bluuebunny/crossref_metadata_2025_split huggingface dataset:
928-P: Capturing Clinical Trends and Lifestyle Behaviour Data of Patients with Diabetes Using an AI-Powered Digital Therapeutic in India
Authors: CHAWLA RAJEEV , KRISHNAKUMAR ARJUN , KHATRY VARSHA , SHAH ABHISHEK , JOSHI SHILPA , PARDIWALA BEHRAM , KOLKE SHARAT , SHAH VIKRANT , IDNANI ROMMEL , MATTOO VINOD 
Published: June 2019

Background: Diabetes self-reported clinical and lifestyle journey by the patient is very poor in India, unless significant additional time is spent by HCPs during appointments. We explored the use of an iPDM (integrated personalized self-management) to amplify self-reported data, without adding any additional time burden to the HCP.
Method: Wellthy Care™ (WC) is a digital therapeutic that delivers an artificial intelligence (AI) augmented disease management program for people with diabetes. In this case, WC was given as a companion to Accu-Chek® Active. WC provides coaching in the form of lessons and quizzes, and uses an AI-based digital persuasion model to encourage users to self-report data on blood glucose, weight, meals, and physical activity, with active feedback on each data point. WC also tracks the duration of physical activity through inbuilt sensors on the phone.
Results: At the time of analysis, a total of 883 users (72.71% males) with an average age of 45.41 years, and an average duration of 30.87 days on the app were available for evaluation. There were a total of 7927 interactions, including 3700 logs and 4207 pieces of content consumed by the users. The users reported a total of 2184 blood sugar logs (499 fasting, 674 pre-meal, 755 post-meal, 256 random), 628 meal logs, 396 activity logs, and 232 weight logs.The average total, fasting, pre-meal, post-meal, and random blood glucose levels were 159.41, 137.8, 144.00, 179.17, and 181.74 mg/dL respectively. The average HbA1c (%), weight, and daily physical activity of the users was 8.64, 74.21 Kg, and 23.94 minutes respectively.
Conclusion: The results confirm Wellthy Care amplifies self-reporting of clinically relevant data by users, without any additional time spent by the treating HCP. An iPDM can be used in resource constrained countries like India to enable the practice of data-driven decision making for personalizing evidence-based care and improving diabetes self-management.

Disclosure
R. Chawla: None. A. Krishnakumar: Employee; Self; Wellthy Therapeutics. V. Khatry: Employee; Self; Roche Diabetes Care. A. Shah: Stock/Shareholder; Self; Wellthy Therapeutics. S. Joshi: None. B. Pardiwala: None. S. Kolke: None. V. Shah: None. R. Idnani: None. V. Mattoo: Consultant; Self; Wellthy Therapeutics.
933-P: Overnight vs. Continuous Long-Term Closed-Loop Control: Patient-Reported Experiences
Authors: SHEPARD JACLYN , GONDER-FREDERICK LINDA , BROWN SUE A. , KOLLAR LAURA L. , EMORY EMMA , KOVATCHEV BORIS 
Published: June 2019

Objective: To evaluate patient experience and preference of overnight vs. continuous long-term (LT) use of closed-loop control (CLC).
Methods: Ten participants (50% female) with T1D diagnosed for ≥1 year participated in the study, with a mean age of 38.0 years, diabetes duration of 15.7 years, and pre-study HbA1c of 7.5% or 58 mmol/mol. The CLC system is comprised of a CGM and a closed-loop control algorithm embedded on an insulin pump. Participants used the system overnight (ON) for 8 weeks and continuous (24/7) use for another 8 weeks. Semi-structured interviews, based on Technology Acceptance Model, were completed after each condition. As part of the interviews, participants rated difficulty, complexity, trust, and LT use probability on a 5-point Likert scale (1 - not at all, 5 - extremely). They also rated utility of the system in BG management, whether benefits outweigh barriers, and system preference on a nominal scale.
Results: Means for the CLC-ON were Difficulty - 1.1, Complexity - 1.25, Trust - 4.6, and Probability of LT Use - 4.1, while means for CLC-24/7 were Difficulty - 1.1, Complexity - 1.1, Trust - 4.5 and Probability of LT Use - 5.0. There were no differences between conditions with the exception of a trend to prefer long-term use of continuous CLC. All participants reported that CLC-ON and CLC-24/7 made it easier to manage their diabetes and that benefits of using CLC, both overnight and 24/7, outweigh drawbacks. All reported preference for using CLC-24/7 on a LT basis compared to CLC-ON. Only one participant (10%) indicated intention to use different systems based on situation.
Conclusions: Participant-reported experiences with the CLC system were generally consistent for overnight and 24/7 use. The majority did not find the system difficult or complex, found it useful in managing their diabetes, and had high trust in the system. However, for LT adoption, there was a clear preference to use CLC on a continuous basis despite perceived ease of use, utility, and trust in the system overnight.

Disclosure
J. Shepard: None. L. Gonder-Frederick: Employee; Self; HFS-Global. Research Support; Self; Dexcom, Inc., Jaeb Center for Health Research, Tandem Diabetes Care. Speaker's Bureau; Self; Diabetes UK. Stock/Shareholder; Self; BeHealth Solutions. S.A. Brown: Research Support; Self; Ascensia Diabetes Care, Dexcom, Inc., Roche Diabetes Care, Tandem Diabetes Care. L.L. Kollar: None. E. Emory: None. B. Kovatchev: Advisory Panel; Self; Sanofi. Board Member; Self; TypeZero Technologies, Inc. Consultant; Self; Sanofi, Tandem Diabetes Care. Research Support; Self; Dexcom, Inc., Roche Diabetes Care, Tandem Diabetes Care. Speaker's Bureau; Self; Dexcom, Inc. Stock/Shareholder; Self; TypeZero Technologies, Inc. Other Relationship; Self; Johnson & Johnson, Sanofi.

Funding
National Institutes of Health
934-P: Continuous, Quantitative, Selective, Nonenzymatic Glucose Monitoring Using Conductimetric Analysis
Authors: WANG BING , PENNATHUR SUMITA , CHOU KUANG-HUA 
Published: June 2019

Commercially available continuous glucose monitors (CGMs) typically use electrochemical sensing methods and depend on the activity of enzymes, which is subject to drift with time. Newly developed optical CGMs also suffer from drift due to the photobleaching of the fluorescent dyes. Accordingly, existing CGMs must be calibrated over periods of hours to days. Here we developed a new molecule that can be used to sense glucose concentration through conductivity sensing. The new recognition molecule binds glucose with a suitable affinity (Kd = 1 mM) and selectivity, and hosts negative charges in physiological conditions after binding with glucose. The glucose binding and charge change alters the charge spices which contribute to the conductivity of solution. Glucose concentration therefore determines the conductivity of solution. We use a conductimetric method based on low voltage AC (∼20 mV) impedance spectroscopy which offers the promise of long-term stability. Current conductimetric sensors shall be interpreted with selective permeable membrane systems and would be used to monitor sampled fluid soon. This sensor does not need expensive enzyme and fluorescent dyes, and the preparation of the novel molecule is easy and low cost. The sensing strategy only uses low voltage power, and thus is more stable than enzymatic and optical methods, providing the possibility of less or no calibration. Our current conductimetric sensors are compatible with the well-developed high frequency AC microchip technology, which makes it lower-powered and easy to be miniaturized.

Disclosure
B. Wang: None. S. Pennathur: Board Member; Self; Laxmi Therapeutic Devices. Consultant; Self; Alveo Technologies. K. Chou: None.

Funding
American Diabetes Association (1-17-VSN-18 to S.P.)
935-P: Identification of Characteristic Daily Glucose Excursions Associated with Triopathy in Adults with Type 1 Diabetes
Authors: MAEDA YASUTAKA , MORITA MAYUKO , TAMURA AYUMI , TAKASU KYOKO , KUROGI YUKIE , NIMURA IKUMI , YOSHIOKA RIE , MINAMI MASAE 
Published: June 2019

Daily glucose profile (DGP) involves various factors contributing to diabetic complications: diet, physical activity, insulin dose, social context and stressors. We aimed to identify specific DGPs susceptive to microvascular complication in T1D, exploring endpoint-oriented CGM metrics.
First, cluster analysis with 5,584 pooled DGPs from 102 T1D subjects detected 4 major clusters characterized as aligned control (A), biphasic dysglycemia (B), continuous nocturnal hyperglycemia (C) and dyscontrol (D) (Figure 1). The presence of neuropathy and nephropathy was significantly associated with the increase of cluster B (+76%, p=0.002) and C (+69%, p=0.002), respectively.
Next, we determined metric ∫B/∫C as the integration of loge (glucose excursions from 70-180 mg/dL):0-12am/:0-6am to represent cluster B/C. To evaluate ∫B/∫C, the retrospective study investigated 18,457 DGPs from 231 adults with T1D (steroid users and available DGPs &lt;10 days were excluded; age 21-78, female 68%, A1c 5.5-12%). The higher ∫B/∫C (Q4) were independent risk factors for retinopathy (OR=3.18), neuropathy (OR=4.69) and the increase of albuminuria (t=2.11) after adjustment for age, gender, duration, smoking, BMI, A1c, HT, HL and T. bilirubin.
New CGM metrics ∫B/∫C derived from vulnerable DGP clusters may support risk assessment and early intervention for diabetic complications.

Disclosure
Y. Maeda: Research Support; Self; Abbott, Arkray, Inc. Speaker's Bureau; Self; Abbott, Arkray, Inc., Astellas Pharma Inc., AstraZeneca, Daiichi Sankyo Company, Limited, Eli Lilly and Company, Kissei Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi, Sumitomo Dainippon Pharma Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Terumo Medical Corporation. M. Morita: None. A. Tamura: None. K. Takasu: None. Y. Kurogi: None. I. Nimura: Speaker's Bureau; Self; Kyowa Hakko Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Taisho Pharmaceutical Co., Ltd. R. Yoshioka: None. M. Minami: Speaker's Bureau; Self; Abbott, Eli Lilly and Company, Medtronic, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi, Terumo Medical Corporation.

Funding
Kondou Kinen Medical Foundation
937-P: Self-Reported Acute Psychological Stress Is Associated with CGM-Based Hyperglycemia in Type 1 Diabetes
Authors: DADLANI VIKASH , PINSKER JORDAN E. , KUMARI KANCHAN , ANDRE CAMILLE C. , CESCON MARZIA , REID COREY , MCCRADY-SPITZER SHELLY K. , THAPA PRABIN , CHURCH MEI MEI , CHOUDHARY DIVYA , DOYLE FRANCIS J. , DASSAU EYAL , KUDVA YOGISH C. 
Published: June 2019

Objective: There have been no clear data describing the association between acute psychological stress and glycemic variability (GV) in people with type 1 diabetes (T1D). Patients self-report that acute stress leads to hyperglycemia.
Methods: Twenty adults with T1D on CGM augmented insulin pump completed self-reported psychological stress diaries for a period of 5 weeks at 2 clinical research centers. Participants reported intensity of stress on a 7-point scale, with 1 indicating mild stress and 7 severe stress, and duration of each stress episode. CGM data were analyzed for week 1 and week 5.
Results: Baseline characteristics were age 44.9±15.0 years, F/M 12/8, HbA1c 6.8±0.7%, and diabetes duration 22.9±15.9 years. Total number of stress events reported was 126 over the two-week period. Subjects reported stress on average of 9±2.2 days representing 64.2%±28.2% of days. GV was compared on days of stress vs. days without stress for each subject. Mean BG did not differ; however, % time spent above 250 mg/dl was less in patients who did not report stress events during the day (6.1± 9.8%) compared to patients with stressful episodes (10.1±17.6%) (p=0.02) (Table).
Discussion: Acute stress in patients with T1D was associated with certain measures of GV. We are currently analyzing GV based on duration and intensity of stress and the time between reported stress and change in glucose.

Disclosure
V. Dadlani: None. J.E. Pinsker: Research Support; Self; Ascensia Diabetes Care, Dexcom, Inc., Insulet Corporation, LifeScan, Inc., Roche Diabetes Care, Tandem Diabetes Care. Speaker's Bureau; Self; Tandem Diabetes Care. K. Kumari: None. C.C. Andre: None. M. Cescon: None. C. Reid: None. S.K. McCrady-Spitzer: None. P. Thapa: None. M. Church: None. D. Choudhary: None. F.J. Doyle: Consultant; Self; ModeAGC. Other Relationship; Self; Insulet Corporation. E. Dassau: Consultant; Self; Eli Lilly and Company, Insulet Corporation. Research Support; Self; Dexcom, Inc., DreaMed Diabetes, Ltd., Insulet Corporation, Roche Diabetes Care, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Speaker's Bureau; Self; Roche Diabetes Care. Other Relationship; Self; ModAGC. Y.C. Kudva: Advisory Panel; Self; Novo Nordisk Inc. Other Relationship; Self; Dexcom, Inc., Roche Diabetes Care, Tandem Diabetes Care.

Funding
JDRF; The Leona M. and Harry B. Helmsley Charitable Trust (2-SRA-2017-503-M-B); Dexcom, Inc. (IIS-2017-043)
938-P: A Novel Wireless Continuous Glucose Monitoring System Using Semiconductor Integration
Authors: MUJEEB-U-RAHMAN MUHAMMAD , NAZARI MEISAM HONARVAR , SENCAN MEHMET 
Published: June 2019

Continuous glucose monitoring (CGM) systems are a key part of modern diabetes management. Although CGMs have advanced significantly, there are still areas of improvement in terms of accuracy, response speed, cost, and size. Such improvements are essential to have a wider adoption among patients. By integrating modern semiconductor and nano technologie, we have created extremely miniaturized (0.1mmx0.6mmx3mm i.e., smaller than a sesame seed) fully wireless, minimally invasive implant for electrochemical glucose sensing in the interstitial fluid. The implant is user-insertable under the skin using a custom injector and is also user-removable. The implant is powered via an external wearable transmitter using standard RFID technology. The transmitter uses a bluetooth low-energy (BLE) link to send the data to a wireless reader for data visualization and further analytics. The smartphone sends data securely to an online database where it is processed, stored, and is shared with caregivers.
We have verified system operation through extensive in-vitro and in-vivo testing (Figure). We have de-risked sensor fabrication and sterilization schemes. The wound healing response and histopathology studies indicate favorable safety and biocompatibility profile for the sensor as it uses standard materials being used in other implants. We are currently working to get FDA IDE for human feasibility testing

Disclosure
M. Mujeeb-U-Rahman: None. M. Honarvar Nazari: None. M. Sencan: Employee; Self; Integrated Medical Sensors Inc. Stock/Shareholder; Self; Integrated Medical Sensors Inc.

Funding
National Institutes of Health; National Science Foundation
939-P: Real-World Performance of the Guardian Connect System with Sugar.IQ
Authors: ARUNACHALAM SIDDHARTH , ZHONG YUXIANG , ABRAHAM SINU BESSY , AGRAWAL PRATIK , VIGERSKY ROBERT , CORDERO TONI L. , KAUFMAN FRANCINE R. 
Published: June 2019

Background: The Guardian Connect continuous glucose monitoring (CGM) system displays current and trending sensor glucose (SG) via smartphone; records insulin, carbohydrate and exercise; and sends predictive high and low SG alerts up to one hour in advance. When used with the Sugar.IQ diabetes assistant application, personalized insights based on behavior patterns (e.g., food log or insulin dose entry) and glycemic outcomes can be tracked with the Glycemic Assist feature.
Methods: System data uploaded between June-November of 2018, by 1765 individuals with diabetes were analyzed. Time in target glucose range (TIR, 70-180 mg/dL) and the Glucose Management Indicator (GMI) were compared between those who used (N=530) or did not use Sugar.IQ. Both groups had ≥5 days of SG data and similar demographic and initial glucose profiles.
Results: System users had a mean GMI of 7.1%, mean±SD SG of 157.0±49.1mg/dL (8.7±2.7mmol/L), and a mean TIR of 64.5%, over the data upload period. When predictive alerts were enabled, excursions were avoided after 31% of high SG alerts and 62% of low SG alerts. Those who accessed Sugar.IQ experienced a TIR increase of 2.7% (p=0.006) and a mean SG decrease of -3.0% (p&lt;0.001), with reductions in SD of SG (47.9mg/dL to 41.5mg/dL, p&lt;0.001) and coefficient of variation of SG (0.32 to 0.29, p&lt;0.001), versus those who did not. Their GMI was also 6.8% versus 6.9% (p=0.007). Those who tracked food at least once/day increased TIR by 5% (p&lt;0.001). Users considered 88% of insights helpful.
Discussion: The Guardian Connect CGM system with Sugar.IQ may advance patient understanding of glucose trends, aid in behavioral change that improves therapy adherence, and lead to better glycemic outcomes.

Disclosure
S. Arunachalam: Employee; Self; Medtronic. Y. Zhong: None. S. Abraham: Employee; Self; Medtronic MiniMed, Inc. P. Agrawal: Employee; Self; Medtronic MiniMed, Inc. Stock/Shareholder; Self; Medtronic. R. Vigersky: Employee; Self; Medtronic MiniMed, Inc. T.L. Cordero: Employee; Self; Medtronic. F.R. Kaufman: Employee; Self; Medtronic.
94-OR: Lipid Nanoparticle-Mediated Delivery of Enhanced Costimulation Blockade to Prevent Type 1 Diabetes
Authors: ZHANG YICHUAN , WANG JIALU , CALDERON-COLON XIOMARA , TIBURZI OLIVIA , LOZANO MARCOS IGLESIAS , PATRONE JULIA , RAIMONDI GIORGIO 
Published: June 2019

Type 1 diabetes (T1D) remains an untreatable autoimmune disease caused by the destruction of pancreatic beta cells by autoreactive T cells. Because of its complex etiology, many immunotherapy strategies have been investigated, but with disappointing results. Costimulation blockade, blocking the CD28 pathway via administration of CTLA4-Ig, is a promising approach, but recent observations suggest its efficacy is antagonized by inflammatory factors. As antigen presenting cells malfunctions and aberrant accumulation of type 1 interferons are associated with T1D, we pose that inhibiting the signaling of inflammatory cytokines via Tofacitinib (Tofa), a JAK inhibitor, would enhance the efficacy of CTLA4-Ig to prevent T1D development. The objective of this study was to design the controlled and localized delivery of Tofa via implementation of biocompatible lipid nanoparticles, Nanostructured Lipid Carrier (NLC), and assess the immunomodulatory impact of this strategy.
We identified a specific composition of NLC that had negligible toxicity, could be readily taken up by multiple immune cells, and had a favorable Tofa encapsulation efficiency. Live animal imaging using fluorescently-labeled NLC confirmed that these particles have the unique property of accumulating in lymphoid tissues. Moreover, when administrated via oral gavage, they bypassed first-pass metabolism and accumulated in spleen, pancreatic and mesenteric lymph nodes. Ex-vivo, Tofa- NLC rapidly delivered Tofa to mouse antigen presenting cells preventing their maturation and the release of inflammatory cytokines. Ongoing experiments show that short-term administration of Tofa-NLC via oral gavage at early (3-week-old) or late (10-week-old) stage in NOD promotes a significant reduction of T1D onset.
Overall, Tofa-NLC represent a promising strategy to complement CTLA4-Ig (currently investigated) and we envision this combination strategy could enhance the efficacy of antigen specific immunotherapy.

Disclosure
Y. Zhang: None. J. Wang: None. X. Calderon-Colon: None. O. Tiburzi: None. M. Iglesias Lozano: None. J. Patrone: None. G. Raimondi: None.
941-P: Frequency of Blood Glucose Monitoring in Relation to Medical Cost and Glycemic Control in Hospitalized Patients with Type 2 Diabetes
Authors: ZHANG LEI , GU YAN , YANG YUXIU , WANG NA , GAO WEIGUO , WANG JUN , YIN XIAOYAN , DONG YANHU 
Published: June 2019

The study aimed to investigate the effect of 7-point or 5-point glucose monitoring on medical costs, glycemic control and the incidence of hypoglycemia in hospitalized patients with type 2 diabetes (T2DM). A total of 4002 patients with T2DM (1490 male and 2512 female cases) with complete medical records were included between 2012 and 2017. The average age was 61.5 years and the mean disease duration 8.68 years. According to the frequency of daily monitoring of blood glucose during hospitalization, patients were divided into 2 subgroups of 5-point group and 7-point group. Patients in 5-point group received fasting blood glucose (FBG), 2h blood glucose (2hBG) after breakfast, 2hBG after lunch, 2hBG after dinner and bedtime blood glucose tests. Patients in 7-point group received additional tests of pre-lunch glucose and pre-dinner blood glucose. Blood glucose monitoring was performed using Johnson & Johnson SureStep blood glucose meter. Comparison of two groups includes duration of in-hospital stay, medical costs, glycemic control and the incidence of hypoglycemia. Patients in 7-point glucose monitoring group had significantly shorter hospital stay (14.4 vs. 16.6 days, P&lt;0.05) and less total medical costs (10324.4 vs. 12087.5 CNY, P&lt;0.05) compared with 5-point group. Laboratory examination cost did not differ significantly between groups (p&gt;0.05). At discharge, both fasting and 2-h glucose decreased significantly compared with baseline levels in either 5-point or 7-point group. In 7-point group, FPG decreased by 2.41mmol/L and 2hPG by 3.9mmol/L. In the 5-point group, the corresponding figures were 2.07mmol/L and 3.6mmol/L, respectively. The incidence of hypoglycemia were 24.2% in 7-point group and 33.1% in 5-point group (P&lt;0.05). In-hospital 7-point daily glucose monitoring improves patients’ adherence to treatment, shortens hospital stay, reduces medical cost, improves blood glucose control, and reduces the incidence of hypoglycemia.

Disclosure
L. Zhang: None. Y. Gu: None. Y. Yang: None. N. Wang: None. W. Gao: None. J. Wang: None. X. Yin: None. Y. Dong: None.
953-P: Sustainable Improvement in Quality of Blood Glucose Control in Users of mySugr’s Integrated Diabetes Management Solution
Authors: MAYER HARALD , BANKOSEGGER RAFAEL P. , KOBER JOHANNA 
Published: June 2019

Objective: The mySugr App is the most widespread mobile health application in the diabetes industry, reaching 1.5M patients in 62 countries. mySugr’s Integrated Diabetes Management solution, the mySugr bundle, introduces unlimited test strip delivery and Certified Diabetes Educator-led coaching. In a previous retrospective study we looked at real world changes in blood glucose (BG) in a U.S. population of mySugr Bundle users. In this follow-up study we extended the observation period of intervention to further analyse the course of effect seen before.
Method: We analyzed changes in BG control (mean±SD, tests in range (TIR), estimated A1c (eA1c)) and frequency of testing. Participants monitored BG ≥3 times/day during the observation period. Data from the first 2 weeks of use (t0), 8 weeks before (t1), 8 weeks after (t2) and 8 to 16 weeks after (t3) initiation of Bundle usage were aggregated and statistically compared using two-sided t-tests.
Results: Study participants were 61 users; 59% with type 1 diabetes, 32.8% with type 2 diabetes, 6.6% with LADA and 1.6% with unreported diabetes type. Baseline BG was 152.0±56.0 mg/dl, eA1c 6.9% and TIR 65%. Significant (p&lt;0.05) improvements were observed in mean BG (-11,8 mg/dl), standard deviation (-5,48 mg/dl), TIR (+6.8%), readings above target (-7.2%) and eA1c (-0.41%) between t0 and t3. A significant improvement was also observed in monitoring frequency (+21.4%) between t1 and t3.
Conclusion: Our previous study suggested use of the mySugr Bundle triggered positive changes of glucose control at 8 weeks post intervention. We were now able to show a sustainable improvement in BG control over an extended time period of 16 weeks, indicating the potential benefits of mobile interventions that combine complementary treatment strategies for therapy adherence over longer time periods. Given that improvements were observed in well-controlled patients, findings support further studies in a wider study population range.

Disclosure
H. Mayer: Employee; Self; mySugr. R.P. Bankosegger: Employee; Self; mySugr. J. Kober: Employee; Self; mySugr.