bluuebunny/crossref_metadata_2025 huggingface dataset:
857-P: Attitudes of Physicians to Chances, Risks, and Future Options Regarding Digitalization and New Technologies in Diabetes
Authors: KULZER BERNHARD , HERMANNS NORBERT , EHRMANN DOMINIC , HEINEMANN LUTZ
Published: June 2020

There are few results on physicians’ attitudes towards digitalization and new technologies in diabetes care. In this study we asked diabetologists in Germany about their attitudes regarding digitalization and new technologies in diabetes care. A total of 326 physicians completed the survey (42,6% female; mean age: 52.2 years). Per facility, 243 people with diabetes used Flash sensor-based glucose monitoring (iscCGM), 69 used real-time continuous glucose monitoring (RCGM), and 86 used CSII. 76% of physicians reported a positive or very positive attitude towards digitalization in diabetes care and 76% of physicians rated the potential of digitalization to improve diabetes therapy as large to very large. Major advantages of digitalization referred to better communication with the patient (71.6%), decision support with therapy decisions (66.8%) and more empowerment for patients (62.3%). The three major barriers were unclear payment of digital services (80.0%), legal issues (50.3%), and high investment costs (46.5%). Currently, the most important topics are software for the analysis of glucose data (rank 1) better compatibility of different systems (rank 2) and AID-Systems (rank 3). The current and gain of importance withnin the next 5 years (in brackets) is assessed as follows: Software for the analysis of glucose data 72,3% (+15,9%); AID-Systems 22,9% (+58,6%); Apps (26,7% (+41,8%); Telemedicine 9,6% (+37,7%).

In summary, most physicians have a very positive attitude toward digitalization and perceive the potential of digitization as very high. Especially the importance of AID systems will increase. For the actual implementation in clinical routine, however, it is also important to consider the barriers described by diabetologists.

Disclosure

B. Kulzer: Research Support; Self; Abbott, AstraZeneca, Berlin-Chemie AG, Roche Diabetes Care. Speaker’s Bureau; Self; Abbott, Ascensia Diabetes Care, Berlin-Chemie AG, Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Roche Diabetes Care. N. Hermanns: Advisory Panel; Self; Roche Diabetes Care. Research Support; Self; Abbott, AstraZeneca, Berlin-Chemie AG. D. Ehrmann: Speaker’s Bureau; Self; Abbott, Berlin-Chemie AG, Glooko, Inc. Other Relationship; Self; Dexcom, Inc., Roche Diabetes Care. L. Heinemann: Consultant; Self; Becton, Dickinson and Company, LifeCare, Inc., Roche Diabetes Care. Stock/Shareholder; Self; Profil Institute for Clinical Research.

Funding

Berlin-Chemie AG
858-P: Different Attitudes of Physicians, Parents of Children with Diabetes, and People with Diabetes towards Digitization in Diabetes
Authors: KULZER BERNHARD , HERMANNS NORBERT , EHRMANN DOMINIC , HEINEMANN LUTZ
Published: June 2020

Digitalization has an increasing relevance in diabetes care. However, little is known if attitudes towards digitalization in diabetes care differ between people with diabetes (PWD) and health care professionals (HCP). As part of the annual digitalization report an online survey about the attitudes towards digitalization was completed by 3,427 PWD (PWDT1: 65,6%, ParentsT1:8.1%, PWDT2 25,5%) and 326 HCP. Attitudes towards digitalization were most positive in ParentsT1 (89,5%), PWD1T (85,3) rated it as very important) followed by HCP (75.3) and PWD2T (74.0%; p <0.01). Software for analyzing glucose data was found most important by HCP (72% rated it as one of the three most important issues) whereas PWD rated its importance significantly lower (51.3% PWD1T; 47.0 PWD2T, p<.01). Interestingly were Diabetes Apps only perceived as important by a minority (HCP: 23.1%; PWD1T: 30.8%; PWD2T 32.9%). Online education was found most relevant in PWD2T (32.6%), whereas PWD1T (17.8%) or HCP (13.8%) were less enthusiastic (p<.01). Closed loop systems were rated as very important by 63,3% of ParentsT1, 65.6% of PWD1T, whereas only 41.7% of HCP rated them as relevant. In type 2 diabetes closed loop systems were less important (18.9%; p<.0.05). Interestingly attitudes towards digitalization differ considerably between HCP and PWD. HCP perceived glucose-analysis-software as most relevant, whereas enthusiasm in PWD was less pronounced. Relevance of diabetes APPS were rated as surprisingly low in all groups. Closed loop systems are of special interest in PWD1T, whereas HCP were remarkably HCPs less enthusiastic.

Disclosure

B. Kulzer: Research Support; Self; Abbott, AstraZeneca, Berlin-Chemie AG, Roche Diabetes Care. Speaker’s Bureau; Self; Abbott, Ascensia Diabetes Care, Berlin-Chemie AG, Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Roche Diabetes Care. N. Hermanns: Advisory Panel; Self; Roche Diabetes Care. Research Support; Self; Abbott, AstraZeneca, Berlin-Chemie AG. D. Ehrmann: Speaker’s Bureau; Self; Abbott, Berlin-Chemie AG, Glooko, Inc. Other Relationship; Self; Dexcom, Inc., Roche Diabetes Care. L. Heinemann: Consultant; Self; Becton, Dickinson and Company, LifeCare, Inc., Roche Diabetes Care. Stock/Shareholder; Self; Profil Institute for Clinical Research.

Funding

Berlin-Chemie AG
86-LB: Accuracy of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring (CGM) System during Elective Abdominal Surgery
Authors: TRIPYLA AFRODITI , HERZIG DAVID , NAKAS CHRISTOS , DEHAIS JOACHIM , ANDREOU ANDREAS , AMIET FRANZISKA , GLOOR BEAT , VOGT ANDREAS , BALLY LIA
Published: June 2020

Aim: To assess the accuracy of the Dexcom G6 CGM system during elective abdominal surgery.

Methods: Twenty adults with (pre-)diabetes scheduled for abdominal surgery (>2h) (5 females, age 69±13 yrs, BMI 27.3±6.6 kg/m2, HbA1c 7.0±1.3%) wore the Dexcom G6 sensor from 7±2 days preoperatively until hospital discharge. Reference capillary glucose values were obtained every 20min from induction of anaesthesia until 2h post-surgery using the Accu-Chek® Inform II meter. The primary endpoint was the mean absolute relative difference (ARD) between sensor and reference method.

Results: Mean±SD operating time was 306±170min and included pancreas/liver (45%), upper GI (10%), lower GI (40%) and kidney (5%) surgeries. The mean±SD and median [interquartile range] ARD of 523 paired CGM/reference values were 12.7±8.7% and 10.4% [4.3%, 19.7%], respectively. A total of 99.4% pairs were in Clarke error grid Zones A or B (A, 76.5%, B 22.9%, Figure 1). Overall, 65.8% of sensor readings were within the limits specified by the ISO 15197:2013 norm. Sensor readings were available for 98.6% [95.9%, 100%] of the perioperative time. Intraoperative sensor replacement was required in one instance. There were no adverse device effects.

Conclusion: Perioperative use of the Dexcom G6 system showed satisfying accuracy, opening new avenues for perioperative diabetes care.

Disclosure

A. Tripyla: None. D. Herzig: None. C. Nakas: None. J. Dehais: None. A. Andreou: None. F. Amiet: None. B. Gloor: None. A. Vogt: None. L. Bally: None.

Funding

Dexcom, Inc. (HOS-2019-005)
861-P: Glycemic Improvements following Mobile-Enabled Remote Patient Monitoring: A Randomized Control Study
Authors: SHENG TONG , PARKS LINDA , BABIKIAN SARINE , SINGH VIKRAM , GREENFIELD MICHAEL , CLEMENTS MARK A.
Published: June 2020

Mobile-enabled remote patient monitoring (RPM) may improve glycemic outcomes for people with diabetes. In the current study, we randomized persons with type 2 diabetes (PWT2D) with baseline HbA1c between 7.5% - 12.5% into either a mobile app-enabled RPM group or a control group without RPM. Participants in the RPM group were remotely monitored on a weekly basis for glycemic events and SMBG check behaviors and received telephonic coaching as needed between quarterly clinic visits. The control group received coaching only during quarterly clinic visits. In this interim analysis, we assessed HbA1c at baseline and at 3 months for both groups. Cohort characteristics for participants completing both study visits (RPM n = 80; control n = 82) included median age 60 years [IQR: 52 - 67], 48.1% female, 73.4% non-Hispanic White, 67.3% on insulin, median duration of diabetes 14 years [IQR: 9 - 20], and median baseline HbA1c of 8.4% [IQR: 7.9 - 8.9]. We observed improvements in HbA1c after 3 months in both the RPM and control groups (-0.7% [IQR: -1.0 - -.2] and -0.3% [IQR: -.8 - -.1]; both Ps < .005, respectively). The improvement in HbA1c was greater in the RPM group (T = 2.47; P = .015). Among participants with baseline HbA1c ≥ 8.5%, the RPM group improved by -1.1% [IQR: -1.9 - -.4] while the control group improved by -.4% [IQR: -.8 - .3] (T = 2.63; P = .01). In the current study, we found that mobile-enabled RPM with telephonic coaching led to significantly improved HbA1c in 3 months. The HbA1c improvement was greater for PWT2D with higher baseline HbA1c, consistent with previous literature. These findings demonstrate the short-term efficacy of mobile-enabled RPM. Diabetes care teams can assist mid-life and older adults with T2D to achieve significant improvements in glycemic control via use of a mobile self-management app along with recurring short telephonic coaching sessions.

Disclosure

T. Sheng: Employee; Self; Glooko, Inc. L. Parks: Employee; Self; Glooko, Inc. S. Babikian: Employee; Self; Glooko, Inc. V. Singh: Employee; Self; Glooko, Inc. M. Greenfield: Consultant; Self; Glooko, Inc. M.A. Clements: Consultant; Self; Glooko, Inc. Other Relationship; Self; Glooko, Inc.
864-P: Hyperglycemia Drives Glycemic Variability in Patients with Type 2 Diabetes (T2DM)
Authors: OLAWSKY EVAN A. , ZHANG YUAN , ALVEAR ALISON C. , EBERLY LYNN E. , CHOW LISA S.
Published: June 2020

We performed quantified glycemic variability using continuous glucose monitoring (CGM) in people with T2DM at high (n=10) or low (n=8) 5-year risk for hypoglycemia to examine if high 5 year risk for hypoglycemia was associated with more short-term (2 weeks) glycemic variability and hypoglycemia.

Methods: Participants with T2DM [10W/8M, mean(SD): age: 59.5 (12.3) years], HbA1c: 7.6% (1.3%), fructosamine: 303 (46) umol/l] were preclassified as high or low 5 year risk for hypoglycemia. Each participant wore 2 blinded CGMs (1 Freestyle LibrePro/arm) for 2 weeks.

Results: HbA1c and fructosamine did not differ between groups. (Table1) The test/retest coefficient of variation (CV) measures the variation between glucose variability metrics from two sensors on the same person, adjusted for the mean of a given metric. The 2 sensors had the strongest test-re-test (<0.1) for CV, SD, Mean, and MODD. In both the high and low risk group, HbA1c correlated with glycemic measures (r:0.4 to 0.7). In the low risk group, fructosamine (r:0.6 to 0.9) correlated with glycemic measures better than HbA1c.

Conclusions: Regardless of 5 year risk status, short-term hypoglycemia was infrequent and not different between groups. Hba1c and fructosamine correlated with glycemic variability. Glycemic variability was less in the low risk than high risk group, supporting that high glucose (≥180 mg/dL) drives much of the glycemic variability in T2DM.

Disclosure

E.A. Olawsky: None. Y. Zhang: None. A.C. Alvear: None. L.E. Eberly: None. L.S. Chow: None.

Funding

Academic Health Center (FRD17.08); National Institutes of Health (UL1TR002494)
867-P: Ongoing Manufacturer-Led Clinical Surveillance of Two Blood Glucose Monitoring Test Strip Systems
Authors: SETFORD STEVEN J. , KATZ LAURENCE B. , GRADY MIKE , MACLEOD KIRSTY , CAMERON HILARY
Published: June 2020

There are no requirements for manufacturers of blood glucose monitoring systems (BGMS) to ensure their products continue to meet accuracy claims post-launch. Reported here is an on-going manufacturer-initiated clinical surveillance programme for two globally distributed BGMS: OneTouch Verio and OneTouch Select Plus, launched in 2009 and 2015 respectively.

Test strip batches were randomly and routinely sampled from the manufacturer’s (LifeScan Inc.) finished product and tested in clinic using capillary blood from subjects with diabetes (testing performed by professional staff). BGMS accuracy was determined against a reference instrument (results in Table). A small number of ’control’ batches were also sent to clinic on a repeat basis for on-going assessment of test variability (data not included in analysis).

Both products met clinical accuracy requirements for all years as defined by EN ISO 15197:2015 (min. 95% of all BGMS values within ±15 mg/dL of reference at blood glucose (BG) <100 mg/dL or ±15% at BG ≥100 mg/dL). Furthermore, the OneTouch Verio product, available in U.S. markets, met the clinical accuracy criterion as proposed in current FDA guidance (min. 95% of all BGMS values within ±15% of reference at all BG levels).

The manufacturer advocates that all manufacturers of glucose monitoring systems for diabetes patients adopt and maintain a similarly robust surveillance program.

Disclosure

S.J. Setford: Employee; Self; LifeScan Scotland. L.B. Katz: Employee; Self; LifeScan, Inc. M. Grady: Employee; Self; LifeScan, Inc. K. Macleod: Employee; Self; LifeScan Scotland. H. Cameron: None.
874-P: Variation of Measured HbA1c from Predicted HbA1c on Freestyle Libre
Authors: MUTHABATHULA JAYASRI , GRIXTI LYDIA , FLETCHER-SALT TAMSIN , NAYAK ANANTH U.
Published: June 2020

Aims/objectives: To explore the variation of the predicted HbA1c in the Free Style Libre (FSL) flash glucose monitoring from the simultaneous measured laboratory HbA1c (IFCC) value.

Methods: We included all patients (n=114) with adequate data on FSL download who also had HbA1c estimation in the biochemistry laboratory as a part of follow-up review after FSL initiation for glycaemia management in diabetes. The date of measured HbA1c estimation was used in the FSL download to obtain a predicted HbA1c (2 months data download). The difference between the measured HbA1c and predicted HbA1c was calculated to obtain the variation between the two.

Results: The measured HbA1c prior to and post FSL initiation were 68.2±15.1 and 59.9±1.2 mmol/mol respectively, i.e the HbA1c improved by mean 8.3 mmol/mol (std. error 0.99) (P<0.001, paired sample t-test). The mean time duration between the pre and follow-up HbA1c estimations was 5.3±1.9 months. The predicted HbA1c on FSL download at follow-up was 61.8±10.1 mmol/mol. The correlation between the mean blood glucose on FSL and predicted HbA1c was significant (r=0.999) which would be expected as the predicted HbA1c was calculated from mean glucose in FSL. There was a significant correlation between measured HbA1c and predicted HbA1c was (r=0.86, P<0.001) The difference between the measured and predicted HbA1c was minus 2.3±7.2 mmol/mol with a wide range (minus 35 to +12 mmol/mol) with the difference being clinical significant (>10 mmol/mol difference) in 18.4% of the cohort.

Conclusions: This study confirms the variation of the measured HbA1c from that predicted from FSL flash glucose download data could be clinically significant in about a fifth of individuals. Variety of factors could contribute to such variation and may have clinical implications while managing individuals with diabetes.

Disclosure

J. Muthabathula: None. L. Grixti: None. T. Fletcher-Salt: None. A.U. Nayak: None.
875-P: Utilization of Continuous Glucose Monitors Is Associated with Reduction in Inpatient and Outpatient Emergency Acute Diabetes Events Regardless of Prior Blood Test Strip Usage
Authors: HIRSCH IRL B. , KERR MATTHEW S.D. , ROBERTS GREGORY J. , SOUTO DIANA , NABUTOVSKY YELENA , BERGENSTAL RICHARD M.
Published: June 2020

Despite its potential benefits, access to continuous glucose monitors (CGMs) is often restricted based on blood glucose monitoring frequency. We aim to study if CGM efficacy depends on blood test strip (TS) usage prior to CGM initiation.

IBM MarketScan™ Commercial Claims and Medicare Supplemental databases were used in this retrospective, observational analysis. MarketScan contains insurance billing claims for inpatient, outpatient and pharmacy expenses. Cohort requirements included: de novo CGM purchase in 2017 Q1-2018 Q2, type 1 or type 2 diabetes, ≥18 years old, fast- or short-acting insulin, ≥ 6-months pre-CGM observation time. Blood TS usage was determined based on purchases 6 months pre-CGM. Primary outcome was acute diabetes events (ADE): hospitalization with hyper-/hypoglycemia as the primary diagnosis or outpatient emergency associated with a code of hyper-/hypoglycemia. Andersen-Gill Cox regression compared event rates 6-months pre-/post-CGM.

The cohort (n=12,521, age 43.8±15.2 years, 50.8% male, 77% type 1) experienced a reduction in ADE from 0.245 to 0.132 events/patient-year (HR: 0.54 [0.49 0.59]; P:<0.001). A similar reduction was seen in patients using <4 and ≥4 TS per day. A reduction was seen in all TS usage groups.

Initiation of CGM use was associated with reduced ADE regardless of baseline blood TS usage.

Disclosure

I.B. Hirsch: Consultant; Self; Abbott, Bigfoot Biomedical, Roche Diabetes Care. Research Support; Self; Medtronic, Omnipod. M.S.D. Kerr: Employee; Self; Abbott. G.J. Roberts: Employee; Self; Abbott. D. Souto: Employee; Self; Abbott. Y. Nabutovsky: Employee; Self; Abbott. R.M. Bergenstal: Consultant; Self; Ascensia Diabetes Care, Johnson & Johnson. Other Relationship; Self; Abbott, Dexcom, Inc., Hygieia, Lilly Diabetes, Medtronic, Novo Nordisk A/S, Onduo, Roche Diabetes Care, Sanofi, UnitedHealth Group.
88-OR: Glyoxalase-1 Gene Transfer Attenuated Diastolic Dysfunction in Female db/db Mice
Authors: BIDASEE KESHORE
Published: June 2020

Background: More than 25% of middle-aged people living with diabetes mellitus (DM) have myocardial dysfunction including early onset diastolic dysfunction (DD), harbingers for symptomatic heart failure and frequent hospitalizations. This DD which is more prevalent in females than in males is associated with increased systemic inflammation, coronary microvascular dysfunction, myocardial fibrosis/stiffness and ischemia. Here we show using the db/db mouse model of DM that the diverse pathobiologies associated with DD are originating from accumulation of the glycolysis by-product, methylglyoxal (MG) arising from inflammation-induced downregulation of the MG-degrading enzyme glyoxalase-1 (Glo1).

Methods/Results: At six month of age, female db/db mice developed degree I-II DD, with increases in E:e’ ratio, and isovolumetric relaxation time. Speckle tracking analyses also indicated increased global longitudinal and circumferential strains. Histopathological analyses of ex vivo hearts showed increased amounts of the inflammation-induced protein vascular adhesion protein-1 (VAP-1), reduced level of Glo1, increased MG and the MG-adduct, MG-H1, microvascular leakage, micro-ischemia and fibrosis. Time to decay of myocytes evoked Ca2+ transient was also increased. Administration of a single injection of an engineered adeno-associated virus that uses the promoter of an inflammation-induced protein, endothelin-1 (AAV2/9-Endo-Glo1) to express Glo1 in hearts of three months db/db mice, attenuate coronary microvascular leakage, ischemia, fibrosis and myocardial and myocyte dysfunction, establishing a cause-effect relationship between MG accumulation and myocardial dysfunction in db/db mice.

Conclusions: These new data implicates accumulation of MG as a contributing cause of myocardial dysfunction type 2 DM. They also show that an AAV driven by the promoter of an inflammation-induced protein to express Glo1 in hearts of db/db mice can successfully attenuate DD.

Disclosure

K. Bidasee: None.
882-P: Resolution of Hypoglycemia Using CGM Data
Authors: NORLANDER LISA M. , SATAM KEYUREE , HANES SARAH , BUCKINGHAM BRUCE A.
Published: June 2020

Background: Continuous glucose monitors (CGM) are the new standard for detecting hypoglycemia in T1D. No guidelines have been published that address monitoring during the return to euglycemia.

Methods: CGM data was gathered from 50 children and adolescents (ages 7-17) attending a week-long diabetes camp. All campers were treated according to camp protocol with 10-20g of carbohydrates depending on the size of the child and severity of hypoglycemia.

Results: 241 hypoglycemic events were analyzed using CGM data. 57 events had a nadir <54 mg/dl and 184 were 54 to <70 mg/dl. When measuring 15 min from the nadir, 89% of the <70 mg/dl group had risen above 70 mg/dl vs. only 47% of the <54 mg/dl group. During the day, a nadir <54 mg/dl took an average of 19 min to return to >70 mg/dl vs. 27 min at night. Nadirs <70 mg/dl took an average of 11 min during the day and 12 min at night to return to >70 mg/dl. Duration of hypoglycemia for nadirs <54 mg/dl vs. <70 mg/dl averaged 40 min vs. 18 min. Mean duration of hypoglycemia for the <54 mg/dl group was 35 min during the day vs. 49 min at night. Mean duration of hypoglycemia for the <70 mg/dl group was 18 min during the day and 20 min at night.

Conclusion: The depth of CGM hypoglycemia can help guide when to obtain a meter BG when treating hypoglycemia. If the glucose is <70 but >54 mg/dl, 89% will resolve within 15 min of the nadir; however less than 50% of those <54 mg/dl will have responded by 15 min and should have a meter BG if sensor is not >70 mg/dl at 15 min.

Disclosure

L.M. Norlander: None. K. Satam: None. S. Hanes: None. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Medtronic. Research Support; Self; Beta Bionics, Inc., Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care.
89-OR: FGFR1/MAPKs/AP-1 Signaling Mediates Cardiomyopathy in Streptozotocin-Induced Type 1 Diabetes
Authors: CHEN XIONG , WANG YAFENG , SHEN FEIXIA
Published: June 2020

Diabetic cardiomyopathy is a complex entity associated with multiple contributing mechanisms and consequent manifestations in the clinic. Emerging evidence implicates that increased activity of fibroblast growth factor receptor 1 (FGFR1) is required during induced cardiac damage and remodeling. However, little is known about the roles of FGFR1 on diabetic cardiomyopathy (DCM). We hypothesized that the high-concentration glucose (HG)/diabetes induced cardiac pathophysiological and malfunctional alterations are linked to the activation of FGFR1. We tested this hypothesis by challenging cultured cardiomyocytes with high-concentration glucose and myocardium of streptozotocin (STZ)-induced type 1 diabetic mice (T1D). This study indicated that FGFR1 phosphorylation was increased in myocardium of streptozotocin (STZ)-induced type 1 diabetic mice (T1D) and cultured cardiomyocytes to high-concentration glucose. The inactivation of FGFR1 by selective inhibitors AZD4547, neutralized the increased FGFR1 phosphorylation and significantly reduced myocardial structural and functional deficits in type 1 diabetic mice. In vitro, overexpression of FGFR1 by lentivirus-transfection aggravated HG-induced fibrosis and hypertrophy in cardiomyocytes. Blocking FGFR1 by AZD4547 or CRISPER-Cas9 knockout, HG-induced fibrosis and hypertrophy in cardiomyocytes were significantly decreased. Then, GSEA analysis of RNA-sequencing implied that collagen5a1(Col5a1) and periostin (Postn) were associated with fibrosis and myosin heavy chain 4/7/8/9 (Myh4/7/8/9) were associated with hypertrophy. Analysis by PASTAA database and confirmatory tests by inhibiting FGFR1 or MAPKs indicated that MAPKs/AP-1 plays a crucial role in FGkFR1-mediated cardiomyocyte injuries challenged by HG. These results reveal an unrecognized FGFR1/MAPKs/AP-1 signaling axis involved in the development and progression of DCM and suggest that AZD4547 might be a potential agent for treating DCM.

Disclosure

X. Chen: None. Y. Wang: None. F. Shen: None.

Funding

National Natural Science Foundation of China (81700335)
890-P: Durability of Continuous Glucose Monitoring (CGM) Use in Young Children, Teens, and Young Adults with Type 1 Diabetes (T1D)
Authors: DESALVO DANIEL , KANAPKA LAUREN , BAUZA COLLEEN , XIE CICILYN , DIMEGLIO LINDA , LAFFEL LORI M. , MILLER KELLEE
Published: June 2020

Use of CGM can optimize glycemic control; however, consistency of CGM use in youth and teens/young adults with T1D has been low in prior studies. We assessed 1-year use of Dexcom CGM in young children (ages 2 to <8y) in the Strategies to Enhance New CGM in Early Childhood (SENCE) study and in teens/young adults (ages 14 to <25y) in the CGM Intervention in Teens and Young Adults (CITY) study. Analyses included average # of days/week and percent of CGM wear time over 4 weeks prior to 6 and 12-month study visits. CGM use data from month 6 and 12 months are shown in the Table. For 84 youth in SENCE, median # days/week of CGM use was 7.0 with CGM being used 92% of time at 12 months; 79% were using CGM 7 days/week and only 2% discontinued CGM altogether. In 70 teens/young adults in CITY, median # of days/week of CGM use was 6.8, with CGM being used 86% of time at 12 months; 46% were using CGM 7 days/week and 9% discontinued CGM. At 12 months 88% of SENCE participants and 97% of CITY participants using CGM reported dosing insulin with CGM without using confirmatory fingerstick blood glucose value; 54% and 55%, respectively used remote monitoring features. CGM use in cohorts of very young children, teens and young adults was higher than previously reported. Improved CGM features, including mobile app data display, remote monitoring and non-adjunctive approval for dosing insulin, likely contributed to increased use.

Disclosure

D. DeSalvo: Consultant; Self; Dexcom, Inc., Insulet Corporation. L. Kanapka: None. C. Bauza: None. C. Xie: None. L. DiMeglio: None. L.M. Laffel: Advisory Panel; Self; Roche Diabetes Care. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Insulogic LLC, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk Inc., Sanofi US. K. Miller: None.

Funding

The Leona M. and Harry B. Helmsley Charitable Trust; Dexcom, Inc.
892-P: Comparison of Dexcom G6 CGM with Self-Monitoring Blood Glucose in Young Adults with Type 1 Diabetes: The Millennial Study
Authors: THABIT HOOD , MUBITA WOMBA M. , FULLWOOD CATHERINE , AZMI SHAZLI , URWIN ANDREA , DOUGHTY IAN M. , LEELARATHNA LALANTHA , PAUL-PRABHU JOSHI
Published: June 2020

Improving glycaemic control in young people with type 1 diabetes (T1D) remains challenging. No study has specifically evaluated efficacy and usability of DexCom G6 CGM in this cohort. Adolescents and young adults with T1D (age 16 to 25 years old) on multiple daily insulin injections (MDI) or insulin pump therapy (CSII) were recruited into an 8-week, open-label, randomised, crossover design clinical trial. Participants monitored daily glucose levels either with DexCom G6 CGM or self-monitoring blood glucose (SMBG) in random order during two 8-week study periods. Blinded CGM was applied for a 3-week period during the control phase. Data from 29 participants were analysed (mean±SD age 21.3±2.3years, 16 [55.2%] female, baseline A1c 78.7±14.4mmol/mol, diabetes duration 13.1±5.1years, BMI 25.4±4.7kg/m2, CSII/MDI users= 17/12). The primary outcome, time spent in target range (70-180mg/dl) as recorded by CGM was significantly higher during CGM compared to the control period (see Table). CGM use reduced mean sensor glucose and time spent above target. A1c level was also reduced by 8.9mmol/mol (95% CI -4.3 to -13.3, p<0.005) in the CGM period. Time spent below target increased on CGM, no episodes of severe hypoglycaemia or DKA occurred. Median sensor use was 86% during the study.

In conclusion, CGM use improves time in target and A1c levels in young people with T1D.

Disclosure

H. Thabit: Research Support; Self; Dexcom, Inc. W.M. Mubita: None. C. Fullwood: None. S. Azmi: None. A. Urwin: None. I.M. Doughty: None. L. Leelarathna: Advisory Panel; Self; Abbott Laboratories, Medtronic, Novo Nordisk A/S, Sanofi. Research Support; Self; Dexcom, Inc., Novo Nordisk A/S. Speaker’s Bureau; Self; Medtronic. J. Paul-Prabhu: None.

Funding

Dexcom, Inc.
893-P: Miniaturized, User-Insertable Wireless Continuous Glucose Monitoring System with Next Generation Speed, Accuracy, and Longevity
Authors: MUJEEB-U-RAHMAN MUHAMMAD , NAZARI MEISAM HONARVAR , SENCAN MEHMET
Published: June 2020

The accuracy, response speed, cost, and size are important determinants of the performance of a Continuous Glucose Monitoring (CGM) system. Current CGM systems either require (i) percutaneous wires with bulky skin-worn transmitters, frequent removal/insertion, and thousands of dollars, or (ii) bulky implants, special semi-surgical procedures, and frequent recalibrations. By integrating modern semiconductor and nano technologies, IMS invented miniaturized (0.1mmx0.6mmx3mm i.e., smaller than a sesame seed) fully wireless, minimally invasive subdermal CGM platform. The sensor is user-insertable under the skin using an injector and is also user-removable. It is powered via an external smartwatch transmitter using standard RFID technology. This enables low power RF communication with the transmitter. The transmitter uses a bluetooth low-energy link to send the data to a smartphone reader enabling machine-learning based decision support.

IMS has verified the system through extensive in-vitro and in-vivo testing; the latest test for more than 1 month in a porcine model (Figure 1). The sensor shows fast response speed, best-in-class accuracy, and highly biocompatible operation due to use of standard materials and small size. We are currently working to get FDA IDE for first-in-human study.

Figure 1. Sensor Performance Results (a) using FDA iCGM (b) Clarke Error Grid.

Disclosure

M. Mujeeb-U-Rahman: None. M. Honarvar Nazari: None. M. Sencan: Employee; Self; Integrated Medical Sensors.

Funding

National Institutes of Health (DK109811, DK111001)
898-P: Benefit of Continuous Glucose Monitoring (CGM) in Reducing Hemoglobin A1c Is Sustained through 12 Months of Use among Adolescents and Young Adults with Type 1 Diabetes (T1D)
Authors: MILLER KELLEE , KANAPKA LAUREN , BAUZA COLLEEN , LAFFEL LORI M.
Published: June 2020

The CGM Intervention in Teens and Young Adults (CITY) trial demonstrated reductions in hemoglobin A1c (HbA1c) and hypoglycemia using CGM compared with intermittent blood glucose monitoring over a 6-month period. To determine if this improvement would be sustained, we evaluated outcomes in participants who continued CGM use through 12 months. The study was completed by 70 of 74 (95%) in the CGM group (43% female, median age 17 yrs, 67% non-Hispanic white, and 47% insulin pump users). Central-lab measured HbA1c and CGM measured glycemic outcomes at 12 months were compared with baseline (CGM at baseline was masked). HbA1c decreased from 8.9% at baseline to 8.3% at 12 months (p<0.001) (Table). Time spent in range 70-180 mg/dL was 38% at baseline and 41% at 12 months (P=0.3). Median percent time <70 mg/dL was reduced from 3.4% (49 min/day) at baseline to 1.1% (16 min/day) at 12 months (p<0.001). Similar improvements were observed for time <54 mg/dL with a decrease from a median of 1.0% (14 minutes/day) at baseline to 0.1% (<2 minutes/day) at 12 months. Glycemic variability measured by coefficient of variation was reduced from 42% at baseline to 37% at 12 months (p<0.001). These results demonstrate improvements in outcomes for teens and young adults with CGM use over a 12-month period with substantial improvements in HbA1c and reductions in hypoglycemia.

Disclosure

K. Miller: None. L. Kanapka: None. C. Bauza: None. L.M. Laffel: Advisory Panel; Self; Roche Diabetes Care. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Insulogic LLC, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk Inc., Sanofi US.

Funding

The Leona M. and Harry B. Helmsley Charitable Trust; Dexcom, Inc.
901-P: Evaluation of the Analytical Performance of YSI 2900D Compared with YSI 2300 STAT Plus for Glucose Concentration Measurements
Authors: HERNANDEZ MOISES , BEYSEN CARINE , HOMPESCH MARCUS , MORROW LINDA
Published: June 2020

Background: The production of YSI 2300 STAT (YSI 2300), a widely used Class II in-vitro diagnostics medical device for calibrating blood glucose monitoring systems, has been discontinued and replaced by new generation analyzers such as the YSI 2900D Biochemistry Analyzer (YSI 2900). The aim of this study was to evaluate the analytical performance of the YSI 2900D (YSI 2900) laboratory instrument using the validated YSI 2300 STAT Plus™ (YSI 2300) medical device as the reference method.

Methods: Serum controls (YSI and NIST SRM 965b) and blood and plasma samples were used to assess precision, accuracy (bias) and linearity of both analyzers for glucose concentration measurements. Human blood (n= 4 subject) was collected to prepare blood and plasma samples with low (1-70 mg/dL), mid (70-125 mg/dL) and high (125-900 mg/dL) glucose concentrations. Both analyzers employed a glucose oxidase amperometric biosensor and were configured with the same parameters. Daily membrane integrity and linearity checks were performed prior to conducting sample analyses. Results: Both instruments passed the daily performance checks prior to sample analyses. The YSI 2900 analyzer demonstrated similar within-run precision as the YSI 2300 (CV < 2% for each analyzer and each serum control tested). A total of 80 blood samples (range: 3.7-766.3 mg/dL) and 80 plasma samples (range: 4.7-880.7 mg/dL) were analyzed in triplicate on both analyzers. Paired results from the YSI 2900 and YSI 2300 showed a high correlation coefficient (R2 > 0.99) and similar regression statistics for both blood and plasma samples. Both the YSI 2900 and the YSI 2300 analyzers met accuracy (bias) criteria and Clarke error grid analysis demonstrated clinical accuracy with 100% of blood and 100% of plasma results in zone A.

Conclusion: Results from this study demonstrates that the YSI 2900 analyzer is analytically comparable to the YSI 2300 for a wide range of blood and plasma glucose concentrations.

Disclosure

M. Hernandez: None. C. Beysen: Employee; Self; ProSciento. M. Hompesch: Board Member; Self; ProSciento. Employee; Self; ProSciento. Stock/Shareholder; Self; ProSciento. L. Morrow: Employee; Spouse/Partner; Lilly Diabetes. Employee; Self; ProSciento.

Funding

YSI
909-P: The Related Factors Accounting for the Discrepancy between Estimated Hemoglobin A1c Derived from CGMS and the Measured A1C in Patients with Type 2 Diabetes
Authors: LIN BEISI , XU WEN , LIU ZHIGU , YANG DAIZHI , SU YANNA , CHEN YALAN , YAN JINHUA , YAO BIN
Published: June 2020

Objective: Continuous glucose monitoring system (CGMS) is emerging as an important tool in management of diabetes. Estimated glycated hemoglobin (eA1c), a CGM-derived metric, can be widely used if it is highly matched with the measured glycated hemoglobin (A1c). This study aimed to evaluate the relationship between eA1c and A1c measured by high performance liquid chromatography.

Methods: Data were collected from T2D patients between July 2017 and December 2019. Patients with abnormal hemoglobin levels and acute diabetic complications were excluded. Enrolled patients were divided into 3 groups based on the difference of eA1c and A1c (ΔA1c=eA1c-A1c): matched group (ΔA1c from -0.099% to 0.099%), overestimated group (ΔA1c ≥ +0.1%), and underestimated group (ΔA1c ≤ -0.1%). The indices of glycemic variability (GV) were obtained from CGMS.

Results: The 102 enrolled patients were 55.9(12.1) [mean (SD)] years old, with the measured A1c of 6.89(1.25)% and eA1c of 6.20(0.65)%. A positive correlation between eA1c and measured A1c (r= 0.50, p<0.001) was found. Majority of the patients were allocated in the underestimated group (13.7%, 19.6% and 66.7% of the patients in the matched, overestimated and underestimated groups, respectively). ΔA1c was -0.027(0.06)%, 0.59(0.39)% and -1.20(1.03)% (p<0.001) in these 3 groups, respectively. Age, BMI, duration of disease, type of hypoglycemic therapy, duration and intensity of hypoglycemia, blood pressure, lipid profiles, and the indices of intra-day GV among the 3 groups were similar. Multivariate logistic regression analysis revealed that gender (β=7.99, p=0.01), hematocrit (β=4.28, p=0.01) and mean of daily differences (MODD) (β=-7.44, p=0.02) were independently related with ΔA1c.

Conclusions: eA1c was generally underestimated compared to measured A1c in T2D patients. Gender, hematocrit and MODD were identified as significant factors accounting for this discrepancy.

Disclosure

B. Lin: None. W. Xu: None. Z. Liu: None. D. Yang: None. Y. Su: None. Y. Chen: None. J. Yan: None. B. Yao: None.

Funding

National Key Research and Development Program of China (2016YFC1304801)
912-P: Two Novel Pharmacokinetic Parameters Assess Dietary Glucose Concentration Changes in a Diabetic Patient Using Freestyle Libre Continuous Glucose Monitoring (CGM)
Authors: MELISH JOHN S.
Published: June 2020

Background: CGM is used to monitor/assess diet related glucose excursions and suggest treatment changes in types 1 and 2 diabetes. Two CGM data derived parameters, timed glucose clearance (GLCL(T,I) and timed insulin sensitivity index Si(T,I) are developed to quantify treatment responses to food, medication, and activity.

Method: Glucose Clearance (GLCL) = Interstitial fluid volume (Vd)/time of the (t1) rise and return to baseline (t2) of the diet related glucose concentration curve. GLCL(T,I) indicates the time = T between insulin administration (t0) to the initial glucose concentration rise from baseline (t1). I = insulin dose. The Si(T,I) = GLCL(T,I)/rapid acting insulin dose administered. Vd = 0.15 * kg body weight * 10 expressed as deciliters (dL).

Result: Example #1 - Two similar breakfasts: oatmeal (1 cup), 6 strawberries, ½ cup blueberries and ½ cup cottage cheese (46 g CHO) ingested on two different occasions. Vd = 116 dL. Breakfast (A): T = 0 minutes, glucose curve duration = 180 min, I = 13 units, GLCL(0,13) = 64.4 ml/min and SI(0,13) = 5.0 mL/(min*unit). Breakfast (B): T = 45 min; curve duration = 90/min; I = 12 units, GLCL(45,12) = 129 mL/minute and SI(45,12) = 10.8 mL/(minute*unit).

Example #2 - Lunch: madras lentils and hot dog. T = 0 minutes, I = 14 units. Glucose curve duration = 270 min. GLCL(T,I) = 43 mL/min; Si(T,I) = 3.07 mL/(min*unit).

Conclusion: Two quantitative parameters assessed similar meals and showed marked differences in duration and height of the glucose concentration curves. They illustrate the importance of insulin injection timing and dosing. The calculations are also applied to a meal without carbohydrate (CHO) counting and can be compared with a comparable subsequent meal. The calculations do not depend on CHO counting and can be applied to Identical mixed meals. Straightforward calculations are applied retrospectively to CGM generated data beyond current more qualitative CGM data evaluations.

Disclosure

J.S. Melish: None.
916-P: Precision Evaluation of Clinical Laboratory Glucose Reference Systems
Authors: PHILLIPS STUART , SETFORD STEVEN J. , SHEARER DAVID M. , SMITH ANTONY , ROSS JONATHAN N.
Published: June 2020

Background: In response to the discontinuation of the industry standard YSI 2300 STAT PLUS glucose analyser Lifescan, as a major manufacturer of blood glucose measurement systems, initiated a comparative evaluation of currently marketed point of care (POC) glucose measurement devices to identify a potential replacement comparator system within a clinical environment.

Method: Four POC devices were selected for in-depth assessment. Glucose measurement precision is a key performance metric for a comparator device, with higher standard deviation and coefficient of variation values imparting greater measurement uncertainty to diabetes test systems. This laboratory assessment used venous whole blood samples collected in Lithium Heparin coated tubes and tested within 12 hours of blood draw. All potential sources of variation such as donor and operator were controlled to give a best-case indication of performance.

Results: Precision data were generated for the YSI 2300 STAT PLUS and four POC devices. 20 replicates were obtained per device at each of four glucose concentrations (50, 100, 200 and 500 mg/dL). The Abbott i-STAT Alinity (using CG8+ cartridge) demonstrated consistently lower standard deviation and coefficient of variation values when compared to the YSI 2300 STAT PLUS and other tests systems.

Conclusions: A comparison of four currently marketed POC devices indicated that only one demonstrates precision performance that is equivalent or better than the YSI 2300 STAT PLUS across a wide range of glucose concentrations and thus is a strong candidate as a replacement clinical comparator system.

Disclosure

S. Phillips: Employee; Self; LifeScan, Inc. Employee; Spouse/Partner; LifeScan, Inc. S.J. Setford: Employee; Self; LifeScan Scotland. D.M. Shearer: None. A. Smith: Employee; Self; LifeScan, Inc. J.N. Ross: Employee; Self; LifeScan, Inc.
920-P: Continuous Glucose Monitor Utilization and Adherence in Children with Type 1 Diabetes
Authors: MONTGOMERY EMILY L. , JAWAD KAHIR S. , EUBANKS STEPHANY , WINTERGERST KUPPER A. , RUSH HEATHER M. , WATSON SARA
Published: June 2020

Use of continuous glucose monitors (CGM) is associated with lower HbA1c, with the best effect seen for those using the sensor at least 6 of 7 days. Prior studies have shown youth with type 1 diabetes to have poor adherence to CGM use. We aim to evaluate CGM adherence during typical use in our patients with type 1 diabetes.

In this retrospective chart review, the medical records for all patients treated with type 1 diabetes mellitus at the University of Louisville Physicians Pediatric Endocrinology outpatient clinic who initiated CGM use between 2017-2019 were reviewed to determine CGM utilization. CGM use data for patients, ages 2-18 years, was extracted from downloads performed at each clinic visit. Data available for review was 14 or 30 days, determined by receiver type.

During the 2-year study period, CGM was initiated for 253 youth mean age 12 years (SD 3.78). Patients were followed for a mean of 13.4 months (SD 6.7), encompassing 784 follow-up visits (3.1 visits per patient, SD 1.94). Within this time, 64 patients (25%) discontinued use, with a mean of 4.7 months of use (SD 5.4), including 24 patients (9.5%) who received the device and never used it. Of the 190 who initiated CGM use, only 142 (56%) reported current CGM use at each follow-up visit during the study period. Continuous use was associated with younger age at initiation of CGM (p=0.001), shorter duration of diabetes (p=0.005), lower HbA1c (p<0.005), and trial of professional CGM (p=0.001). CGM data was available for 429 of the follow-up visits, with 329 visits (77%) demonstrating the sensor was worn for at least 85% of the preceding 14-30 days.

For youth initiating CGM use during a 2-year period, we found a low rate of adherence to CGM use. However, the majority of those with consistent use wore the sensor at least 6 of 7 days, as recommended for effective use. Factors associated with continuous use included earlier implementation and prior professional CGM trial.

Disclosure

E.L. Montgomery: None. K.S. Jawad: None. S. Eubanks: None. K.A. Wintergerst: None. H.M. Rush: None. S. Watson: None.
922-P: LIRA-PRIME: A Randomized Trial in Primary Care Settings of Liraglutide vs. OAD for Glycemic Control in Patients with Type 2 Diabetes Not in Control on Metformin
Authors: UNGER JEFF , KALTOFT MARGIT , KOLHE DEVAYANI , PANDA JAYANT KUMAR , SARGıN MEHMET , WOLTHERS BENJAMIN OLE , ZOGHBI MAROUAN
Published: June 2020

Most patients with type 2 diabetes (T2D) are treated in primary care, but data to guide evidence-based, shared decision making in this setting are scarce. LIRA-PRIME (NCT02730377) was a randomized, open-label, active-controlled trial in a primary care setting, comparing efficacy and safety of liraglutide vs. an oral antidiabetic drug (OAD) in patients with T2D inadequately controlled with metformin. Patients aged ≥18 years, with A1C 7.5-9.0%, recruited from nine countries (219 sites), were randomized 1:1 using an interactive web response system to liraglutide or an OAD (α-glucosidase inhibitor, DPP-4i, meglitinide, SGLT2i, SU or TZD, chosen by their physician) on top of metformin, for up to 104 weeks. Primary endpoint: time to inadequate glycemic control, defined as A1C >7.0% at two consecutive visits after the first 26 weeks of treatment. Key secondary endpoints: time to premature treatment discontinuation, including for inadequate glycemic control, and occurrence of adverse events (AEs). From Mar 2016 to Aug 2017, patients were randomized to liraglutide (N=996) or OAD (N=995; 48% SGLT2i, 40% DPP-4i, 11% SU). Liraglutide significantly reduced the risk of inadequate glycemic control vs. OAD (416/996 [42%] vs. 547/995 [55%] patients, respectively; hazard ratio [95% CI] 0.58 [0.51;0.66]; p<0.0001) and of premature treatment discontinuation (532/996 [53%] vs. 624/995 [63%], respectively; p<0.0001). Median time to inadequate glycemic control (109 vs. 65 weeks; p<0.0001) and premature treatment discontinuation (80 vs. 52 weeks; p<0.0001) was longer with liraglutide vs. OAD. Rates of serious AEs and hypoglycemic episodes were similar, but more patients discontinued due to gastrointestinal AEs with liraglutide vs. OAD (54/980 [6%] vs. 9/984 [1%], respectively). Within global primary care settings, LIRA-PRIME demonstrated longer lasting glycemic control with liraglutide than with an OAD, when added to metformin.

Disclosure

J. Unger: Consultant; Self; Bayer. Research Support; Self; GlaxoSmithKline, Merck, Pfizer, Sanofi, Lilly, Janssen. Stock/Shareholder; Self; Tandem Diabetes. Other Relationship; Self; Abbott, Abbott Diabetes, Novo Nordisk. M. Kaltoft: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. D. Kolhe: Employee; Self; Novo Nordisk. J. Panda: None. M. Sargın: Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., Pfizer Inc. B. Wolthers: Other Relationship; Self; Novo Nordisk. M. Zoghbi: Advisory Panel; Spouse/Partner; Janssen Pharmaceuticals, Inc., New Bridge. Advisory Panel; Self; Novartis AG. Advisory Panel; Spouse/Partner; Novartis AG. Advisory Panel; Self; Novo Nordisk A/S. Advisory Panel; Spouse/Partner; Pfizer Inc., Roche Pharma. Advisory Panel; Self; Sanofi.

Funding

Novo Nordisk A/S