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      First Real-World Experience With Bigfoot Unity: A 6-Month Retrospective Analysis

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          Abstract

          The Bigfoot Unity Diabetes Management System, a smart pen cap system cleared by the U.S. Food and Drug Administration in May 2021, incorporates continuous glucose monitoring data, real-time glycemic alerts, and clinician-directed dose recommendations. This study analyzed real-world clinical outcomes data for an initial cohort ( n = 58, from 13 clinics) managing multiple daily injection insulin therapy using the pen cap system for 6 months. We examined glycemic control, including hypoglycemia events and interaction with and use of the pen cap system. In a cohort mainly consisting of adults with type 2 diabetes and an average age of 62 years, the results demonstrate close adherence to established glycemic targets, including a relatively short amount of time spent in the hypoglycemic range.

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          Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range

          Tadej Battelino, Thomas Danne, Richard M. Bergenstal … (2019)
          Improvements in sensor accuracy, greater convenience and ease of use, and expanding reimbursement have led to growing adoption of continuous glucose monitoring (CGM). However, successful utilization of CGM technology in routine clinical practice remains relatively low. This may be due in part to the lack of clear and agreed-upon glycemic targets that both diabetes teams and people with diabetes can work toward. Although unified recommendations for use of key CGM metrics have been established in three separate peer-reviewed articles, formal adoption by diabetes professional organizations and guidance in the practical application of these metrics in clinical practice have been lacking. In February 2019, the Advanced Technologies & Treatments for Diabetes (ATTD) Congress convened an international panel of physicians, researchers, and individuals with diabetes who are expert in CGM technologies to address this issue. This article summarizes the ATTD consensus recommendations for relevant aspects of CGM data utilization and reporting among the various diabetes populations.
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            Assessing psychosocial distress in diabetes: development of the diabetes distress scale.

            William H. Polonsky, Lawrence Fisher, Jay Earles … (2005)
            The purpose of this study was to describe the development of the Diabetes Distress Scale (DDS), a new instrument for the assessment of diabetes-related emotional distress, based on four independent patient samples. In consultation with patients and professionals from multiple disciplines, a preliminary scale of 28 items was developed, based a priori on four distress-related domains: emotional burden subscale, physician-related distress subscale, regimen-related distress subscale, and diabetes-related interpersonal distress. The new instrument was included in a larger battery of questionnaires used in diabetes studies at four diverse sites: waiting room at a primary care clinic (n = 200), waiting room at a diabetes specialty clinic (n = 179), a diabetes management study program (n = 167), and an ongoing diabetes management program (n = 158). Exploratory factor analyses revealed four factors consistent across sites (involving 17 of the 28 items) that matched the critical content domains identified earlier. The correlation between the 28-item and 17-item scales was very high (r = 0.99). The mean correlation between the 17-item total score (DDS) and the four subscales was high (r = 0.82), but the pattern of interscale correlations suggested that the subscales, although not totally independent, tapped into relatively different areas of diabetes-related distress. Internal reliability of the DDS and the four subscales was adequate (alpha > 0.87), and validity coefficients yielded significant linkages with the Center for Epidemiological Studies Depression Scale, meal planning, exercise, and total cholesterol. Insulin users evidenced the highest mean DDS total scores, whereas diet-controlled subjects displayed the lowest scores (P < 0.001). The DDS has a consistent, generalizable factor structure and good internal reliability and validity across four different clinical sites. The new instrument may serve as a valuable measure of diabetes-related emotional distress for use in research and clinical practice.
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              IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030.

              David Whiting, Leonor Guariguata, Clara Weil … (2011)
              Diabetes is an increasingly important condition globally and robust estimates of its prevalence are required for allocating resources. Data sources from 1980 to April 2011 were sought and characterised. The Analytic Hierarchy Process (AHP) was used to select the most appropriate study or studies for each country, and estimates for countries without data were modelled. A logistic regression model was used to generate smoothed age-specific estimates which were applied to UN population estimates for 2011. A total of 565 data sources were reviewed, of which 170 sources from 110 countries were selected. In 2011 there are 366 million people with diabetes, and this is expected to rise to 552 million by 2030. Most people with diabetes live in low- and middle-income countries, and these countries will also see the greatest increase over the next 19 years. This paper builds on previous IDF estimates and shows that the global diabetes epidemic continues to grow. Recent studies show that previous estimates have been very conservative. The new IDF estimates use a simple and transparent approach and are consistent with recent estimates from the Global Burden of Disease study. IDF estimates will be updated annually. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Clin Diabetes
                Journal ID (iso-abbrev): Clin Diabetes
                Journal ID (publisher-id): clinical diabetes
                Title: Clinical Diabetes : A Publication of the American Diabetes Association
                Publisher: American Diabetes Association
                ISSN (Print): 0891-8929
                ISSN (Electronic): 1945-4953
                Publication date (Print): Fall 2023
                Publication date (Electronic): 21 June 2023
                Publication date PMC-release: 21 June 2023
                Volume: 41
                Issue: 4
                Pages: 539-548
                Affiliations
                [1 ]East Alabama Endocrinology PC, Opelika, AL
                [2 ]Bigfoot Biomedical, Inc., Milpitas, CA
                Author notes
                Corresponding author: John B. Tillman, jtillman@ 123456bigfootbiomedical.com
                Author information
                https://orcid.org/0000-0003-2912-2370
                Article
                Publisher ID: CD220126
                DOI: 10.2337/cd22-0126
                PMC ID: 10577513
                PubMed ID: 37849519
                SO-VID: a2a02a92-6cc2-4cb7-9411-2ee577757743
                Copyright © © 2023 by the American Diabetes Association
                License:

                Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at https://www.diabetesjournals.org/journals/pages/license.

                History
                Page count
                Pages: 10
                Funding
                Funded by: Bigfoot Biomedical, DOI 10.13039/100014395;
                Categories
                Subject: Feature Articles

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