Journal of diabetes science and technology
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J Diabetes Sci Technol · Jan 2013
ReviewFood and Drug Administration regulation of diabetes-related mHealth technologies.
mHealth smartphone applications (apps) offer great promise for managing people with diabetes, as well as those with prediabetes. But to realize that potential, industry needs to get clarity from the U. S. ⋯ Further, should the app simply receive data from a blood glucose meter and graph that data for easier comprehension by the patient, the app would become a class II medical device that requires FDA clearance. Again, we submit that such simple software functionality should not be so discouraged. In this article, we identify the issues that we believe need to be clarified by the FDA in order to unleash the potential of mHealth technology in the diabetes space.
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J Diabetes Sci Technol · Jan 2013
Associations of youth and parent weight status with reported versus predicted daily energy intake and hemoglobin A1c in youth with type 1 diabetes mellitus.
The epidemic of overweight/obesity affects youth with type 1 diabetes mellitus (T1DM) and their families. In youth with T1DM and their parents, we examined weight status with reported and expected energy intake and with youth hemoglobin A1c (HbA1c). ⋯ Similar to the general population, overweight and obesity are prevalent among families of youth with T1DM. Weight status appears to influence self-REI in parents and glycemic control in youth with T1DM, suggesting the need for family-based dietary interventions.
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J Diabetes Sci Technol · Nov 2012
In-vitro performance of the Enlite Sensor in various glucose concentrations during hypobaric and hyperbaric conditions.
There is a need for reliable methods of glucose measurement in different environmental conditions. The objective of this in vitro study was to evaluate the performance of the Enlite® Sensor when connected to either the iPro™ Continuous Glucose Monitor recording device or the Guardian® REAL-Time transmitting device, in hypobaric and hyperbaric conditions. ⋯ The Enlite Sensors connected to either the iPro or the Guardian REAL-Time device provided values continuously. In hyperbaric conditions, no significant differences were seen during changes in ambient pressure; however, during hypobaric conditions, the ISIG was significantly different in the low and high glucose concentrations.
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J Diabetes Sci Technol · Sep 2012
ReviewMobile health applications to assist patients with diabetes: lessons learned and design implications.
Self-management is critical to achieving diabetes treatment goals. Mobile phones and Bluetooth® can supportself-management and lifestyle changes for chronic diseases such as diabetes. A mobile health (mHealth) research platform--the Few Touch Application (FTA)--is a tool designed to support the self-management of diabetes. ⋯ From each of the 10 apps of FTA, respectively, we conclude: (1) automatic BG data transfer is easy to use and provides reassurance; (2) SMS-based education facilitates parent-child communication in T1DM; (3) the T2DM mobile phone diary encourages reflection; (4) the mobile phone diary enhances discussion between patients and HC professionals; (5) the T1DM mobile phone diary is useful and motivational; (6) the T1DM mobile phone picture diary is useful in identifying treatment obstacles; (7) the step counter with automatic data transfer promotes motivation and increases physical activity in T2DM; (8) food information on a phone for T2DM should not be at a detailed level; (9) context sensitivity has good prospects and is possible to implement on today's phones; and (10) BG modeling on mobile phones is promising for motivated T1DM users. We expect that the following elements will be important in future FTA designs: (A) automatic data transfer when possible; (B) motivational and visual user interfaces; (C) apps with considerable health benefits in relation to the effort required; (D) dynamic usage, e.g., both personal and together with HC personnel, long-/short-term perspective; and (E) inclusion of context sensitivity in apps. We conclude that mHealth apps will empower patients to take a more active role in managing their own health.