Continuous Glucose Monitoring Group Research Articles

Clinical Effectiveness of Continuous Glucose Monitoring in Pregnancies Affected by Type 1 Diabetes.

Background: Continuous glucose monitoring (CGM) improves neonatal outcomes in type 1 diabetes pregnancies; however, its effectiveness has not been assessed in a real-world setting in the United States. Objective: The Triple C Study aimed to examine the clinical effectiveness, assessed through maternal glucose control and gestational health outcomes, of CGM use compared with self-monitoring of blood glucose (SMBG) in pregnancies associated with type 1 diabetes in a real-world setting. Research Design and Methods: We retrospectively identified 160 type 1 diabetes pregnancies at the Barbara Davis Center for Diabetes managed with CGM therapy (n = 109) or SMBG (n = 51) over a 6.5-year period (2014-2020). Obstetric care was provided at multiple practices. CGM use was defined as ≥60% wear in the second and third trimesters of pregnancy. Data were obtained from the electronic medical record system, hospital records, and vital statistics departments (Colorado and Wyoming). We used Student's t-test for continuous variables and chi-square test for categorical variables to compare outcomes between groups. Results: The CGM group had more participants meeting trimester-specific hemoglobin A1C (HbA1c) goals throughout pregnancy and postpartum (P < 0.01 in each time period). The CGM group had fewer participants never meeting HbA1c goals in any trimester than the SMBG group (P < 0.001). There were no significant differences in neonatal outcomes between groups, other than for macrosomia (12.8% CGM vs. 29.4% SMBG, P = 0.01). Infants of CGM users required a neonatal intensive care unit admission less often (52.9% CGM vs. 68.3% SMBG, P = 0.0989). Conclusions: CGM use was associated with improved maternal glucose levels in a diverse real-world cohort.

A Pilot Trial of Continuous Glucose Monitoring Upon Emergency Department Discharge Among People With Diabetes Mellitus

ObjectivePeople with diabetes mellitus, particularly those with limited access to longitudinal care, frequently present to the emergency department (ED). Continuous glucose monitoring (CGM) has been shown to improve outcomes in ambulatory settings, so we hypothesized that it would be beneficial if initiated upon ED discharge. MethodsWe randomized adults with diabetes who were seen in the ED for hypo- or hyperglycemia to either 14 days of flash CGM or care coordination alone. All participants were scheduled to follow up in our diabetes specialty clinic. Outcomes included clinic attendance, the 3-month change in hemoglobin A1c, and repeat ED utilization. ResultsWe recruited 30 participants, including 13 with newly diagnosed diabetes. All but one (97%) had type 2 diabetes. We found no significant difference between the CGM (n = 16) and control (n = 14) groups in terms of clinic attendance (75 vs 64%, P = .61) or repeat ED utilization (31 vs 50%, P = .35), although our power was low. The absolute reduction in A1c was greater in the CGM group (5.2 vs 2.4%, P = .08). Among newly diagnosed participants for whom we had data, 7 out of 7 in the CGM group had a follow-up A1c under 7% compared to 1 out of 3 in the control group (P = .03). Over 90% of patients and providers found the CGM useful. ConclusionsOur data demonstrate the feasibility of starting CGM in the ED, a valuable setting for engaging difficult-to-reach patients. Our pilot study was limited by its small sample size, however, as recruitment in the ED can be challenging.

Continuous Glucose Monitoring Provides Durable Glycemic Benefit in Adolescents and Young Adults with Type 1 Diabetes: 12-Month Follow-Up Results

Objective. To further evaluate glycemic outcomes during the observational extension phase of the Continuous Glucose Monitoring (CGM) Intervention for Teens and Young Adults randomized clinical trial (RCT). Subjects and Methods. Following a 26-week RCT comparing CGM with blood glucose monitoring (BGM) in 153 adolescents and young adults aged 14 to &lt;25 years old with suboptimally controlled type 1 diabetes, 70 (89%) participants in the BGM group initiated use of CGM (referred to as BGM–CGM cohort), and 70 (95%) participants in the CGM group continued to use of CGM (CGM–CGM cohort) for an additional 26 weeks. Results. In the CGM–CGM cohort, mean hemoglobin A1c (HbA1c) decreased from 8.9% ± 0.9% (74 ± 9.8 mmol/mol) at randomization to 8.3% ± 1.3% (67 ± 14.2 mmol/mol) at 52 weeks ( p &lt; 0.001 ); however, significant improvement in time in target range (TIR) 70–180 mg/dL was not observed from prerandomization (38% ± 13%) to 52 weeks (41% ± 18%). Median percent time &lt;70 mg/dL decreased from 3.0% before randomization to 1.1% at 52 weeks ( p &lt; 0.001 ). In the BGM–CGM cohort, mean HbA1c decreased from 8.9% ± 1.2% (74 ± 13.1 mmol/mol) before CGM initiation to 8.5% ± 1.3% (69 ± 14.2 mmol/mol) after 26 weeks of CGM use ( p &lt; 0.001 ) and mean TIR increased from 34% ± 12% to 38% ± 15% ( p = 0.01 ). The median percent time &lt;70 mg/dL decreased from 3.3% before CGM initiation to 1.2% after 26 weeks of CGM use ( p &lt; 0.001 ). No participants discontinued CGM use during the extension phase. Conclusions. This further evaluation of CGM supports the findings of the preceding RCT that use of CGM improves glycemic control and reduces hypoglycemia in adolescents and young adults with type 1 diabetes. This trial is registered with NCT03263494.

SAT095 Utilizing Continuous Glucose Monitoring Post Open Heart Surgery

Abstract Disclosure: Y. Chen: None. A. Cuevas Velazquez: None. M.A. Wahab: None. K. Aljassani: None. K. Rajak: None. A. Halder: None. A. Atrash: None. J. Renu: None. Introduction: It is a standardized practice to monitor blood glucose (BG) levels while on insulin infusion therapy in patients who undergo open heart surgery regardless of their diabetes status. Hyperglycemia was often noted in these patients due to catecholamine surge induced by intraoperative stress. This study is to investigate whether using Continuous Glucose Monitoring (CGM) is a safer option compared to traditional finger stick (FS) glycemic monitoring in postoperative patients. Methods: This is a prospective randomized controlled trial. Patients planned for open heart surgery including coronary artery bypass surgery, valvular repair, or replacements at UPMC Harrisburg hospital from May 2021 to August 2022 were voluntarily involved and randomized by 2:1 ratio into CGM or FS glycemic monitoring methods during the first 48-hour postoperative period on insulin infusion therapy and in the intensive care unit (ICU). Patient demographics, comorbidities, diabetes (DM) status, and glycemic data within the first 48 hours after surgery were compared between the two groups. Results: A total of 42 patients were recruited, including 31 males (81.6%). Four patients were excluded due to missing data, 22 were randomized to the CGM group, and 16 to the FS group. There was no difference in demographics between the two groups. The mean glucose level of the CGM group (123.09 mg/dL) was no different from the FS group (116.31mg/dL) (p=0.09). The CGM group detected significantly more events of level 2 hypoglycemia (BG &amp;lt;54 mg/dL, p=0.01) and hyperglycemia (BG&amp;gt;=180 mg/dL, p=0.01) compared to the FS group. In the CGM group, the mean time of normoglycemia (BG 70-179 mg/dL), hypoglycemia, and hyperglycemia in all 22 patients was 91.1%, 2.58%, and 6.34% respectively. Time in normoglycemia was longer in non-DM patients (95.8%) than in DM patients (87.1%). Discussions: CGM signatures the convenience of frequent BG checks, enabling the reduction of glucose variability and improvement of glycemic control. In this study, although no difference was noted in the mean BG between CGM and FS groups, CGM was noted to be especially effective in hypoglycemia detection. Our findings suggest that CGM brings in the potential benefit of improving patient safety compared to traditional glucose monitoring. To conclude, CGM is probably non-inferior as a glucose monitoring method compared to FS and it might bring the additional benefit of improving patient safety by higher sensitivity of detecting significant hyper/hypoglycemic events for postoperative population on insulin drip in the ICU setting. Presentation: Saturday, June 17, 2023

Continuous glucose monitoring metrics and pregnancy outcomes in insulin-treated diabetes: A post-hoc analysis of the GlucoMOMS trial.

To investigate the association between continuous glucose monitoring (CGM) metrics and perinatal outcomes in insulin-treated diabetes mellitus in pregnancy. In a post-hoc analysis of the GlucoMOMS randomized controlled trial, we investigated the association between the metrics of an offline, intermittent CGM, glycated haemoglobin (HbA1c) and perinatal outcomes per trimester in different types of diabetes (type 1, 2 or insulin-treated gestational diabetes mellitus [GDM]). Data were analysed using multivariable binary logistic regression. Outcomes of interest were neonatal hypoglycaemia, pre-eclampsia, preterm birth, large for gestational age (LGA) and Neonatal Intensive Care Unit (NICU) admission. The glucose target range was defined as 3.5-7.8 mmol/L (63-140 mg/dL). Of the 147 participants (N = 50 type 1 diabetes, N = 94 type 2 diabetes/insulin-treated GDM) randomized to the CGM group of the GlucoMOMS trial, 115 participants had CGM metrics available and were included in the current study. We found that, in pregnancies with type 1 diabetes, a higher second trimester mean glucose was associated with LGA (odds ratio 2.6 [95% confidence interval 1.1-6.2]). In type 2 and insulin-treated gestational diabetes, an increased area under the curve above limit was associated with LGA (odds ratio 10.0 [95% confidence interval 1.4-72.8]). None of the CGM metrics were associated with neonatal hypoglycaemia, pre-eclampsia, shoulder dystocia, preterm birth and NICU admission rates for pregnancies complicated by any type of diabetes. In this study, in type 2 diabetes or insulin-treated GDM, the glucose increased area under the curve above limit was associated with increased LGA. In type 1 diabetes, the mean glucose was the major determinant of LGA. Our study found no evidence that other CGM metrics determined adverse pregnancy outcomes.

157-LB: A Randomized Trial of Continuous Glucose Monitoring upon Emergency Department Discharge

Background: People with type 2 diabetes (T2D), particularly those with limited access to longitudinal care, frequently present to the emergency department (ED), leading to increased hospital utilization and disjointed care. Continuous glucose monitoring (CGM) has been shown to improve patient engagement and glycemic outcomes in outpatients, so we hypothesized that it would be beneficial if initiated upon ED discharge. Methods: We randomized adults with T2D who were seen in the ED for hypo- or hyperglycemia to either flash CGM or care coordination alone. All participants were scheduled to follow up in our diabetes specialty clinic within two or three weeks. Outcomes included clinic attendance, patient-reported diabetes-related distress, satisfaction with CGM, and follow-up hemoglobin A1c. Results: We recruited 30 participants, including 13 with newly diagnosed T2D. We found no significant difference between the CGM (n=16) and control (n=14) groups in terms of clinic attendance (75 versus 64%, P=0.69) or the change in diabetes-related distress as measured via the Diabetes Distress Scale. Among participants in the CGM group who returned for follow up, 83% found CGM helpful, as did 90% of their providers. The mean A1c reduction after approximately 3 months was greater in the CGM group (5.2 versus 1.9%, P=0.051), although the groups were not balanced in terms of diabetes duration. Among participants with newly diagnosed T2D, excluding those missing data, five out of five in the CGM group had a follow-up A1c under 7% (from a mean baseline of 12.9%) compared to zero out of two in the control group (P=0.048). Discussion: Our study demonstrates the feasibility of starting CGM in the ED, an important setting for engaging difficult-to-reach patients. We did not see an effect of CGM on follow-up clinic attendance or diabetes-related distress, but there was a trend towards improved A1c at 3 months in the CGM group. Our study was limited by its small sample size, however, as recruitment in the ED can be challenging. Disclosure M. J. O'connor: None. X. Ding: None. C. Hernandez: None. L. M. Hubacz: None. R. J. Church: None. L. O'connor: None. Funding Herman G. Berkman Diabetes Clinical Innovation Fund

Prevalence, characteristics, and health-related quality of life of continuous glucose monitoring use according to the Behavioral Risk Factor Surveillance System 2014-2020.

BACKGROUND: Continuous glucose monitoring (CGM) can improve behavioral and clinical outcomes. The use of CGM in real-world practice appears to be increasing. However, actual prevalence and characteristics of using CGM in real-world practice are unknown. OBJECTIVE: To investigate the prevalence of CGM use by American adults with diabetes mellitus and differences in demographics and health-related quality of life (HRQOL) between users of CGM and self-monitoring of blood glucose (SMBG). METHODS: This serial cross-sectional study using 2014-2020 Behavioral Risk Factor Surveillance System data included nonpregnant adults with self-reported diabetes using CGM or 4-15 times daily SMBG. Outcomes were prevalence of CGM use, demographics, and the 4-item Centers for Disease Control and Prevention HRQOL (CDC HRQOL-4). Unadjusted analysis was performed using univariable regression, and adjusted analysis was performed using nearest neighbor matching to compare CDC HRQOL-4 between SMBG and CGM groups in SAS Studio version 5.2. RESULTS: Among 12,053 included respondents, 231 (1.9%) reported using CGM, and prevalence increased from 0.4% in 2014 to 4.1% in 2020. Compared with SMBG users, CGM users were more likely to be younger (50.3 years vs 56.1 years; P < 0.001), employed (59.6% vs 30.6%; P = 0.001), earn at least $75,000/year (48.5% vs 22.0%, P < 0.001), have insurance coverage (99.7% vs 95.4%; P = 0.005), and report fewer comorbidities (history of myocardial infarction, stroke, arthritis, depressive disorder, and kidney disease; all P < 0.05). After nearest neighbor matching, diabetes management-related characteristics were shown to have statistically significant differences between CGM and SMBG users including: age at diabetes diagnosis (30.6 vs 35.6 years; P = 0.005), not seeing a doctor because of cost concern (2.6% vs 7.8%; P = 0.011), checking hemoglobin A1c biannually (91.3% vs 86.6%; P = 0.047), performing daily foot self-examination (58.9% vs 69.6%; P = 0.028), receiving foot examination by a health care professional annually (87.9% vs 93.5%; P = 0.048), and receiving a shingles vaccine in the past (16.5% vs 10.1%; P = 0.024). CDC HRQOL-4 were shown to be similar between the 2 groups across the 4 domains (general health, physical, mental, and combined physical and mental health). CONCLUSIONS: An increased trend in CGM use was observed from 2014 to 2020. Economic factors were associated with CGM use over SMBG, and CGM use did not show a difference in HRQOL measured across the 4 domains.

Insulin pump therapy with and without continuous glucose monitoring in pregnant women with type 1 diabetes: a prospective observational Orchestra Foundation study in Poland

AimsThe effects of continuous subcutaneous insulin infusion (CSII) therapy with or without continuous glucose monitoring (CGM) on neonatal outcomes and glycemic outcomes of pregnant women with type 1 diabetes (T1D), living in Poland, were assessed.MethodsThis prospective observational study enrolled women with T1D (N = 481, aged 18–45 years) who were pregnant or planned pregnancy. All used CSII therapy and a subset used CGM with CSII (CSII + CGM). Neonatal outcomes (e.g., rate of large for gestational age [LGA] delivery [birth weight > 90th percentile]) and maternal glycemia (e.g., HbA1c and percentage of time at sensor glucose ranges) were evaluated.ResultsOverall HbA1c at trimesters 1, 2, and 3 was 6.8 ± 1.1% (50.9 ± 12.3 mmol/mol, N = 354), 5.8 ± 0.7% (40.1 ± 8.0 mmol/mol, N = 318), and 5.9 ± 0.7% (41.4 ± 8.0 mmol/mol, N = 255), respectively. A HbA1c target of < 6.0% (42 mmol/mol) at each trimester was achieved by 20.9% (74/354), 65.1% (207/318), and 58.0% (148/255), respectively. For women using CSII + CGM versus CSII only, HbA1c levels at trimesters 1, 2, and 3 were 6.5 ± 0.9% versus 7.1 ± 1.3% (47.8 ± 9.7 mmol/mol versus 54.3 ± 14.0 mmol/mol, p < 0.0001), 5.7 ± 0.6% versus 6.0 ± 0.9% (38.9 ± 6.5 mmol/mol versus 41.6 ± 9.3 mmol/mol, p = 0.0122), and 5.8 ± 0.6% versus 6.1 ± 0.8% (40.3 ± 6.9 mmol/mol versus 42.9 ± 9.1 mmol/mol, p = 0.0117), respectively. For the overall, CSII only, and CSII + CGM groups, rates of LGA delivery were 22.7% (74/326), 24.6% (34/138), and 21.3% (40/188), respectively.ConclusionsObservational assessment of women with T1D using CSII therapy demonstrated low HbA1c throughout pregnancy and low rates of LGA. The addition of CGM to CSII therapy compared to CSII therapy alone was associated with some improved maternal glycemic and neonatal outcomes.Clinicaltrials.gov identifierNCT01779141 (January 2013).

OR03-3 Impact of Continuous Glucose Monitoring (CGM) on Lifestyle Modifications in Individuals with Prediabetes

Abstract Introduction Adherence to lifestyle modifications can prevent diabetes; however, this poses a challenge for most individuals. CGM is an effective tool for glycemic control and lifestyle modifications in patients with diabetes on insulin therapy. We explored the impact of CGM use in individuals with prediabetes. Hypothesis Individuals using CGM in addition to diabetes education will show improved adherence to lifestyle modifications and greater reduction of HbA1c as compared to those receiving diabetes education alone.Design57 individuals with prediabetes were randomized to use CGM for 3 months along with diabetes education (CGM group) or receive diabetes education alone (EDU group). Food frequency (UKDDQ) and physical activity (IPAQ) questionnaires were completed by participants at the beginning and at the end of the study (6 months). Primary outcomes were lifestyle modifications and changes in HbA1c. Secondary outcomes were changes in weight and blood pressure. Results Both groups reported an increase in healthy food choices; however, EDU group performed better (EDU: 12.4 vs 9.2, p&amp;lt;0.01, CGM: 10.6 vs 9.5, p 0.08). Unhealthy food choices were reduced in both groups. CGM group reported a greater increase in moderate physical activity levels (CGM: 230 vs 61 minutes/week, p 0.01, EDU: 78.5 vs 48 minutes/week, p 0.22). Vigorous physical activity was reported by more individuals in CGM group than EDU (35% vs 4%). Greater reduction in mean HbA1c was noted in CGM group (5.7 vs 5.9%, p 0.05) compared to EDU (5.8 vs 5.9%, p 0.01). 33% of participants in both groups had normalization of HbA1c at the end of study. CGM group had greater reduction in weight (3.5 vs 0.8 lb, p 0.1) and systolic BP (12 vs 2.4 mmHg, p 0.01) than EDU. Irrespective of group assignment, the study population had improvement in all outcomes despite the beginning of COVID-19 pandemic during 4th month of the study. Smaller number of participants in the CGM group reported negative impact of the pandemic on their lifestyle modifications than EDU (Diet: 68% vs 80%, Physical activity: 48% vs 64%). Majority of CGM group participants were able to maintain lifestyle changes after discontinuing CGM use (Diet: 72%, Physical activity: 84%). On comparing both interventions, 56% of CGM group participants felt CGM to be more helpful than education for lifestyle modifications, while 40% felt both interventions helped equally. Conclusions CGM use in addition to diabetes education resulted in improvement in physical activity, food choices, HbA1c, weight, and BP in individuals with prediabetes. The significance of diabetes education was noted by greater improvement in food choices in EDU group. CGM can be an effective tool for diabetes prevention with lifestyle modifications in prediabetes. The long-term impact of CGM use and cost-benefit analysis in high-risk patients needs to be explored further. Presentation: Saturday, June 11, 2022 12:00 p.m. - 12:15 p.m.

Continuous Glucose Monitoring-Guided Insulin Administration in Hospitalized Patients With Diabetes: A Randomized Clinical Trial.

The efficacy and safety of continuous glucose monitoring (CGM) in adjusting inpatient insulin therapy have not been evaluated. This randomized trial included 185 general medicine and surgery patients with type 1 and type 2 diabetes treated with a basal-bolus insulin regimen. All subjects underwent point-of-care (POC) capillary glucose testing before meals and bedtime. Patients in the standard of care (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 CGM profile. Primary end points were differences in time in range (TIR; 70-180 mg/dL) and hypoglycemia (<70 mg/dL and <54 mg/dL). There were no significant differences in TIR (54.51% ± 27.72 vs. 48.64% ± 24.25; P = 0.14), mean daily glucose (183.2 ± 40 vs. 186.8 ± 39 mg/dL; P = 0.36), or percent of patients with CGM values <70 mg/dL (36% vs. 39%; P = 0.68) or <54 mg/dL (14 vs. 24%; P = 0.12) between the CGM-guided and POC groups. Among patients with one or more hypoglycemic events, compared with POC, the CGM group experienced a significant reduction in hypoglycemia reoccurrence (1.80 ± 1.54 vs. 2.94 ± 2.76 events/patient; P = 0.03), lower percentage of time below range <70 mg/dL (1.89% ± 3.27 vs. 5.47% ± 8.49; P = 0.02), and lower incidence rate ratio <70 mg/dL (0.53 [95% CI 0.31-0.92]) and <54 mg/dL (0.37 [95% CI 0.17-0.83]). The inpatient use of real-time Dexcom G6 CGM is safe and effective in guiding insulin therapy, resulting in a similar improvement in glycemic control and a significant reduction of recurrent hypoglycemic events compared with POC-guided insulin adjustment.

Continuous glucose monitoring: A cost-effective tool to reduce pre-term birth rates in women with type one diabetes.

Women with type one diabetes experience poorer obstetric outcomes than normoglycaemic women in pregnancy. To investigate the cost and clinical effectiveness of continuous glucose monitoring (GCM) compared to self-monitoring of blood glucose in improving obstetric outcomes in women with type one diabetes during pregnancy. This retrospective cohort study included women with type one diabetes referred to a state-wide tertiary obstetric centre before and after the introduction of government-funded CGMs in Australia in March 2019. Forty-nine women using CGMs were propensity matched on a range of clinical features with a historical group of 49 women with type one diabetes who exclusively used intermittent self-monitoring of blood in the year prior to the introduction of funding of sensors. Medical records and administrative cost data were audited to quantify cost and clinical effectiveness. There were significantly lower pre-term (95% CI 0.39-0.922; P=0.026) and very pre-term birth rates (95% CI 1.002-1.184; P=0.041) in the CGM group. There was a significant reduction in the length of antenatal inpatient hospital stay (P < 0.01) and adult special care unit stay (P=0.013) and neonatal admission to the neonatal intensive care unit (P=0.0262) in the continuous glucose monitoring group. CGMs represented a net cost saving to the health care sector of $12 063 per pregnancy where the device was used, with an incremental cost-effectiveness ratio of $3275 per prevented pre-term birth. CGM use in pregnancy is a cost-effective intervention for reducing the risk of pre-term birth in women with type one diabetes, resulting in a net cost benefit to the health sector.

140-LB: Management of Inpatient Hyperglycemia Guided by Continuous Glucose Monitoring (CGM) in Insulin-Treated Patients with Diabetes—A Randomized Clinical Trial

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.

688-P: Comparing Rates of Sensor-Detected Hypoglycaemia and Patient-Reported Hypoglycaemia by Method of Glucose Monitoring: The Hypo-METRICS Trial

Continuous glucose monitoring (CGM) allows greater detection of hypoglycemia. We compared rates and duration of sensor detected hypoglycemia (SDH) and patient reported hypoglycemia (PRH) in people with type 1 diabetes (T1D) and normal awareness of hypoglycemia (NAH) (Gold score &amp;gt;4) using either flash or capillary blood glucose (CGB) monitoring. We included 91 participants (70 CGM vs. 21 CBG) with T1D with &amp;gt;1 hypoglycemic episode in the last month. They used blinded CGM in addition to their usual glucose monitoring and recorded PRH (symptomatic event that resolved on carbohydrate ingestion, or a self-measured glucose &amp;lt;72 mg/dl) in real time on a smartphone app for weeks. Sleep status was obtained using wrist wore actigraphy. Median (IQR) time in range (TIR) , 59.4 (17.4) vs 60.1 (16.9) % p=.54 and time below range, 4.6 (5.3) vs. 3.6 (5.7) % p=0.39, were not different. There were no significant differences in rates or duration of SDH &amp;lt;70 mg/dl or &amp;lt;54 mg/dl (table 1) . Rates of PRH were higher in the CGM group while awake, 2.9 (2.6) vs. 1.9 (2.6) episodes/week p=.039, with no difference during sleep. Median duration of SDH &amp;lt; 40mg/dl while awake was longer, 20.1 (12.7) vs. 43.2 (7.0) minutes p=.0068. For a given TIR, people with T1DM have similar hypoglycemia exposure regardless of mode of monitoring. CGM enhances awareness of events and shortens events &amp;lt; 40mg/dl whilst awake. Disclosure P.Divilly: None. S.R.Heller: Advisory Panel; Eli Lilly and Company, Medtronic, Mylan N.V., Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker’s Bureau; Novo Nordisk A/S. M.Evans: Advisory Panel; Pila Pharma, Zucara Therapeutics, Other Relationship; Abbott Diabetes, Dexcom, Inc., Medtronic, Novo Nordisk, Research Support; AstraZeneca, Sanofi, Speaker’s Bureau; Lilly Diabetes. S.A.Amiel: Advisory Panel; Medtronic, Novo Nordisk, Other Relationship; Sanofi. P.Choudhary: Advisory Panel; Abbott Diabetes, Lilly Diabetes, Medtronic, Research Support; Novo Nordisk, Speaker’s Bureau; Dexcom, Inc., Glooko, Inc., Insulet Corporation, Sanofi. A.Seibold: Employee; Abbott Diabetes, Stock/Shareholder; Abbott. G.Martine-edith: Other Relationship; Novo Nordisk. Z.Mahmoudi: Employee; Novo Nordisk A/S. N.Zaremba: None. U.Soeholm: Research Support; Novo Nordisk A/S. B.E.De galan: Research Support; Novo Nordisk. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi. R.J.Mccrimmon: Advisory Panel; Novo Nordisk, Sanofi, Research Support; Diabetes UK, European Union, MedImmune. E.Renard: Consultant; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Insulet Corporation, LifeScan, Lilly, Novo Nordisk, Roche Diabetes Care, Sanofi, Tandem Diabetes Care, Inc. Funding Innovative Medicines Initiative (777460)

700-P: Use of Continuous Glucose Monitoring Does Not Alter Hypoglycemic Awareness in Patients with Type 2 Diabetes Mellitus

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.

Magnitude of Glycemic Improvement in Patients with Type 2 Diabetes Treated with Basal Insulin: Subgroup Analyses from the MOBILE Study.

Objective:To determine if type 2 diabetes patients using basal insulin without prandial insulin with worse glycemic control at baseline would have the greatest benefit from using real-time continuous glucose monitoring (CGM).Methods:We conducted a post hoc analysis of the MOBILE Study, a multicenter trial examining the impact of CGM versus self-monitoring with a blood glucose meter (BGM) in patients with type 2 diabetes treated with basal insulin without prandial insulin. Participants were divided into subgroups based on baseline hemoglobin A1c (HbA1c) and baseline time-in-range 70–180 mg/dL (TIR). Change in TIR from baseline was calculated within each subgroup.Results:In subgroups based on baseline HbA1c, compared with the BGM group, the CGM group had 14% greater increase in TIR for participants with baseline HbA1c ≥8.5%, 14% greater increase for baseline HbA1c ≥9.0%, 22% greater increase for baseline HbA1c ≥9.5%, and 32% greater increase for baseline HbA1c ≥10.0% (P-value for interaction = 0.27). The time spent with glucose >250 mg/dL was significantly lower with CGM compared with BGM among participants with higher HbA1c values (P for interaction = 0.004). Results in subgroups based on baseline TIR paralleled the results in subgroups based on baseline HbA1c.Conclusion:While the benefit of CGM on TIR among patients with type 2 diabetes treated with basal insulin is apparent across the range of baseline glycemic control, the greatest impact of CGM is in those with the worst baseline glycemic control, particularly among those with HbA1c ≥10%.Clinical Trial Registration number: NCT03566693.

Telemetric Continuous Glucose Monitoring During the COVID-19 Pandemic in Isolated Hospitalized Patients in Denmark: A Randomized Controlled Exploratory Trial.

Objective: To investigate whether telemetric continuous glucose monitoring (CGM) in hospitalized and isolated patients with diabetes mellitus and coronavirus disease 2019 (COVID-19) is associated with better glycemic outcomes and fewer patient health care worker contacts compared to blood glucose monitoring by traditional point-of-care (POC) glucose testing and to investigate the user aspect of implementing a CGM-system in-hospital. Materials and Methods: A randomized controlled exploratory trial was performed on hospitalized and isolated patients with diabetes and COVID-19 from May 2020 until February 2021 at Nordsjællands Hospital, Denmark. Participants were randomized to nonblinded telemetric CGM (as the only glucose monitoring method) or traditional POC glucose testing + blinded CGM. The primary endpoint was time in range (TIR) based on CGM data in both groups. A questionnaire about the user aspect of the CGM system was answered by health care personnel (HCP). Results: We included 64 participants in the analysis, 31 in the CGM group and 33 in the POC glucose group. TIR median was 46% for the CGM group and 68% for the POC glucose group (P = 0.368). The mean glucose value for the CGM group was 11.1 and 10.8 mmol/L in the POC glucose group (P = 0.372). CGM was associated with fewer POC glucose measurements (P < 0.001). Out of 30 HCPs, 28 preferred telemetric CGM over POC glucose testing. Conclusion: Remote glucose monitoring by CGM did not improve glycemic outcomes compared to traditional POC glucose testing, but was associated with fewer patient-personnel contacts, saving time for HCPs performing diabetes-related tasks. Most HCPs preferred CGM. The study is registered at http://www.clinicaltrials.gov (#NCT04430608).

Randomized comparison of self-monitored blood glucose (BGM) versus continuous glucose monitoring (CGM) data to optimize glucose control in type 2 diabetes

AimsEvaluate whether structured BGM testing (BGM) or real-time CGM (CGM) lead to improved glucose control (A1c). Determine which approach optimized glucose control more effectively. Methods—multi-arm paralleltrial of three type 2 diabetes (T2D) therapies ± metformin: (1) sulfonylurea (SU), (2) incretin (DPP4 inhibitor or GLP-1 agonist), or (3) insulin. After a baseline CGM, 114 adult subjects were randomized to either BGM (4 times daily) or CGM (24/7) for 16 weeks with therapies adjusted every 4 weeks. ResultsA1c means decreased from 8.19 to 7.07 (1.12% difference) with CGM (n = 59) and 7.85 to 7.03 (0.82% difference) with BGM (n = 55) (p < 0.001). BGM and CGM groups showed significant improvements in time in range and glucose variability—with no significant difference between the two groups. Clinically important hypoglycemia (<50 mg/dL) was significantly reduced for the CGM group compared with BGM (p < 0.01), particularly in subjects taking insulin or therapies with higher hypoglycemic risk (SU). ConclusionIn T2D, structured, consistent use of glucose data regardless of device (structured BGM or CGM) leads to improvements in A1c control. CGM is more effective than BGM in minimizing hypoglycemia particularly for those using higher hypoglycemic risk therapies.

Effectiveness of Continuous Glucose Monitoring in Older Adults with Type 2 Diabetes Treated with Basal Insulin.

Objective: To evaluate the effectiveness and safety of real-time continuous glucose monitoring (CGM) in adults 65 years old and older with type 2 diabetes (T2D) using basal without bolus insulin. Research Design and Methods: Using data from the MOBILE randomized trial comparing CGM versus blood glucose meter (BGM) monitoring for T2D treated with basal insulin, the treatment effect in participants ≥65 years (range: 65-79 years, N = 42) was compared with the treatment effect in participants <65 years (range: 33-64 years, N = 133). Results: For participants ≥65 years old, mean change in hemoglobin A1c (HbA1c) was -1.08% in the CGM group and -0.38% in the BGM group (adjusted mean difference = -0.65% [95% confidence interval (CI) -1.49 to 0.19]). In contrast, the adjusted mean difference in HbA1c between treatment groups was -0.35% [95% CI -0.77 to 0.07] in the <65 years age group. For time in range 70-180 mg/dL (TIR), mean adjusted treatment group difference was 19% (95% CI 4 to 35, P = 0.01) in ≥65 years old participants and 12% (95% CI 4 to 19, P = 0.003) in those <65 years old. Comparable treatment group differences favoring the CGM group were observed in both the ≥65 and <65 years age groups for mean glucose and less time >180, 250, and 300 mg/dL. Hypoglycemia was low in both groups with little difference between treatment groups in both age groups. Conclusions: In this study of adults with T2D treated with basal insulin without bolus insulin, participants ≥65 years old using CGM had a greater increase in TIR and a reduction in hyperglycemia than those using BGM and the benefit appeared to be at least as great as that observed in younger adults.

Continuous glucose monitoring for the prevention of morbidity and mortality in preterm infants.

Preterm infants are susceptible to hyperglycaemia and hypoglycaemia, which may lead to adverse neurodevelopment. The use of continuous glucose monitoring (CGM) devicesmight help in keeping glucose levels in the normal range, and reduce the need for blood sampling. However, the use of CGM might be associated with harms in the preterm infant. To assess the benefits and harms of CGM versus intermittent modalities to measure glycaemia in preterm infants 1. at risk of hypoglycaemia or hyperglycaemia; 2. with proven hypoglycaemia; or 3. with proven hyperglycaemia. We searched CENTRAL (2021, Issue 4); PubMed; Embase; and CINAHL in April2021. We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomized controlled trials (RCTs) and quasi-RCTs. We included RCTs and quasi-RCTs comparing the use of CGM versus intermittent modalities to measure glycaemia in preterm infants at risk of hypoglycaemia or hyperglycaemia; with proven hypoglycaemia; or with proven hyperglycaemia. We assessed the methodological quality of included trials using Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria (assessing randomization, blinding, loss to follow-up, and handling of outcome data). We evaluated treatment effects using a fixed-effect model with risk ratio (RR) with 95% confidence intervals (CI) for categorical data and mean, standard deviation (SD), and mean difference (MD) for continuous data. We used the GRADE approach to assess the certainty of the evidence. We included four trials enrolling 300infants in our updated review. We included one new study and excluded another previously included study (because the inclusion criteria of the review have been narrowed). Wecomparedthe use ofCGM to intermittent modalities in preterm infantsat risk of hypoglycaemia or hyperglycaemia; however, one of these trialswas analyzedseparately because CGMwas used as a standalone device, without being coupled to a control algorithm as in the other trials.We identified no studies in preterm infants with provenhypoglycaemia orhyperglycaemia. None of the four included trials reported the neurodevelopmental outcome (i.e. the primary outcome of this review), or seizures. The effect of the use of CGM on mortality during hospitalization is uncertain (RR 0.59,95% CI 0.16 to 2.13; RD -0.02, 95% CI -0.07to 0.03; 230 participants; 2studies; very low-certainty evidence). The certaintyof the evidence was very low for all outcomesbecause of limitations in study design, and imprecision of estimates. One studyisongoing (estimated sample size 60 infants) and planned to be completed in 2022. There is insufficient evidence to determine if CGM affects preterm infant mortality or morbidities. We are very uncertain of the safety of CGM and the available management algorithms, and many morbidities remain unreported. Preterminfants at risk of hypoglycaemia or hyperglycaemiawere enrolled in all four included studies. No studies have been conducted in preterm infants with provenhypoglycaemia orhyperglycaemia. Long-term outcomeswerenot reported.Events of necrotizing enterocolitis,reported in the study published in 2021, were lower in the CGM group. However, the effect of CGM on this outcome remains very uncertain. Clinical trials are required to determine the most effective CGM and glycaemic management regimens in preterm infants before larger studies can be performed to assess the efficacy of CGM for reducing mortality, morbidity, and long-term neurodevelopmental impairments.

Continuous glucose monitoring in extremely preterm infants in intensive care: the REACT RCT and pilot study of ‘closed-loop’ technology

BackgroundHyperglycaemia and hypoglycaemia are common in preterm infants and are associated with increased mortality and morbidity. Continuous glucose monitoring is widely used to target glucose control in adults and children, but not in neonates.ObjectiveTo evaluate the role of continuous glucose monitoring in the preterm infant.DesignThe REAl-time Continuous glucose moniToring in neonatal intensive care project combined (1) a feasibility study, (2) a multicentre randomised controlled trial and (3) a pilot of ‘closed-loop’ continuous glucose monitoring. The feasibility study comprised a single-centre study (n = 20). Eligibility criteria included a birthweight ≤ 1200 g and aged ≤ 48 hours. Continuous glucose monitoring was initiated to support glucose control. The efficacy and safety outcomes guided the design of the randomised controlled trial. The randomised controlled trial comprised a European multicentre trial (n = 182). Eligibility criteria included birthweight ≤ 1200 g and aged ≤ 24 hours. Exclusion criteria included any lethal congenital abnormality. Continuous glucose monitoring was initiated to support glucose control within 24 hours of birth. In the intervention group, the continuous glucose monitoring sensor provided real-time data on glucose levels, which guided clinical management. In control infants, the continuous glucose monitoring data were masked, and glucose level was managed in accordance with standard clinical practice and based on the blood glucose levels. The primary outcome measure was the percentage of time during which the sensor glucose level was within the target range of 2.6–10 mmol/l. Secondary outcome measures included mean sensor glucose level, the percentage of time during which the sensor glucose level was within the target range of 4–8 mmol/l, the percentage of time during which the sensor glucose level was in the hyperglycaemic range (i.e. &gt; 15 mmol/l) and sensor glucose level variability. Safety outcomes included hypoglycaemia exposure. Acceptability assessment and health economic analyses were carried out and further exploratory health outcomes were explored. The mean percentage of time in glucose target range of 2.6–10 mmol/l was 9% higher in infants in the continuous glucose monitoring group (95% confidence interval 3% to 14%;p = 0.002), and the mean time in the target range of 4–8 mmol/l was 12% higher in this group (95% confidence interval 4% to 19%;p = 0.004). There was no difference in the number of episodes of hypoglycaemia. Exploratory outcomes showed a reduced risk of necrotising enterocolitis in the intervention arm (odds ratio 0.33, 95% confidence interval 0.13 to 0.78;p = 0.01). Health economic analyses demonstrated that continuous glucose monitoring was cost-effective on the basis of the cost per additional case of adequate glucose control between 2.6 and 10 mmol/l. The ‘closed-loop’ study was a single-center pilot study, with eligibility criteria including a birthweight of ≤ 1200 g and aged ≤ 48 hours. Infants underwent continuous glucose monitoring for the first week of life (n = 21), with those in the intervention group receiving closed-loop insulin delivery between 48 and 72 hours of age. The primary outcome of percentage of time in the target range (i.e. sensor glucose 4–8 mmol/l) increased from a median of 26% (interquartile range 6–64%) to 91% (interquartile range 78–99%) during closed-loop insulin delivery (p &lt; 0.001).LimitationsThese studies have not defined the optimal targets for glucose control or the best strategies to achieve them in these infants.Future workStudies are needed to evaluate the longer-term impact of targeting glucose control on clinical outcomes.ConclusionsContinuous glucose monitoring in extremely preterm infants can improve glucose control, with closed-loop insulin delivery having further potential to target glucose levels. Staff and parents felt that the use of continuous glucose monitoring improved care and the results of the health economic evaluation favours the use of continuous glucose monitoring.Trial registrationCurrent Controlled Trials ISRCTN12793535.FundingThis project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and National Institute for Health Research (NIHR) partnership. This will be published in full inEfficacy and Mechanism Evaluation; Vol. 8, No. 16. See the NIHR Journals Library website for further project information. Medtronic plc provided some MiniMed™ 640G systems and Nova Biomedical (Waltham, MA, USA) provided point-of-care devices.