Digital Health Interventions for Diabetes: Everything to Gain and Nothing to Lose.

IN BRIEF The traditional approach to integrating new therapies involves long, expensive roadmaps with evidence generation required for multiple stakeholders, most notably regulators and clinicians. More recently, new technologies such as insulin delivery systems and continuous glucose monitoring devices have become mainstream without complete clinical evidence being available when they were first introduced. There is tremendous enthusiasm from investors, industry, and people with diabetes regarding the potential of digital health to add value to diabetes care, and this enthusiasm exists despite a paucity of high-quality clinical evidence from traditional randomized clinical trials. Moreover, the potential of diabetes digital health technologies has been recognized by the U.S. Food and Drug Administration and other regulators, who are changing their approaches to allow easier, earlier access to diabetes software and devices. This wager that digital health will add value makes sense.

Digital Diabetes Congress 2019.

New applications of digital health software and sensors for diabetes are rapidly becoming available. The link between healthcare, wearable or carryable devices, and the use of smartphones is increasingly being used by patients for timely information and by healthcare professionals to deliver information and personalized advice and to encourage healthy behavior. To assemble stakeholders from academia, industry, and government, Diabetes Technology Society and Sansum Diabetes Research Institute hosted the 3rd Annual Digital Diabetes Congress on May 14-15, 2019 in San Francisco. Physicians, entrepreneurs, attorneys, psychologists, and other leaders in the diabetes technology field came together to discuss current and future trends and applications of digital tools in diabetes. The meeting focused on eight topics: 1) User Interface/User Experience (UI/UX) for Digital Health, 2) clinical aspects, 3) marketing, 4) investment, 5) regulation, 6) who owns the data, 7) engagement, and 8) the future of digital health. This meeting report contains summaries of the meeting's eight plenary sessions and eight panel discussions, which were all focused on an important aspect of the development, use, and regulation of diabetes digital tools.

A Review of Predictive Low Glucose Suspend and Its Effectiveness in Preventing Nocturnal Hypoglycemia.

To evaluate the effectiveness of predictive low glucose suspend (PLGS) systems within sensor-augmented insulin infusion pumps at preventing nocturnal hypoglycemia in patients with type 1 diabetes (DM1), we performed a systematic review and meta-analysis of randomized crossover trials. Pubmed and Google Scholar were searched for randomized crossover trials, published between January 2013 and July 2018, in nonpregnant outpatients with DM1, which compared event rates during PLGS overnight periods and non-PLGS overnight periods. The primary outcome was the proportion of overnight periods with one or more hypoglycemic measurement. When available, individual patient data were used to assess the effect of clustering measurements within patients. Four studies (272 patients, 10,735 patient-nights: 5422 PLGS and 5313 non-PLGS) were included in the meta-analysis. Two studies reported patient-level data that permitted assessment of the effect of clustering measurements within patients. The effect on the risk difference was minimal. The proportion of overnight periods with one or more episodes of hypoglycemia was 19.6% for the PLGS periods and 27.8% for the non-PLGS periods. Based on the pooled estimate, PLGS overnight periods were associated with an 8.8% lower risk of hypoglycemia (risk difference -0.088; 95% CI -0.119 to -0.056, I2 = 67.4%, τ2 = 0.0006, 4 studies). PLGS systems can reduce nocturnal hypoglycemic events in patients with DM1.

Diabetes Technology Society Report on the FDA Digital Health Software Precertification Program Meeting.

Diabetes Technology Society (DTS) convened a meeting about the US Food and Drug Administration (FDA) Digital Health Software Precertification Program on August 28, 2018. Forty-eight attendees participated from clinical and academic endocrinology (both adult and pediatric), nursing, behavioral health, engineering, and law, as well as representatives of FDA, National Institutes of Health (NIH), National Telecommunications and Information Administration (NTIA), and industry. The meeting was intended to provide ideas to FDA about their plan to launch a Digital Health Software Precertification Program. Attendees discussed the four components of the plan: (1) excellence appraisal and certification, (2) review pathway determination, (3) streamlined premarket review process, and (4) real-world performance. The format included (1) introductory remarks, (2) a program overview presentation from FDA, (3) roundtable working sessions focused on each of the Software Precertification Program's four components, (4) presentations reflecting the discussions, (5) questions to and answers from FDA, and (6) concluding remarks. The meeting provided useful information to the diabetes technology community and thoughtful feedback to FDA.

Digital Diabetes Congress 2018.

Digital health is capturing the attention of the healthcare community. This paradigm whereby healthcare meets the internet uses sensors that communicate wirelessly along with software residing on smartphones to deliver data, information, treatment recommendations, and in some cases control over an effector device. As artificial intelligence becomes more widely used, this approach to creating individualized treatment plans will increase the opportunities for patients, even if they are in remote settings, to communicate with and learn from healthcare professionals. Simple design is needed to promote use of these tools, especially for the purpose of increased adherence to treatment. Widespread adoption by the healthcare industry will require better outcomes data, which will most likely be in the form of safety and effectiveness results from robust randomized controlled trials, as well as evidence of privacy and security. Such data will be needed to convince investors to direct resources into and regulators to clear new digital health tools. Diabetes Technology Society and William Sansum Diabetes Center launched the Digital Diabetes Congress in 2017 because of great interest in determining the potential benefits, metrics of success, and appropriate components of mobile applications for diabetes. The second annual meeting in this series took place on May 22-23, 2018 in San Francisco. This report contains summaries of the meeting's 4 plenary lectures and 10 sessions. This meeting report presents a summary of how 55 panelists, speakers, and moderators, who are leaders in healthcare technology, see the current and future landscape of digital health tools applied to diabetes.

A Review of Blood Glucose Monitor Accuracy.

The aim of this study was to assess the accuracy of blood glucose monitors (BGMs) from studies reported in the medical literature. A literature review was performed of publications between 2010 and 2017 that presented data about the accuracy of BGMs using ISO 15197 2003 and/or ISO 15197 2013 as target standards. We found 58 publications describing the performance of 143 unique BGM systems, 59 of which were Food and Drug Administration (FDA) cleared. When compared with non-FDA-cleared BGMs, FDA-cleared BGMs were significantly more likely to pass both ISO 15197 2003 (OR = 2.39, CI 1.45-3.92, P < 0.01) and ISO 15197 2013 standards (OR = 2.20, CI 1.51-3.27, P < 0.01). Newer meters were more likely to pass both ISO 15197 2003 and ISO 15197 2013 standards. Many of the studies were supported by BGM manufacturers, and when compared with independent studies, an FDA-cleared BGM was significantly more likely to pass in a manufacturer-supported study for both ISO 15197 2003 (OR = 22.4, CI 8.73-21.57, P < 0.001) and ISO 15197 2013 (OR = 23.08, CI 10.16-60.03, P < 0.001). BGM accuracy should be assessed independently following regulatory clearance to ensure accurate performance. Failure to meet performance levels mandated by standards can result in deleterious clinical and economic effects.