Jaeb Center for Health Research

Stevens Point, FL, United States

Jaeb Center for Health Research

Stevens Point, FL, United States

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Importance: Vascular endothelial growth factor plays a role in proliferative diabetic retinopathy (PDR). Intravitreal injection of saline has been shown potentially to lead to improved visual acuity compared with observation alone in eyes with vitreous hemorrhage. Therefore, it is important to determine if intravitreal anti-vascular endothelial growth factor can reduce vitrectomy rates (and risks associated with vitrectomy) compared with saline for vitreous hemorrhage from PDR that precludes placement or confirmation of complete panretinal photocoagulation. Objective: To evaluate intravitreal ranibizumab compared with intravitreal saline injections on vitrectomy rates for vitreous hemorrhage from PDR. Design: Phase 3, double-masked, randomized, multicenter clinical trial. Data reported were collected from June 2010 to March 2012 and include 16 weeks of follow-up. Setting: Community-based and academic-based ophthalmology practices specializing in retinal diseases. Participants: Two hundred sixty-one eyes of 261 study participants, who were at least 18 years of age with type 1 or type 2 diabetes mellitus. Study eyes had vitreous hemorrhage from PDR precluding panretinal photocoagulation completion. Intervention: Eyes were randomly assigned to 0.5-mg intravitreal ranibizumab (n=125) or intravitreal saline (n=136) at baseline and 4 and 8 weeks. Main Outcome Measure: Cumulative probability of vitrectomy within 16 weeks. Results: Cumulative probability of vitrectomy by 16 weeks was 12% with ranibizumab vs 17% with saline (difference, 4%; 95% CI, -4% to 13%) and of complete panretinal photocoagulation without vitrectomy by 16 weeks was 44% and 31%, respectively (P=.05). The mean (SD) visual acuity improvement from baseline to 12 weeks was 22 (23) letters and 16 (31) letters, respectively (P=.04). Recurrent vitreous hemorrhage occurred within 16 weeks in 6% and 17%, respectively (P=.01). One eye developed endophthalmitis after saline injection. Conclusions and Relevance: Overall, the 16-week vitrectomy rates were lower than expected in both groups. This study suggests little likelihood of a clinically important difference between ranibizumab and saline on the rate of vitrectomy by 16 weeks in eyes with vitreous hemorrhage from PDR. Short-term secondary outcomes including visual acuity improvement, increased panretinal photocoagulation completion rates, and reduced recurrent vitreous hemorrhage rates suggest biologic activity of ranibizumab. Long-term benefits remain unknown. Whether vitrectomy rates after saline or ranibizumab injection are different than observation alone cannot be determined from this study. © 2013 American Medical Association. All rights reserved.

Russell S.J.,Massachusetts General Hospital | Beck R.W.,Jaeb Center for Health Research
Diabetes Care | Year: 2016

The development of artificial pancreas systems has evolved to the point that pivotal studies designed to assess efficacy and safety are in progress or soon to be initiated. These pivotal studies are intended to provide the necessary data to gain clearance from the U.S. Food and Drug Administration, coverage by payers, and adoption by patients and clinicians. Although there will not be one design that is appropriate for every system, there are certain aspects of protocol design that will be considerations in all pivotal studies designed to assess efficacy and safety. One key aspect of study design is the intervention to be used by the control group. A case can be made that the control group should use the currently available best technology, which is sensor-augmented pump therapy. However, an equally, if not more, compelling case can be made that the control intervention should be usual care. In this Perspective, we elaborate on this issue and provide a pragmatic approach to the design of clinical trials of artificial pancreas systems. © 2016 by the American Diabetes Association.

Bressler N.M.,Johns Hopkins University | Beck R.W.,Jaeb Center for Health Research | Ferris III F.L.,U.S. National Institutes of Health
New England Journal of Medicine | Year: 2011

A 55-year-old man with a 20-year history of type 2 diabetes mellitus was referred to a retina specialist after noticing a few black floaters in his left eye for the preceding week. His glycated hemoglobin level was 8.2%. He had no history of laser treatment for proliferative diabetic retinopathy in either eye. Ophthalmoscopic examination of the right eye showed venous beading, intraretinal microvascular abnormalities, and no macular edema. Ophthalmoscopic examination of the left eye showed extensive neovascularization of the disk, consisting of new vessels extending beyond the optic disk in all directions (Fig. 1A). The retina specialist diagnosed severe nonproliferative diabetic retinopathy in the right eye and high-risk proliferative diabetic retinopathy in the left eye, with no macular edema in either eye. The specialist recommended prompt initiation of panretinal photocoagulation in the left eye. Copyright © 2011 Massachusetts Medical Society.

Miller K.M.,Jaeb Center for Health Research | Foster N.C.,Jaeb Center for Health Research | Beck R.W.,Jaeb Center for Health Research | Bergensta R.M.,International Diabetes Center Park Nicollet | And 4 more authors.
Diabetes Care | Year: 2015

To examine the overall state of metabolic control and current use of advanced diabetes technologies in the U.S., we report recent data collected on individuals with type 1 diabetes participating in the T1D Exchange clinic registry. Data from 16,061 participants updated between 1 September 2013 and 1 December 2014 were compared with registry enrollment data collected from 1 September 2010 to 1 August 2012. Mean hemoglobin A1c (HbA1c) was assessed by year of age from <4 to >75 years. The overall average HbA1c was 8.2% (66 mmol/mol) at enrollment and 8.4% (68 mmol/mol) at the most recent update. During childhood, mean HbA1c decreased from 8.3% (67 mmol/mol) in 2-4-year-olds to 8.1% (65 mmol/mol) at 7 years of age, followed by an increase to 9.2% (77 mmol/mol) in 19-year-olds. Subsequently, mean HbA1c values decline gradually until 30 years of age, plateauing at 7.5-7.8%(58-62mmol/mol) beyond age 30 until amodest drop inHbA1c below 7.5% (58mmol/mol) in those 65 years of age. Severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) remain all too common complications of treatment, especially in older (SH) and younger patients (DKA). Insulin pump use increased slightly from enrollment (58-62%), and use of continuous glucose monitoring (CGM) did not change (7%). Although the T1D Exchange registry findings are not population based and could be biased, it is clear that there remains considerable room for improving outcomes of treatment of type 1 diabetes across all age-groups. Barriers to more effective use of current treatments need to be addressed and new therapies are needed to achieve optimal metabolic control in people with type 1 diabetes. ©2015 by the American Diabetes Association.

Beck R.W.,Jaeb Center for Health Research
Archives of Ophthalmology | Year: 2011

With the recent increases and future projected increases in the incidence of type 2 diabetes mellitus and with the incidence increasing in teenagers and young adults, the already substantial public health effect of diabetes and diabetic retinopathy will become greater in years to come. Despite the strength of the evidence that optimizing control of glucose, blood pressure, and lipid levels will reduce the incidence and progression of diabetic retinopathy, metabolic control remains suboptimal for many patients with diabetes. In addition, many patients do not follow recommended guidelines for regular eye examinations, which is unfortunate because there is good evidence that with regular follow-up and intervention with photocoagulation as indicated, severe vision loss from diabetic retinopathy is uncommon. Yet, diabetic retinopathy is a leading cause of severe vision loss in adults. The current health care system too often fails to adequately manage diabetes and is lacking in providing proper education and motivation for patients to optimize their metabolic control. In addition to treating retinopathy, ophthalmologists can play an important role in educating and motivating patients to achieve better metabolic control, which, if successful, potentially could do more to reduce the progression of retinopathy than any of the ocular treatments currently in the armamentarium of the ophthalmologist. ©2011 American Medical Association. All rights reserved.

Gal R.L.,Jaeb Center for Health Research
Cochrane database of systematic reviews (Online) | Year: 2012

Optic neuritis is an inflammatory disease of the optic nerve. It occurs more commonly in women than in men. Usually presenting with an abrupt loss of vision, recovery of vision is almost never complete. Closely linked in pathogenesis to multiple sclerosis, it may be the initial manifestation for this condition. In certain patients, no underlying cause can be found. To assess the effects of corticosteroids on visual recovery of patients with acute optic neuritis. We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 1), MEDLINE (January 1950 to February 2012), EMBASE (January 1980 to February 2012), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to February 2012), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). There were no date or language restrictions in the electronic searches for trials. The electronic databases were last searched on 21 February 2012. We also searched reference lists of identified trial reports to find additional trials. We included randomized trials that evaluated corticosteroids, in any form, dose or route of administration, in people with acute optic neuritis. Two authors independently extracted the data on methodological quality and outcomes for analysis. We included six randomized trials which included a total of 750 participants. Two trials evaluated low dose oral corticosteroids while one trial evaluated low dose intravenous corticosteroids across two treatment arms and two trials evaluated a higher dose of intravenous corticosteroids. One three-arm trial evaluated low-dose oral corticosteroids and high-dose intravenous corticosteroids against placebo. Trials evaluating oral corticosteroids compared varying doses of corticosteroids with placebo. Hence, we did not conduct a meta-analysis of such trials. In a meta-analysis of trials evaluating corticosteroids with total dose greater than 3000 mg administered intravenously, the relative risk of normal visual acuity with intravenous corticosteroids compared with placebo was 1.06 (95% confidence interval (CI) 0.89 to 1.27) at six months and 1.06 (95% CI 0.92 to 1.22) at one year. The risk ratio of normal contrast sensitivity for the same comparison was 1.10 (95% CI 0.92 to 1.32) at six months follow up. We did not conduct a meta-analysis for this outcome at one year follow up since there was substantial statistical heterogeneity. The risk ratio of normal visual field for this comparison was 1.08 (95% CI 0.96 to 1.22) at six months and 1.02 (95% CI 0.86 to 1.20) at one year. Quality of life was assessed and reported in one trial. There is no conclusive evidence of benefit in terms of recovery to normal visual acuity, visual field or contrast sensitivity with either intravenous or oral corticosteroids at the doses evaluated in trials included in this review.

Elman M.J.,Elman Retina Group | Ayala A.,Jaeb Center for Health Research | Bressler N.M.,Wilmer Eye Institute | Browning D.,Charlotte Eye Ear Nose and Throat Assoc. | And 4 more authors.
Ophthalmology | Year: 2015

Objective To report 5-year results from a previously reported trial evaluating intravitreal 0.5 mg ranibizumab with prompt versus deferred (for ≥24 weeks) focal/grid laser treatment for diabetic macular edema (DME). Design Multicenter, randomized clinical trial. Participants Among participants from the trial with 3 years of follow-up who subsequently consented to a 2-year extension and survived through 5 years, 124 (97%) and 111 (92%) completed the 5-year visit in the prompt and deferred groups, respectively. Methods Random assignment to ranibizumab every 4 weeks until no longer improving (with resumption if worsening) and prompt or deferred (≥24 weeks) focal/grid laser treatment. Main Outcome Measures Best-corrected visual acuity at the 5-year visit. Results The mean change in visual acuity letter score from baseline to the 5-year visit was +7.2 letters in the prompt laser group compared with +9.8 letters in the deferred laser group (mean difference, -2.6 letters; 95% confidence interval, -5.5 to +0.4 letters; P = 0.09). At the 5-year visit in the prompt versus deferred laser groups, there was vision loss of ≥10 letters in 9% versus 8%, an improvement of ≥10 letters in 46% versus 58%, and an improvement of ≥15 letters in 27% versus 38% of participants, respectively. From baseline to 5 years, 56% of participants in the deferred group did not receive laser. The median number of injections was 13 versus 17 in the prompt and deferral groups, including 54% and 45% receiving no injections during year 4 and 62% and 52% receiving no injections during year 5, respectively. Conclusions Five-year results suggest focal/grid laser treatment at the initiation of intravitreal ranibizumab is no better than deferring laser treatment for ≥24 weeks in eyes with DME involving the central macula with vision impairment. Although more than half of eyes in which laser treatment is deferred may avoid laser for at least 5 years, such eyes may require more injections to achieve these results when following this protocol. Most eyes treated with ranibizumab and either prompt or deferred laser maintain vision gains obtained by the first year through 5 years with little additional treatment after 3 years. © 2015 American Academy of Ophthalmology.

Gwiazda J.E.,Jaeb Center for Health Research
Investigative Ophthalmology and Visual Science | Year: 2011

PURPOSE. To determine whether progressive-addition lenses (PALs) relative to single-vision lenses (SVLs) slow the progression of low myopia in children with high accommodative lag and near esophoria. METHODS. One hundred eighteen children 8 to <12 years of age with spherical equivalent refraction (SER) from-0.75 to-2.50 D and near esophoria ≥2 PD were enrolled in this double-masked multicenter randomized trial. A key additional eligibility criterion was high accommodative lag, initially defined as at least 0.50 D (accommodative response less than 2.50 D for a 3.00-D demand) and later restricted further to at least 1.00 D. One hundred four subjects had accommodative lag of at least 1.00 D, and 14 had lag between 0.50 and 0.99 D. The children were randomized to receive either PALs with a +2.00-D addition or standard SVLs. The clinicians performing the outcome testing, as well as the children and their families, were masked to treatment group. Follow-up visits occurred every 6 months for 3 years. At annual visits, refractive error was assessed in each eye by using cycloplegic autorefraction. The main outcome measure was change from baseline to 3 years in SER by cycloplegic autorefraction. RESULTS. The mean change in SER between baseline and the 3-year primary outcome visit was-0.87 D in the PAL group and-1.15 D in the SVL group, for a difference of 0.28 D (95% confidence interval [CI], 0.01-0.55D). CONCLUSIONS. The PALs used in this study were found to have a statistically but not clinically significant effect of slowing myopia progression in children with high accommodative lag and near esophoria. © 2011 The Association for Research in Vision and Ophthalmology, Inc.

Beck R.W.,Jaeb Center for Health Research | Tamborlane W.V.,Yale University | Bergenstal R.M.,International Diabetes Center at Park Nicollet | Miller K.M.,Jaeb Center for Health Research | And 2 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2012

Context: The T1D Exchange includes a clinic-based registry, a patient-centric web site called Glu, and a biobank. Objective: The aim of the study was to describe the T1D Exchange clinic registry and provide an overview of participant characteristics. Design: Data obtained through participant completion of a questionnaire and chart extraction include diabetes history, management, and monitoring; general health; lifestyle; family history; socioeconomic factors; medications; acute and chronic diabetic complications; other medical conditions; and laboratory results. Setting: Data were collected from 67 endocrinology centers throughout the United States. Patients: We studied 25,833 adults and children with presumed autoimmune type 1 diabetes (T1D). Results: Participants ranged in age from less than 1 to 93 yr, 50% were female, 82% were Caucasian, 50% used an insulin pump, 6% used continuous glucose monitoring, and 16% had a first-degree family member with T1D. Glycosylated hemoglobin at enrollment averaged 8.3% and was highest in 13 to 25 yr olds. The prevalence of renal disease was ≤4% until T1D was present for at least 10 yr, and retinopathy treatment was ≤2% until T1D was present for at least 20 yr. A severe hypoglycemic event (seizure or coma) in the prior 12 months was reported by 7% of participants and diabetic ketoacidosis in the prior 12 months by 8%. Conclusions: The T1D Exchange clinic registry provides a database of important information on individuals with T1D in the United States. The rich dataset of the registry provides an opportunity to address numerous issues of relevance to clinicians and patients, including assessments of associations between patient characteristics and diabetes management factors with outcomes. Copyright © 2012 by The Endocrine Society.

BOSTON--(BUSINESS WIRE)--T1D Exchange, a nonprofit organization accelerating research to improve outcomes in type 1 diabetes, today published a major research study in Diabetes Care that confirms the use of Continuous Glucose Monitoring (CGM) without regular use of confirmatory Blood Glucose Measurements (BGM) is safe and effective. For years, patients with type 1 diabetes have relied on blood glucose monitoring (BGM), widely known as the finger prick method, to measure their blood glucose levels many times each day and make insulin dosing decisions based on this information. CGM monitors are small wearable devices that automatically capture real-time glucose measures via a sensor that is inserted under the skin and transmits the information wirelessly to a monitoring and display device. CGM systems can detect and alert patients when they may be at risk of hyperglycemia (high blood glucose) or hypoglycemia (low blood glucose), both of which require intervention to avoid more dangerous complications. Over the past few years, adoption of CGM to monitor blood glucose levels has widely grown, according to T1D Exchange’s Clinical Registry which has health data on 32,000 patients with type 1 diabetes. Specifically, adoption of CGM in the registry cohort has grown from 7% CGM use overall (in analysis completed in 2010-2012) to 21% CGM use overall (in analysis completed during 2014-2015). The T1D Exchange Replace-BG research study was conceived to better understand how CGM systems are used by patients, how they affect their health outcomes and to build evidence that will be required to support access to and reimbursement of CGM systems. This research is also critical to advance the field of automated insulin delivery. Automated insulin delivery (AID), commonly referred to the “artificial pancreas,” is the evolution of current diabetes management devices to an integrated system incorporating insulin pumps, algorithms and CGM technology that will allow insulin delivery with little or no input from the patient – thereby relieving a significant burden while improving outcomes. As the first major study of its kind, T1D Exchange coordinated the multi-center study through its clinic network and enrolled 226 adults with type 1 diabetes. All study participants were provided with a Dexcom’s G4 Continuous Glucose Monitoring System with an enhanced algorithm, which was used for the 6-month duration of the study. Participants were split into two study arms: 149 participants dosed their insulin based on the CGM reading alone without first confirming with a blood glucose meter measurement and 77 were required to confirm the CGM reading with a blood glucose measurement before dosing insulin. Among the major findings of the study is the confirmation there was no difference in outcomes for those using only CGM and those using both CGM and BGM. “This study is an important step to support regulatory pathways for the automation of insulin delivery for people with type 1 diabetes,” says Dana Ball, executive director and co-founder of T1D Exchange. “These data are supportive of the recent FDA decision to approve the Dexcom G5 indication for insulin dosing and removes a key obstacle that has prevented reimbursement of CGM by Medicare.” "We are grateful that organizations such as T1D Exchange recognize the need to build evidence around the safety and efficacy of CGM use in treatment decisions,” says Kevin Sayer, president and chief executive officer of Dexcom. “We hope results from this study and the recent FDA decision to expand the indication of the Dexcom G5 system will diminish the hassle and pain of finger stick testing and expand access to CGM technology—ultimately leading to improved control for people with diabetes." This study was funded by The Leona M. and Harry B. Helmsley Charitable Trust and CGMs were donated by Dexcom. The research is being presented today at Advanced Technologies and Treatments for Diabetes (ATTD) in Paris, France by principal investigators from the Jaeb Center for Health Research in Tampa, FL, Katrina J. Ruedy, MSPH, and Roy W. Beck M.D., Ph.D., Director, T1D Exchange Clinic Coordinating Center. “As a practicing endocrinologist, I typically advise my patients who use CGM technology to make treatment decisions based on a BGM reading; however, many of my patients often use CGM readings to make decisions about insulin doses,” stated Grazia Aleppo, MD, Northwestern University and lead author of the study. “The results of this study assures clinicians that patients using CGM for treatment decisions is as safe and effective as BGM.” About T1D Exchange T1D Exchange was founded on the belief that people affected by type 1 diabetes need better solutions faster – better treatments and better care. Our nonprofit organization takes an innovative approach that puts the community of people touched by type 1 diabetes at the center of research that will meaningfully impact their lives. Our integrated model offers researchers access to aggregated clinical, biological, patient-reported outcomes and electronic health record data, all while fostering collaboration among patients, physicians, researchers and industry. Our model is multi-faceted and complex, but our goal is simple: to tangibly improve outcomes for people with type 1 diabetes as fast as humanly possible.

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