Publications by authors named "Roy W Beck"

286 Publications

A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial.

Lancet 2021 01;397(10270):208-219

Schneider Children's Medical Center, Petah Tikva, Israel.

Background: Management of type 1 diabetes is challenging. We compared outcomes using a commercially available hybrid closed-loop system versus a new investigational system with features potentially useful for adolescents and young adults with type 1 diabetes.

Methods: In this multinational, randomised, crossover trial (Fuzzy Logic Automated Insulin Regulation [FLAIR]), individuals aged 14-29 years old, with a clinical diagnosis of type 1 diabetes with a duration of at least 1 year, using either an insulin pump or multiple daily insulin injections, and glycated haemoglobin (HbA) levels of 7·0-11·0% (53-97 mmol/mol) were recruited from seven academic-based endocrinology practices, four in the USA, and one each in Germany, Israel, and Slovenia. After a run-in period to teach participants how to use the study pump and continuous glucose monitor, participants were randomly assigned (1:1) using a computer-generated sequence, with a permuted block design (block sizes of two and four), stratified by baseline HbA and use of a personal MiniMed 670G system (Medtronic) at enrolment, to either use of a MiniMed 670G hybrid closed-loop system (670G) or the investigational advanced hybrid closed-loop system (Medtronic) for the first 12-week period, and then participants were crossed over with no washout period, to the other group for use for another 12 weeks. Masking was not possible due to the nature of the systems used. The coprimary outcomes, measured with continuous glucose monitoring, were proportion of time that glucose levels were above 180 mg/dL (>10·0 mmol/L) during 0600 h to 2359 h (ie, daytime), tested for superiority, and proportion of time that glucose levels were below 54 mg/dL (<3·0 mmol/L) calculated over a full 24-h period, tested for non-inferiority (non-inferiority margin 2%). Analysis was by intention to treat. Safety was assessed in all participants randomly assigned to treatment. This trial is registered with ClinicalTrials.gov, NCT03040414, and is now complete.

Findings: Between June 3 and Aug 22, 2019, 113 individuals were enrolled into the trial. Mean age was 19 years (SD 4) and 70 (62%) of 113 participants were female. Mean proportion of time with daytime glucose levels above 180 mg/dL (>10·0 mmol/L) was 42% (SD 13) at baseline, 37% (9) during use of the 670G system, and 34% (9) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] -3·00% [95% CI -3·97 to -2·04]; p<0·0001). Mean 24-h proportion of time with glucose levels below 54 mg/dL (<3·0 mmol/L) was 0·46% (SD 0·42) at baseline, 0·50% (0·35) during use of the 670G system, and 0·46% (0·33) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] -0·06% [95% CI -0·11 to -0·02]; p<0·0001 for non-inferiority). One severe hypoglycaemic event occurred in the advanced hybrid closed-loop system group, determined to be unrelated to study treatment, and none occurred in the 670G group.

Interpretation: Hyperglycaemia was reduced without increasing hypoglycaemia in adolescents and young adults with type 1 diabetes using the investigational advanced hybrid closed-loop system compared with the commercially available MiniMed 670G system. Testing an advanced hybrid closed-loop system in populations that are underserved due to socioeconomic factors and testing during pregnancy and in individuals with impaired awareness of hypoglycaemia would advance the effective use of this technology FUNDING: National Institute of Diabetes and Digestive and Kidney Diseases.
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http://dx.doi.org/10.1016/S0140-6736(20)32514-9DOI Listing
January 2021

Health-Related Quality of Life and Treatment Satisfaction in Parents and Children with Type 1 Diabetes Using Closed-Loop Control.

Diabetes Technol Ther 2021 Jan 28. Epub 2021 Jan 28.

University of Virginia Center for Diabetes Technology, Charlottesville, Virginia, USA.

Hybrid closed-loop systems increase time-in-range (TIR) and reduce glycemic variability. Person-reported outcomes (PROs) are essential to assess the utility of new devices and their impact on quality of life. This article focuses on the PROs for pediatric participants (ages 6-13 years) with type 1 diabetes (T1D) and their parents during a trial using the Tandem Control-IQ system, which was shown to increase TIR and improve other glycemic metrics. One hundred and one children 6 to 13 years old with T1D were randomly assigned to closed-loop control (CLC) or sensor-augmented pump (SAP) in a 16-week randomized clinical trial with extension to 28 weeks during which the SAP group crossed over to CLC. Health-related quality of life and treatment satisfaction measures were obtained from children and their parents at baseline, 16 weeks, and 28 weeks. Neither the children in the CLC group nor their parents had statistically significant changes in PRO outcomes compared with the SAP group at the end of the 16-week randomized controlled trial and the 28-week extension. Parents in the CLC group reported nonsignificant improvements in some PRO scores when compared with the SAP group at 16 weeks, which were sustained at 28 weeks. Sleep scores for parents improved from "poor sleep quality" to "adequate sleep quality" between baseline and 16 weeks, however, the change in scores was not statistically different between groups. Children with T1D who used the Control-IQ system did not experience increased burden compared with those using SAP based on person-reported outcomes from the children and their parents. Clinical Trials Registration: NCT03844789.
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http://dx.doi.org/10.1089/dia.2020.0532DOI Listing
January 2021

Extended Use of the Control-IQ Closed-Loop Control System in Children With Type 1 Diabetes.

Diabetes Care 2021 Feb 21;44(2):473-478. Epub 2020 Dec 21.

Center for Diabetes Technology, University of Virginia, Charlottesville, VA.

Objective: To further evaluate the safety and efficacy of the Control-IQ closed-loop control (CLC) system in children with type 1 diabetes.

Research Design And Methods: After a 16-week randomized clinical trial (RCT) comparing CLC with sensor-augmented pump (SAP) therapy in 101 children 6-13 years old with type 1 diabetes, 22 participants in the SAP group initiated use of the CLC system (referred to as SAP-CLC cohort), and 78 participants in the CLC group continued use of CLC (CLC-CLC cohort) for 12 weeks.

Results: In the SAP-CLC cohort, mean percentage of time in range 70-180 mg/dL (TIR) increased from 55 ± 13% using SAP during the RCT to 65 ± 10% using CLC ( < 0.001), with 36% of the cohort achieving TIR >70% plus time <54 mg/dL <1% compared with 14% when using SAP ( = 0.03). Substantial improvement in TIR was seen after the 1st day of CLC. Time <70 mg/dL decreased from 1.80% to 1.34% ( < 0.001). In the CLC-CLC cohort, mean TIR increased from 53 ± 17% prerandomization to 67 ± 10% during the RCT and remained reasonably stable at 66 ± 10% through the 12 weeks post-RCT. No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either cohort.

Conclusions: This further evaluation of the Control-IQ CLC system supports the findings of the preceding RCT that use of a closed-loop system can safely improve glycemic control in children 6-13 years old with type 1 diabetes from the 1st day of use and demonstrates that these improvements can be sustained through 28 weeks of use.
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http://dx.doi.org/10.2337/dc20-1729DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7818334PMC
February 2021

A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes. Reply.

N Engl J Med 2020 12;383(25):2484

University of Colorado Anschutz Medical Campus, Aurora, CO

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http://dx.doi.org/10.1056/NEJMc2030417DOI Listing
December 2020

More time in glucose range during exercise days than sedentary days in adults living with type 1 diabetes.

Diabetes Technol Ther 2020 Dec 1. Epub 2020 Dec 1.

University of Pennsylvania Perelman School of Medicine, 14640, Philadelphia, Pennsylvania, United States;

Objective: This study analysis was designed to examine the 24-hour effects of exercise on glycemic control as measured by continuous glucose monitoring (CGM).

Methods: Individuals with type 1 diabetes (ages 15-68 years; HbA1c: 7.5±1.5% [mean±SD]) were randomly assigned to complete twice-weekly aerobic, high-intensity interval, or resistance-based exercise sessions in addition to their personal exercise sessions for a period of 4 weeks. Exercise was tracked with wearables and glucose concentrations assessed using CGM. An exercise day was defined as a 24-hour period after the end of exercise, while a sedentary day was defined as any 24-hour period with no recorded exercise ≥10 minutes long. Sedentary days start at least 24 hours after the end of exercise.

Results: Mean glucose was lower (150±45 vs. 166±49 mg/dL, p=0.01), % time-in-range [70-180 mg/dL] higher (62±23 vs. 56±25%, p=0.03), % time >180 mg/dL lower (28±23% vs. 37±26%, p=0.01), and % time <70 mg/dL higher (9.3±10.9% vs. 7.1±9.1%, p=0.04) on exercise days compared with sedentary days. Glucose variability and % time <54 mg/dL did not differ significantly between exercise and sedentary days. No significant differences in glucose control by exercise type were observed.

Conclusion: Participants had lower 24-hour mean glucose levels and a greater TIR on exercise days compared with sedentary days, with mode of exercise affecting glycemia similarly. In summary, this study offers data supporting frequency of exercise as a method of facilitating glucose control but does not suggest an effect for mode of exercise.
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http://dx.doi.org/10.1089/dia.2020.0495DOI Listing
December 2020

A Real-World Prospective Study of the Safety and Effectiveness of the Loop Open Source Automated Insulin Delivery System.

Diabetes Technol Ther 2020 Nov 23. Epub 2020 Nov 23.

Jaeb Center for Health Research, 15310 Amberly Drive, Suite 350, Tampa, Florida, United States, 33647;

Objective: To evaluate the safety and effectiveness of the Loop Do-It-Yourself (DIY) automated insulin delivery system.

Research Design And Methods: A prospective real-world observational study was conducted, which included 558 adults and children (age range 1 to 71 years, mean HbA1c 6.8±1.0%) who initiated Loop either on their own or with community-developed resources and provided data for 6 months.

Results: Mean time-in-range 70-180 mg/dL (TIR) increased from 67±16% at baseline (prior to starting Loop) to 73±13% during the 6 months (mean change from baseline 6.6%, 95% confidence interval 5.9% to 7.4%; P<0.001). TIR increased in both adults and children, across the full range of baseline HbA1c, and in participants with both high and moderate income levels. Median time <54 mg/dL was 0.40% at baseline and changed by -0.05% (95% confidence interval -0.09% to -0.03%, P<0.001). Mean HbA1c was 6.8±1.0% at baseline and decreased to 6.5±0.8% after 6 months (mean difference= -0.33%, 95% confidence interval -0.40% to -0.26%, P<0.001). The incidence rate of reported severe hypoglycemia events was 18.7 per 100 person-years, a reduction from the incidence rate of 181 per 100 person-years during the 3 months prior to the study. Among the 481 users providing Loop data at 6 months, median CGM use was 96% (interquartile range 91% to 98%) and median time Loop was modulating basal insulin was at least 83% (interquartile range 73% to 88%).

Conclusions: The Loop open source system can be initiated with community-developed resources and used safely and effectively by adults and children with T1D.
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http://dx.doi.org/10.1089/dia.2020.0535DOI Listing
November 2020

Closed-Loop Insulin Therapy Improves Glycemic Control in Adolescents and Young Adults: Outcomes from the International Diabetes Closed-Loop Trial.

Diabetes Technol Ther 2021 Jan 21. Epub 2021 Jan 21.

Research Division, Department of Pediatrics, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, USA.

To assess the efficacy and safety of closed-loop control (CLC) insulin delivery system in adolescents and young adults with type 1 diabetes. Prespecified subanalysis of outcomes in adolescents and young adults aged 14-24 years old with type 1 diabetes in a previously published 6-month multicenter randomized trial. Participants were randomly assigned 2:1 to CLC (Tandem Control-IQ) or sensor augmented pump (SAP, various pumps+Dexcom G6 CGM) and followed for 6 months. Mean age of the 63 participants was 17 years, median type 1 diabetes duration was 7 years, and mean baseline HbA1c was 8.1%. All 63 completed the trial. Time in range (TIR) increased by 13% with CLC versus decreasing by 1% with SAP (adjusted treatment group difference = +13% [+3.1 h/day]; 95% confidence interval [CI] 9-16,  < 0.001), which largely reflected a reduction in time >180 mg/dL (adjusted difference -12% [-2.9 h/day],  < 0.001). Time <70 mg/dL decreased by 1.6% with CLC versus 0.3% with SAP (adjusted difference -0.7% [-10 min/day], 95% CI -1.0% to -0.2%,  = 0.002). CLC use averaged 89% of the time for 6 months. The mean adjusted difference in HbA1c after 6 months was 0.30% in CLC versus SAP (95% CI -0.67 to +0.08,  = 0.13). There was one diabetic ketoacidosis episode in the CLC group. CLC use for 6 months was substantial and associated with improved TIR and reduced hypoglycemia in adolescents and young adults with type 1 diabetes. Thus, CLC has the potential to improve glycemic outcomes in this challenging age group. The clinical trial was registered with ClinicalTrials.gov (NCT03563313).
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http://dx.doi.org/10.1089/dia.2020.0572DOI Listing
January 2021

Glycaemic profiles of diverse patients with type 2 diabetes using basal insulin: MOBILE study baseline data.

Diabetes Obes Metab 2021 Feb 17;23(2):631-636. Epub 2020 Nov 17.

Dexcom, Inc., San Diego, California.

Basal insulin is often prescribed to patients with suboptimally controlled type 2 diabetes (T2D); however, its therapeutic efficacy is inadequate in many. During the MOBILE study's baseline phase, we evaluated 173 participants' continuous glucose monitoring (CGM) data (mean ± SD age 57 ± 9 years; 50% female; HbA1c 9.1% [range 7.1%-11.6%]; 40% using sulphonylureas; 19% using NPH; reported self-monitored blood glucose [SMBG] frequency median 1.0 checks/day) who were using basal, but not prandial insulin. Blinded CGM data were recorded for 10 days prior to randomization. The mean glucose value was 208 ± 47 mg/dL and it was lowest in the early morning. Mean time in the 70-180 mg/dL range was 9.6 ± 6.1 hours/day (40% ± 25%). Hyperglycaemia was extensive with medians of 14.7 (61%) and 5.0 (20.9%) hours/day with glucose greater than 180 and 250 mg/dL, respectively. Hypoglycaemia was infrequent (median [IQR] 0 [0, 4.3] minutes/day [0.0% {0.0%, 0.3%}] with glucose less than 70 mg/dL). Blinded CGM highlights the limitations of infrequent SMBG in basal insulin users with T2D and allows characterization of hyperglycaemia and hypoglycaemia in basal insulin users with suboptimal control. The MOBILE study randomized phase will define the benefits of using real-time CGM compared with SMBG in this population.
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http://dx.doi.org/10.1111/dom.14238DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7839741PMC
February 2021

Glycemic Improvement Using Continuous Glucose Monitoring by Baseline Time in Range: Subgroup Analyses from the DIAMOND Type 1 Diabetes Study.

Diabetes Technol Ther 2020 Oct 20. Epub 2020 Oct 20.

Jaeb Center for Health Research, Tampa, Florida, USA.

The DIAMOND study demonstrated that real-time continuous glucose monitors (rtCGMs) improve glycemia for adults with type 1 diabetes using multiple daily injections. This analysis explores the relationship between baseline time in range (TIR) and improvement in TIR using rtCGMs or self-monitoring of blood glucose (SMBG). Baseline TIR was divided into three categories: <40% (9.6 h per day), <50% (12 h per day), and <60% (14.4 h per day). Compared with SMBG, use of rtCGMs increased mean TIR by an additional 16 min per day for participants with a baseline TIR <40%, 77 min per day for baseline TIR <50%, and 88 min per day for baseline TIR <60%. A greater percentage of participants increased TIR by >4 h per day using rtCGMs within the three baseline TIR groups. For participants with a baseline TIR <50%, 29% of rtCGM users improved their TIR by >4 h per day compared with no SMBG users ( < 0.001). Similar trends were found for improvement in mean glucose and time spent in hyper- and hypoglycemic ranges.
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http://dx.doi.org/10.1089/dia.2020.0471DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7906860PMC
October 2020

Diabetes Telehealth Solutions: Improving Self-Management Through Remote Initiation of Continuous Glucose Monitoring.

J Endocr Soc 2020 Sep 23;4(9):bvaa076. Epub 2020 Jun 23.

Northwestern University Feinberg School of Medicine, Chicago, Illinois.

The purpose of this study was to evaluate feasibility of initiating continuous glucose monitoring (CGM) through telehealth as a means of expanding access. Adults with type 1 diabetes (N = 27) or type 2 diabetes using insulin (N = 7) and interest in starting CGM selected a CGM system (Dexcom G6 or Abbott FreeStyle Libre), which they received by mail. CGM was initiated with a certified diabetes care and education specialist providing instruction via videoconference or phone. The primary outcome was days per week of CGM use during the last 4 weeks. Hemoglobin A (HbA) was measured at baseline and 12 weeks. Participant self-reported outcome measures were also evaluated. All 34 participants (mean age, 46 ± 18 years; 53% female, 85% white) were using CGM at 12 weeks, with 94% using CGM at least 6 days per week during weeks 9 to 12. Mean HbA decreased from 8.3 ± 1.6 at baseline to 7.2 ± 1.3 at 12 weeks ( < .001) and mean time in range (70-180 mg/dL, 3.9-10.0 mmol/L) increased from an estimated 48% ± 18% to 59% ± 20% ( < .001), an increase of approximately 2.7 hours/day. Substantial benefits of CGM to quality of life were observed, with reduced diabetes distress, increased satisfaction with glucose monitoring, and fewer perceived technology barriers to management. Remote CGM initiation was successful in achieving sustained use and improving glycemic control after 12 weeks as well as improving quality-of-life indicators. If widely implemented, this telehealth approach could substantially increase the adoption of CGM and potentially improve glycemic control for people with diabetes using insulin.
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http://dx.doi.org/10.1210/jendso/bvaa076DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448105PMC
September 2020

A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes.

N Engl J Med 2020 08;383(9):836-845

From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).

Background: A closed-loop system of insulin delivery (also called an artificial pancreas) may improve glycemic outcomes in children with type 1 diabetes.

Methods: In a 16-week, multicenter, randomized, open-label, parallel-group trial, we assigned, in a 3:1 ratio, children 6 to 13 years of age who had type 1 diabetes to receive treatment with the use of either a closed-loop system of insulin delivery (closed-loop group) or a sensor-augmented insulin pump (control group). The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring.

Results: A total of 101 children underwent randomization (78 to the closed-loop group and 23 to the control group); the glycated hemoglobin levels at baseline ranged from 5.7 to 10.1%. The mean (±SD) percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter increased from 53±17% at baseline to 67±10% (the mean over 16 weeks of treatment) in the closed-loop group and from 51±16% to 55±13% in the control group (mean adjusted difference, 11 percentage points [equivalent to 2.6 hours per day]; 95% confidence interval, 7 to 14; P<0.001). In both groups, the median percentage of time that the glucose level was below 70 mg per deciliter was low (1.6% in the closed-loop group and 1.8% in the control group). In the closed-loop group, the median percentage of time that the system was in the closed-loop mode was 93% (interquartile range, 91 to 95). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group.

Conclusions: In this 16-week trial involving children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with the use of a closed-loop system than with the use of a sensor-augmented insulin pump. (Funded by Tandem Diabetes Care and the National Institute of Diabetes and Digestive and Kidney Diseases; ClinicalTrials.gov number, NCT03844789.).
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http://dx.doi.org/10.1056/NEJMoa2004736DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7920146PMC
August 2020

Assessing Mealtime Macronutrient Content: Patient Perceptions Versus Expert Analyses via a Novel Phone App.

Diabetes Technol Ther 2021 Feb 29;23(2):85-94. Epub 2020 Sep 29.

Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.

People with type 1 diabetes estimate meal carbohydrate content to accurately dose insulin, yet, protein and fat content of meals also influences postprandial glycemia. We examined accuracy of macronutrient content estimation via a novel phone app. Participant estimates were compared with expert nutrition analyses performed via the Remote Food Photography Method© (RFPM©). Data were collected through a novel phone app. Participants were asked to take photos of meals/snacks on the day of and day after scheduled exercise, enter carbohydrate estimates, and categorize meals as low, typical, or high protein and fat. Glycemia was measured via continuous glucose monitoring. Participants ( = 48) were 15-68 years (34 ± 14 years); 40% were female. The phone app plus RFPM© analysis captured 88% ± 29% of participants' estimated total energy expenditure. The majority (70%) of both low-protein and low-fat meals were accurately classified. Only 22% of high-protein meals and 17% of high-fat meals were accurately classified. Forty-nine percent of meals with <30 g of carbohydrates were overestimated by an average of 25.7 ± 17.2 g. The majority (64%) of large carbohydrate meals (≥60 g) were underestimated by an average of 53.6 ± 33.8 g. Glycemic response to large carbohydrate meals was similar between participants who underestimated or overestimated carbohydrate content, suggesting that factors beyond carbohydrate counting may impact postprandial glycemic response. Accurate estimation of total macronutrients in meals could be leveraged to improve insulin decision support tools and closed loop insulin delivery systems; development of tools to improve macronutrient estimation skills should be considered.
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http://dx.doi.org/10.1089/dia.2020.0357DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7868577PMC
February 2021

Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial.

JAMA 2020 06;323(23):2388-2396

Jaeb Center for Health Research, Tampa, Florida.

Importance: Adolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated.

Objective: To determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes.

Design, Setting, And Participants: Randomized clinical trial conducted between January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9%.

Interventions: Participants were randomized 1:1 to undergo CGM (CGM group; n = 74) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n = 79).

Main Outcomes And Measures: The primary outcome was change in HbA1c from baseline to 26 weeks. There were 20 secondary outcomes, including additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate.

Results: Among the 153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study. In the CGM group, 68% of participants used CGM at least 5 days per week in month 6. Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01). Of 20 prespecified secondary outcomes, there were statistically significant differences in 3 of 7 binary HbA1c outcomes, 8 of 9 CGM metrics, and 1 of 4 patient-reported outcomes. The most commonly reported adverse events in the CGM and BGM groups were severe hypoglycemia (3 participants with an event in the CGM group and 2 in the BGM group), hyperglycemia/ketosis (1 participant with an event in CGM group and 4 in the BGM group), and diabetic ketoacidosis (3 participants with an event in the CGM group and 1 in the BGM group).

Conclusions And Relevance: Among adolescents and young adults with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks. Further research is needed to understand the clinical importance of the findings.

Trial Registration: ClinicalTrials.gov Identifier: NCT03263494.
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http://dx.doi.org/10.1001/jama.2020.6940DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7298603PMC
June 2020

Glycemic Outcomes of Use of CLC Versus PLGS in Type 1 Diabetes: A Randomized Controlled Trial.

Diabetes Care 2020 08 29;43(8):1822-1828. Epub 2020 May 29.

Jaeb Center for Health Research, Tampa, FL

Objective: Limited information is available about glycemic outcomes with a closed-loop control (CLC) system compared with a predictive low-glucose suspend (PLGS) system.

Research Design And Methods: After 6 months of use of a CLC system in a randomized trial, 109 participants with type 1 diabetes (age range, 14-72 years; mean HbA, 7.1% [54 mmol/mol]) were randomly assigned to CLC ( = 54, Control-IQ) or PLGS ( = 55, Basal-IQ) groups for 3 months. The primary outcome was continuous glucose monitor (CGM)-measured time in range (TIR) for 70-180 mg/dL. Baseline CGM metrics were computed from the last 3 months of the preceding study.

Results: All 109 participants completed the study. Mean ± SD TIR was 71.1 ± 11.2% at baseline and 67.6 ± 12.6% using intention-to-treat analysis (69.1 ± 12.2% using per-protocol analysis excluding periods of study-wide suspension of device use) over 13 weeks on CLC vs. 70.0 ± 13.6% and 60.4 ± 17.1% on PLGS (difference = 5.9%; 95% CI 3.6%, 8.3%; < 0.001). Time >180 mg/dL was lower in the CLC group than PLGS group (difference = -6.0%; 95% CI -8.4%, -3.7%; < 0.001) while time <54 mg/dL was similar (0.04%; 95% CI -0.05%, 0.13%; = 0.41). HbA after 13 weeks was lower on CLC than PLGS (7.2% [55 mmol/mol] vs. 7.5% [56 mmol/mol], difference -0.34% [-3.7 mmol/mol]; 95% CI -0.57% [-6.2 mmol/mol], -0.11% [1.2 mmol/mol]; = 0.0035).

Conclusions: Following 6 months of CLC, switching to PLGS reduced TIR and increased HbA toward their pre-CLC values, while hypoglycemia remained similarly reduced with both CLC and PLGS.
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http://dx.doi.org/10.2337/dc20-0124DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7372060PMC
August 2020

Glycemic Monitoring and Management in Advanced Chronic Kidney Disease.

Endocr Rev 2020 10;41(5)

University of Washington, Division of Nephrology, Kidney Research Institute, and Institute of Translational Health Sciences, Seattle, Washington.

Glucose and insulin metabolism in patients with diabetes are profoundly altered by advanced chronic kidney disease (CKD). Risk of hypoglycemia is increased by failure of kidney gluconeogenesis, impaired insulin clearance by the kidney, defective insulin degradation due to uremia, increased erythrocyte glucose uptake during hemodialysis, impaired counterregulatory hormone responses (cortisol, growth hormone), nutritional deprivation, and variability of exposure to oral antihyperglycemic agents and exogenous insulin. Patients with end-stage kidney disease frequently experience wide glycemic excursions, with common occurrences of both hypoglycemia and hyperglycemia. Assessment of glycemia by glycated hemoglobin (HbA1c) is hampered by a variety of CKD-associated conditions that can bias the measure either to the low or high range. Alternative glycemic biomarkers, such as glycated albumin or fructosamine, are not fully validated. Therefore, HbA1c remains the preferred glycemic biomarker despite its limitations. Based on observational data for associations with mortality and risks of hypoglycemia with intensive glycemic control regimens in advanced CKD, an HbA1c range of 7% to 8% appears to be the most favorable. Emerging data on the use of continuous glucose monitoring in this population suggest promise for more precise monitoring and treatment adjustments to permit fine-tuning of glycemic management in patients with diabetes and advanced CKD.
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http://dx.doi.org/10.1210/endrev/bnaa017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7366347PMC
October 2020

Short-term Outcomes After Very Low-Dose Intravitreous Bevacizumab for Retinopathy of Prematurity.

JAMA Ophthalmol 2020 06;138(6):698-701

Mayo Clinic, Rochester, Minnesota.

Importance: Intravitreous bevacizumab (0.25 mg to 0.625 mg) is commonly used to treat type 1 retinopathy of prematurity (ROP), but there are concerns about systemic toxicity, particularly the risk of neurodevelopmental delay. A much lower dose may be effective for ROP while reducing systemic risk. Previously, after testing doses of 0.25 mg to 0.031 mg, doses as low as 0.031 mg were found to be effective in small cohorts of infants.

Objective: To find the lowest dose of intravitreous bevacizumab effective for severe ROP.

Design, Setting, And Participants: Between April 2017 and May 2019, 59 premature infants with type 1 ROP in 1 or both eyes were enrolled in a masked, multicenter, dose de-escalation study. In cohorts of 10 to 14 infants, 1 eye per infant received 0.016 mg, 0.008 mg, 0.004 mg, or 0.002 mg of intravitreous bevacizumab. Diluted bevacizumab was prepared by individual research pharmacies and delivered using 300-µL syringes with 5/16-inch, 30-guage fixed needles. Analysis began July 2019.

Interventions: Bevacizumab intravitreous injections at 0.016 mg, 0.008 mg, 0.004 mg, or 0.002 mg.

Main Outcomes And Measures: Success was defined as improvement by 4 days postinjection and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks.

Results: Fifty-five of 59 enrolled infants had 4-week outcomes completed; the mean (SD) birth weight was 664 (258) g, and the mean (SD) gestational age was 24.8 (1.6) weeks. A successful 4-week outcome was achieved for 13 of 13 eyes (100%) receiving 0.016 mg, 9 of 9 eyes (100%) receiving 0.008 mg, 9 of 10 eyes (90%) receiving 0.004 mg, but only 17 of 23 eyes (74%) receiving 0.002 mg.

Conclusions And Relevance: These data suggest that 0.004 mg may be the lowest dose of bevacizumab effective for ROP. Further investigation is warranted to confirm effectiveness of very low-dose intravitreous bevacizumab and its effect on plasma vascular endothelial growth factor levels and peripheral retinal vascularization.
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http://dx.doi.org/10.1001/jamaophthalmol.2020.0334DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7180729PMC
June 2020

The Course of Visual Recovery after Optic Neuritis: Experience of the Optic Neuritis Treatment Trial.

Ophthalmology 2020 04;127(4S):S174-S181

Biostatistics Center, George Washington University, Rockville, Maryland.

Purpose: To define the time course of visual recovery after optic neuritis and factors predictive of this course in the patients enrolled in the Optic Neuritis Treatment Trial.

Methods: The cohort for this study consisted of the 438 patients who completed the 6-month follow-up visit. Visual acuity was measured at baseline and at seven follow-up visits during the first 6 months. Factors predictive of recovery were evaluated with univariate and multivariate statistical tests.

Results: Visual recovery was rapid in all three treatment groups. In almost all patients, regardless of treatment group and initial severity of visual loss, improvement began within the first month. Among the 278 patients with baseline visual acuity of 20/ 50 or worse, all patients improved at least one line of visual acuity, and all except six improved at least three lines, during the 6-month follow-up period. Baseline visual acuity was the best predictor of the 6-month visual acuity outcome (P = 0.0001). Older age was statistically associated with a slightly worse outcome (P = 0.02), but this appeared to be of no clinical importance.

Conclusions: In most patients with optic neuritis, visual recovery is rapid. The only factor of value in predicting the visual outcome is initial severity of visual loss. However, even when initial loss is severe, visual recovery is still good in most patients. Patients not following the usual course of visual recovery should be considered atypical. For such patients, further investigation in regard to etiology of the visual loss may be appropriate.
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http://dx.doi.org/10.1016/j.ophtha.2020.01.027DOI Listing
April 2020

Effect of Exercise and Meals on Continuous Glucose Monitor Data in Healthy Individuals Without Diabetes.

J Diabetes Sci Technol 2020 Feb 17:1932296820905904. Epub 2020 Feb 17.

Barbara Davis Center for Diabetes, Aurora, CO, USA.

Objective: The aim of these analyses was to characterize the effect of exercise and meals on glucose concentrations in healthy individuals without diabetes.

Methods: Healthy individuals without diabetes (age ≥6 years) with nonobese body mass index were enrolled at 12 centers within the T1D Exchange Clinic Network. Participants wore a blinded Dexcom G6 for up to ten days. Throughout this sensor wear, participants completed a daily log indicating times and type of any exercise and start times of meals and snacks.

Results: A total of 153 participants (age 7-80 years) were included in the analyses. Exercise induced a mean change of -15 ± 18 mg/dL from baseline to nadir sensor glucose level. Mean nadir glucose concentration during nights following exercise days was 82 ± 11 mg/dL compared with 85 ± 11 mg/dL during nights following nonexercise days ( = .05). Mean change from baseline to nadir sensor glucose level during aerobic exercise was -15 ± 18 and -9 ± 12 mg/dL for resistance exercise ( = .25). Overnight nadir glucose during nights following aerobic and resistance exercise was 83 ± 12 and 76 ± 14 mg/dL, respectively ( = .25). Overall mean peak postprandial glucose per participant increased from 93 ± 10 mg/dL premeal to 130 ± 13 mg/dL with an average time to peak glucose per participant of 97 ± 31 minutes. Consumption of alcohol on the day prior did not impact overnight mean or nadir glucose.

Conclusion: The present analysis provides important data characterizing the effect of exercise and meals on glucose in healthy individuals without diabetes. These data provide a repository to which future therapies, whether pharmacologic or technologic, can be compared.
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http://dx.doi.org/10.1177/1932296820905904DOI Listing
February 2020

Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. Reply.

N Engl J Med 2020 02;382(6):578

Jaeb Center for Health Research, Tampa, FL.

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http://dx.doi.org/10.1056/NEJMc1915995DOI Listing
February 2020

Effect of telephone calls from a centralized coordinating center on participant retention in a randomized clinical trial.

Clin Trials 2020 04 27;17(2):195-201. Epub 2020 Jan 27.

Beetham Eye Institute, Joslin Diabetes Center, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.

Background/aims: In clinical trials, participant retention is critical to reduce bias and maintain statistical power for hypothesis testing. Within a multi-center clinical trial of diabetic retinopathy, we investigated whether regular phone calls to participants from the coordinating center improved long-term participant retention.

Methods: Among 305 adults in the Diabetic Retinopathy Clinical Research Retina Network Protocol S randomized trial, 152 participants were randomly assigned to receive phone calls at baseline, 6 months, and annually through 3 years (annual contact group) while 153 participants were assigned to receive a phone call at baseline only (baseline contact group). All participants could be contacted if visits were missed. The main outcomes were visit completion, excluding deaths, at 2 years (the primary outcome time point) and at 5 years (the final time point).

Results: At baseline, 77% (117 of 152) of participants in the annual contact group and 76% (116 of 153) in the baseline contact group were successfully contacted. Among participants in the annual contact group active at each annual visit (i.e. not dropped from the study or deceased), 85% (125 of 147), 79% (108 of 136), and 88% (110 of 125) were contacted successfully by telephone around the time of the 1-, 2-, and 3-year visits, respectively. In the annual and baseline contact groups, completion rates for the 2-year primary outcome visit were 88% (129 of 147) versus 87% (125 of 144), respectively, with a risk ratio of 1.01 (95% confidence interval: 0.93-1.10,  = .81). At 5 years, the final study visit, participant completion rates were 67% (96 of 144) versus 66% (88 of 133) with a risk ratio of 1.01 (95% confidence interval = 0.85-1.19,  = .93). At 2 years, the completion rate of participants successfully contacted at baseline was 89% (202 of 226) versus 80% (52 of 65) among those not contacted successfully (risk ratio = 1.12, 95% confidence interval = 0.98-1.27,  = .09); at 5 years, the completion percentages by baseline contact success were 69% (148 of 213) versus 56% (36 of 64; risk ratio = 1.24, 95% confidence interval = 0.98-1.56,  = .08).

Conclusion: Regular phone calls from the coordinating center to participants during follow-up in this randomized clinical trial did not improve long-term participant retention.
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http://dx.doi.org/10.1177/1740774519894229DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7673295PMC
April 2020

Randomized Controlled Trial of Mobile Closed-Loop Control.

Diabetes Care 2020 03 14;43(3):607-615. Epub 2020 Jan 14.

Jaeb Center for Health Research, Tampa, FL

Objective: Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system.

Research Design And Methods: This protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA <10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L.

Results: Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC ( = 65) versus SAP ( = 62); 125 participants completed the study. CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference -1.7% [95% CI -2.4, -1.0]; < 0.0001 for superiority). CGM time above 10 mmol/L was 40% at baseline and 34% during follow-up in the CLC group vs. 43% and 39%, respectively, in the SAP group (mean difference -3.0% [95% CI -6.1, 0.1]; < 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device.

Conclusions: In meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable.
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http://dx.doi.org/10.2337/dc19-1310DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7035585PMC
March 2020

HbA1c Levels in Type 1 Diabetes from Early Childhood to Older Adults: A Deeper Dive into the Influence of Technology and Socioeconomic Status on HbA1c in the T1D Exchange Clinic Registry Findings.

Diabetes Technol Ther 2020 09;22(9):645-650

Department of Pediatrics - Endocrinology and Diabetes, Stanford University, Stanford California.

The T1D Exchange Clinic Registry figure of HbA1c levels according to age has become a classic picture of how average HbA1c varies from childhood to elderly. To further assess the course of HbA1c across the life span in T1D, we created similar figures stratified by device use and socioeconomic status (SES). Mean HbA1c was plotted versus age for 21,253 T1D Exchange Clinic Registry participants with an HbA1c measurement between January 1, 2016 and March 31, 2018 according to device use, race/ethnicity, and measures of SES. Across the age range from childhood to elderly, continuous glucose monitoring (CGM) use without an insulin pump had better average HbA1c than pump without CGM; and among CGM users, pump and injection users had similar HbA1c levels. Any device use (pump or CGM) was associated with better HbA1c levels than no device use across the age range. Lower SES and African American race were associated with higher HbA1c across the age range. Across all device use, SES, and race/ethnicity factors, average HbA1c levels were highest in adolescents and young adults. Although the plot of average HbA1c from early childhood to elderly shifts according to device use and SES factors, the shape of the plots remains reasonably constant with highest HbA1c levels in adolescents and young adults. These findings emphasize the importance of targeting adolescence and early adulthood as the ages with the greatest need for improving diabetes management irrespective of device use and SES.
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http://dx.doi.org/10.1089/dia.2019.0393DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7640747PMC
September 2020

Nonadjunctive Use of Continuous Glucose Monitoring: The End of Fingersticks?

Diabetes Technol Ther 2020 02 15;22(2):67-68. Epub 2019 Nov 15.

University of Virginia Center for Diabetes Technology, Charlottesville, Virginia.

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http://dx.doi.org/10.1089/dia.2019.0387DOI Listing
February 2020

Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes.

N Engl J Med 2019 10 16;381(18):1707-1717. Epub 2019 Oct 16.

From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).

Background: Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes.

Methods: In this 6-month randomized, multicenter trial, patients with type 1 diabetes were assigned in a 2:1 ratio to receive treatment with a closed-loop system (closed-loop group) or a sensor-augmented pump (control group). The primary outcome was the percentage of time that the blood glucose level was within the target range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter), as measured by continuous glucose monitoring.

Results: A total of 168 patients underwent randomization; 112 were assigned to the closed-loop group, and 56 were assigned to the control group. The age range of the patients was 14 to 71 years, and the glycated hemoglobin level ranged from 5.4 to 10.6%. All 168 patients completed the trial. The mean (±SD) percentage of time that the glucose level was within the target range increased in the closed-loop group from 61±17% at baseline to 71±12% during the 6 months and remained unchanged at 59±14% in the control group (mean adjusted difference, 11 percentage points; 95% confidence interval [CI], 9 to 14; P<0.001). The results with regard to the main secondary outcomes (percentage of time that the glucose level was >180 mg per deciliter, mean glucose level, glycated hemoglobin level, and percentage of time that the glucose level was <70 mg per deciliter or <54 mg per deciliter [3.0 mmol per liter]) all met the prespecified hierarchical criterion for significance, favoring the closed-loop system. The mean difference (closed loop minus control) in the percentage of time that the blood glucose level was lower than 70 mg per deciliter was -0.88 percentage points (95% CI, -1.19 to -0.57; P<0.001). The mean adjusted difference in glycated hemoglobin level after 6 months was -0.33 percentage points (95% CI, -0.53 to -0.13; P = 0.001). In the closed-loop group, the median percentage of time that the system was in closed-loop mode was 90% over 6 months. No serious hypoglycemic events occurred in either group; one episode of diabetic ketoacidosis occurred in the closed-loop group.

Conclusions: In this 6-month trial involving patients with type 1 diabetes, the use of a closed-loop system was associated with a greater percentage of time spent in a target glycemic range than the use of a sensor-augmented insulin pump. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; iDCL ClinicalTrials.gov number, NCT03563313.).
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http://dx.doi.org/10.1056/NEJMoa1907863DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7076915PMC
October 2019

Advances in technology for management of type 1 diabetes.

Lancet 2019 10 15;394(10205):1265-1273. Epub 2019 Sep 15.

King's College London, Faculty of Life Sciences and Medicine, Guy's Hospital, London, UK.

Technological advances have had a major effect on the management of type 1 diabetes. In addition to blood glucose meters, devices used by people with type 1 diabetes include insulin pumps, continuous glucose monitors, and, most recently, systems that combine both a pump and a monitor for algorithm-driven automation of insulin delivery. In the next 5 years, as many advances are expected in technology for the management of diabetes as there have been in the past 5 years, with improvements in continuous glucose monitoring and more available choices of systems that automate insulin delivery. Expansion of the use of technology will be needed beyond endocrinology practices to primary-care settings and broader populations of patients. Tools to support decision making will also need to be developed to help patients and health-care providers to use the output of these devices to optimise diabetes management.
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http://dx.doi.org/10.1016/S0140-6736(19)31142-0DOI Listing
October 2019

Emphasizing Optimal Diabetes Management for All Races/Ethnicities, but Not Race/Ethnicity-Specific Cut Points for Hemoglobin A1c.

JAMA Ophthalmol 2019 Aug 22. Epub 2019 Aug 22.

Jaeb Center for Health Research, Tampa, Florida.

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http://dx.doi.org/10.1001/jamaophthalmol.2019.3233DOI Listing
August 2019

The T1D Exchange Clinic Network and Registry: 10 Years of Enlightenment on the State of Type 1 Diabetes in the United States.

Diabetes Technol Ther 2019 06;21(6):310-312

Jaeb Center for Health Research, Tampa, Florida.

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http://dx.doi.org/10.1089/dia.2019.0129DOI Listing
June 2019

Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study.

J Clin Endocrinol Metab 2019 10;104(10):4356-4364

Yale School of Medicine, New Haven, Connecticut.

Context: Use of continuous glucose monitoring (CGM) is increasing for insulin-requiring patients with diabetes. Although data on glycemic profiles of healthy, nondiabetic individuals exist for older sensors, assessment of glycemic metrics with new-generation CGM devices is lacking.

Objective: To establish reference sensor glucose ranges in healthy, nondiabetic individuals across different age groups using a current generation CGM sensor.

Design: Multicenter, prospective study.

Setting: Twelve centers within the T1D Exchange Clinic Network.

Patients Or Participants: Nonpregnant, healthy, nondiabetic children and adults (age ≥6 years) with nonobese body mass index.

Intervention: Each participant wore a blinded Dexcom G6 CGM, with once-daily calibration, for up to 10 days.

Main Outcome Measures: CGM metrics of mean glucose, hyperglycemia, hypoglycemia, and glycemic variability.

Results: A total of 153 participants (age 7 to 80 years) were included in the analyses. Mean average glucose was 98 to 99 mg/dL (5.4 to 5.5 mmol/L) for all age groups except those over 60 years, in whom mean average glucose was 104 mg/dL (5.8 mmol/L). The median time between 70 to 140 mg/dL (3.9 to 7.8 mmol/L) was 96% (interquartile range, 93 to 98). Mean within-individual coefficient of variation was 17 ± 3%. Median time spent with glucose levels >140 mg/dL was 2.1% (30 min/d), and median time spent with glucose levels <70 mg/dL (3.9 mmol/L) was 1.1% (15 min/d).

Conclusion: By assessing across age groups in a healthy, nondiabetic population, normative sensor glucose data have been derived and will be useful as a benchmark for future research studies.
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http://dx.doi.org/10.1210/jc.2018-02763DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7296129PMC
October 2019

Glucose Management Indicator (GMI): Insights and Validation Using Guardian 3 and Navigator 2 Sensor Data.

Diabetes Care 2019 04 6;42(4):e60-e61. Epub 2019 Feb 6.

Manchester Diabetes Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, U.K.

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http://dx.doi.org/10.2337/dc18-2479DOI Listing
April 2019