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.

Digital Diabetes Congress 2017.

The purpose of developing mobile applications for diabetes is generally to: (1) provide enhanced access to timely information for patients, health care professionals, and researchers; (2) facilitate remote monitoring and diagnosis of patients, often based on information delivered by wearable devices; (3) provide decision support to assist patients in selecting treatment; or (4) deliver timely recommendations for treatment to increase adherence to prescribed therapy. There is a perception that mobile applications can provide meaningful clinical benefits, however, there is only sparse convincing evidence to support this belief at the present time. Compounding this problem is the short life span of digital software, such that if a traditional type of randomized controlled trial is conducted on a product, by the time the study has been designed, approved by an IRB, conducted, and analyzed, the product might have significantly changed to a next generation system. Because of great interest in establishing what are the potential benefits, metrics of success, and appropriate components of mobile applications for diabetes, Diabetes Technology Society and William Sansum Diabetes Center launched the Digital Diabetes Congress, March 7-8, 2017, in San Francisco. This report contains summaries of the meeting's 12 sessions. Each summary was written by the session's moderator who helped develop the session prior to the event and keep it on track during the event. This meeting report presents a summary of how 57 panelists, speakers, and moderators, who are leaders in digital health, see the current and future landscape of digital health tools applied to diabetes.

Analysis of Inner and Outer Retinal Thickness in Patients Using Hydroxychloroquine Prior to Development of Retinopathy.

IMPORTANCE: Retinopathy is a known risk of long-term use of hydroxychloroquine sulfate. However, whether the inner as well as outer retina are involved before retinopathy develops and whether changes in the retina might signal impending toxic effects during screening remain unknown. OBJECTIVE: To determine the degree of inner and outer retinal involvement in short- and long-term use of hydroxychloroquine before the development of retinopathy. DESIGN, SETTING, AND PARTICIPANTS: This retrospective medical record review of spectral-domain optical coherence tomography (SD-OCT) findings was performed at an academic medical center. Thirty-two patients without retinopathy and with high-quality SD-OCT images were studied. Twenty-seven patients were age matched (49-65 years old) for comparison of retinal layers among patients who used the drug less than 5 years (n = 12) or longer than 15 years (n = 15) at the initial visit. Populations were also defined (without age limitation) for comparison of change during 25 to 52 months of follow-up among patients with initial use of less than 5 years (n = 7) or longer than 15 years (n = 8). Data were collected from 2010 to 2015. MAIN OUTCOMES AND MEASURES: Measurements of inner and outer retinal thickness in SD-OCT images using commercial software and a Stanford pixel-by-pixel segmentation software that also provided topographic maps of thickness dimensions and change. RESULTS: Thirty-two patients (5 men and 27 women) were included in the analysis. Measurements of inner retinal thickness between short- and long-term hydroxychloroquine users (n = 27) in different retinal regions, and during a median 39 months of follow-up (n = 15), showed no statistically significant differences or change. Similarly, no significant differences or changes were identified in outer retinal thickness except for the final visit of 1 patient who developed focal parafoveal thinning, a toxic effect of hydroxychloroquine use. Cirrus ganglion cell analysis measurements were inaccurate in the presence of outer retinal damage. CONCLUSIONS AND RELEVANCE: The inner retina appears not to be involved in hydroxychloroquine-induced retinopathy to any clinically relevant degree within the limitations of our sample size. No clinically apparent warning of outer retinal damage was seen in the SD-OCT images of long-term hydroxychloroquine users until the actual appearance of focal retinopathy. Early detection of hydroxychloroquine-induced retinopathy is known to prevent visual acuity loss and serious progression after the therapy is stopped, and these data suggest that screening should seek distinct new areas of retinopathy (shown by topographic thickness maps) rather than long-term progressive thinning.

Visual Prognosis of Eyes Recovering From Macular Hole Surgery Through Automated Quantitative Analysis of Spectral-Domain Optical Coherence Tomography (SD-OCT) Scans.

PURPOSE: To determine the value of topographic spectral-domain optical coherence tomography (SD-OCT) imaging features assessed after macular hole repair surgery in predicting visual acuity (VA) outcomes. METHODS: An automated algorithm was developed to topographically outline and quantify area, extent, and location of defects in the ellipsoid zone (EZ) band and inner retina layers in SD-OCT scans. We analyzed the correlation of these values with VA in longitudinal observations from 35 patients who underwent successful macular hole surgery, in their first observation after surgery (within 2 months), and in a single observation within 6 to 12 months after surgery. Image features assessed at the first visit after surgery were also investigated as possible predictors of future VA improvement. RESULTS: Significant correlation with longitudinal VA was found for the extent, circularity, and ratio of defects in EZ band at the fovea and parafoveal regions. The ratio of defects in EZ band at the fovea, temporal-inner, and inferior-inner macula regions showed significant strong correlation with VA within 6 to 12 months post surgery. Patients with worse vision outcome at such time also had a significantly higher rate of inner retinal defects in the superior-outer region in their first postsurgery observation. CONCLUSIONS: A lowering extent of EZ band defects in the foveal and parafoveal regions is a good indicator of postsurgery VA recovery. Attention should also be given to postsurgical alterations in the inner retina, as patients with more extensive atrophic changes appear to have slower or worse VA recovery despite closure of the macular hole.

Localization of damage in progressive hydroxychloroquine retinopathy on and off the drug: inner versus outer retina, parafovea versus peripheral fovea.

PURPOSE: To evaluate the relative involvement of inner and outer retina in hydroxychloroquine (HCQ) retinopathy while on the drug, and after drug cessation, using data from spectral-domain optical coherence tomography (SD-OCT). METHODS: A total of 102 SD-OCT scans were obtained from 11 patients (classified as having early, moderate, or severe stages of toxicity) over a period of 4 years after cessation of HCQ. The inner and outer retina boundaries were identified automatically to measure thickness and characterize progression topographically. RESULTS: The segmentation of retinal layers was verified in SD-OCT cross-sections for all eyes and scans included in this study (a total of 102 scans). Topographic analysis showed that inner retina was not involved in HCQ toxicity to any meaningful degree, either between stages of retinopathy or after the drug is stopped. The characteristic bull's eye pattern of outer macula thinning appears when comparing moderate retinopathy (before any RPE damage) to the early stage. Later damage, as toxicity evolved to a severe stage, was diffuse across most of the macula. If the drug was stopped at an early or moderate stage, progression was limited to the first year and occurred diffusely without parafoveal localization. CONCLUSIONS: Hydroxychloroquine retinopathy primarily involves outer retina (photoreceptors). Outer retinal thinning while using HCQ initially involves the parafovea, but becomes diffuse across the macula as damage progresses or after drug cessation. When HCQ is stopped at an early or moderate stage (before RPE damage), progression seems to be limited to the first year.

Effect of disease stage on progression of hydroxychloroquine retinopathy.

IMPORTANCE: Hydroxychloroquine sulfate retinopathy can progress after the drug is stopped. It is not clear how this relates to the stage of retinopathy or whether early screening with modern imaging technology can prevent progression and visual loss. OBJECTIVE: To determine the relationship between progression of retinopathy and the severity of disease using objective data from optical coherence tomography and assess the value of early screening for the toxic effects of hydroxychloroquine. DESIGN, SETTING, AND PARTICIPANTS: Clinical findings in patients with hydroxychloroquine retinopathy were monitored with repeated anatomical and functional examinations for 13 to 40 months after the drug was stopped in a referral practice in a university medical center. Eleven patients participated, with the severity of toxic effects categorized as early (patchy parafoveal damage shown on field or objective testing), moderate (a 50%-100% parafoveal ring of optical coherence tomography thinning but intact retinal pigment epithelium), and severe (visible bull's-eye damage). MAIN OUTCOMES AND MEASURES: Visual acuity, white 10-2 visual field pattern density plots, fundus autofluorescence, spectral-density optical coherence tomography cross sections, thickness (from cube diagrams), and ellipsoid zone length. RESULTS: Visual acuity and visual fields showed no consistent change. Fundus autofluorescence showed little or no change except in severe cases in which the bull's-eye damage expanded progressively. Optical coherence tomography cross sections showed little visible change in early and moderate cases but progressive foveal thinning (approximately 7 µm/y) and loss of ellipsoid zone (in the range of 100 µm/y) in severe cases, which was confirmed by quantitative measurements. The measurements also showed some foveal thinning (approximately 4 µm/y) and deepening of parafoveal loss in moderate cases, but the breadth of the ellipsoid zone remained constant in both early and moderate cases. A few cases showed a suggestion of ellipsoid zone improvement. CONCLUSIONS AND RELEVANCE: Patients with hydroxychloroquine retinopathy involving the retinal pigment epithelium demonstrated progressive damage on optical coherence tomography for at least 3 years after the drug was discontinued, including loss of foveal thickness and cone structure. Cases recognized before retinal pigment epithelium damage retained foveal architecture with little retinal thinning. Early recognition of hydroxychloroquine toxic effects before any fundus changes are visible, using visual fields and optical coherence tomography (along with fundus autofluorescence and multifocal electroretinography as indicated), will greatly minimize late progression and the risk of visual loss.