2,385 results match your criteria Journal of Diabetes Science and Technology [Journal]


Clinical Trial Recruitment and Retention of College Students with Type 1 Diabetes via Social Media: An Implementation Case Study.

J Diabetes Sci Technol 2019 Apr 22:1932296819839503. Epub 2019 Apr 22.

1 Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, MA, USA.

Background: We sought to quantify the efficiency and acceptability of Internet-based recruitment for engaging an especially hard-to-reach cohort (college-students with type 1 diabetes, T1D) and to describe the approach used for implementing a health-related trial entirely online using off-the-shelf tools inclusive of participant safety and validity concerns.

Method: We recruited youth (ages 17-25 years) with T1D via a variety of social media platforms and other outreach channels. We quantified response rate and participant characteristics across channels with engagement metrics tracked via Google Analytics and participant survey data. Read More

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http://dx.doi.org/10.1177/1932296819839503DOI Listing

Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter.

J Diabetes Sci Technol 2019 Apr 11:1932296819841357. Epub 2019 Apr 11.

1 Pfützner Science & Health Institute, Germany.

Background: In recent clinical trials, use of the MyGlucoHealth blood glucose meter (BGM) and electronic diary was associated with an unusual reporting pattern of glycemic data and hypoglycemic events. Therefore, the performance of representative BGMs used by the patients was investigated to assess repeatability, linearity, and hematocrit interference in accordance with regulatory guidelines.

Method: Ten devices and 6 strip lots were selected using standard randomization and repeatability procedures. Read More

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http://dx.doi.org/10.1177/1932296819841357DOI Listing

Postmarket Surveillance of Blood Glucose Monitor Systems Is Needed for Safety of Subjects and Accurate Determination of Effectiveness in Clinical Trials of Diabetes Drugs and Devices.

Authors:
David C Klonoff

J Diabetes Sci Technol 2019 Apr 11:1932296819843398. Epub 2019 Apr 11.

1 Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA.

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http://dx.doi.org/10.1177/1932296819843398DOI Listing

Efficacy and Safety of Degludec Compared to Glargine 300 Units/mL in Insulin-Experienced Patients With Type 2 Diabetes: Trial Protocol Amendment (NCT03078478).

J Diabetes Sci Technol 2019 Apr 11:1932296819841585. Epub 2019 Apr 11.

4 Li Ka Shing Knowledge Institute, Division of Endocrinology and Metabolism, St Michael's Hospital, University of Toronto, Toronto, Canada.

Background: A head-to-head trial (NCT03078478) between insulin degludec and insulin glargine U300 with the primary objective of comparing the risk of hypoglycemia is being conducted. During trial conduct, safety concerns related to the glycemic data collection system led to a postinitiation protocol amendment, described here.

Methods: This randomized (1:1), open-label, treat-to-target, multinational trial was initiated in March 2017 with a planned treatment period of 52 weeks (16 weeks titration + 36 weeks maintenance). Read More

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http://dx.doi.org/10.1177/1932296819841585DOI Listing
April 2019
1 Read

System Accuracy Assessment of a Blood Glucose Meter With Wireless Internet Access Associated With Unusual Hypoglycemia Patterns in Clinical Trials.

J Diabetes Sci Technol 2019 Apr 11:1932296819841353. Epub 2019 Apr 11.

2 Sciema UG, Mainz, Germany.

Background: In recent randomized clinical trials, an unusual reporting pattern of glycemic data and hypoglycemic events potentially related to an internet enabled blood glucose meter (MyGlucoHealth, BGM) was observed. Therefore, this clinical study was conducted to evaluate the system accuracy of the BGM in accordance with the ISO15197:2015 guidelines with additional data collection.

Methods: To investigate system accuracy, 10 of 3088 devices and 6 of 23 strip lots, used in the trials, were selected by a randomization procedure and a standard repeatability assessment. Read More

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http://dx.doi.org/10.1177/1932296819841353DOI Listing
April 2019
2 Reads

Real-World Evidence Should Be Used in Regulatory Decisions About New Pharmaceutical and Medical Device Products for Diabetes.

J Diabetes Sci Technol 2019 Apr 3:1932296819839996. Epub 2019 Apr 3.

4 Sansum Diabetes Research Institute, Santa Barbara, CA, USA.

Randomized clinical trials (RCTs) are no longer the sole source of data to inform guidelines, regulatory, and policy decisions. Real-world data (RWD), collected from registries, electronic health records, insurance claims, pharmacy records, social media, and sensor outputs from devices form real-world evidence (RWE), which can supplement evidence from RCTs. Benefits of using RWE include less time and cost to produce meaningful data; the ability to capture additional information, including social determinants of health that can impact health outcomes; detection of uncommon adverse events; and the potential to apply machine learning and artificial intelligence to the delivery of health care. Read More

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http://dx.doi.org/10.1177/1932296819839996DOI Listing
April 2019
2 Reads

Accuracy of a Point-of-Care Hemoglobin A1c Assay.

J Diabetes Sci Technol 2019 Apr 3:1932296819836101. Epub 2019 Apr 3.

1 Diabetes Center, Massachusetts General Hospital, Boston, MA, USA.

Point-of-care test (POCT) HbA1c assays provide rapidly available results for clinical decision-making. Accuracy and precision must be established. Venous blood samples from 300 patients were assayed for HbA1c by a laboratory technician ("laboratory assessment") with the POCT Alere Afinion™ assay and a laboratory (Premier Affinity) assay. Read More

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http://dx.doi.org/10.1177/1932296819836101DOI Listing
April 2019
1 Read

The Effect of Daily Use of Plantar Mechanical Stimulation Through Micro-Mobile Foot Compression Device Installed in Shoe Insoles on Vibration Perception, Gait, and Balance in People With Diabetic Peripheral Neuropathy.

J Diabetes Sci Technol 2019 Apr 3:1932296819839703. Epub 2019 Apr 3.

1 Interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, USA.

Objective:: People with diabetic peripheral neuropathy (DPN) have impaired gait and balance performance. The aim of this study is to investigate therapeutic effectiveness of mechanical stimulation through a wearable foot compression device equipped in a shoe insole on vibration perception, balance control and gait performance in people with DPN.

Methods:: Using a single-arm 4-week intervention study design, we examined effectiveness of daily use of shoes equipped with the foot compression device (Footbeat™, AVEX, Grand Junction, CO, USA) on improving vibration perception threshold (VPT), skin perfusion pressure (SPP), ankle brachial index (ABI), lower extremities edema (circumferences in the calf and ankle), and motor performance (postural sway with eyes open and closed conditions, and gait performance during normal, dual-task and fast walking). Read More

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http://dx.doi.org/10.1177/1932296819839703DOI Listing
April 2019
4 Reads

Real-World Hypoglycemia Avoidance With a Predictive Low Glucose Alert Does Not Depend on Frequent Screen Views.

J Diabetes Sci Technol 2019 Apr 3:1932296819840691. Epub 2019 Apr 3.

1 Dexcom, Inc, San Diego, CA, USA.

Background:: Frequent real-time continuous glucose monitoring (rtCGM) data viewing has been associated with reduced mean glucose and frequent scanning of an intermittently scanned continuous glucose monitoring (isCGM) system has been associated with reduced hypoglycemia for patients with diabetes. However, requiring patients to frequently interact with their glucose monitoring devices to detect actual or impending hypoglycemia is burdensome. We hypothesized that a predictive low glucose alert, which forecasts glucose ≤55 mg/dL within 20 minutes and is included in a new rtCGM system, could mitigate hypoglycemia without requiring frequent device interaction. Read More

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http://dx.doi.org/10.1177/1932296819840691DOI Listing
April 2019
2 Reads

A Case Report of Diabetic Ketoacidosis With Combined Use of a Sodium Glucose Transporter 2 Inhibitor and Hybrid Closed-Loop Insulin Delivery.

J Diabetes Sci Technol 2019 Mar 31:1932296819838875. Epub 2019 Mar 31.

1 Division of Endocrinology and Metabolism, University of California, San Francisco, San Francisco, CA, USA.

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http://dx.doi.org/10.1177/1932296819838875DOI Listing
March 2019
4 Reads

Impact of Medicare Continuous Subcutaneous Insulin Infusion Policies in Patients With Type 1 Diabetes.

J Diabetes Sci Technol 2019 Mar 31:1932296819838292. Epub 2019 Mar 31.

2 T1D Exchange, Boston, MA, USA.

Background:: The Centers for Medicare and Medicaid Services (CMS) has numerous requirements for coverage of continuous subcutaneous insulin infusion (CSII; insulin pump). Due to recent improvements in diabetes treatment, people with type 1 diabetes are living longer, resulting in an increase in the number of individuals who are eligible for Medicare and are impacted by CMS policies regarding CSII.

Methods:: Two hundred forty-one adults with type 1 diabetes who had been on CSII with CMS coverage for at least 6 months were surveyed. Read More

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http://journals.sagepub.com/doi/10.1177/1932296819838292
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http://dx.doi.org/10.1177/1932296819838292DOI Listing
March 2019
3 Reads

Evaluating Glucose Control With a Novel Composite Continuous Glucose Monitoring Index.

J Diabetes Sci Technol 2019 Mar 31:1932296819838525. Epub 2019 Mar 31.

3 Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.

Objective:: The objective was to describe a novel composite continuous glucose monitoring index (COGI) and to evaluate its utility, in adults with type 1 diabetes, during hybrid closed-loop (HCL) therapy and multiple daily injections (MDI) therapy combined with real-time continuous glucose monitoring (CGM).

Methods:: COGI consists of three key components of glucose control as assessed by CGM: Time in range (TIR), time below range (TBR), and glucose variability (GV) (weighted by 50%, 35% and 15%). COGI ranges from 0 to 100, where 1% increase of time <3. Read More

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http://dx.doi.org/10.1177/1932296819838525DOI Listing
March 2019
1 Read

Simple Linear Support Vector Machine Classifier Can Distinguish Impaired Glucose Tolerance Versus Type 2 Diabetes Using a Reduced Set of CGM-Based Glycemic Variability Indices.

J Diabetes Sci Technol 2019 Mar 31:1932296819838856. Epub 2019 Mar 31.

1 Department of Information Engineering, University of Padova, Padova, Italy.

Background:: Many glycemic variability (GV) indices exist in the literature. In previous works, we demonstrated that a set of GV indices, extracted from continuous glucose monitoring (CGM) data, can distinguish between stages of diabetes progression. We showed that 25 indices driving a logistic regression classifier can differentiate between healthy and nonhealthy individuals; whereas 37 GV indices and four individual parameters, feeding a polynomial-kernel support vector machine (SVM), can further distinguish between impaired glucose tolerance (IGT) and type 2 diabetes (T2D). Read More

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http://dx.doi.org/10.1177/1932296819838856DOI Listing
March 2019
1 Read

Tissue Response to Subcutaneous Infusion Catheter.

J Diabetes Sci Technol 2019 Mar 31:1932296819837972. Epub 2019 Mar 31.

1 Department of Chemical Engineering and Materials Science, Wayne State University, Detroit, MI, USA.

Insulin infusion pump, continuous glucose monitoring (CGM), and insulin infusion set (IIS) have been developed to be increasingly feasible for people with type 1 diabetes (T1D). Several recently approved CGMs are transitioning from 7-day to 10-day wear time without the need for fingerprick recalibration. Nevertheless, studies and improvements on IIS, a critical part of insulin pump therapy, have been limited. Read More

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http://journals.sagepub.com/doi/10.1177/1932296819837972
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http://dx.doi.org/10.1177/1932296819837972DOI Listing
March 2019
7 Reads

Comment on Grino et al: Suitability of Flash Glucose Monitoring for Detection of Hypoglycemia.

J Diabetes Sci Technol 2019 Mar 31:1932296819838534. Epub 2019 Mar 31.

2 Bite Medical Consulting, Bramley, UK.

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http://dx.doi.org/10.1177/1932296819838534DOI Listing
March 2019
1 Read

Social Media Content Analysis of Public Diabetes Facebook Groups.

J Diabetes Sci Technol 2019 Mar 31:1932296819839099. Epub 2019 Mar 31.

1 East Carolina University, Greenville, NC, USA.

Introduction:: Relatively little is known about how Facebook groups are used to facilitate diabetes self-management support. This study provides a critical analysis of public diabetes Facebook groups and their content.

Methods:: Two trained researchers independently identified 34 public Facebook diabetes groups. Read More

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http://dx.doi.org/10.1177/1932296819839099DOI Listing

Pan-European Economic Analysis to Identify Cost Savings for the Health Care Systems as a Result of Integrating Glucose Monitoring Based Telemedical Approaches Into Diabetes Management.

J Diabetes Sci Technol 2019 Mar 27:1932296819835172. Epub 2019 Mar 27.

1 Sciarc GmbH, Baierbrunn, Germany.

Background:: Self-monitoring of blood glucose supported by the diabetes-app OneTouch Reveal® has demonstrated to improve HbA1c. We aimed at analyzing costs savings related the integration of telemedical features into diabetes management.

Methods:: Data from a randomized controlled trial were used to assess the 10-year risk of patients for fatal myocardial infarction (MI). Read More

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http://journals.sagepub.com/doi/10.1177/1932296819835172
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http://dx.doi.org/10.1177/1932296819835172DOI Listing
March 2019
3 Reads

Creating a Legion of Diabetes Patient Advocates: DPAC Policy Training Meeting and Hill Day.

J Diabetes Sci Technol 2019 Mar 25:1932296819832867. Epub 2019 Mar 25.

1 Diabetes Patient Advocacy Coalition, www.diabetespac.org , Tampa, FL, USA.

The Diabetes Patient Advocacy Coalition (DPAC) held a Policy Training Meeting and Hill Day September 29-October 1, 2018, in Washington, DC. Attendees were members of DPAC's Board of Directors and Staff, Patient Advisory Board, and individuals identified through a competitive call for applicants on DPAC's website and social media. We were joined by advocates from the Association of Black Cardiologists and the Endocrine Society. Read More

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http://dx.doi.org/10.1177/1932296819832867DOI Listing

The Need for Accuracy in Hemoglobin A1c Proficiency Testing: Why the Proposed CLIA Rule of 2019 Is a Step Backward.

J Diabetes Sci Technol 2019 Mar 22:1932296819841699. Epub 2019 Mar 22.

8 National Institutes of Health, Bethesda, MD, USA.

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http://dx.doi.org/10.1177/1932296819841699DOI Listing
March 2019
5 Reads

Hemoglobinopathies and Hemoglobin A1c in Diabetes Mellitus.

Authors:
David C Klonoff

J Diabetes Sci Technol 2019 Mar 22:1932296819841698. Epub 2019 Mar 22.

1 Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA.

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http://dx.doi.org/10.1177/1932296819841698DOI Listing

Evaluating the Impact of Human Factors and Pen Needle Design on Insulin Pen Injection.

J Diabetes Sci Technol 2019 Mar 17:1932296819836987. Epub 2019 Mar 17.

1 BD Technologies and Innovation, Research Triangle Park, NC, USA.

Background:: Limited published data exists quantifying the influence of human factors (HF) and pen needle (PN) design on delivery outcomes of pen injection systems. This preclinical in vivo study examines the impact of PN hub design and applied force against the skin during injection on needle penetration depth (NPD).

Method:: To precisely locate injection depth, PN injections (20 µl; 2 IU, U-100 volume equivalent) of iodinated contrast agent were administered to the flank of Yorkshire swine across a range of clinically relevant application forces against the skin (0. Read More

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http://dx.doi.org/10.1177/1932296819836987DOI Listing

Diabetes Technology and Waste: A Complex Problem Piling Up!

J Diabetes Sci Technol 2019 Mar 13:1932296819836395. Epub 2019 Mar 13.

2 WNWN International, Inc, Burlington, CT, USA.

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http://dx.doi.org/10.1177/1932296819836395DOI Listing

Remote Monitoring of Diabetes: A Cloud-Connected Digital System for Individuals With Diabetes and Their Health Care Providers.

J Diabetes Sci Technol 2019 Mar 12:1932296819834054. Epub 2019 Mar 12.

13 CERITD (Centre d'étude et de Recherche pour l'Intensification du Traitement du Diabète), Evry, Department of Diabetes, Sud-Francilien Hospital, Corbeil-Essonnes, France.

Benefits of telemedicine have been proven in the field of diabetes. Among a number of technical solutions, Diabeo® has been studied in both type 1 and type 2 diabetes with intensive insulin therapy. This digital therapeutic system contains a self-monitoring glucose logbook and offers automated insulin dose recommendations thanks to a fully customizable algorithm. Read More

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http://dx.doi.org/10.1177/1932296819834054DOI Listing
March 2019
2 Reads

A Clinical Training Program for Hybrid Closed Loop Therapy in a Pediatric Diabetes Clinic.

J Diabetes Sci Technol 2019 Mar 12:1932296819835183. Epub 2019 Mar 12.

1 University of Colorado, Denver, Barbara Davis Center for Childhood Diabetes, Aurora, CO, USA.

Background:: Hybrid closed loop (HCL) therapy is now available in clinical practice for treatment of type 1 diabetes; however, there is limited research on how to educate patients on this new therapy. The purpose of this quality improvement project was to optimize a HCL education program for pediatric patients with type 1 diabetes (T1D).

Methods:: Our multidisciplinary team developed a novel HCL clinical training program for current insulin pump users, using a quality improvement process called the Plan-Do-Study-Act model. Read More

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http://journals.sagepub.com/doi/10.1177/1932296819835183
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http://dx.doi.org/10.1177/1932296819835183DOI Listing
March 2019
5 Reads

Time to Insulin Initiation in Type 2 Diabetes Patients in 2010/2011 and 2016/2017 in Germany.

J Diabetes Sci Technol 2019 Mar 12:1932296819835196. Epub 2019 Mar 12.

5 Klinik Innere Medizin III, Diabetologie / Nephrologie / Hypertensiologie, Sophien- und Hufeland-Klinikum Weimar, Weimar, Germany.

Background:: The aim of the current study was to determine whether the time to insulin therapy initiation in patients with type 2 diabetes in primary care in Germany has changed in recent years.

Methods:: Longitudinal data from general practices in Germany (Disease Analyzer) were analyzed. These data included information of 7128 patients (age: 68. Read More

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http://dx.doi.org/10.1177/1932296819835196DOI Listing

Using Social Media to Broaden Understanding of the Barriers and Facilitators to Exercise in Adults With Type 1 Diabetes.

J Diabetes Sci Technol 2019 Mar 12:1932296819835787. Epub 2019 Mar 12.

1 Department of Family and Community Medicine, Penn State College of Medicine, Hershey, PA, USA.

Background:: Many people with type 1 diabetes (T1D) do not achieve levels of exercise recommended by the American Diabetes Association, often due to unique barriers, including fear of hypoglycemia. This study aimed to broaden the understanding of barriers and facilitators to exercise among adults with T1D by exploring social media-specifically T1D-themed blogs-in addition to more traditional interviews and journals.

Methods:: Data sources included exercise-focused T1D blog posts (n = 67) and associated comments (n = 717), as well as interviews of and journals kept by adults with T1D (n = 10). Read More

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http://dx.doi.org/10.1177/1932296819835787DOI Listing

The New FDA Real-World Evidence Program to Support Development of Drugs and Biologics.

Authors:
David C Klonoff

J Diabetes Sci Technol 2019 Mar 12:1932296819832661. Epub 2019 Mar 12.

1 Diabetes Research Institute; Mills-Peninsula Health Services, San Mateo, CA, USA.

FDA has launched a Real World Evidence (RWE) Program for using real-world evidence (RWE) to help support new indications for already approved drugs or biologics and postapproval studies. The plan also includes stakeholder engagement efforts, demonstration projects, leadership activities, and development of guidance documents to assist developers interested in using real-world data (RWD) to develop RWE to support FDA regulatory decisions. This plan was mandated by the Cures Act passed in 2016. Read More

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http://dx.doi.org/10.1177/1932296819832661DOI Listing
March 2019
1 Read

Accuracy and Precision of a Point-of-Care HbA1c Test.

J Diabetes Sci Technol 2019 Mar 10:1932296819831292. Epub 2019 Mar 10.

1 Abbott Rapid Diagnostics, a division of Abbott Laboratories, San Diego, CA, USA.

Background:: Point-of-care (POC) hemoglobin A1c (HbA1c) testing has advantages over laboratory testing, but some questions have remained regarding the accuracy and precision of these methods. The accuracy and the precision of the POC Afinion™ HbA1c Dx test were investigated.

Methods:: Samples spanning the assay range were collected from prospectively enrolled subjects at three clinical sites. Read More

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http://journals.sagepub.com/doi/10.1177/1932296819831292
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http://dx.doi.org/10.1177/1932296819831292DOI Listing
March 2019
9 Reads

Elderly Patients With Diabetes: Special Aspects to Consider.

J Diabetes Sci Technol 2019 Mar 10:1932296819833862. Epub 2019 Mar 10.

3 Johannes Gutenberg University Mainz, Mainz, Germany.

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http://dx.doi.org/10.1177/1932296819833862DOI Listing

CGM Benefits and Burdens: Two Brief Measures of Continuous Glucose Monitoring.

J Diabetes Sci Technol 2019 Mar 10:1932296819832909. Epub 2019 Mar 10.

3 Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.

Background:: Continuous glucose monitors (CGM) are underutilized by individuals with type 1 diabetes (T1D), particularly during the adolescent years. Little is known about perceptions of CGM benefit and burdens, and few tools exist to quantify this information.

Methods:: Two questionnaires were developed and validated-Benefit of CGM (BenCGM) and Burdens of CGM (BurCGM)-in a sample of adolescents ages 12-19 years involved in the T1D Exchange Registry. Read More

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http://dx.doi.org/10.1177/1932296819832909DOI Listing
March 2019
2 Reads

Insulin-Based Infusion System: Advancing the Development.

J Diabetes Sci Technol 2019 Mar 10:1932296819832876. Epub 2019 Mar 10.

2 Steno Diabetes Center North Jutland, Aalborg, Denmark.

Background:: Deviations in glucose control in critical care have been shown to increase mortality and morbidity. However, optimal glucose control through present technologies has shown to be a challenge. The insulin balanced infusion system (IBIS) is a new and emerging technology. Read More

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http://dx.doi.org/10.1177/1932296819832876DOI Listing
March 2019
4 Reads

State of the Science: A Scoping Review and Gap Analysis of Diabetes Online Communities.

J Diabetes Sci Technol 2019 Mar 10:1932296819831042. Epub 2019 Mar 10.

5 Department of Family and Community Medicine, Penn State College of Medicine, Hershey, PA, USA.

Background:: Individuals with diabetes are using online resources to engage in diabetes online communities to find diabetes-related support and information. The benefits and consequences of DOC (diabetes online community) use are unclear. This scoping review aims to map existing research focused on organic DOCs in which individuals affected by diabetes are interacting with peers. Read More

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http://dx.doi.org/10.1177/1932296819831042DOI Listing

Fingerstick Precision and Total Error of a Point-of-Care HbA1c Test.

J Diabetes Sci Technol 2019 Mar 6:1932296819831273. Epub 2019 Mar 6.

1 Abbott Rapid Diagnostics, a division of Abbott Laboratories, San Diego, CA, USA.

Background:: Point-of-care (POC) HbA1c tests hold the promise of reducing the rates of undiagnosed diabetes, provided they exhibit acceptable analytical performance. The precision and total error of the POC (Afinion™ HbA1c Dx) test were investigated using whole blood samples obtained by fingerstick and venipuncture.

Methods:: Fingerstick samples spanning the assay range were collected from 61 subjects at three representative POC sites. Read More

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http://dx.doi.org/10.1177/1932296819831273DOI Listing

Impact of CGM on the Management of Hypoglycemia Problems: Overview and Secondary Analysis of the HypoDE Study.

J Diabetes Sci Technol 2019 Mar 6:1932296819831695. Epub 2019 Mar 6.

1 Research Institute Diabetes Academy Mergentheim (FIDAM), Bad Mergentheim, Germany.

Hypoglycemia remains the limiting factor of near-normal glucose control in people with diabetes using insulin therapy. Continuous glucose monitoring (CGM) may be able to avoid hypoglycemia and support the management of hypoglycemia problems in clinical care. Real-time continuous glucose monitoring (rtCGM) systems provide alerts if certain predetermined hypo- or hyperglycemic thresholds are exceeded. Read More

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http://dx.doi.org/10.1177/1932296819831695DOI Listing

Proof of Concept Study to Assess the Influence of Oxygen Partial Pressure in Capillary Blood on SMBG Measurements.

J Diabetes Sci Technol 2019 Mar 6:1932296819833369. Epub 2019 Mar 6.

1 Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.

Background:: Measurement results provided by blood glucose monitoring systems (BGMS) can be affected by various influencing factors. For some BGMS using glucose oxidase (GOx)-based test strips, one of these factors is the oxygen partial pressure (pO) of the applied blood sample. Because assessing the potential influence of pO when measuring capillary blood samples is not straight-forward, we performed a proof of concept study. Read More

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http://dx.doi.org/10.1177/1932296819833369DOI Listing

The Expanding Role of Real-World Evidence Trials in Health Care Decision Making.

Authors:
David C Klonoff

J Diabetes Sci Technol 2019 Mar 6:1932296819832653. Epub 2019 Mar 6.

1 Diabetes Research Institute; Mills-Peninsula Health Services, San Mateo, CA, USA.

Real-world evidence (RWE) is the clinical evidence about benefits or risks of medical products derived from analyzing real world data (RWD), which are data collected through routine clinical practice. This article discusses the advantages and disadvantages of RWE studies, how these studies differ from randomized controlled trials (RCTs), how to overcome barriers to current skepticism about RWE, how FDA is using RWE, how to improve the quality of RWE, and finally the future of RWE trials. Read More

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http://dx.doi.org/10.1177/1932296819832653DOI Listing

2018 Diabetes Technology Meeting Agenda.

Authors:

J Diabetes Sci Technol 2019 Mar;13(2):282-292

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http://dx.doi.org/10.1177/1932296819833861DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6399798PMC
March 2019
1 Read

NMR Spectroscopic Analysis to Evaluate the Quality of Insulin: Concentration, Variability, and Excipient Content.

J Diabetes Sci Technol 2019 Feb 19:1932296819831995. Epub 2019 Feb 19.

2 Queen Silvia Children's Hospital, Sahlgrenska University Hospital and Sahlgrenska Academy, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden.

Known and consistent bioactivity between samples of insulin is essential to correctly estimate the dose. Insulin concentration is not the same thing as bioactivity, however, and methods to correctly determine both are required. Here we show that one dimensional nuclear magnetic resonance (1D NMR), in contrast to, for example, reverse phase high pressure liquid chromatography, can be used to determine both insulin concentration as well as confirm the structural integrity required for activity. Read More

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http://journals.sagepub.com/doi/10.1177/1932296819831995
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http://dx.doi.org/10.1177/1932296819831995DOI Listing
February 2019
3 Reads

Carbohydrate Requirement for Exercise in Type 1 Diabetes: Effects of Insulin Concentration.

J Diabetes Sci Technol 2019 Feb 15:1932296819826962. Epub 2019 Feb 15.

2 Department of Engineering and Architecture, University of Trieste, Trieste, Italy.

Physical activity is a keystone of a healthy lifestyle as well as of management of patients with type 1 diabetes. The risk of exercise-induced hypoglycemia, however, is a great challenge for these patients. The glycemic response to exercise depends upon several factors concerning the patient him/herself (eg, therapy, glycemic control, training level) and the characteristics of the exercise performed. Read More

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http://dx.doi.org/10.1177/1932296819826962DOI Listing
February 2019
1 Read

Impact of Human Factors Testing on Medical Device Design: Validation of an Automated CGM Sensor Applicator.

J Diabetes Sci Technol 2019 Feb 14:1932296819831071. Epub 2019 Feb 14.

4 CGParkin Communications, Inc, Henderson, NV, USA.

Improving user engagement with continuous glucose monitoring (CGM) is considered a major requirement for achieving optimal treatment efficacy. Human factors testing is needed to ensure that CGM product designs and requisite training simplify the user experience and enhance usability and patient safety. Dexcom, Inc, recently introduced a novel, "one-button" automatic sensor applicator (ASA) for use with the Dexcom G6 (rtCGM) system. Read More

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http://dx.doi.org/10.1177/1932296819831071DOI Listing
February 2019

Gamification and Behavior Change Techniques in Diabetes Self-Management Apps.

J Diabetes Sci Technol 2019 Feb 14:1932296818822998. Epub 2019 Feb 14.

1 Health Psychology, Johannes Gutenberg University Mainz, Mainz, Germany.

Background:: Diabetes management apps may have positive effects on diabetes self-management. It remains unclear, however, which app features are particularly effective and encourage sustained app usage. Behavior change techniques (BCTs) and gamification are promising approaches to improve user engagement. Read More

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http://dx.doi.org/10.1177/1932296818822998DOI Listing
February 2019
2 Reads

Performance and Usability of Three Systems for Continuous Glucose Monitoring in Direct Comparison.

J Diabetes Sci Technol 2019 Feb 7:1932296819826965. Epub 2019 Feb 7.

2 Abteilung für Innere Medizin / Kompetenzzentrum Diabetes, Privatklinik Wehrle-Diakonissen, Salzburg, Austria.

Background:: To be able to compare continuous glucose monitoring (CGM) systems, they have to be worn in parallel by the same subjects. This study evaluated the performance and usability of three different CGM systems in direct comparison.

Method:: In this open, prospective study at two sites, 54 patients with diabetes wore three CGM systems each (Dexcom G5™ Mobile CGM system [DG5], Guardian™ Connect system [GC], and a Roche CGM system [RCGM]) in parallel for 6 or 7 days in a mixed inpatient and outpatient setting. Read More

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http://journals.sagepub.com/doi/10.1177/1932296819826965
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http://dx.doi.org/10.1177/1932296819826965DOI Listing
February 2019
5 Reads

Evidence From a Long-Term, Systematic Post-Market Surveillance Program: Clinical Performance of a Hematocrit-Insensitive Blood Glucose Test Strip.

J Diabetes Sci Technol 2019 Feb 7:1932296819826968. Epub 2019 Feb 7.

1 LifeScan Scotland, Inverness, UK.

Background:: Described is a manufacturer's systematic post-market evaluation of the long-term clinical accuracy of a commercially available blood glucose monitoring (BGM) test strip product.

Methods:: Production batches of test strips were routinely and regularly sampled and evaluated in a clinical setting to assess product accuracy. Evaluations were performed on capillary blood samples from a minimum of 100 subjects with diabetes, by clinical staff according to instructions for use. Read More

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http://dx.doi.org/10.1177/1932296819826968DOI Listing
February 2019

Continuous Glucose Monitoring Diving and Diabetes: An Update of the Swedish Recommendations.

J Diabetes Sci Technol 2019 Feb 2:1932296819826584. Epub 2019 Feb 2.

2 Department of Pediatrics, Hospital of Halland, Kungsbacka, Sweden.

Divers travel to different countries to explore various diving sites worldwide. In 2005, the Divers Alert Network (DAN) published their guidelines for recreational diving and diabetes mellitus. However, although years have passed, there is still no consensus in the form of international guidelines on diabetes and diving. Read More

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February 2019
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Nasal Glucagon Versus Injectable Glucagon for Severe Hypoglycemia: A Cost-Offset and Budget Impact Analysis.

J Diabetes Sci Technol 2019 Jan 30:1932296819826577. Epub 2019 Jan 30.

1 Ossian Health Economics and Communications, Basel, Switzerland.

Background:: Severe hypoglycemic events (SHEs) in patients with diabetes are associated with substantial health care costs in the United States (US). Injectable glucagon (IG) is currently available for treatment of severe hypoglycemia but is associated with frequent handling errors. Nasal glucagon (NG) is a novel, easier-to-use treatment that is more often administered successfully. Read More

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http://dx.doi.org/10.1177/1932296819826577DOI Listing
January 2019
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Glycemic Variability: Risk Factors, Assessment, and Control.

Authors:
Boris Kovatchev

J Diabetes Sci Technol 2019 Jan 29:1932296819826111. Epub 2019 Jan 29.

1 University of Virginia School of Medicine and School of Engineering and Applied Sciences, UVA Center for Diabetes Technology, Charlottesville, VA, USA.

Glycemic variability (GV) a well-established risk factor for hypoglycemia and a suspected risk factor for diabetes complications. GV is also a marker of the instability of a person's metabolic system, expressed as frequent high and low glucose excursions and overall volatile glycemic control. In this review, the author discusses topics related to the assessment, quantification, and optimal control of diabetes, including (1) the notion that optimal control of diabetes, that is, lowering of HbA1c-the commonly accepted gold-standard outcome-can be achieved only if accompanied by simultaneous reduction of GV; (2) assessment and visualization of the two principal dimensions of GV, amplitude and time, which is now possible via continuous glucose monitoring (CGM) and various metrics quantifying GV and the risks associated with hypo- and hyperglycemic excursions; and (3) the evolution of diabetes science and technology beyond quantifying GV and into the realm of GV control via pharmacological agents, for example, GLP-1 receptor agonists and DPP-4 inhibitors, which have pronounced variability-reducing effect, or real-time automated closed-loop systems commonly referred to as the "artificial pancreas. Read More

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http://dx.doi.org/10.1177/1932296819826111DOI Listing
January 2019
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Hypoglycemia Incidence and Factors Associated in a Cohort of Patients With Type 2 Diabetes Hospitalized in General Ward Treated With Basal Bolus Insulin Regimen Assessed by Continuous Glucose Monitoring.

J Diabetes Sci Technol 2019 Jan 24:1932296818823720. Epub 2019 Jan 24.

7 Department of Medicine, Emory University, Atlanta, GA, USA.

Introduction:: Continuous glucose monitoring (CGM) is a better tool to detect hyper and hypoglycemia than capillary point of care in insulin-treated patients during hospitalization. We evaluated the incidence of hypoglycemia in patients with type 2 diabetes (T2D) treated with basal bolus insulin regimen using CGM and factors associated with hypoglycemia.

Methods:: Post hoc analysis of a prospective cohort study. Read More

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http://dx.doi.org/10.1177/1932296818823720DOI Listing
January 2019
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New Opportunities for Digital Health to Thrive.

J Diabetes Sci Technol 2019 Mar 24;13(2):159-163. Epub 2019 Jan 24.

2 Sansum Diabetes Research Institute, Santa Barbara, CA, USA.

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http://dx.doi.org/10.1177/1932296818822215DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6399801PMC

Behavioral Theory: The Missing Ingredient for Digital Health Tools to Change Behavior and Increase Adherence.

Authors:
David C Klonoff

J Diabetes Sci Technol 2019 Mar 24;13(2):276-281. Epub 2019 Jan 24.

1 Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA.

Behavioral theory is an important factor for designing digital health tools for diabetes to increase adherence to treatment. Many digital health products have not incorporated this method for achieving behavior change. This oversight might explain the disappointing outcomes of many products in this class. Read More

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http://dx.doi.org/10.1177/1932296818820303DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6399799PMC
March 2019
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Insulin-Based Infusion System: Preliminary Study.

J Diabetes Sci Technol 2019 Jan 24:1932296818821349. Epub 2019 Jan 24.

2 Departments of Clinical Medicine and Endocrinology, Aalborg University Hospital, Aalborg, Denmark.

Background:: Optimal glucose control has been shown to be useful in critical care as well as in other settings. Glucose concentrations in patients admitted to critical care are characterized by marked variability and hypoglycemia due to inadequate sensing and treatment technologies.

Methods:: The insulin balanced infusion system (IBIS) is a closed-loop system that uses a system controller, two syringe pumps, and capillary glucose sensor intravenously infusing regular insulin and/or dextrose. Read More

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http://dx.doi.org/10.1177/1932296818821349DOI Listing
January 2019
9 Reads