabetes distress (DDS) and hypoglycemic concerns (HABS) were observed (P < 0.001). Most (93%) participants were satisfied or very satisfied with the G6 System and 73% found it very easy to use.Conclusions: The first 3 months of CGM use was correlated with improvements in psychosocial outcomes and improved HbA1c levels for people with T1D or T2D who use IIT.

Expanding Flash Continuous Glucose Monitoring Technology to a Broader Population.

According to the Centers for Disease Control and Prevention, 88 million people have prediabetes, and another 34.2 million have diabetes (1). Projections indicate that, by 2060, the number of adults with diabetes in the United States will triple (2). The literature is rife with data indicating that a large majority of people with diabetes fail to reach optimal glucose control despite advances in diabetes care and technology (3). Similarly, a large majority of individuals with prediabetes develop diabetes, despite widespread public health interventions (4,5). Technological advances in diabetes care to address these shortcomings are needed. Since the introduction of continuous glucose monitoring (CGM) more than 20 years ago, rapid advancements in its accuracy, reliability, and ease of use have occurred (6). As CGM technology continues to evolve, it has become clear that appropriate use of CGM can lead to improvements in glycemic control, although assessment of patient preference, willingness to wear a CGM device, potential for adherence, cost, need for alarm features, and ability to integrate with an insulin pump need to be considered for each patient (7). Although use of real-time CGM has improved, rates of adoption remain less than anticipated and lower than what is likely to be beneficial to patients in clinical practice (8). On the other hand, use of flash CGM (sometimes called intermittently scanned CGM) continues to increase rapidly in the United States …

Glycemic Control Improvement in Italian Children and Adolescents With Type 1 Diabetes Followed Through Telemedicine During Lockdown Due to the COVID-19 Pandemic

Background/ObjectiveTo minimize the wide spread of coronavirus disease (COVID-19) pandemic, Italy was placed in an almost complete lockdown state that forced people to “stay at home”. Aim of this study was to evaluate the effects of lockdown on glycemic control in children and adolescents with type 1 diabetes (T1D) followed through telemedicine.Subjects/MethodsThis observational study involved patients with T1D using the real-time continuous glucose monitoring (CGM) Dexcom G6®. Ambulatory glucose profile data from the 3-months before schools closure (November 26, 2019–February 23, 2020; T0) and from the 3-months of consecutive lockdown (February 24–May 18, 2020; T1) were compared.ResultsSixty-two children and adolescents (11.1 ± 4.37 years, 50% males) with T1D (median time disease 3.67 years) were enrolled in the study. Insulin total daily dose was unchanged, while time spent on physical activities was decreased (p<0.0001). Despite the lack of statistical significance, median value of the glucose management indicator decreased from 7.4% to 7.25%. Glucose standard deviation (p<0.0001) and coefficient of variation (p=0.001) improved across the study. Median time in range increased from 60.5% to 63.5% (p=0.008), time above range decreased from 37.3% to 34.1% (p=0.048), and time below range decreased from 1.85% to 1.45% (p=0.001).ConclusionsOverall, in our children and adolescents with T1D glycemic control improved during lockdown. Despite patients were confined to their homes and limited to exercise, our data suggest that the use of real-time CGM, the continuous parental management, and the telemedicine can display beneficial effects on T1D care.