bluuebunny/crossref_metadata_2025 huggingface dataset:
849-P: Accuracy and Precision of Continuous Glucose Monitoring (CGM) in Hospitalized Patients Undergoing Radiology Procedures
Authors: MIGDAL ALEXANDRA , SPANAKIS ELIAS , GALINDO RODOLFO J. , DAVIS GEORGIA , SINGH LAKSHMI G. , SATYARENGGA MEDHA , FAYFMAN MAYA , PASQUEL FRANCISCO J. , ALBURY BONNIE S. , URRUTIA MARIA A. , ZAMUDIO KARLA W. , GIBANICA SEID , CARDONA SAUMETH , PENG LIMIN , UMPIERREZ GUILLERMO E.
Published: June 2020

Background: There is increasing interest in using CGM for the inpatient management of diabetes in non-ICU settings. Current industry guidelines recommend removing devices when undergoing certain radiology procedures due to concerns about potential interference with CGM system functioning. However, there is no published data on the impact of CGM precision and accuracy after radiation and contrast exposure to support this recommendation.

Methods: We collected data on 49 adult medicine and surgery patients with type 1 and type 2 diabetes who were monitored with Dexcom CGM systems before and after radiology procedures (x-rays, CT scan, catheterization/angiography). The primary outcome was glycemic variability by percent coefficient of variation (%CV) as reported by CGM 2-hours pre and post imaging. Secondary outcome was the mean absolute relative difference (MARD) between matched glucose pairs from capillary point-of-care and CGM pre and post imaging procedure.

Results: There were no significant differences in mean blood glucose (BG) or %CV seen on CGM readings for all imaging procedures combined (delta mean BG -7.7 ±26.0, p=0.051; %CV 18.0% pre vs. 19.1% post, p=0.65) or when stratified by x-ray (delta mean BG -8.8 ±29.9, p=0.15; %CV 20.1% pre vs. 21.5% post, p=0.60) vs. CT scan/catheterization/angiography (delta mean BG -6.3 ±20.6, p=0.19; %CV 15.2% pre vs. 15.9% post, p=0.97). The overall MARD was 13.3% pre-imaging and 12.7% post-imaging. The overall percentage of glucose values within ±15%/15mg/dl, ±20%/20mg/dl, and ±30%/30mg/dl of the POC reference value was 69%, 80%, and 94%, respectively pre-imaging, and 69%, 82% and 93% post-imaging (p=NS). Clarke Error Grid analysis showed 98.1% of glucoses falling into Zones A and B pre-imaging and 99.7% post-imaging.

Conclusions: Preliminary data suggests that ongoing CGM usage during multiple radiology procedures is safe and reliable without interference or disruption in CGM data transmission.

Disclosure

A. Migdal: None. E. Spanakis: Research Support; Self; Dexcom, Inc. R.J. Galindo: Advisory Panel; Self; Lilly Diabetes. Consultant; Self; Valeritas, Inc. Research Support; Self; Novo Nordisk Inc. Other Relationship; Self; UpToDate. G. Davis: None. L.G. Singh: None. M. Satyarengga: None. M. Fayfman: None. F.J. Pasquel: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. Research Support; Self; Dexcom, Inc., Merck Sharp & Dohme Corp., National Institutes of Health. B.S. Albury: None. M.A. Urrutia: None. K.W. Zamudio: None. S. Gibanica: None. S. Cardona: None. L. Peng: None. G.E. Umpierrez: None.

Funding

Dexcom, Inc.
85-LB: Freestyle Libre System Use Associated with Reduction in Acute Diabetes Events and All-Cause Hospitalizations in Patients with Type 2 Diabetes without Bolus Insulin
Authors: MILLER EDEN , KERR MATTHEW S.D. , ROBERTS GREGORY J. , SOUTO DIANA , NABUTOVSKY YELENA , WRIGHT EUGENE
Published: June 2020

Data on the benefit of continuous glucose monitors (CGM) in people with diabetes not using intensive insulin therapy is limited. We describe clinical outcomes after a FreeStyle Libre® system purchase in people with type 2 diabetes (T2D) not using bolus insulin. 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. Cohort requirements included: de novo CGM, FreeStyle Libre system purchase 2017 Q4-2018 Q4, T2D diagnosis, ≥18 years old, no fast-/short-acting insulin, ≥6-months pre-index observation time. Primary outcome was acute diabetes events (ADE): hospitalization with hyper-/hypoglycemia as primary diagnosis or outpatient emergency with same codes. Secondary outcome was all-cause hospitalization. Andersen-Gill Cox regression compared event rates 6-months pre-/post-index. The cohort (n= 7,167, age 53.3±9.5 years, 51.5% male, avg. post-index follow-up 155 days) saw a reduction in ADE from 0.071 to 0.052 events/pt-yr (HR: 0.70 [0.57 0.85]; P:<0.001). Hospitalizations reduced from 0.180 to 0.161 events/pt-yr (HR: 0.87 [0.78 0.98]; P: 0.025). After FreeStyle Libre system purchase, T2D patients not on bolus insulin had lower rates of ADE and all-cause hospitalization.

Disclosure

E. Miller: None. M.S.D. Kerr: Employee; Self; Abbott. G.J. Roberts: Employee; Self; Abbott. D. Souto: Employee; Self; Abbott. Y. Nabutovsky: Employee; Self; Abbott. E. Wright: Advisory Panel; Self; Abbott, Sanofi. Consultant; Self; Abbott, AstraZeneca, Bayer U.S., Boehringer Ingelheim Pharmaceuticals, Inc., MannKind Corporation, Merck & Co., Inc., Voluntis France. Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes.
85-OR: Islet-Autonomous Inflammatory Signaling Propagates Autoimmunity and Promotes Diabetes in Nonobese Diabetic Mice
Authors: PINEROS ANNIE , KULKARNI ABHISHEK , HERNANDEZ-PEREZ MARIMAR , ORR KARA , GLENN LINDSEY , REISSAUS CHRISTOPHER A. , GANNON MAUREEN , MCDUFFIE MARCIA J. , NADLER JERRY , MORRIS MARGARET A. , MIRMIRA RAGHAVENDRA , TERSEY SARAH A.
Published: June 2020

The type 1 diabetes (T1D) pathogenesis has been viewed as being initiated and propagated by directed autoimmunity against islet β cells. In recent years, we and others have taken a new perspective placing the β cell itself as the initiating cell. 12/15-lipoxygenase (12/15-LOX), an enzyme involved in arachidonic acid metabolism, is expressed in β cells and macrophages. Global deletion of the gene encoding 12/15-LOX (Alox15) prevents diabetes in the NOD mouse model of T1D via reduction in cellular production of proinflammatory mediators in islets and macrophages. We hypothesized that this protective phenotype largely emanates from the loss of 12/15-LOX in the islet rather than immune cells. To test this hypothesis, we generated inducible islet-specific Alox15 knockout mice (Alox15∆islet) on the NOD background. Control female mice (Alox15loxp/loxp;Pdx1PB-CreERTM/+) exhibited diabetes incidence greater than 75%, whereas Alox15∆islet females showed a significant decrease in the incidence of diabetes (<10%, P<0.05). During the prediabetic phase (8 weeks of age), both control and Alox15∆islet females exhibited similar β cell mass (0.70±0.08 g vs. 0.72±0.06 g, P=NS) and insulitis severity (score 1.89±0.17 vs. 1.74±0.19, P=NS). By contrast, at this same stage, Alox15∆islet mice showed increased Treg (CD4+FoxP3+) numbers in the spleen and pancreatic lymph node compared to controls (P<0.05) with no changes in Th1 (CD4+IFNγ+) and Th17 (CD4+IL17+) cells compared to control mice (P=NS). At 12 weeks of age, however, Alox15∆islet mice exhibited increased β-cell mass (0.40±0.05 g vs. 0.61±0.14 g, P=<0.05) and decreased insulitis severity (score 2.63±0.18 vs. 1.76±0.13, P=<0.05). Together, these data suggest that 12/15-LOX promotes islet inflammation and the destruction of β cells during the pathogenesis of autoimmune T1D, and supports the notion that inflammatory pathways intrinsic to the islet may initiate and propagate signals that exacerbate autoimmunity.

Disclosure

A. Pineros: None. A. Kulkarni: None. M. Hernandez-Perez: None. K. Orr: None. L. Glenn: None. C.A. Reissaus: None. M. Gannon: None. M.J. McDuffie: None. J. Nadler: None. M.A. Morris: Stock/Shareholder; Spouse/Partner; Becton, Dickinson and Company, Bristol-Myers Squibb, Johnson & Johnson, Medtronic, Sanofi. R. Mirmira: Advisory Panel; Self; Hibercell, Sigilon Therapeutics, Veralox Therapeutics. Employee; Spouse/Partner; Eli Lilly and Company. S.A. Tersey: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (R01DK105588)
851-P: Technology Use by Age and Region in Adults with Type 1 Diabetes (T1D) in the SAGE Study
Authors: EDELMAN STEVEN , BRUTTOMESSO DANIELA , CLOSE KELLY L. , VIANNA ANDRE G. , LAUAND FELIPE , BRETTE SANDRINE , RENARD ERIC
Published: June 2020

Glycemic control is suboptimal in many people with T1D. Diabetes technology may help improve diabetes management but data on its use in specific age groups and geographies is limited.

SAGE was a multinational, cross-sectional study using data from medical records and interviews of eligible participants (N=3858) aged ≥26 years with T1D for ≥1 year. The use of diabetes technology in different regions (Asia, Eastern Europe, Western Europe [WE], Latin America and Middle East) by predefined age groups (26-<45; 45-<65; ≥65 years) was assessed by a technology use questionnaire.

Overall, finger stick blood glucose meters were used most frequently (92.0%), with similar proportions of participants using them across regions and age groups. Use of continuous glucose meters (CGM; 23.2%), insulin pumps (19.5%) and blood ketone meters (11.1%) varied between regions, while usage within each region varied somewhat between age groups (Table). Overall, use of an insulin dosing app was low (4.6%) and mostly when recommended by an HCP, with slightly more frequent use in those aged 26-<45 years (5.5%) compared with older age groups (45-<65 years, 3.9%; ≥65 years, 3.5%).

Use of CGM, insulin pump and blood ketone meter is notably higher in WE than other regions. Globally, use of an insulin dosing app is low and appears to be mostly driven by HCP recommendations. Increased use of diabetes technology may help individuals and HCPs to manage diabetes better.

Disclosure

S. Edelman: Advisory Panel; Self; Brightsight, InPen, Lexicon Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk A/S. Board Member; Self; Senseonics. Speaker’s Bureau; Self; AstraZeneca, MannKind Corporation, Merck & Co., Inc., Sanofi. D. Bruttomesso: Consultant; Self; Abbott, Eli Lilly and Company, Movi, Novo Nordisk, Roche Diagnostics, Sanofi. K.L. Close: Other Relationship; Self; Abbott, Air Liquide, American Diabetes Association, AstraZeneca, Dexcom, Inc., Janssen Pharmaceuticals, Inc., JDRF, Leona M. and Harry B. Helmsley Charitable Trust, Lilly Diabetes, Merck & Co., Inc. A.G. Vianna: Board Member; Self; Abbott, Medtronic, Novo Nordisk A/S. Research Support; Self; Sanofi. Speaker’s Bureau; Self; Lilly Diabetes. F. Lauand: Employee; Self; Sanofi. S. Brette: Other Relationship; Self; Sanofi. E. Renard: Board Member; Self; Abbott, Insulet Corporation, Novo Nordisk A/S, Roche Diabetes Care. Consultant; Self; Air Liquide, Eli Lilly and Company, Sanofi. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care.

Funding

Sanofi
86-OR: High-Fat Diet Prevents Autoimmune Diabetes in NOD Mice
Authors: CLARK AMY L. , YAN ZIHAN , CHEN SOPHIA X. , FUESS MATT , MCGINN GABRIELLE , REMEDI MARIA S.
Published: June 2020

Type 1 diabetes (T1D) has a strong genetic predisposition and requires an environmental trigger to initiate autoimmune destruction of beta cells. The rate of childhood obesity has risen in parallel to the rate of T1D, suggesting high fat diet (HFD) may be an environmental trigger in the development of autoimmune diabetes. Supporting this hypothesis, HFD can induce insulin resistance, beta cell stress, dysfunctional insulin production, and beta cell death. To explore the role of HFD in the development of T1D, 4 week-old non-obese diabetic (NOD) female mice were placed on HFD or chow diet (CD). At 10 weeks of age NOD mice fed with HFD demonstrated a significant increase in body weight and non-fasting blood glucose along with mild glucose intolerance compared with NOD CD fed mice. Histological analysis at 10 weeks of age revealed significantly less pancreatic immune cell infiltration and increased beta cell mass in HFD fed mice compared to CD fed mice. By 15 weeks of age, HFD fed NOD animals demonstrated impaired glucose tolerance similar to CD fed mice, increased glucose-stimulated insulin secretion and total insulin content, and insulin resistance. Surprisingly, at 25 weeks of age the HFD fed NOD mice were completely protected from the development of diabetes, while as expected 70% of NOD CD fed mice had developed diabetes.

In summary, this study demonstrates that in the NOD model of T1D HFD reduced islet immune cell infiltration, increased beta cell mass, insulin content and insulin secretion protecting the mice from development of diabetes. The mechanism underlying this protection seems to be two-fold: expansion of beta cell mass and prevention of autoimmune-mediated beta cell death. Our data correlate with other recent studies indicating that early stimulation of beta cell replication can induce immune tolerance in NOD animals preventing T1D. Identification of the mechanisms by which HFD leads to prevention of diabetes in NOD animals may lead to the development of novel therapeutic interventions to prevent T1D in humans.

Disclosure

A.L. Clark: None. Z. Yan: None. S.X. Chen: None. M. Fuess: None. G. McGinn: None. M.S. Remedi: None.

Funding

National Institutes of Health (P30DK020579, K12HD076224-04)
860-P: Users with Type 2 Diabetes Using a Digital Platform Experienced Sustained Improvement in Blood Glucose Levels
Authors: HERSHCOVITZ YIFAT , DAR SHARON , FENIGER EITAN
Published: June 2020

Introduction: Reduction of high readings and maintaining blood glucose target levels (fasting and post-meal) are great challenges in managing diabetes. Digital engagement can play a key role in enhancing patient understanding of their condition and helping them make better decisions regarding their actual situation. The Dario platform allows for real time evaluation of blood glucose levels change over time and for a precise intervention based on actual behavioral and clinical indicators.

Method: A retrospective data evaluation (Q1:2018-2019) was performed on the Dario® data base. A population of active users (18 measurements per month with the Dario® System on average) with type 2 diabetes (T2D), non-Insulin treated was evaluated over a full year. High blood glucose readings (180-400 mg/dL, >250 mg/dL), fasting readings (<126 mg/dL) and post-meal readings (<180mg/dL) ratios were assessed in their first month of use until the 12th month.

Results: For 9,200 users with T2D, non-Insulin users, the average ratio of high glycemia events (180-400 mg/dL) from entire set of measurements was reduced by 26% (18.62% vs. 23.43%) while readings of >250mg/dL were reduced by 33% (4.65% vs. 6.93%) over a year. Fasting measurements analysis revealed an increase of 16% in ratios of readings <126 mg/dL per entire set of fasting measurements (40.59% vs. 34.92%) on average. Post-meal readings ratio of <180 mg/dL per entire post-meal measurements increased by 5% (73.75% vs. 70.42%) on average over a year.

Conclusion: Digital diabetes platform results in a large population are consistent with previous studies and show the potential to promote behavior modification in users with T2D. The study demonstrates that digital management platform may assist user to better control their blood glucose levels and sustain behavioral change. This observational data presents an improvement in high glycemia readings ratios, and an increase in prediabetes fasting blood glucose levels sustained over one year.

Disclosure

Y. Hershcovitz: Employee; Self; DarioHealth. S. Dar: Employee; Self; DarioHealth. E. Feniger: Employee; Self; DarioHealth.
868-P: Live Coaching Improves Glycemic Control and DSMQ Scale in People with Type 2 Diabetes
Authors: KATZ LAURENCE B. , NELAND KRISTIN D. , ROLANDO DEANNA J. , SHEARER DAVID M.
Published: June 2020

People with diabetes face numerous challenges to effective self-management of blood glucose (BG) including access to diabetes education and support. This study explores how a coaching program structured around the AADE7 Self-Care Behaviors™ and evidence-based behavior change strategies optimized for remote interaction between the coach and participant can improve glycemic control. Certified Diabetes Educator coaches used a care management platform, Welkin Health, that displays BG test results from integration with the OneTouch Reveal diabetes mobile app. Welkin supports communication methods with patients including email, SMS and telephone communication. The software platform also uses logic to prioritize patients who need attention so the coach can better manage their relationship with the participant. Adult participants with type 2 diabetes and HbA1c ≥8.0% received an AccuBase A1c mail-in test kit at baseline and weeks 12 and 24 to measure their HbA1c levels. Each participant used a OneTouch Verio Flex glucose meter connected by Bluetooth to OneTouch Reveal app. After 12 weeks (n=67), mean HbA1c declined by 0.85% from 9.19% to 8.34% (p<0.05) and 65% of subjects had an HbA1c decrease of >0.5%. After 24 weeks, mean change in HbA1c was still 0.78% less than baseline (p<0.05) with 51% of participants experiencing a decline of >0.5%. The decline in HbA1c occurred without any increase in hypoglycemic events. There was a 14.1% increase in % of results in range (p<0.05). Improvement in HbA1c came without any substantial change in testing frequency. In addition, there were various positive changes in the Diabetes Self-Management Questionnaire (DSMQ) scale.

In conclusion, live coaching using the Welkin Patient Relationship Management technology in conjunction with the OneTouch Reveal diabetes app resulted in significant improvement in glycemic control in participants with type 2 diabetes who were in relatively poor control.

Disclosure

L.B. Katz: Employee; Self; LifeScan, Inc. K.D. Neland: Research Support; Self; LifeScan, Inc. D.J. Rolando: None. D.M. Shearer: None.
870-P: A1C Reductions and Improved Patient-Reported Outcomes following CGM Initiation in Insulin-Managed T2D
Authors: NOAR ADAM , WELSH JOHN , PRICE DAVID A.
Published: June 2020

Initiating therapeutic continuous glucose monitoring (CGM) can affect A1C levels and patients’ relationship to their diabetes. We used real-world A1C data to quantify short-term glycemic changes in people with T2D new to CGM. Eligibility was assessed during calls to Dexcom regarding its G6 CGM system. Criteria included ages 25-65 years, use of intensive insulin therapy (IIT), no prior CGM use, coverage with a non-government health plan, willingness to provide validated A1C values and survey responses at baseline and at ∼12 weeks after CGM initiation, and willingness to share CGM data via CLARITY (Dexcom). Patient-reported outcome (PRO) surveys included the diabetes distress scale (DDS), hypoglycemic attitudes and behavior scale (HABS), and diabetes quality of life short inventory (DQOL). G6 satisfaction and ease of use were also assessed. Data from 39 participants were available for this interim analysis. Compared to baseline, the ∼12-week data showed a mean 1.5 percentage point reduction in A1C (Figure). Nineteen (49%) of the participants had at least a 1 percentage point A1C reduction. PRO scores improved by 31% for the DDS, by 22% for the HABS, and by 24% for the DQOL. Most participants found the G6 system satisfactory or very satisfactory (95%) and very easy to use (85%). Patients with T2D using IIT may experience significant glycemic and psychosocial benefits within 12 weeks of starting G6 CGM.

Disclosure

A. Noar: Employee; Self; Dexcom, Inc., Tandem Diabetes Care. J. Welsh: Employee; Self; CSL Behring. D.A. Price: Employee; Self; Dexcom, Inc.
871-P: Baseline Time-in-Range Association with Glycemic Improvement in Adults with Type 1 Diabetes (T1D)
Authors: CALHOUN PETER , PRICE DAVID A. , BECK ROY
Published: June 2020

The DIAMOND study demonstrated real-time continuous glucose monitors (CGM) improve glycemic control for adults with T1D using multiple daily injections; subsequent analysis showed greatest benefit in participants with higher baseline A1C. This analysis assesses the relationship between baseline time in range (TIR) and change in TIR during the study with CGM or self-monitoring of blood glucose (SMBG). Baseline TIR was divided into three categories: <40% (9.6 h/d), <50% (12 h/d), and <60% (14.4 h/d). Of 153 participants, mean A1C was 8.6±0.6% and the mean TIR was 46±12% (10.9±2.9 h/d) at baseline. Mean increase in TIR was greater among CGM users versus SMBG users for all three baseline TIR categories (18 min/d for baseline TIR <40%, 90 min/d for baseline TIR <50%, 88 min/d for baseline TIR <60%). A greater percentage of participants using CGM had >4 h/d increase in TIR across all baseline TIR groups, and >2 h/d increase in TIR in most baseline TIR groups, although a few were not significant due to small sample size (Figure). The most noticeable difference occurred for participants with a baseline TIR <50%, with 29% of CGM users increasing TIR by >4 h/d compared with no SMBG users (P=0.004). Similar trends were found for improvement in mean glucose and time spent in hyper- and hypoglycemic ranges. Overall, results suggest greater improvement in glycemic control for CGM users than for SMBG users across all baseline TIR groups.

Disclosure

P. Calhoun: Stock/Shareholder; Self; Dexcom, Inc. D.A. Price: Employee; Self; Dexcom, Inc. R. Beck: None.

Funding

Dexcom, Inc.
879-P: Positive Impact of Use of Continuous Glucose Monitoring on Glycemic Outcomes in Young Adults with Type 1 Diabetes, in Adult Clinical Setting, Independent of Insulin Administration Method
Authors: TOSCHI ELENA , GABBAY ROBERT A. , CLIFT AUSTIN , BENNETTI MADELINE , ATAKOV-CASTILLO ASTRID
Published: June 2020

Introduction: Young adults (YA) with type 1 diabetes (T1D) are at risk of poor glycemic control. Use of continuous glucose monitoring (CGM) has been shown to improve glucose control. However, real-world data on the impact of CGM use on glucose control in YA is limited.

Methods: We analyzed data from electronic medical records collected across 2018 from a tertiary adult clinic of YA patients age 18- 30 yrs with T1D. A1C and insulin administration methods defined as sliding scale (SS), multiple daily injection while carbohydrate counting (MDI), or via pump therapy (Pump) were collected along with CGM use.

Results: Data from 891 patients (mean age 26±3, T1D duration 12±7 years, 52% female, average A1C 7.9%±1.5) were analyzed. Twelve % (n= 110) were on SS; 37% (n=331) on MDI, and 51% (n= 450) on pump therapy; mean age of all 3 groups was 26 ± 3yrs. Use of CGM was recorded in 32% of patients on SS, while use of CGM was recorded in 46% and 66% of patients using MDI and pump, respectively.

A1C differed between CGM users and non-users in each subgroup.

Conclusion: With increasing complexity of insulin regimen, CGM use rises. However, independent of insulin administration method, CGM use was associated with lower A1C. These findings highlight the potential benefit of CGM use, in YA with T1D in adult clinic settings.

Disclosure

E. Toschi: None. R.A. Gabbay: Advisory Panel; Self; FormHealth, Health Reveal, Lark, Onduo, Vida Health. A. Clift: None. M. Bennetti: None. A. Atakov-Castillo: None.
880-P: Is Time-in-Range Independent of A1C? A Study in Asian Indian Population
Authors: KESAVADEV JOTHYDEV , SHANKAR ARUN , KRISHNAN GOPIKA , SABOO BANSHI D. , SANAL GEETHU , KRISHNA B MEERA , TS SANAL , JOTHYDEV SUNITHA
Published: June 2020

Time-in-Range (TIR) has been recently established as a treatment target in diabetes to complement the time-tested A1c. Studies in the Caucasian population have shown that every 10% increase in TIR corresponds to 0.8% reduction in A1c. To study the relationship between TIR with A1c in the Asian-Indian population, CGM data from EMR of patients with type 1 and type 2 diabetes (n=424) followed up by a telemedicine program (DTMS) at our comprehensive diabetes care center in Kerala was obtained. Mann Whitney U test, t-test, ANOVA, and Pearson correlation coefficient were used for univariate analysis. Baseline characteristics were age 54 + 14 years, Gender frequency: F/M 127/297, diabetes duration 10.83+8.24 years, A1c 7.44+1.17 (%), eA1c 6.74+1.24 (%), and Average Blood Glucose (ABG) 146.96 + 35.62 (mg/dL). All the patients were eligible for a reduction of A1C <7.5%. In this subset of Asian-Indian population, our statistical analysis revealed that a TIR of >70% corresponds to an A1c level of <7.5% in agreement with the previous studies. In our telemedicine-based chronic care model, an A1c of <7.5% was achieved in 67.5% of the subjects. However only 36% achieved a TIR >70% and 66% achieved a TIR >60%; a finding which underscores the significance of TIR independent of A1c levels. The study suggests that TIR should evolve as a powerful target and predictor of diabetes complications and should be a routine measure in diabetes care.

Disclosure

J. Kesavadev: Speaker’s Bureau; Self; Biocon, Novo Nordisk Inc., Sanofi-Aventis. A. Shankar: None. G. Krishnan: None. B.D. Saboo: None. G. Sanal: None. M. Krishna B: None. S. Ts: None. S. Jothydev: None.
884-P: Discrepancies in Key Metrics of Glycemic Control between Retrospective Continuous Glucose Monitoring System and Flash Glucose Monitoring in Adult Patients with Type 1 Diabetes
Authors: ZHOU YONGWEN , DENG HONGRONG , YANG DAIZHI , YAN JINHUA , XU WEN , LIU HONGXIA , GAN LU , LUO SIHUI , ZHENG XUEYING , LIANG HUA , YAO BIN , WENG JIANPING
Published: June 2020

Limited data on head-to-head comparisons between the flash glucose monitoring (FGM) system (FreeStyle Libre®, FSL) and retrospective continuous glucose monitoring (CGM) system (IproTM2) were available. The study aimed to compare glycemic metrics derived from two devices in adult patients with type 1 diabetes (T1D). Adult T1D patients with HbA1c of 7 to 10% were recruited and randomized to adopt FSL or self-monitoring blood glucose in the 24-week trial (NCT03522870). In the FSL group, glucose was simultaneously measured by FSL and IproTM2s on patients’ different arms for 14 days at 12 and 24 weeks. Data collected on the day of insertion and detachment and those of insufficient quality (<90%) were excluded. Each FSL glucose value was aligned with the closet IproTM2 value(lag time<2min). Glycemic metrics were calculated via Glyculator 2.0 software and differences between them were assessed. From May 2018 to November 2019, a total of 31287 paired data collected from 27 adult T1D patients (male/female 7/20; age 30.2±8.9yrs; duration 8.9[6.2,13.1]yrs; HbA1c 7.6±0.8%) were included. The median number of days with available CGM data was 11.3(9.9,12.0). Agreement between the two devices’ measurements was satisfactory (R2=0.85, P<0.001). Time in range 70-180mg/dl (%, TIR) was significantly lower in FSL than that in IproTM2 (59.5[49.3,66.7] vs. 62.3[51.6,69.5] %, P=0.02). Significant difference in time spent below 70 and 54mg/dl(%) was observed with the higher ones in FSL group (<70mg/dl, 7.2[5.6,13.8] vs. 4.5[2.0,9.2] %, P=0.02; <54mg/dl, 2.6[1.3,5.3] vs. 1.4[0.4,3.0] %, P=0.04). There were no significant differences in time spent over 180 and 250mg/dl (%), and glycemic variability including CV and MAGE (all P>0.05). In the 14-days wearing of the different devices simultaneously, there was a close agreement between FSL and Ipro2 but significant differences were observed in TIR and time spent in hypoglycemia.

Disclosure

Y. Zhou: None. H. Deng: None. D. Yang: None. J. Yan: None. W. Xu: None. H. Liu: None. L. Gan: None. S. Luo: None. X. Zheng: None. H. Liang: None. B. Yao: None. J. Weng: None.

Funding

National Key Research and Development Program of China (2017YFC1309600); Natural Science Foundation of Guangdong Province (2018A030313251)
89-LB: The Effect of GIP on Plasma Glucose in a Setting of Prandial Insulin Overdose and Physical Activity after Meal Intake in Patients with Type 1 Diabetes
Authors: HOE BJØRN , NGUYEN HEIMBÜRGER SEBASTIAN M. , GASBJERG LÆRKE S. , LYNGGAARD MADS B. , HARTMANN BOLETTE , HOLST JENS J. , VILSBØLL TINA , LUND ASGER , ENGBERG SUSANNE , DEJGAARD THOMAS F. , CHRISTENSEN MIKKEL B. , KNOP FILIP K.
Published: June 2020

Gluco-regulatory effects of the insulinotropic and glucagonotropic gut hormone glucose-dependent insulinotropic polypeptide (GIP) in type 1 diabetes (T1D) are unclear. We evaluated the effects of exogenous and endogenous GIP on plasma glucose excursions in a setting of prandial insulin over-dose and physical activity after meal ingestion.

In a randomized, placebo-controlled, double-blinded, crossover study, 12 men with T1D (age [mean±SD]: 26±6.6 years; BMI: 23±2.3 kg/m2; HbA1c: 6.5±2.7% (48.4±6.3 mmol/mol); diabetes duration: 11.3±5.5 years; plasma C-peptide <200 pmol/L) underwent three separate study days involving a liquid mixed meal test with 125% of regular prandial insulin dose, 30 minutes of intermediate bicycling (60 minutes after mixed-meal), and 270 minute infusions of GIP, the GIP receptor antagonist GIP(3-30)NH2 and placebo, respectively.

The GIP infusion attenuated postprandial plasma glucose excursions (Cmax-Cmin) by [mean±SEM] 1.5±0.5 mmol/L and 0.92±0.56 mmol/L compared to GIP(3-30)NH2 and placebo, respectively (P=0.03). Infused glucose needed to avoid plasma glucose <2.5 mmol/L was similar on all 3 study days (P=0.13).

In conclusion, GIP infusion seems to attenuate postprandial plasma glucose excursions without significantly increasing the need of glucose to avoid hypoglycemia in patients with T1D.

Disclosure

B. Hoe: None. S.M. Nguyen Heimbürger: None. L.S. Gasbjerg: Stock/Shareholder; Self; Antag Therapeutics. M.B. Lynggaard: None. B. Hartmann: None. J.J. Holst: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Zealand Pharma A/S. Other Relationship; Spouse/Partner; Antag Therapeutics. T. Vilsbøll: Advisory Panel; Self; AstraZeneca, Mundipharma International, Novo Nordisk A/S, Sun Pharmaceutical Industries Ltd. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Medscape, Merck Sharp & Dohme Corp., Sanofi. A. Lund: Speaker’s Bureau; Self; AstraZeneca, Novo Nordisk A/S, Sanofi. S. Engberg: None. T.F. Dejgaard: Advisory Panel; Self; Novo Nordisk A/S. Consultant; Self; Boehringer Ingelheim International GmbH, Novo Nordisk A/S. Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk A/S. M.B. Christensen: None. F.K. Knop: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Mundipharma International, Novo Nordisk A/S, Sanofi. Consultant; Self; Carmot Therapeutics, Inc., Eli Lilly and Company, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Gubra, Novo Nordisk A/S, Sanofi, Zealand Pharma A/S. Speaker’s Bureau; Self; AstraZeneca, Lupin Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Norgine B.V., Novo Nordisk A/S.

Funding

The Leona M. and Harry B. Helmsley Charitable Trust (2018PG-T1D037)
891-P: Detecting Dawn Phenomenon in T1D with Continuous Glucose Monitoring and Activity Tracking
Authors: ABRAHAM SINU BESSY , KANG DAE , ZHONG YUXIANG , AGRAWAL PRATIK , CORDERO TONI L. , VIGERSKY ROBERT
Published: June 2020

Background and Aims: Dawn phenomenon (DP) refers to the morning rise in glucose levels observed in individuals with diabetes. While continuous glucose monitoring (CGM) may detect rates of change (ROC) in sensor glucose (SG) levels, ensuring that DP is not due to unannounced carbs can be challenging. Hence, a combination of CGM and activity data were used to identify true DP.

Method: MiniMed™ 530G system data were uploaded between 6/2017-10/2017 by 33 individuals. Corresponding heart rate, steps, and metabolic equivalents (METs) were acquired with Fitbit® Charge 2™. Nights without carb or bolus entry from 12-6AM were analyzed. Nights with SG ROC >0.28mg/dL/min (ROC between peak and nadir) and no activity (METs <1.5) ±30min of nadir were identified as true DP; those involving activity (METs >1.5) ±30min of nadir were identified as involving unannounced carb (UC); and those with no nadir were identified as ideal.

Results: Individuals had 26 nights with DP, 27 nights with UC, and 39 ideal nights and the Table shows differences in the features related to each. The ROC of SG rise due to DP was lower, took longer time to reach peak, and tended to have a higher SG at nadir when compared with UC.

Conclusion: Dawn phenomenon can be identified and characterized in real-world conditions using CGM and fitness tracking. Detecting DP may help improve nocturnal and early morning glycemic management.

Disclosure

S. Abraham: Employee; Self; Medtronic. D. Kang: None. Y. Zhong: Employee; Self; Medtronic. P. Agrawal: None. T.L. Cordero: Employee; Self; Medtronic. R. Vigersky: Employee; Self; Medtronic.
894-P: Intermittent Use of Flash Glucose Monitoring (FGM) and Education Improves Glycemia in Type 2 Diabetes (T2D) in Singapore: Pilot Data from Glimpse Project
Authors: CHANDRAN SURESH RAMA , GANDHI MIHIR , ADAIKAN KALA , TAN NGIAP CHUAN , PHOON IAN K.Y. , GARDNER DAPHNE
Published: June 2020

Limited evidence exists on the use of FGM in people with type 2 diabetes (T2D) on non-prandial insulin therapies.

Aim: To study the feasibility of intermittent FGM and education among sub-optimally controlled T2D. Adult T2Ds on any treatment but prandial insulin, HbA1c 7.5-10%, received Freestyle Libre sensor and structured education. Sensor use was continuous for 6 weeks (w), then 2 weekly up to 24w. A blinded sensor was worn at -2w and 24w. n=28, 11 men, mean age 55± 12 y, BMI 27.2 ± 4 kg/m2, 6/28 on basal insulin. Mean HbA1c fell from baseline of 8.5 ± 0.5% to 7.9 ± 0.9% (69 to 63 mmol/mol, p=0.001) and was sustained to 24w (fig 1). SD and TAR (>13.9 mmol/L) showed a trend to improvement (Table 1). Intermittent FGM use with education in T2D showed a sustained improvement in glycemia up to 24 weeks.

Disclosure

S. Rama Chandran: None. M. Gandhi: None. K. Adaikan: None. N. Tan: None. I.K.Y. Phoon: None. D. Gardner: None.

Funding

Singapore Ministry of Health (MH34:31/2)
897-P: Real-World Response to Real-Time Continuous Glucose Monitoring by Caregivers of Children with Type 1 Diabetes
Authors: HOWELL HALEY , YEUNG BRITTANY J. , NGUYEN ANDREW , WONG JENISE C.
Published: June 2020

The use of real-time continuous glucose monitoring (CGM) is on the rise in children with type 1 diabetes (T1D), but little is known about how caregivers respond to high and low sensor glucose (SG) values in a real-world setting. We previously reported results from a cross-sectional survey, distributed throughout the United States, of 169 caregivers of children with T1D using CGM. In the current study, 21 of these participants, who were also using insulin pumps, voluntarily contributed their device data anonymously through the Tidepool platform. Up to 90 days of CGM and pump data per participant were analyzed to determine how caregivers respond to SG levels below and above target range. The children had a mean age of 8.8 ± 3.0 years, were 60% female, were 15% ethnic minority or mixed ethnicity, and had an average hemoglobin A1c of 7.2% ± 0.8%. For these participants in a 90-day period, there were a total of 453,908 CGM values, or a mean of 7205 values per 30 days per participant (mean 2263 to 14,323 values per 30 days for each participant). The average SG was 171.7 ± 29.9 mg/dL, with 57.8% of sensor values between 70-180 mg/dL. The percentage of values in hypoglycemic range (<70 mg/dL) was 2.9% and the percentage in hyperglycemic range (>180 mg/dL) was 39.3%. Per 30 days, participants had means of 26.6 ± 30.3 hypoglycemic and 73.7 ± 28.6 hyperglycemic events lasting at least 15 minutes. Glucose values were rarely entered into pumps within 5 minutes of having SG values outside of target range for at least 15 minutes and were entered for 2.7% ± 5.3% of hypoglycemic and 3.0% ± 3.5% of hyperglycemic episodes. In response to high SG lasting at least 15 minutes, an insulin bolus was given 4.7% ± 4.0% of the time within 5 minutes and 59.3% ± 36.8% of the time within 60 minutes. The variable response to hypo- and hyperglycemia suggests further interventions that decrease the need for caregivers to perform active tasks in response to CGM data may help ease management burden and improve time in target range.

Disclosure

H. Howell: None. B.J. Yeung: None. A. Nguyen: None. J.C. Wong: Consultant; Self; pH Pharma. Research Support; Self; Dexcom, Inc.

Funding

Dexcom, Inc. (IIS-2017-048)
9-LB: Novel Somatostatin Receptor 2 Antagonist ZT-01 Prevents Hypoglycemia Onset in STZ-Diabetic Rats by Improving Glucagon Secretion
Authors: AIKEN JULIAN , D’SOUZA NINOSCHKA C. , SIMONSON ERIC , FARHAT RAWAD , CHAN OWEN , LIGGINS RICHARD , RIDDELL MICHAEL
Published: June 2020

Iatrogenic hypoglycemia remains one of the most serious risks for people with type 1 diabetes (T1D) undergoing intensive insulin therapy. Development of counterregulatory failure, occurring in the early stages of diabetes, highlighted by loss of the ability to secrete glucagon in response to hypoglycemia, is one of the main contributing factors. While the reason for this loss is still uncertain, it has been suggested that enhanced secretion of the pancreatic hormone, somatostatin, in T1D may play a role. Previously, it was reported that antagonism of somatostatin receptor 2 (SSTR2) with the peptide PRL-2903 successfully improved the glucagon response to insulin-induced hypoglycemia in streptozotocin (STZ)-diabetic rats. In the current study, we assessed the effectiveness of a new SSTR2 antagonist, ZT-01, to prevent hypoglycemia during an insulin bolus challenge and evaluated the effect of both ZT-01 and PRL-2903 under stepped hyperinsulinemic-euglycemic-hypoglycemic clamp conditions. In both studies, STZ-diabetic rats maintained with daily insulin were administered either vehicle, PRL-2903 (10 mg/kg) or ZT-01 (10 mg/kg) intraperitoneally, one hour prior to the induction of hypoglycemia. ZT-01 was more effective than PRL-2903 in preventing the onset of hypoglycemia in response to the insulin bolus challenge. Median time of hypoglycemia onset (BG ≤54 mg/dL) was 60 min in controls, 70 min with PRL-2903 administration, and 125 min with ZT-01 administration. Furthermore, all control and PRL-2903 dosed rats experienced, while 28% of rats receiving ZT-01, avoided hypoglycemia. During the hypoglycemic clamp, ZT-01 was more effective than PRL-2903 at improving glucagon responses in hypoglycemia. ZT-01 administration increased glucagon peak by 4-fold over the response to PRL-2903 (P<0.05). We conclude that ZT-01 may be an effective compound that can be used for the restoration of the glucagon response to hypoglycemia in patients with T1D.

Disclosure

J. Aiken: None. N.C. D’Souza: None. E. Simonson: None. R. Farhat: None. O. Chan: None. R. Liggins: Advisory Panel; Self; Zucara Therapeutics Inc. Stock/Shareholder; Self; Zucara Therapeutics Inc. M. Riddell: Advisory Panel; Self; Zucara Therapeutics Inc. Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc., Insulet Corporation. Speaker’s Bureau; Self; Medtronic, Novo Nordisk A/S.

Funding

JDRF; The Leona M. and Harry B. Helmsley Charitable Trust
90-OR: Inhibition of miRNA-200b Rescues Diabetes-Impaired Angiogenesis
Authors: CANNIZZO CARLA , SOLLY EMMA , OLAYA LUISA F. , ABDOLLAHI MARYAM , SUTANTO SURYA S. , TWIGG STEPHEN M. , BURSILL CHRISTINA , TAN JOANNE T. , MCLENNAN SUSAN
Published: June 2020

Impaired angiogenic responses to ischemia characterize the vascular complications associated with diabetes. Diabetic foot ulcers in the presence of ischemia are associated with the most severe outcomes, including a higher rate of mortality and lower probability of healing. Specific micro-RNAs (miRNAs) such as miRNA-200b have been shown to negatively regulate angiogenesis in ischemia. Therefore, we sought to investigate miRNA-200b as a target and biomarker of diabetes-impaired angiogenesis. To assess the importance of miRNA-200b in diabetes-impaired angiogenesis, we transfected endothelial cells with anti-miRNA-200b or anti-miRNA-Neg then performed a functional tubulogenesis assay under high glucose and hypoxic conditions. High glucose impaired tubule formation by 23.6% in response to hypoxia when compared to controls (51.9±15.4 vs. 39.7±23.2, P<0.005), this decrease was prevented by anti-miRNA-200b treatment. Furthermore, in an in vivo hind-limb ischemia model, diabetic mice (n=8-11/group) were injected intramuscularly with anti-miRNA-200b or anti-miRNA-Neg at the time of hind-limb ischemia surgery. Diabetes impaired blood flow reperfusion was assessed by laser Doppler perfusion imaging (LDPI) in anti-miRNA-Neg control mice (LDPI: 0.27), and this was rescued by inhibition of miRNA-200b to nondiabetic levels (LDPI: 0.41, P<0.05). To assess the utility of miRNA-200b as a biomarker of delayed healing, plasma miRNA-200b was measured in a rodent excisional wound model. When compared to controls, diabetes elevated plasma miRNA-200b in both unwounded and wounded animals, suggesting a diabetes related change. Whether this change is seen in humans remains to be investigated.

In conclusion, this study has identified that miRNA-200b is a potential target of diabetes-impaired angiogenesis as shown in this preclinical model of predominant ischemia in a diabetes setting.

Disclosure

C. Cannizzo: None. E. Solly: None. L.F. Olaya: None. M. Abdollahi: None. S.S. Sutanto: None. S.M. Twigg: Advisory Panel; Self; Abbott, AstraZeneca, Sanofi. Speaker’s Bureau; Self; Abbott, AstraZeneca, Novo Nordisk Inc., Roche Diabetes Care, Sanofi. C. Bursill: None. J.T. Tan: None. S. McLennan: None.
900-P: HbA1c Is an Insufficient Glucose Control Assessment Tool in Type 1 and Type 2 Treated with Insulin
Authors: TOTOMIROVA TZVETELINA , ARNAUDOVA MILA , DASKALOVA IVONA
Published: June 2020

HbA1c is currently used for assessment of glucose control in type 1 and type 2 diabetes patients treated with different therapeutic regiments. Different conditions besides glucose concentration affect its level and, in many cases, HbA1c is insufficient to present glucose control. In our study we compare representativeness of usually used control assessment tools such HbA1c and multiple daily blood glucose measurements with results derived from CGM record. We studied a group of 106 patients (60 men, 46 women; mean age 58.23±10.81 years), 21 patients with type 1 diabetes (on intensified regimen) and 85 patients with type 2 diabetes (33 - on oral medications, 31 - on pre-mixed insulin, 21 - on intensified insulin regimen). Patients were observed for three-month period - they performed eight-point BG measurements at least three time weekly, HbA1c was measured at the end of this period and continuous glucose monitoring with iProTM was performed for seven days. In oral medication treated group a high positive correlation was found between HbA1c (7.13±0.85%) and average blood glucose level during period of CGM (7.15±1.80mmol/l) (p<0.01) with correlation coefficient were (r1=0.742) (p<0.05). In pre-mixed insulin treated group and type 2 with intensified regimen lower positive correlation was found (7.64±1.40% and 7.69±1.23%, respectively 7.64±1.48mmol/l and 7.60±1.30mmol/l), with r2=0.642 (p<0.01) and r3=0.570 (p<0.05). No correlation was found in type 1 diabetes group (r4=0.083). No correlations were found between HbA1c and number of excursions in other groups. Same trend of correlations was found comparing HbA1c and mean BG level in eight-point profile. We conclude that HbA1c is appropriate assessment tool only in oral treated type 2 diabetes patients. In type 1 and insulin treated type 2 patients HbA1c gives relative information about overall control with no precise presenting of glucose fluctuations and out-of-range values of BG.

Disclosure

T. Totomirova: None. M. Arnaudova: None. I. Daskalova: None.
906-P: The Association of British Clinical Diabetologists Audit of Freestyle Libre (FSL) in Diabetes in United Kingdom: Determinants of Time-in-Target Range
Authors: WILMOT EMMA G. , DESHMUKH HARSHAL , PATMORE JANE , SATHYAPALAN THOZHUKAT , WALTON CHRISTOPHER , HERRING ROSELLE , RYDER ROBERT E.
Published: June 2020

Objective: Time in range (TIR) is a novel measure of glucose control endorsed by an international consensus group. TIR describes the percentage of TIR (3.9-10mmol/l), time above range (TAR >10mmol/l) and time below range (TBR, <3.9mmol/l) over a given time period. Given the increased use of FreeStyle Libre (FSL) in the UK we were keen to explore the glucose ranges commonly reported in routine clinical practice.

Methods: The ABCD UK FreeStyle Libre audit invited clinicians to submit routine clinical data from FSL users to a secure web-based tool. Data from 101 UK hospitals were analysed using R3.5.0. Linear regression analysis was used to compare the baseline predictors of TIR . TIR was categorised as internationally accepted (3.9-10mmol/l) or individualised (any range other than 3.0-10mmol/l).

Results: Data were available for 10,370 FSL users; age 38 (±18.7) years, 54% female, diabetes duration 16 (±49) years, and BMI of 25.2 (±16.5) kg/m2. Follow-up HbA1c and TIR data was available for 2191 patients. Of those with both follow-up HbA1c and TIR data, in only 343 (15%) cases did clinicians report on the internationally accepted TIR (3.9-10mmol/l), with a median TIR of 43% (27%-56%). Taking both international and individualised TIR together, 221 (10%) had ≥70% TIR, 822 (37%) ≥50% TIR and 1372 (62%) <50% TIR over 14 days. On multivariate regression analysis baseline age (beta=0.13 P<0.0001, number of FSL scans per day (beta= 0.22, P<0.0001) and baseline HbA1c (beta=-0.45, P<0.0001) were associated with higher TIR. The internationally accepted median TBR (<3.9mmol/l) was 6% (3-11) in this cohort.

Conclusion: This population-based study of FSL users demonstrates a limited uptake of the internationally recommended TIR of 3.9-10mmol/l. There is a need for greater awareness of the international recommendations for TIR measures; only a small proportion of people with type 1 diabetes achieve their goals; the number of scans per day predicts greater TIR.

Disclosure

E.G. Wilmot: Advisory Panel; Self; Abbott, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic. Speaker’s Bureau; Self; Abbott, Eli Lilly and Company, Insulet Corporation, Novo Nordisk Inc., Sanofi. H. Deshmukh: None. J. Patmore: None. T. Sathyapalan: Research Support; Self; Amgen, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk A/S. Other Relationship; Self; Ipsen Biopharmaceuticals. C. Walton: Speaker’s Bureau; Spouse/Partner; Celgene, LEO Pharma, Novartis Pharmaceuticals Corporation. R. Herring: None. R.E. Ryder: Consultant; Self; GI Dynamics Inc. Other Relationship; Self; Novo Nordisk A/S.