106 results on '"Hirsch, Irl B"'
Search Results
2. Inequities in Diabetic Ketoacidosis Among Patients With Type 1 Diabetes and COVID-19: Data From 52 US Clinical Centers.
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Ebekozien, Osagie, Agarwal, Shivani, Noor, Nudrat, Albanese-O'Neill, Anastasia, Wong, Jenise C, Seeherunvong, Tossaporn, Sanchez, Janine, DeSalvo, Daniel, Lyons, Sarah K, Majidi, Shideh, Wood, Jamie R, Acharya, Runa, Aleppo, Grazia, Sumpter, Kathryn M, Cymbaluk, Anna, Shah, Nirali A, Van Name, Michelle, Cruz-Aviles, Lisa, Alonso, Guy Todd, Gallagher, Mary Pat, Sanda, Srinath, Feuer, Alexis Jamie, Cossen, Kristina, Rioles, Nicole, Jones, Nana-Hawa Yayah, Kamboj, Manmohan K, and Hirsch, Irl B
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Humans ,Diabetic Ketoacidosis ,Diabetes Mellitus ,Type 1 ,Prognosis ,Prevalence ,Cross-Sectional Studies ,Socioeconomic Factors ,Adolescent ,Adult ,Child ,Child ,Preschool ,African Americans ,European Continental Ancestry Group ,Hispanic Americans ,United States ,Female ,Male ,Health Status Disparities ,Young Adult ,COVID-19 ,SARS-CoV-2 ,DKA ,inequities ,type 1 diabetes ,Inequities ,Type 1 Diabetes ,Endocrinology & Metabolism ,Clinical Sciences ,Paediatrics and Reproductive Medicine - Abstract
ObjectiveWe examined whether diabetic ketoacidosis (DKA), a serious complication of type 1 diabetes (T1D) was more prevalent among Non-Hispanic (NH) Black and Hispanic patients with T1D and laboratory-confirmed coronavirus disease 2019 (COVID-19) compared with NH Whites.MethodThis is a cross-sectional study of patients with T1D and laboratory-confirmed COVID-19 from 52 clinical sites in the United States, data were collected from April to August 2020. We examined the distribution of patient factors and DKA events across NH White, NH Black, and Hispanic race/ethnicity groups. Multivariable logistic regression analysis was performed to examine the odds of DKA among NH Black and Hispanic patients with T1D as compared with NH White patients, adjusting for potential confounders, such as age, sex, insurance, and last glycated hemoglobin A1c (HbA1c) level.ResultsWe included 180 patients with T1D and laboratory-confirmed COVID-19 in the analysis. Forty-four percent (n = 79) were NH White, 31% (n = 55) NH Black, 26% (n = 46) Hispanic. NH Blacks and Hispanics had higher median HbA1c than Whites (%-points [IQR]: 11.7 [4.7], P
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- 2021
3. Use of continuous glucose monitoring when initiating glucagon‐like peptide‐1 receptor agonist therapy in insulin‐treated diabetes.
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Hirsch, Irl B., Parkin, Christopher G., Cavaiola, Tricia Santos, and Bergenstal, Richard M.
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CONTINUOUS glucose monitoring , *TYPE 2 diabetes , *TYPE 1 diabetes , *CONTINUING medical education , *MYOCARDIAL infarction , *INSULIN aspart , *PEPTIDE receptors - Abstract
Glucagon‐like peptide‐1 receptor agonist (GLP‐1RA) medications have been shown to be effective in achieving optimal glucose control and reducing all‐cause death, cardiovascular death, nonfatal myocardial infarction, hospitalization for heart failure, and end‐stage kidney disease in individuals with type 1 (T1D) and type 2 diabetes (T2D). However, use of these medications has been associated with increased hypoglycaemia risk in patients treated with concomitant antihyperglycaemic medications. The risk is particularly high in patients with T1D due to their loss of glucagon counter‐regulatory response. This article reviews the effect of GLP‐1RA formulations on the development of hypoglycaemia in individuals with T1D and T2D treated with insulin therapy, discusses the benefits of continuous glucose monitoring with GLP‐1RA treatment, and presents strategies for safely initiating GLP‐1RA therapy in these individuals. Continuing Medical Education: Please visit https://health.learning.wiley.com/courses/dom-26s7 to complete an accredited learning activity for this article and receive 2.0 AMA PRA Category 1 Credit™. [ABSTRACT FROM AUTHOR]
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- 2024
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4. The association of resilience with HbA1c and key psychosocial factors in emerging adults with type 1 diabetes.
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O'Daffer, Alison, Yi-Frazier, Joyce P, Roberts, Alissa J, Lowry, Sarah J, Pihoker, Catherine, Hirsch, Irl B, Weaver, Kathryn W, Zenno, Anna, and Malik, Faisal S
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TYPE 1 diabetes ,TRANSITION to adulthood ,PSYCHOLOGICAL factors ,YOUNG adults ,HEALTH behavior - Abstract
Objective Emerging adults (EAs) with type 1 diabetes (T1D) have difficulty meeting glycemic targets and have a high prevalence of mental health comorbidities. Resilience, the ability to harness resources needed to sustain one's emotional and physical well-being, may be a key factor impacting poor mental health and glycemic outcomes. We aimed to (a) evaluate the association between resilience, HbA
1c , and key psychosocial factors and (b) explore whether resilience moderates the relationship between psychosocial factors (depression, diabetes-related distress, anxiety) and HbA1c in EAs with T1D. Method EAs with T1D (N = 233) (mean age = 19.9 years (SD = 1.6), range 16.8–24.7) seen at an EA-specific diabetes clinic completed resilience, diabetes-related distress, depression, and anxiety measures and had their HbA1c level evaluated. We used linear regression models and conducted moderation analyses for the resilience factor. Results Resilience was strongly associated with HbA1c , depression, diabetes-related distress, and anxiety in EAs with T1D. We did not find evidence that resilience moderates the relationship between depression, anxiety, or diabetes-related distress and HbA1c . Conclusions This study found that resilience is a highly relevant psychological factor associated with HbA1c and a key mental health factor for EAs with T1D. Novel interventions are needed to ameliorate high diabetes-related distress and HbA1c , and bolstering resilience may be one avenue to explore. Future research on resilience should longitudinally characterize and evaluate whether resilience may be a mechanism underlying the relationship between poor psychosocial outcomes and not meeting glycemic targets in EAs with T1D. [ABSTRACT FROM AUTHOR]- Published
- 2024
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5. Efficacy and Safety of a Tubeless AID System Compared With Pump Therapy With CGM in the Treatment of Type 1 Diabetes in Adults With Suboptimal Glycemia: A Randomized, Parallel-Group Clinical Trial.
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Renard, Eric, Weinstock, Ruth S., Aleppo, Grazia, Bode, Bruce W., Brown, Sue A., Castorino, Kristin, Hirsch, Irl B., Kipnes, Mark S., Laffel, Lori M., Lal, Rayhan A., Penfornis, Alfred, Riveline, Jean-Pierre, Shah, Viral N., Thivolet, Charles, Ly, Trang T., Farret, Anne, Villard, Orianne, Masri, Manal Al, Stone, Sheri L., and Bzdick, Suzan
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BLOOD sugar monitors ,TYPE 1 diabetes ,HYPOGLYCEMIA ,KETOACIDOSIS ,ADULTS - Abstract
OBJECTIVE: To examine the efficacy and safety of the tubeless Omnipod 5 automated insulin delivery (AID) system compared with pump therapy with a continuous glucose monitor (CGM) in adults with type 1 diabetes with suboptimal glycemic outcomes. RESEARCH DESIGN AND METHODS: In this 13-week multicenter, parallel-group, randomized controlled trial performed in the U.S. and France, adults aged 18–70 years with type 1 diabetes and HbA
1c 7–11% (53–97 mmol/mol) were randomly assigned (2:1) to intervention (tubeless AID) or control (pump therapy with CGM) following a 2-week standard therapy period. The primary outcome was a treatment group comparison of time in range (TIR) (70–180 mg/dL) during the trial period. RESULTS: A total of 194 participants were randomized, with 132 assigned to the intervention and 62 to the control. TIR during the trial was 4.2h/day higher in the intervention compared with the control group (mean difference 17.5% [95% CI 14.0%, 21.1%]; P < 0.0001). The intervention group had a greater reduction in HbA1c from baseline compared with the control group (mean ± SD −1.24 ± 0.75% [−13.6 ± 8.2 mmol/mol] vs. −0.68 ± 0.93% [−7.4 ± 10.2 mmol/mol], respectively; P < 0.0001), accompanied by a significantly lower time <70 mg/dL (1.18 ± 0.86% vs. 1.75 ± 1.68%; P = 0.005) and >180 mg/dL (37.6 ± 11.4% vs. 54.5 ± 15.4%; P < 0.0001). All primary and secondary outcomes were met. No instances of diabetes-related ketoacidosis or severe hypoglycemia occurred in the intervention group. CONCLUSIONS: Use of the tubeless AID system led to improved glycemic outcomes compared with pump therapy with CGM among adults with type 1 diabetes, underscoring the clinical benefit of AID and bolstering recommendations to establish AID systems as preferred therapy for this population. [ABSTRACT FROM AUTHOR]- Published
- 2024
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6. The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)
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Holt, Richard I. G., DeVries, J. Hans, Hess-Fischl, Amy, Hirsch, Irl B., Kirkman, M. Sue, Klupa, Tomasz, Ludwig, Barbara, Nørgaard, Kirsten, Pettus, Jeremy, Renard, Eric, Skyler, Jay S., Snoek, Frank J., Weinstock, Ruth S., and Peters, Anne L.
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- 2021
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7. Improving Continuous Glucose Monitoring Use in Emerging Adults With Type 1 Diabetes.
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Malik, Faisal S., Perez, Samantha G., Lowry, Sarah, Weaver, Kathryn W., Hirsch, Irl B., Pihoker, Catherine, Moss, Ashley C., Ehrhardt, Nicole, and Roberts, Alissa J.
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TYPE 1 diabetes ,MEDICAL quality control ,INTERPROFESSIONAL relations ,EVALUATION of human services programs ,MEDICAL care ,CONTINUOUS glucose monitoring ,QUALITY assurance ,HEALTH equity ,ADULTS - Abstract
Quality Improvement Success Stories are published by the American Diabetes Association in collaboration with the American College of Physicians and the National Diabetes Education Program. This series is intended to highlight best practices and strategies from programs and clinics that have successfully improved the quality of care for people with diabetes or related conditions. Each article in the series is reviewed and follows a standard format developed by the editors of Clinical Diabetes. The following article describes a quality improvement project focused on increasing the use of continuous glucose monitoring among emerging adults with type 1 diabetes enrolled in a health care transition program in the state of Washington. [ABSTRACT FROM AUTHOR]
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- 2024
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8. A Randomized Comparison of Postprandial Glucose Excursion Using Inhaled Insulin Versus Rapid-Acting Analog Insulin in Adults With Type 1 Diabetes Using Multiple Daily Injections of Insulin or Automated Insulin Delivery.
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Hirsch, Irl B., Beck, Roy W., Marak, Martin Chase, Calhoun, Peter, Mottalib, Adham, Salhin, Amna, Manessis, Anastasios, Coviello, Andrea D., Bhargava, Anuj, Thorsell, Ashley, Atakov Castillo, Astrid, Bode, Bruce W., Levister, Camilla, Levy, Carol J., Donahue, Cassandra, Cordero, Christian, Beatson, Christie, Langel, Christine R., Jacobson, Christopher, and Kurek, Corey
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INSULIN derivatives , *TYPE 1 diabetes , *BLOOD sugar , *INSULIN therapy , *INSULIN - Abstract
OBJECTIVE: To compare postprandial glucose excursions following a bolus with inhaled technosphere insulin (TI) or subcutaneous rapid-acting analog (RAA) insulin. RESEARCH DESIGN AND METHODS: A meal challenge was completed by 122 adults with type 1 diabetes who were using multiple daily injections (MDI), a nonautomated pump, or automated insulin delivery (AID) and who were randomized to bolus with their usual RAA insulin (n = 61) or TI (n = 61). RESULTS: The primary outcome, the treatment group difference in area under the curve for glucose >180 mg/dL over 2 h, was less with TI versus RAA (adjusted difference −12 mg/dL, 95% CI −22 to −2, P = 0.02). With TI, the glucose excursion was smaller (P = 0.01), peak glucose lower (P = 0.01), and time to peak glucose shorter (P = 0.006). Blood glucose <70 mg/dL occurred in one participant in each group. CONCLUSIONS: Postmeal glucose excursion was smaller with TI than with RAA insulin in a cohort that included both AID and MDI users. [ABSTRACT FROM AUTHOR]
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- 2024
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9. Noninvasive Real-Time Glucose Monitoring Is in the Near Future.
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Hirsch, Irl B., Tirosh, Amir, and Navon, Ami
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CONTINUOUS glucose monitoring , *BLOOD sugar monitoring , *BLOOD sugar , *TYPE 1 diabetes , *TYPE 2 diabetes - Abstract
Objective: Since the introduction of continuous glucose monitoring (CGM) technology, developers have rigorously researched the feasibility of creating a noninvasive glucose monitoring device. In a recent pilot study, investigators reported a strong correlation between glucose values obtained from novel noninvasive monitoring device (GWave) values to venous and capillary glucose measurements. Research Design and Methods: We investigated whether the level of accuracy observed in the pilot study could be reproduced in a larger cohort, using a smaller third-generation manufacturable device (Gen III GWave) containing a standardized sensor chip that can be mass produced for commercial use. The evaluation assessed concordance with capillary blood glucose, reproducibility between two Gen III devices, and accuracy during insulin-induced hypoglycemia. Results: Assessment of samples from 75 subjects (type 2 diabetes, n = 6; type 1 diabetes, n = 28; nondiabetic pregnant subjects, n = 10; and nondiabetic, n = 31) showed that 97% of values were in Zone A with 3% in Zone B of the Clarke Error Grid, with a mean absolute relative difference of 6.7% from reference blood glucose. Comparison between two independent Gen III GWave devices demonstrated reproducibility between the sensors (R2 = 0.95), with 100% of values within Zone A. In the hypoglycemia assessment, measurements from the Gen III sensor tightly followed the capillary glucose measurements down to 42 mg/dL (2.3 mmol/L), whereas the CGM measurements from two different CGM only converged with the GWave and capillary glucose readings after 90 min of decreasing glucose levels. Conclusion: Our results show promise as potentially the first noninvasive technology. Future studies will focus on larger number of people in all glucose ranges. Real-time noninvasive blood glucose monitoring is possible using GWave technology. [ABSTRACT FROM AUTHOR]
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- 2024
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10. Should We Bury HbA1c?
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Bovee, Laura B. and Hirsch, Irl B.
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BLOOD sugar monitors , *TYPE 1 diabetes , *DIABETIC nephropathies , *GLYCEMIC control , *HEALTH equity , *DIABETIC retinopathy , *SAFETY-net health care providers , *SICKLE cell trait , *MEDICAID - Abstract
The article titled "Should We Bury HbA1c?" explores the use of glycated hemoglobin (HbA1c) in diabetes care. It acknowledges that while HbA1c is commonly used and cost-effective, it has limitations due to various factors such as red blood cell turnover, certain diseases, and race/ethnicity. The article suggests the need to consider these limitations and explore alternative methods for managing diabetes. It also discusses the use of continuous glucose monitoring (CGM) as a real-time tool for monitoring glucose levels, but highlights the limited availability and accessibility of CGM, leading to healthcare disparities. The article emphasizes the importance of policy changes to improve CGM access and recognizes HbA1c as a complementary metric to CGM for predicting diabetes complications. [Extracted from the article]
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- 2024
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11. Poor Glycemic Control Is Associated With More Rapid Kidney Function Decline After the Onset of Diabetic Kidney Disease.
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Shah, Hetal S, McGill, Janet B, Hirsch, Irl B, Wu, Chunyi, Galecki, Andrzej, Boer, Ian H de, Mauer, Michael, and Doria, Alessandro
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GLYCEMIC control ,DIABETIC nephropathies ,KIDNEY physiology ,TYPE 1 diabetes ,TYPE 2 diabetes ,GLYCOSYLATED hemoglobin - Abstract
Background The role of glycemic control and its variability on the rate of kidney function decline after the onset of diabetic kidney disease (DKD) remains unclear. Methods The association between baseline glycated hemoglobin (HbA1c) and rates of estimated glomerular filtration rate (eGFR) loss during follow-up was examined by mixed-effects linear regression in 530 individuals with type 1 diabetes and early-to-moderate DKD from the Preventing Early Renal Loss (PERL) trial and 2378 individuals with type 2 diabetes and established DKD from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. The benefit of intensive vs standard glycemic control in slowing eGFR decline was examined in ACCORD. The associations between continuous glucose monitoring-derived short-term glycemic variability indices and rate of eGFR decline were also evaluated in PERL. Results A higher baseline HbA1c was associated with a more negative eGFR slope in both PERL and ACCORD (−0.87 and −0.27 mL/min/1.73 m
2 /year per Hba1c unit increment, P <.0001 and P =.0002, respectively). In both studies, the strength of this association progressively increased with increasing levels of albuminuria (P for interaction <.05). Consistent with this, the benefit of intensive glycemic control on eGFR decline was greater in ACCORD participants with severe rather than moderate albuminuria (+1.13 vs + 0.26 mL/min/1.73 m2 /year, P =.01). No independent associations were found in PERL between short-term glycemic variability indices and rate of eGFR decline. Conclusion In both type 1 and type 2 diabetes, poor glycemic control is associated with a more rapid rate of glomerular filtration rate decline after DKD onset, especially in persons with severe albuminuria. [ABSTRACT FROM AUTHOR]- Published
- 2024
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12. Discordance between mean glucose and time in range in relation to HbA1c in individuals with type 1 diabetes: results from the GOLD and SILVER trials.
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Sterner Isaksson, Sofia, Imberg, Henrik, Hirsch, Irl B., Schwarcz, Erik, Hellman, Jarl, Wijkman, Magnus, Bolinder, Jan, Nyström, Thomas, Holmer, Helene, Hallström, Sara, Ólafsdóttir, Arndís F., Pekkari, Sofia, Polonsky, William, and Lind, Marcus
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Aims/hypothesis: Previous studies have shown that individuals with similar mean glucose levels (MG) or percentage of time in range (TIR) may have different HbA
1c values. The aim of this study was to further elucidate how MG and TIR are associated with HbA1c . Methods: Data from the randomised clinical GOLD trial (n=144) and the follow-up SILVER trial (n=98) of adults with type 1 diabetes followed for 2.5 years were analysed. A total of 596 paired HbA1c /continuous glucose monitoring measurements were included. Linear mixed-effects models were used to account for intra-individual correlations in repeated-measures data. Results: In the GOLD trial, the mean age of the participants (± SD) was 44±13 years, 63 (44%) were female, and the mean HbA1c (± SD) was 72±9.8 mmol/mol (8.7±0.9%). When correlating MG with HbA1c , MG explained 63% of the variation in HbA1c (r=0.79, p<0.001). The variation in HbA1c explained by MG increased to 88% (r=0.94, p value for improvement of fit <0.001) when accounting for person-to-person variation in the MG–HbA1c relationship. Time below range (TBR; <3.9 mmol/l), time above range (TAR) level 2 (>13.9 mmol/l) and glycaemic variability had little or no effect on the association. For a given MG and TIR, the HbA1c of 10% of individuals deviated by >8 mmol/mol (0.8%) from their estimated HbA1c based on the overall association between MG and TIR with HbA1c . TBR and TAR level 2 significantly influenced the association between TIR and HbA1c . At a given TIR, each 1% increase in TBR was related to a 0.6 mmol/mol lower HbA1c (95% CI 0.4, 0.9; p<0.001), and each 2% increase in TAR level 2 was related to a 0.4 mmol/mol higher HbA1c (95% CI 0.1, 0.6; p=0.003). However, neither TIR, TBR nor TAR level 2 were significantly associated with HbA1c when accounting for MG. Conclusions/interpretation: Inter-individual variations exist between MG and HbA1c , as well as between TIR and HbA1c , with clinically important deviations in relatively large groups of individuals with type 1 diabetes. These results may provide important information to both healthcare providers and individuals with diabetes in terms of prognosis and when making diabetes management decisions. [ABSTRACT FROM AUTHOR]- Published
- 2024
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13. Consensus Recommendations for the Use of Automated Insulin Delivery Technologies in Clinical Practice
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Phillip, Moshe, Nimri, Revital, Bergenstal, Richard M, Barnard-Kelly, Katharine, Danne, Thomas, Hovorka, Roman, Kovatchev, Boris P, Messer, Laurel H, Parkin, Christopher G, Ambler-Osborn, Louise, Amiel, Stephanie A, Bally, Lia, Beck, Roy W, Biester, Sarah, Biester, Torben, Blanchette, Julia E, Bosi, Emanuele, Boughton, Charlotte K, Breton, Marc D, Brown, Sue A, Buckingham, Bruce A, Cai, Albert, Carlson, Anders L, Castle, Jessica R, Choudhary, Pratik, Close, Kelly L, Cobelli, Claudio, Criego, Amy B, Davis, Elizabeth, de Beaufort, Carine, de Bock, Martin I, DeSalvo, Daniel J, DeVries, J Hans, Dovc, Klemen, Doyle, Francis J, Ekhlaspour, Laya, Shvalb, Naama Fisch, Forlenza, Gregory P, Gallen, Geraldine, Garg, Satish K, Gershenoff, Dana C, Gonder-Frederick, Linda A, Haidar, Ahmad, Hartnell, Sara, Heinemann, Lutz, Heller, Simon, Hirsch, Irl B, Hood, Korey K, Isaacs, Diana, Klonoff, David C, Kordonouri, Olga, Kowalski, Aaron, Laffel, Lori, Lawton, Julia, Lal, Rayhan A, Leelarathna, Lalantha, Maahs, David M, Murphy, Helen R, Nørgaard, Kirsten, O'Neal, David, Oser, Sean, Oser, Tamara, Renard, Eric, Riddell, Michael C, Rodbard, David, Russell, Steven J, Schatz, Desmond A, Shah, Viral N, Sherr, Jennifer L, Simonson, Gregg D, Wadwa, R Paul, Ward, Candice, Weinzimer, Stuart A, Wilmot, Emma G, Battelino, Tadej, General Internal Medicine, APH - Health Behaviors & Chronic Diseases, and AGEM - Amsterdam Gastroenterology Endocrinology Metabolism
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closed-loop ,Endocrinology ,consensus recommendations ,automated insulin delivery ,type 1 diabetes ,Endocrinology, Diabetes and Metabolism ,610 Medicine & health ,610 Medizin und Gesundheit - Abstract
The significant and growing global prevalence of diabetes continues to challenge people with diabetes (PwD), healthcare providers, and payers. While maintaining near-normal glucose levels has been shown to prevent or delay the progression of the long-term complications of diabetes, a significant proportion of PwD are not attaining their glycemic goals. During the past 6 years, we have seen tremendous advances in automated insulin delivery (AID) technologies. Numerous randomized controlled trials and real-world studies have shown that the use of AID systems is safe and effective in helping PwD achieve their long-term glycemic goals while reducing hypoglycemia risk. Thus, AID systems have recently become an integral part of diabetes management. However, recommendations for using AID systems in clinical settings have been lacking. Such guided recommendations are critical for AID success and acceptance. All clinicians working with PwD need to become familiar with the available systems in order to eliminate disparities in diabetes quality of care. This report provides much-needed guidance for clinicians who are interested in utilizing AIDs and presents a comprehensive listing of the evidence payers should consider when determining eligibility criteria for AID insurance coverage.
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- 2023
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14. Bridging dose of U‐100 glargine with first dose of insulin degludec improves glycaemia in the 48 h after transition in twice‐daily glargine users.
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Thirumalai, Arthi, Chao, Jing H., Kaleru, Thanmai, Dong, Xiaofu, Mandava, Patali, Khakpour, Dori, and Hirsch, Irl B.
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CONTINUOUS glucose monitoring ,INSULIN ,BLOOD sugar monitors ,INSULIN therapy ,TYPE 1 diabetes - Abstract
Aims: To study the effects of a bridging dose of U‐100 glargine (U‐100G) with the first dose of degludec in type 1 diabetes (T1D) patients transitioning from glargine to degludec, by comparing the glucose metrics 48 h before and after the transition. Materials and Methods: Patients with T1D on a stable U‐100G regimen and with glycated haemoglobin concentration <75 mmol/mol were randomized (double‐blind) to one dose of placebo or U‐100G with first dose of degludec, administered at 9:00 pm. Patients on once‐daily U‐100G at baseline received 50% of total U‐100G dose (bridging dose), while patients on twice‐daily U‐100G received 50% of the evening U‐100G dose. Participants wore a continuous glucose monitor during the study. Results: Forty participants were randomized, of whom 37 completed the study. The cohort was 65% male, the mean age was 47 years, duration of T1D 22 years, BMI 26 kg/m2, HbA1c 51 mmol/mol and total daily insulin dose 0.7 units/kg body weight. The bridging group included 19 participants (once‐daily U‐100G: n = 12; twice‐daily U‐100G: n = 7) and the placebo group included 18 participants (once‐daily U‐100G: n = 12; twice‐daily U‐100G: n = 6). Change in time in range (TIR) was not significantly different between the two treatment groups. In secondary analyses, among twice‐daily U‐100G users, TIR (3.9‐10 mmol/L) increased 8% in the bridging group in the 48 h after first dose of degludec compared to the preceding 48 h, while participants in the placebo group had a 9.5% decrease (p = 0.027). Conclusions: A subgroup of well‐controlled twice‐daily U‐100G users transitioning to degludec benefited from a 50% bridging dose of evening U‐100G with the first dose of degludec in a small pilot study. [ABSTRACT FROM AUTHOR]
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- 2024
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15. New advances in type 1 diabetes.
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Subramanian, Savitha, Khan, Farah, and Hirsch, Irl B.
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INSULIN therapy ,TYPE 1 diabetes ,GLUCAGON-like peptide-1 agonists ,GLYCOSYLATED hemoglobin ,PANCREATIC beta cells ,INSULIN ,PATIENT care ,INSULIN pumps ,CONTINUOUS glucose monitoring ,MEDICAL research ,SODIUM-glucose cotransporter 2 inhibitors ,AUTOMATION ,GENETICS ,BIOMARKERS ,DIABETES ,HYPOGLYCEMIA - Published
- 2024
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16. Prevention of Cardiovascular Disease in Type 1 Diabetes.
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Manrique-Acevedo, Camila, Hirsch, Irl B., and Eckel, Robert H.
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TYPE 1 diabetes , *DIABETIC nephropathies , *HEART failure , *CARDIOVASCULAR diseases , *PREVENTIVE medicine , *PEOPLE with diabetes , *GLYCEMIC control - Abstract
The article focuses on preventing cardiovascular disease in individuals with type 1 diabetes. Topics discussed include the biological mechanisms of cardiovascular disease in type 1 diabetes, strategies for reducing cardiovascular disease burden such as glycemic control and treatment of hypercholesterolemia, and management approaches for associated risk factors like hypertension and obesity.
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- 2024
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17. Coverage for Continuous Glucose Monitoring for Individuals with Type 2 Diabetes Treated with Nonintensive Therapies: An Evidence-Based Approach to Policymaking.
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Aleppo, Grazia, Hirsch, Irl B., Parkin, Christopher G., McGill, Janet, Galindo, Rodolfo, Kruger, Davida F., Levy, Carol J., Forlenza, Gregory P., Umpierrez, Guillermo E., Grunberger, George, and Bergenstal, Richard M.
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TYPE 2 diabetes , *TYPE 1 diabetes , *INSULIN therapy , *GLUCOSE , *ENDOCRINE diseases , *HYPERGLYCEMIA - Abstract
Numerous studies have demonstrated the clinical benefits of continuous glucose monitoring (CGM) in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D) who are treated with intensive insulin regimens. Based on this evidence, CGM is now a standard of care for individuals within these diabetes populations and widely covered by commercial and public insurers. Moreover, recent clinical guidelines from the American Diabetes Association and American Association of Clinical Endocrinology now endorse CGM use in individuals treated with nonintensive insulin regimens. However, despite increasing evidence supporting CGM use for individuals treated with less-intensive insulin therapy or noninsulin medications, insurance coverage is limited or nonexistent. This narrative review reports key findings from recent randomized, observational, and retrospective studies investigating use of CGM in T2D individuals treated with basal insulin only and/or noninsulin therapies and presents an evidence-based rationale for expanding access to CGM within this population. [ABSTRACT FROM AUTHOR]
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- 2023
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18. Evaluation of Insulin Pump Infusion Sites in Type 1 Diabetes: The DERMIS Study.
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Kalus, Andrea, Shinohara, Michi M., Wang, Ruikang, Baran, Jesica D., Dong, Xiaofu, Khakpour, Dori, Lu, Jie, and Hirsch, Irl B.
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TYPE 1 diabetes ,INSULIN pumps ,OPTICAL coherence tomography ,PLASTICS ,SUBCUTANEOUS infusions ,INSULIN therapy ,ACANTHOSIS nigricans - Abstract
OBJECTIVE: Continuous subcutaneous insulin infusion (CSII) for type 1 diabetes is increasing in use. Pump site failures are common, but little is known about skin changes from pump use. Using noninvasive optical coherence tomography (OCT), OCT angiography (OCTA), and skin biopsies, we evaluated skin changes from chronic insulin infusion. RESEARCH DESIGN AND METHODS: In this cross-sectional study, OCT operating at a 1,310-nm central wavelength with a bandwidth of 100 nm was performed immediately before skin punch biopsies were collected at three sites: the current site, with the infusion set removed at time of OCT and biopsy; the recovery site, with the infusion set removed 3 days before biopsy; and the control site, which was never used for any insulin infusion or injection. RESULTS: OCT and OCTA identified characteristics of increased inflammation and vessel density at pump sites compared with control sites. Histologic analysis of pump sites showed differences in skin architecture, including fibrosis, inflammation (including increased tissue eosinophils), and fat necrosis. Immunohistochemical staining showed differences between infusion and control sites regarding staining of ILGF-I and transforming growth factor-β3. CONCLUSIONS: These findings support allergic sensitization as a potentially common reaction at CSII sites. The leading candidates causing this include insulin preservatives, plastic materials, and adhesive glue used in device manufacturing. The inflammatory response caused by these common allergic responses may result in tissue changes responsible for the infusion site failures seen frequently in clinical practice. [ABSTRACT FROM AUTHOR]
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- 2023
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19. Assessment of Glucose Monitoring Adherence in Medicare Beneficiaries with Insulin-Treated Diabetes.
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Puckrein, Gary A., Hirsch, Irl B., Parkin, Christopher G., Taylor, Bruce T., Norman, Gregory J., Xu, Liou, Marrero, David G., Norman, Gregory, and Marerro, David G
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MEDICARE , *MEDICAID beneficiaries , *MEDICARE beneficiaries , *DISEASE risk factors , *BLOOD sugar monitoring , *INSULIN therapy , *GLUCOSE - Abstract
Background: We investigated the potential associations between race/ethnicity and adherence to prescribed glucose monitoring in a sample of Medicare beneficiaries with diabetes and how adherence to the method used impacted diabetes-related inpatient hospitalizations and associated costs among beneficiaries with intensive insulin-treated diabetes. Methods: This 12-month retrospective analysis utilized Centers for Medicare & Medicaid Services data to identify Medicare beneficiaries who used intensive insulin therapy from January through December 2018 and classified them into four groups: (1) persons using real-time continuous glucose monitoring (rtCGM), (2) persons using any method of blood glucose monitoring (BGM) who followed prescribed use patterns (adherent), (3) persons who were prescribed BGM but were nonadherent in its use, and (4) no record of any form of BGM. Analyses compared these groups and the role that comorbidities (Charlson Comorbidity Index [CCI]), and race/ethnicity played on group assignment, diabetes-related inpatient hospitalizations, and costs. Results: Among the 1,329,061 persons assessed, 38.14% had no record of glucose monitoring and 35.42% were BGM nonadherent. Similarly, among the 629,514 beneficiaries with a CCI risk score of ≥2, 466,646 (74.13%) were either nonadherent to BGM or had no monitoring record. The percentage of White (3.65%) rtCGM adherent beneficiaries was significantly larger than Black (1.58%) and Hispanic (1.28%) beneficiaries, both P < 0.0001. Hospitalizations and costs were higher for Black and Hispanic beneficiaries versus Whites within the risk score ≥ 2 group regardless of glucose monitoring method. Conclusions: Race is associated with increased hospitalizations and costs associated with diabetes care and absence of any form of BGM was associated with higher rates of comorbidities. Persons of color were less likely to use rtCGM despite Medicare coverage. New initiatives that promote diabetes self-management education and support services are needed to improve utilization of glucose monitoring within the Medicare diabetes population. [ABSTRACT FROM AUTHOR]
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- 2023
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20. Animal insulin therapy induces a biased insulin antibody response that persists for years after introduction of human insulin
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Oak, Shilpa, Phan, Thanh-Hien Thi, Gilliam, Lisa K., Hirsch, Irl B., and Hampe, Christiane S.
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- 2010
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21. Identifying Suicide Risk in Adolescents and Young Adults With Type 1 Diabetes: Are Depression Screeners Sufficient?
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Moss, Ashley C., Roberts, Alissa J., Yi-Frazier, Joyce P., Read, Kendra L., Taplin, Craig E., Weaver, Kathryn W., Pihoker, Catherine, Hirsch, Irl B., and Malik, Faisal S.
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DIAGNOSIS of mental depression ,SUICIDE ,PREDICTIVE tests ,TYPE 1 diabetes ,DISEASE susceptibility ,QUESTIONNAIRES ,RESEARCH funding ,DISEASE complications - Abstract
Objective: Examine the utility of suicide-risk items embedded within depression screeners for identifying the presence of suicide risk in adolescents and young adults (AYA) with type 1 diabetes.Research Design and Methods: Sensitivity, specificity, and predictive value of self-report of suicide risk on the Patient Health Questionniaire-9 (PHQ-9) were compared with the pediatric psychologist-administered Columbia-Suicide Severity Rating Scale (C-SSRS) as the reference standard for AYA with type 1 diabetes seen in a multidisciplinary AYA Diabetes Program clinic.Results: Of 133 participants, 9.8% and 11.3% reported suicide risk on the PHQ-9 and C-SSRS, respectively. Sensitivity of the PHQ-9 risk item was 53.3% (95% CI 27.4%-77.7%), specificity was 95.7% (95% CI 89.9%-98.4%), positive predictive value was 61.5% (95% CI 32.3%-84.9%), and negative predictive value was 94.2% (95% CI 87.9-97.4%).Conclusions: Depression screeners appear to under-identify AYA with type 1 diabetes who may otherwise be at risk for suicide. [ABSTRACT FROM AUTHOR]- Published
- 2022
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22. The relationship between hypoglycaemia and glucose variability in type 1 diabetes.
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Perlman, Jordan E., Gooley, Theodore A., Meyers, Jedidiah, and Hirsch, Irl B.
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TYPE 1 diabetes ,INSULIN aspart ,HYPOGLYCEMIA ,INSULIN ,GLUCOSE - Abstract
Nonlinear terms for %CV were considered by modelling %CV as a restricted cubic spline with knots at the 5th, 25th, 50th, 75th and 95th percentiles of the observed %CV values. Keywords: continuous glucose monitoring; glucose variability; hypoglycaemia; type 1 diabetes mellitus EN continuous glucose monitoring glucose variability hypoglycaemia type 1 diabetes mellitus 733 736 4 03/11/22 20220401 NES 220401 INTRODUCTION Hypoglycaemia is a considerable barrier to intensified blood glucose management in type 1 diabetes mellitus (T1DM). In addition, we assessed the association between HbA1c and TBR to see if %CV or HbA1c provided a better fit to the model for TBR. [Extracted from the article]
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- 2022
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23. Early Trajectory of Estimated Glomerular Filtration Rate and Long-term Advanced Kidney and Cardiovascular Complications in Type 1 Diabetes.
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Perkins, Bruce A., Bebu, Ionut, Gao, Xiaoyu, Karger, Amy B., Hirsch, Irl B., Karanchi, Harsha, Molitch, Mark E., Zinman, Bernard, Lachin, John M., and de Boer, Ian H.
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TYPE 1 diabetes ,GLOMERULAR filtration rate ,CARDIOLOGICAL manifestations of general diseases ,MAJOR adverse cardiovascular events ,INSULIN pumps ,KIDNEY transplantation ,DIABETES complications ,CHRONIC kidney failure complications ,CLINICAL trials ,KIDNEYS ,CARDIOVASCULAR diseases ,CARDIOVASCULAR system ,ALBUMINURIA ,DISEASE complications - Abstract
Objective: Rapid loss of estimated glomerular filtration rate (eGFR) within its normal range has been proposed as a strong predictor of future kidney disease. We investigated this association of eGFR slope early in the course of type 1 diabetes with long-term incidence of kidney and cardiovascular complications.Research Design and Methods: The annual percentage change in eGFR (slope) was calculated during the Diabetes Control and Complications Trial (DCCT) for each of 1,441 participants over a mean of 6.5 years and dichotomized by the presence or absence of early rapid eGFR loss (slope ≤-3% per year) as the exposure of interest. Outcomes were incident reduced eGFR (eGFR <60 mL/min/1.73 m2), composite cardiovascular events, or major adverse cardiovascular events (MACE) during the subsequent 24 years post-DCCT closeout follow-up.Results: At DCCT closeout (the baseline for this analysis), diabetes duration was 12 ± 4.8 years, most participants (85.9%) had normoalbuminuria, mean eGFR was 117.0 ± 13.4 mL/min/1.73 m2, and 149 (10.4%) had experienced early rapid eGFR loss over the preceding trial phase. Over the 24-year subsequent follow-up, there were 187 reduced eGFR (6.3 per 1,000 person-years) and 113 MACE (3.6 per 1,000 person-years) events. Early rapid eGFR loss was associated with risk of reduced eGFR (hazard ratio [HR] 1.81, 95% CI 1.18-2.79, P = 0.0064), but not after adjustment for baseline eGFR level (HR 0.94, 95% CI 0.53-1.66, P = 0.84). There was no association with composite cardiovascular events or MACE.Conclusions: In people with type 1 diabetes primarily with normal eGFR and normoalbuminuria, the preceding slope of eGFR confers no additional association with kidney or cardiovascular outcomes beyond knowledge of an individual's current level. [ABSTRACT FROM AUTHOR]- Published
- 2022
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24. Towards prediction of type 1 diabetes patients who fail to achieve glycemic target
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Jensen, Morten Hasselstrøm, Cichosz, Simon Lebech, Hejlesen, Ole, Hirsch, Irl B., and Vestergaard, Peter
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Type 1 diabetes ,continuous glucose monitoring ,prediction - Abstract
In this study, we investigated which predictors from people with type 1 diabetes at initiation of intensive treatment that increase the risk of not achieving glycemic target. Data from a clinical trial with type 1 diabetes people (n=460) were used in a logistic regression model to analyze the effect of the predictors on achievement of glycemic target. Results indicate that age, smoking, glycated hemoglobin, 1,5-anhydroglucitol and fluctuation from continuous glucose monitoring are predictors of achievement of glycemic target, which can be used in an algorithm to predict people who fail to achieve glycemic target.
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- 2020
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25. Integrating Continuous Glucose Monitoring Into Clinical Practices and Patients' Lives.
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Hirsch, Irl B. and Miller, Eden
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GLUCOSE , *MEDICAL personnel , *PRIMARY care , *TYPE 1 diabetes , *DIABETES , *INSULIN pumps - Abstract
Numerous studies have demonstrated the clinical benefits of continuous glucose monitoring (CGM) in individuals with diabetes. Within ongoing innovations in CGM technology, individuals now have an expanding array of options that allow them to select the device that meets their individual needs and preferences. Although demand for CGM in primary care continues to grow, many clinicians are reluctant to prescribe this technology due to their unfamiliarity with the various devices, uncertainty about which devices are best suited to each patient and the feasibility of using CGM. This article reviews the features and functionality of the most recent commercially available CGM devices and provides guidance for integrating CGM use into clinical practices. [ABSTRACT FROM AUTHOR]
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- 2021
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26. Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes.
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Brown, Sue A., Forlenza, Gregory P., Bode, Bruce W., Pinsker, Jordan E., Levy, Carol J., Criego, Amy B., Hansen, David W., Hirsch, Irl B., Carlson, Anders L., Bergenstal, Richard M., Sherr, Jennifer L., Mehta, Sanjeev N., Laffel, Lori M., Shah, Viral N., Bhargava, Anuj, Weinstock, Ruth S., MacLeish, Sarah A., DeSalvo, Daniel J., Jones, Thomas C., and Aleppo, Grazia
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TYPE 1 diabetes ,INSULIN ,DIABETIC acidosis ,ADULTS ,DIABETES ,RESEARCH ,RESEARCH methodology ,HYPOGLYCEMIC agents ,BLOOD sugar ,MEDICAL cooperation ,EVALUATION research ,COMPARATIVE studies ,RANDOMIZED controlled trials ,INSULIN pumps ,RESEARCH funding ,STATISTICAL sampling ,LONGITUDINAL method - Abstract
Objective: Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal safety study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets.Research Design and Methods: This single-arm, multicenter, prospective study enrolled 112 children (age 6-13.9 years) and 129 adults (age 14-70 years). A 2-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery. Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA1c and percent time in sensor glucose range 70-180 mg/dL ("time in range").Results: A total of 235 participants (98% of enrolled, including 111 children and 124 adults) completed the study. HbA1c was significantly reduced in children by 0.71% (7.8 mmol/mol) (mean ± SD: 7.67 ± 0.95% to 6.99 ± 0.63% [60 ± 10.4 mmol/mol to 53 ± 6.9 mmol/mol], P < 0.0001) and in adults by 0.38% (4.2 mmol/mol) (7.16 ± 0.86% to 6.78 ± 0.68% [55 ± 9.4 mmol/mol to 51 ± 7.4 mmol/mol], P < 0.0001). Time in range was improved from standard therapy by 15.6 ± 11.5% or 3.7 h/day in children and 9.3 ± 11.8% or 2.2 h/day in adults (both P < 0.0001). This was accomplished with a reduction in time in hypoglycemia <70 mg/dL among adults (median [interquartile range]: 2.00% [0.63, 4.06] to 1.09% [0.46, 1.75], P < 0.0001), while this parameter remained the same in children. There were three severe hypoglycemia events not attributable to automated insulin delivery malfunction and one diabetic ketoacidosis event from an infusion site failure.Conclusions: This tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA1c levels and time in target glucose range with a very low occurrence of hypoglycemia. [ABSTRACT FROM AUTHOR]- Published
- 2021
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27. Characteristics of Continuous Glucose Monitoring Metrics in Persons with Type 1 and Type 2 Diabetes Treated with Multiple Daily Insulin Injections.
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Hallström, Sara, Hirsch, Irl B., Ekelund, Magnus, Sofizadeh, Sheyda, Albrektsson, Henrik, Dahlqvist, Solveig, Svensson, Ann-Marie, and Lind, Marcus
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TYPE 1 diabetes , *TYPE 2 diabetes , *GLUCOSE , *INSULIN , *STANDARD deviations , *INSULIN therapy , *RESEARCH , *BLOOD sugar monitoring , *RESEARCH methodology , *BLOOD sugar , *EVALUATION research , *BENCHMARKING (Management) , *COMPARATIVE studies - Abstract
Background: Although guidelines advocate similar continuous glucose monitoring (CGM) targets for insulin-treated persons with type 1 diabetes (T1D) and type 2 diabetes (T2D), it is unclear how these persons differ with respect to hypoglycemia, glucose variability, and other CGM metrics in clinical practice. Methods: We used data from 2 multicenter randomized-controlled trials (GOLD and MDI-Liraglutide) where 161 persons with T1D and 124 persons with T2D treated with multiple daily injections were included and monitored with masked CGM. Results: Persons from both cohorts had similar mean glucose levels, 10.9 mmol/L (196 mg/dL) in persons with T1D and 10.8 mmol/L (194 mg/dL) in persons with T2D. Time in hypoglycemia (<3.9 mmol/L [70 mg/dL]) was 5.1% and 1.0% for persons with T1D and T2D, respectively (P < 0.001). Corresponding estimates for the standard deviations of mean glucose levels were 4.4 mmol/L (79 mg/dL) versus 3.0 (54 mg/dL) (P < 0.001), for coefficient of variation 41% versus 28% (P < 0.001), and for time in range 38.2% versus 45.3%, respectively (P = 0.004). Mean C-peptide levels were 0.05 nmol/L and 0.67 nmol/L (P < 0.001) for persons with T1D and T2D, respectively. Conclusions: Persons with T1D compared with persons with T2D treated with multiple daily insulin injections spend considerably more time in hypoglycemia, have higher glucose variability, and less "time in range." This needs to be taken into account in daily clinical care and in recommended targets for CGM metrics. [ABSTRACT FROM AUTHOR]
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- 2021
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28. COVID-19 Hospitalization in Adults with Type 1 Diabetes: Results from the T1D Exchange Multicenter Surveillance Study.
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O'Malley, Grenye, Ebekozien, Osagie, Desimone, Marisa, Pinnaro, Catherina T., Roberts, Alissa, Polsky, Sarit, Noor, Nudrat, Aleppo, Grazia, Basina, Marina, Tansey, Michael, Steenkamp, Devin, Vendrame, Francesco, Lorincz, Ilona, Mathias, Priyanka, Agarwal, Shivani, Golden, Lauren, Hirsch, Irl B., and Levy, Carol J.
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TYPE 1 diabetes ,INSULIN pumps ,BLOOD sugar monitors ,COVID-19 ,ENDOCRINE diseases ,MIDDLE East respiratory syndrome - Published
- 2021
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29. The Digital/Virtual Diabetes Clinic: The Future Is Now-Recommendations from an International Panel on Diabetes Digital Technologies Introduction.
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Phillip, Moshe, Bergenstal, Richard M., Close, Kelly L., Danne, Thomas, Garg, Satish K., Heinemann, Lutz, Hirsch, Irl B., Kovatchev, Boris P., Laffel, Lori M., Mohan, Viswanathan, Parkin, Christopher G., and Battelino, Tadej
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MEDICAL personnel ,DIGITAL technology ,COVID-19 ,DIABETES ,TYPE 1 diabetes - Abstract
The increasing prevalence of diabetes, combined with a growing global shortage of health care professionals (HCP), necessitates the need to develop new approaches to diabetes care delivery to expand access to care, lessen the burden on people with diabetes, improve efficiencies, and reduce the unsustainable financial liability on health systems and payers. Use of digital diabetes technologies and telehealth protocols within a digital/virtual diabetes clinic has the potential to address these challenges. However, several issues must be resolved to move forward. In February 2020, organizers of the Advanced Technologies & Treatments for Diabetes Annual Conference convened an international panel of HCP, researchers, patient advocates, and industry representatives to review the status of digital diabetes technologies, characterize deficits in current technologies, and identify issues for consideration. Since that meeting, the importance of using telehealth and digital diabetes technologies has been demonstrated amid the global coronavirus disease (COVID-19) pandemic. This article summarizes the panel's discussion of the opportunities, obstacles, and requisites for advancing the use of these technologies as a standard of care for the management of diabetes. [ABSTRACT FROM AUTHOR]
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- 2021
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30. The majority of people with type 1 diabetes and multiple daily insulin injections benefit from using continuous glucose monitoring: An analysis based on the GOLD randomized trial (GOLD‐5).
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Ólafsdóttir, Arndís F., Bolinder, Jan, Heise, Tim, Polonsky, William, Ekelund, Magnus, Wijkman, Magnus, Pivodic, Aldina, Ahlén, Elsa, Schwarcz, Erik, Nyström, Thomas, Hellman, Jarl, Hirsch, Irl B., and Lind, Marcus
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TYPE 1 diabetes ,GLUCOSE analysis ,INSULIN ,MEDICAL personnel ,BLOOD sugar ,GLYCOSYLATED hemoglobin - Abstract
Aim: To identify responders to continuous glucose monitoring (CGM) in relation to reductions in HbA1c and percentage of time spent in hypoglycaemia after initiation of CGM for individuals with type 1 diabetes treated with multiple daily insulin injections. Materials and Methods: We analysed data from 142 participants in the GOLD randomized clinical trial. We evaluated how many lowered their HbA1c by more than 0.4% (>4.7 mmol/mol) or decreased the time spent in hypoglycaemia over 24 hours by more than 20 or 30 minutes, and which baseline variables were associated with those improvements. Results: Lower reduction of HbA1c was associated with greater reduction of hypoglycaemia (r = −0.52; P <.0001). During CGM, 47% of participants lowered their HbA1c values by more than 0.4% (>4.7 mmol/mol) than with self‐measurement of blood glucose, and 47% decreased the time spent in hypoglycaemia by more than 20 minutes over 24 hours. Overall, 78% either reduced their HbA1c by more than 0.4% (>4.7 mmol/mol) or the time spent in hypoglycaemia by more than 20 minutes over 24 hours, but only 14% improved both. Higher HbA1c, a lower percentage of time at less than 3.0 or 3.9 mmol/L, a lower coefficient of variation (CV) and a higher percentage of time above 13.9 mmol/L (P =.016) were associated with greater HbA1c reduction during CGM. The variables associated with a greater reduction of time in hypoglycaemia were female sex, greater time with glucose levels at less than 3.0 mmol/L, higher CV, and higher hypoglycaemia confidence as evaluated by a hypoglycaemic confidence questionnaire. Conclusion: The majority of people with type 1 diabetes managed by multiple daily insulin injections benefit from CGM; some experienced reduced HbA1c while others reduced the time spent in hypoglycaemia. These factors need to be considered by healthcare professionals and decision‐makers for reimbursement and diabetes guidelines. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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31. Sustained Intensive Treatment and Long-term Effects on HbA1c Reduction (SILVER Study) by CGM in People With Type 1 Diabetes Treated With MDI.
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Lind, Marcus, Ólafsdóttir, Arndís F., Hirsch, Irl B., Bolinder, Jan, Dahlqvist, Sofia, Pivodic, Aldina, Hellman, Jarl, Wijkman, Magnus, Schwarcz, Erik, Albrektsson, Henrik, Heise, Tim, and Polonsky, William
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TYPE 1 diabetes ,TREATMENT effectiveness ,PATIENT satisfaction ,BLOOD sugar monitoring ,OVERTIME ,INSULINOMA ,BLOOD sugar ,HYPOGLYCEMIC agents ,INSULIN ,RANDOMIZED controlled trials ,QUESTIONNAIRES ,CROSSOVER trials ,STATISTICAL sampling ,SILVER - Abstract
Objective: Continuous glucose monitoring (CGM) reduces HbA1c and time spent in hypoglycemia in people with type 1 diabetes (T1D) treated with multiple daily insulin injections (MDI) when evaluated over shorter time periods. It is unclear to what extent CGM improves and helps to maintain glucose control, treatment satisfaction, diabetes distress, hypoglycemic concerns, and overall well-being over longer periods of time.Research Design and Methods: The GOLD trial was a randomized crossover trial performed over 16 months of CGM treatment in people with T1D treated with MDI. People completing the trial (n = 141) were invited to participate in the current SILVER extension study in which 107 patients continued CGM treatment over 1 year along with the support of a diabetes nurse every 3 months.Results: The primary end point of the change in HbA1c over 1.0-1.5 years of CGM use compared with previous self-monitoring of blood glucose during GOLD showed a decrease in HbA1c of 0.35% (95% CI 0.19-0.50, P < 0.001). Time spent in hypoglycemia <3.0 mmol/L (54 mg/dL) and <4.0 mmol/L (72 mg/dL) decreased from 2.1% to 0.6% (P < 0.001) and from 5.4% to 2.9% (P < 0.001), respectively. Overall well-being (World Health Organization 5-item well-being index, P = 0.009), treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire, P < 0.001), and hypoglycemic confidence (P < 0.001) increased, while hypoglycemic fear (Hypoglycemia Fear Survey-Worry, P = 0.016) decreased and diabetes distress tended to decrease (Problem Areas in Diabetes Scale, P = 0.06). From randomization and screening in GOLD, HbA1c was lowered by 0.45% (P < 0.001) and 0.68% (P < 0.001) after 2.3 and 2.5 years, respectively.Conclusions: The SILVER study supports beneficial long-term effects from CGM on HbA1c, hypoglycemia, treatment satisfaction, well-being, and hypoglycemic confidence in people with T1D managed with MDI. [ABSTRACT FROM AUTHOR]- Published
- 2021
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32. Driving Safety in Adolescents and Young Adults With Type 1 Diabetes.
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Roberts, Alissa J., Moss, Ashley, Malik, Faisal S., Taplin, Craig, Pihoker, Catherine, Hirsch, Irl B., Read, Kendra, and Yi-Frazier, Joyce P.
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AUTOMOBILE driving ,CHI-squared test ,HYPOGLYCEMIA ,TYPE 1 diabetes ,RESEARCH funding ,SAFETY ,T-test (Statistics) ,TRAFFIC accidents ,DATA analysis software ,DESCRIPTIVE statistics - Abstract
The article discusses the self-reported driving practices, hypoglycemia management practices, and substance use and texting while driving in people with adolescent and young adult (AYA) drivers with type 1 diabetes. Also cited are the driving safety risk factors in AYA drivers like poor executive function and lack of driving experience, and the recommendations by the American Diabetes Association (ADA) to promote safe driving in people with type 1 diabetes.
- Published
- 2020
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33. The Association Between HbA1c and Time in Hypoglycemia During CGM and Self-Monitoring of Blood Glucose in People With Type 1 Diabetes and Multiple Daily Insulin Injections: A Randomized Clinical Trial (GOLD-4).
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Seyed Ahmadi, Shilan, Westman, Klara, Pivodic, Aldina, Ólafsdóttir, Arndís F., Dahlqvist, Sofia, Hirsch, Irl B., Hellman, Jarl, Ekelund, Magnus, Heise, Tim, Polonsky, William, Wijkman, Magnus, Schwarcz, Erik, and Lind, Marcus
- Subjects
BLOOD sugar monitoring ,TYPE 1 diabetes ,CLINICAL trials ,HYPOGLYCEMIA ,INSULIN ,BLOOD sugar analysis ,RESEARCH ,TIME ,RESEARCH methodology ,BLOOD sugar ,MEDICAL cooperation ,EVALUATION research ,DRUG administration ,COMPARATIVE studies ,RANDOMIZED controlled trials ,CROSSOVER trials ,SUBCUTANEOUS injections - Abstract
Objective: According to recent guidelines, individuals with type 1 diabetes should spend <4.0% of time per day with glucose levels <3.9 mmol/L (<70 mg/dL) and <1.0% per day with glucose levels <3.0 mmol/L (<54 mg/dL).Research Design and Methods: In the GOLD randomized crossover trial, 161 individuals with type 1 diabetes treated with multiple daily insulin injections (MDI) were randomized to continuous glucose monitoring (CGM) or conventional therapy with self-monitoring of blood glucose (SMBG) and evaluated over 16 months. We estimated the association between time spent in hypoglycemia and various mean glucose and HbA1c levels.Results: Time spent in hypoglycemia (<3.9 mmol/L and <3.0 mmol/L) increased significantly with lower mean HbA1c and mean glucose levels during both CGM and conventional therapy. During CGM, 24 (57.1%) individuals with HbA1c <7.5% (<58 mmol/mol) had <1.0% time spent in hypoglycemia <3.0 mmol/L and 23 (54.8%) had <4.0% time spent in hypoglycemia <3.9 mmol/L. During CGM, mean time spent in hypoglycemia for individuals with mean HbA1c 7.0% (52 mmol/mol) was estimated to be 5.4% for <3.9 mmol/L and 1.5% for <3.0 mmol/L. The corresponding values during SMBG were 9.2% and 3.5%, respectively. Individuals with mean glucose levels of 8 mmol/L spent 4.9% units more time with glucose levels <3.9 mmol/L and 2.8% units more time <3.0 mmol/L during SMBG compared with CGM.Conclusions: Reaching current targets for time in hypoglycemia while at the same time reaching HbA1c targets is challenging for patients with type 1 diabetes treated with MDI both with CGM and SMBG monitoring. However, CGM is associated with considerably less time in hypoglycemia than SMBG at a broad range of HbA1c levels and is crucial for patients with MDI treatment if they are to have a chance to approach hypoglycemia targets. [ABSTRACT FROM AUTHOR]- Published
- 2020
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34. Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial.
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Pratley, Richard E., Kanapka, Lauren G., Rickels, Michael R., Ahmann, Andrew, Aleppo, Grazia, Beck, Roy, Bhargava, Anuj, Bode, Bruce W., Carlson, Anders, Chaytor, Naomi S., Fox, D. Steven, Goland, Robin, Hirsch, Irl B., Kruger, Davida, Kudva, Yogish C., Levy, Carol, McGill, Janet B., Peters, Anne, Philipson, Louis, and Philis-Tsimikas, Athena
- Subjects
BLOOD sugar monitoring ,HYPOGLYCEMIA ,TYPE 2 diabetes ,DISEASES in older people ,CLINICAL trials ,PATIENT monitoring equipment ,BLOOD sugar monitors ,BLOOD sugar analysis ,RESEARCH ,HYPERGLYCEMIA ,RESEARCH methodology ,TYPE 1 diabetes ,HYPOGLYCEMIC agents ,EVALUATION research ,MEDICAL cooperation ,COMPARATIVE studies ,RANDOMIZED controlled trials - Abstract
Importance: Continuous glucose monitoring (CGM) provides real-time assessment of glucose levels and may be beneficial in reducing hypoglycemia in older adults with type 1 diabetes.Objective: To determine whether CGM is effective in reducing hypoglycemia compared with standard blood glucose monitoring (BGM) in older adults with type 1 diabetes.Design, Setting, and Participants: Randomized clinical trial conducted at 22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes.Interventions: Participants were randomly assigned in a 1:1 ratio to use CGM (n = 103) or standard BGM (n = 100).Main Outcomes and Measures: The primary outcome was CGM-measured percentage of time that sensor glucose values were less than 70 mg/dL during 6 months of follow-up. There were 31 prespecified secondary outcomes, including additional CGM metrics for hypoglycemia, hyperglycemia, and glucose control; hemoglobin A1c (HbA1c); and cognition and patient-reported outcomes, with adjustment for multiple comparisons to control for false-discovery rate.Results: Of the 203 participants (median age, 68 [interquartile range {IQR}, 65-71] years; median type 1 diabetes duration, 36 [IQR, 25-48] years; 52% female; 53% insulin pump use; mean HbA1c, 7.5% [SD, 0.9%]), 83% used CGM at least 6 days per week during month 6. Median time with glucose levels less than 70 mg/dL was 5.1% (73 minutes per day) at baseline and 2.7% (39 minutes per day) during follow-up in the CGM group vs 4.7% (68 minutes per day) and 4.9% (70 minutes per day), respectively, in the standard BGM group (adjusted treatment difference, -1.9% (-27 minutes per day); 95% CI, -2.8% to -1.1% [-40 to -16 minutes per day]; P <.001). Of the 31 prespecified secondary end points, there were statistically significant differences for all 9 CGM metrics, 6 of 7 HbA1c outcomes, and none of the 15 cognitive and patient-reported outcomes. Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, -0.3%; 95% CI, -0.4% to -0.1%; P <.001). The most commonly reported adverse events using CGM and standard BGM, respectively, were severe hypoglycemia (1 and 10), fractures (5 and 1), falls (4 and 3), and emergency department visits (6 and 8).Conclusions and Relevance: Among adults aged 60 years or older with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in hypoglycemia over 6 months. Further research is needed to understand the long-term clinical benefit.Trial Registration: ClinicalTrials.gov Identifier: NCT03240432. [ABSTRACT FROM AUTHOR]- Published
- 2020
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35. Ranting in 2022: Not More of the Same.
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Hirsch, Irl B.
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TYPE 2 diabetes , *CONGREGATE housing , *TYPE 1 diabetes , *MEDICAL assistants , *MEDICAL quality control , *MEDICAL care - Abstract
In my letter, I pointed out how this patient with 40 years of type 1 diabetes has impaired hypoglycemia awareness, and that it was nonsensical that we prescribe a Krispy Crème donut when the insurance was already paying for an insulin pump, a continuous glucose monitor, and a PSCK-9 inhibitor. I am still speechless about a patient several years ago, admitted with euglycemic DKA, who at the time was diagnosed with type 2 diabetes (later found to have type 1 diabetes), receiving an SGLT2 inhibitor, and the drug was not discontinued, even while he was an inpatient! The patient is in her 70s, type 1 diabetes for >40 years, and is now living in an assisted living facility, which allows her to receive fixed doses of prandial insulin with correction doses. Take, for example, my 60-year-old male patient with type 1 diabetes and a previous myocardial infarction who needed a glucagon prescription. [Extracted from the article]
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- 2022
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36. Preventing Early Renal Loss in Diabetes (PERL) Study: A Randomized Double-Blinded Trial of Allopurinol-Rationale, Design, and Baseline Data.
- Author
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Afkarian, Maryam, Polsky, Sarit, Parsa, Afshin, Aronson, Ronnie, Caramori, Maria Luiza, Cherney, David Z., Crandall, Jill P., de Boer, Ian H., Elliott, Thomas G., Galecki, Andrzej T., Goldfine, Allison B., Haw, J. Sonya, Hirsch, Irl B., Karger, Amy B., Lingvay, Ildiko, Maahs, David M., McGill, Janet B., Molitch, Mark E., Perkins, Bruce A., and Pop-Busui, Rodica
- Subjects
DIABETIC nephropathies ,TYPE 1 diabetes ,RENIN-angiotensin system ,THERAPEUTICS ,DIABETES ,ALBUMINURIA ,BLOOD pressure ,COMPARATIVE studies ,GLOMERULAR filtration rate ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,URIC acid ,EVALUATION research ,BLIND experiment ,DISEASE progression ,ALLOPURINOL ,DISEASE complications - Abstract
Objective: Higher serum uric acid (SUA) is associated with diabetic kidney disease (DKD). Preventing Early Renal Loss in Diabetes (PERL) evaluates whether lowering SUA with allopurinol slows glomerular filtration rate (GFR) loss in people with type 1 diabetes (T1D) and mild to moderate DKD. We present the PERL rationale, design, and baseline characteristics.Research Design and Methods: This double-blind, placebo-controlled, multicenter trial randomized 530 participants with T1D, estimated GFR (eGFR) of 40-99.9 mL/min/1.73 m2, SUA ≥4.5 m/dL, and micro- to macroalbuminuric DKD or normoalbuminuria with declining kidney function (NDKF) (defined as historical eGFR decline ≥3 mL/min/1.73 m2/year) to allopurinol or placebo. The primary outcome is baseline-adjusted iohexol GFR (iGFR) after 3 years of treatment plus a 2-month washout period.Results: Participants are 66% male and 84% white. At baseline, median age was 52 years and diabetes duration was 35 years, 93% of participants had hypertension, and 90% were treated with renin-angiotensin system inhibitors (median blood pressure 127/71 mmHg). Median HbA1c was 8%, SUA 5.9 mg/dL, iGFR 68 mL/min/1.73 m2, and historical eGFR slope -3.5 mL/min/1.73 m2/year. Compared with participants with albuminuria (n = 419), those with NDKF (n = 94) were significantly older (56 vs. 52 years), had lower HbA1c (7.7 vs. 8.1%) and SUA (5.4 vs. 6.0 mg/dL), and had higher eGFR (82 vs. 74 mL/min/1.73 m2) and historical eGFR loss (-4.7 vs. -2.5 mL/min/1.73 m2/year). These differences persisted when comparing groups with similar rates of historical eGFR loss.Conclusions: PERL will determine the effect of allopurinol on mild to moderate DKD in T1D, with or without albuminuria. Participants with normoalbuminuria and rapid GFR loss manifested many DKD risk factors of those with albuminuria, but with less severity. [ABSTRACT FROM AUTHOR]- Published
- 2019
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37. Connecting the Dots: Validation of Time in Range Metrics With Microvascular Outcomes.
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Hirsch, Irl B., Sherr, Jennifer L., and Hood, Korey K.
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BLOOD sugar monitoring , *TYPE 1 diabetes , *DIABETES , *HEALTH outcome assessment , *TIME , *ACQUISITION of data - Abstract
The article offers information on a study related to the validation of time in range metrics with microvascular outcomes. It notes the diabetes control and complications trial (DCCT) which identified the relationship between intensive diabetes management for those with type 1 diabetes (T1D) and a delay in progression of microvascular complications.
- Published
- 2019
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- View/download PDF
38. The Hybrid Closed-Loop System: Evolution and Practical Applications.
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Weaver, Kathryn W. and Hirsch, Irl B.
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INSULIN pumps , *BLOOD sugar monitoring , *BLOOD sugar analysis , *INSULIN therapy , *COMPARATIVE studies , *HYPOGLYCEMIC agents , *INSULIN , *TYPE 1 diabetes , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH , *EVALUATION research , *EQUIPMENT & supplies ,PREVENTION of diabetes complications - Abstract
Achievement of well-controlled blood glucose is essential for preventing complications in patients with type 1 diabetes. Since the inception of continuous subcutaneous insulin infusion, the aim has been to develop an artificial pancreas, with the ability to use an automated algorithm to deliver one or more hormones in response to blood glucose with the intent to keep blood sugar as close to a prespecified target as possible. Development and rapid improvement of continuous glucose sensor technology has recently allowed swift progress toward a fully closed-loop insulin delivery system. In 2017, Medtronic began marketing the 670G insulin pump with Guardian 3 sensor. When in auto mode, this is a hybrid closed-loop insulin delivery system that automatically adjusts basal insulin delivery every 5 min based on sensor glucose to maintain blood glucose levels as close to a specific target as possible. Patients receive prandial insulin by entering carbohydrate amount into the bolus calculator. Early studies show improvement in HbA1c in both adults and adolescents with this technology. Initial safety trials showed no occurrence of diabetic ketoacidosis or hypoglycemia. The utility of this device is limited by blood glucose targets of 120 and 150 mg/dL that are unacceptably high for some patients. Notwithstanding recent advances, we are far from a system that is able to replicate islet function in the form of a fully automated, multihormonal blood glucose control device. [ABSTRACT FROM AUTHOR]
- Published
- 2018
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39. Why Are We Failing to Address the Issue of Access to Insulin? A National and Global Perspective.
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Beran, David, Hirsch, Irl B., and Yudkin, John S.
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INSULIN , *TYPE 2 diabetes , *KETOACIDOSIS , *HIV infections , *AIDS , *LIFE expectancy , *PEOPLE with diabetes , *INSULIN therapy , *PUBLIC sector & economics , *COMPARATIVE studies , *HEALTH services accessibility , *HEALTH status indicators , *INCOME , *TYPE 1 diabetes , *RESEARCH methodology , *MEDICAL care costs , *MEDICAL cooperation , *RESEARCH , *WORLD health , *GOVERNMENT aid , *PRIVATE sector , *PUBLIC sector , *EVALUATION research , *ECONOMICS ,DEVELOPING countries - Abstract
Insulin was discovered in 1921 and soon became widely available in high-income countries. However, many people currently in need of this life-saving medicine are unable to access it. This is a global phenomenon, impacting not only populations of low- and middle-income countries but low-income populations in the U.S. In the U.S., the rate of diabetic ketoacidosis remains high in certain subpopulations, the cost of insulin being the main precipitating factor. On a global level the main cause of mortality for a child with type 1 diabetes is a lack of access to insulin, and in sub-Saharan Africa the life expectancy of a child with type 1 diabetes can be as low as 1 year. One lens for considering the issue of access to health and medicines is to consider society as a three-legged stool. In this paradigm, the role of the public sector is to provide "protections" to the population it serves; the private sector is made up of "responsible businesses" that supply many of the goods and services people need; and the plural sector comprises communities and not-for-profits providing the "social affiliations" that are needed. For HIV/AIDS, each of these "legs" played a role in improving access. Civil society raised awareness of the issue and advocated for access to treatment. Governments provided funding and responses both nationally and globally. Finally, the private sector played its role, under pressure from civil society and governments, in lowering the price of medicines and developing programs to expand access. Here, we use this framework to describe the shortcomings in access to insulin from a U.S. and global perspective. [ABSTRACT FROM AUTHOR]
- Published
- 2018
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40. Real-time continuous glucose monitoring in type 1 diabetes: a systematic review and individual patient data meta-analysis.
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Benkhadra, Khalid, Alahdab, Fares, Tamhane, Shrikant, Wang, Zhen, Prokop, Larry J., Hirsch, Irl B., Raccah, Denis, Riveline, Jean‐Pierre, Kordonouri, Olga, and Murad, Mohammad Hassan
- Subjects
TYPE 1 diabetes ,MEASUREMENT of glucose in the body ,PATIENT monitoring ,RANDOMIZED controlled trials ,META-analysis - Abstract
Background Real-time continuous glucose monitoring ( RTCGM) may help in the management of individuals with type 1 diabetes mellitus (T1 DM); however, the evidence supporting its use is unclear. The available meta-analyses on this topic use aggregate data which weaken inference. Objective Individual patient data were obtained from randomized controlled trials ( RCTs) to conduct a meta-analysis and synthesize evidence about the effect of RTCGM on glycosylated haemoglobin (HbA1c), hypoglycaemic events and time spent in hypoglycaemia in T1 DM. Methods We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and Database of Systematic Reviews, and Scopus through January 2015. We included RCTs that enrolled individuals with T1 DM and compared RTCGM vs control group. A two-step regression model was used to pool individual patient data. Results We included 11 RCTs at moderate risk of bias. Meta-analysis suggests that the use of RTCGM is associated with a statistically significant but modest reduction in HbA1c (−0·276; 95% confidence interval −0·465 to −0·087). The improvements in HbA1c were primarily seen in individuals over age 15 years. We were unable to identify a statistically significant difference in time spent in hypoglycaemia or the number of hypoglycaemic episodes although these analyses were imprecise and warrant lower confidence. There was no difference between males and females. Conclusion RTCGM in T1 DM is associated with a reduction in HbA1c primarily in individuals over 15 years of age. We were unable to identify a statistically significant difference in the time spent in hypoglycaemia or the incidence of hypoglycaemic episodes. [ABSTRACT FROM AUTHOR]
- Published
- 2017
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41. Ranting in 2020: Reflecting About the Past and the Future (with Concerns About the Present).
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Hirsch, Irl B.
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MEDICAL personnel , *TYPE 1 diabetes , *BODY odor , *DIABETES , *HISTORY , *MEDICAL care , *MEDICAL quality control , *PRACTICAL politics - Abstract
In academia, there are more evaluations from students, residents, and fellows, but all of us who see patients are now dependent on patient evaluations that come in all forms. I received a hospital discharge summary from an outside hospital where a patient of mine with type 1 diabetes was admitted for intravenous antibiotics for sepsis. Currently, it is family advocacy that is the primary protector for patient safety when admitted to certain hospitals for type 1 diabetes. [Extracted from the article]
- Published
- 2020
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42. Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial.
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Lind, Marcus, Polonsky, William, Hirsch, Irl B., Heise, Tim, Bolinder, Jan, Dahlqvist, Sofia, Schwarz, Erik, Ólafsdóttir, Arndís Finna, Frid, Anders, Wedel, Hans, Ahlén, Elsa, Nyström, Thomas, and Hellman, Jarl
- Subjects
BLOOD sugar monitoring ,GLYCEMIC control ,TREATMENT of diabetes ,TYPE 1 diabetes ,INJECTIONS ,INSULIN therapy ,MEASUREMENT of glucose in the body ,PEOPLE with diabetes ,DISEASES in adults ,THERAPEUTICS ,BLOOD sugar analysis ,COMPARATIVE studies ,CROSSOVER trials ,DRUGS ,DRUG administration ,GLYCOSYLATED hemoglobin ,HYPOGLYCEMIA ,HYPOGLYCEMIC agents ,INSULIN ,RESEARCH methodology ,MEDICAL cooperation ,PATIENT compliance ,PATIENT satisfaction ,RESEARCH ,STATISTICAL sampling ,TIME ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,PSYCHOLOGY - Abstract
Importance: The majority of individuals with type 1 diabetes do not meet recommended glycemic targets.Objective: To evaluate the effects of continuous glucose monitoring in adults with type 1 diabetes treated with multiple daily insulin injections.Design, Setting, and Participants: Open-label crossover randomized clinical trial conducted in 15 diabetes outpatient clinics in Sweden between February 24, 2014, and June 1, 2016 that included 161 individuals with type 1 diabetes and hemoglobin A1c (HbA1c) of at least 7.5% (58 mmol/mol) treated with multiple daily insulin injections.Interventions: Participants were randomized to receive treatment using a continuous glucose monitoring system or conventional treatment for 26 weeks, separated by a washout period of 17 weeks.Main Outcomes and Measures: Difference in HbA1c between weeks 26 and 69 for the 2 treatments. Adverse events including severe hypoglycemia were also studied.Results: Among 161 randomized participants, mean age was 43.7 years, 45.3% were women, and mean HbA1c was 8.6% (70 mmol/mol). A total of 142 participants had follow-up data in both treatment periods. Mean HbA1c was 7.92% (63 mmol/mol) during continuous glucose monitoring use and 8.35% (68 mmol/mol) during conventional treatment (mean difference, -0.43% [95% CI, -0.57% to -0.29%] or -4.7 [-6.3 to -3.1 mmol/mol]; P < .001). Of 19 secondary end points comprising psychosocial and various glycemic measures, 6 met the hierarchical testing criteria of statistical significance, favoring continuous glucose monitoring compared with conventional treatment. Five patients in the conventional treatment group and 1 patient in the continuous glucose monitoring group had severe hypoglycemia. During washout when patients used conventional therapy, 7 patients had severe hypoglycemia.Conclusions and Relevance: Among patients with inadequately controlled type 1 diabetes treated with multiple daily insulin injections, the use of continuous glucose monitoring compared with conventional treatment for 26 weeks resulted in lower HbA1c. Further research is needed to assess clinical outcomes and longer-term adverse effects.Trial Registration: clinicaltrials.gov Identifier: NCT02092051. [ABSTRACT FROM AUTHOR]- Published
- 2017
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43. Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial.
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Ahrén, Bo, Hirsch, Irl B., Pieber, Thomas R., Mathieu, Chantal, Gómez-Peralta, Fernando, Hansen, Troels Krarup, Philotheou, Areti, Birch, Sune, Christiansen, Erik, Jon Jensen, Thomas, Buse, John B., Jensen, Thomas Jon, and ADJUNCT TWO Investigators
- Subjects
- *
GLYCOSYLATED hemoglobin , *TYPE 1 diabetes , *HYPERGLYCEMIA , *ELECTRONIC health records , *WEIGHT gain , *SUBCUTANEOUS injections , *COMBINATION drug therapy , *COMPARATIVE studies , *HYPOGLYCEMIC agents , *INSULIN , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH , *STATISTICAL sampling , *EVALUATION research , *RANDOMIZED controlled trials , *TREATMENT effectiveness , *BLIND experiment - Abstract
Objective: To investigate the efficacy and safety of liraglutide added to capped insulin doses in subjects with type 1 diabetes.Research Design and Methods: A 26-week, placebo-controlled, double-blind, parallel-group trial enrolling 835 subjects randomized 3:1 receiving once-daily subcutaneous liraglutide (1.8, 1.2, and 0.6 mg) or placebo added to an individually capped total daily dose of insulin.Results: Mean baseline glycated hemoglobin (HbA1c) (8.1% [65.0 mmol/mol]) was significantly decreased with liraglutide versus placebo at week 26 (1.8 mg: -0.33% [3.6 mmol/mol]; 1.2 mg: -0.22% [2.4 mmol/mol]; 0.6 mg: -0.23% [2.5 mmol/mol]; placebo: 0.01% [0.1 mmol/mol]). Liraglutide significantly reduced mean body weight (-5.1, -4.0, and -2.5 kg for 1.8, 1.2, and 0.6 mg, respectively) versus placebo (-0.2 kg). Significant reductions in daily insulin dose and increases in quality of life were seen with liraglutide versus placebo. There were higher rates of symptomatic hypoglycemia (21.3 vs. 16.6 events/patient/year; P = 0.03) with liraglutide 1.2 mg vs. placebo and of hyperglycemia with ketosis >1.5 mmol/L with liraglutide 1.8 mg vs. placebo (0.5 vs. 0.1 events/patient/year; P = 0.01).Conclusions: In a broad population of subjects with long-standing type 1 diabetes, liraglutide added to capped insulin reduced HbA1c, body weight, and insulin requirements but with higher rates of hypoglycemia for liraglutide 1.2 mg and hyperglycemia with ketosis for liraglutide 1.8 mg. [ABSTRACT FROM AUTHOR]- Published
- 2016
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- View/download PDF
44. Lowering targets for hemoglobin A1c in children with type 1 diabetes: raising the bar.
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Nambam, Bimota, Hirsch, Irl B, Danne, Thomas, and Schatz, Desmond
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TREATMENT of diabetes , *DIABETES , *ENDOCRINOLOGY , *GLYCOSYLATED hemoglobin , *INSULIN , *TYPE 1 diabetes , *EVALUATION of medical care , *MEDICAL societies , *METABOLIC regulation , *PEDIATRICS , *SERIAL publications , *DATA analysis , *DESCRIPTIVE statistics - Abstract
The article discusses research studies on the hemoglobin A1c (HbA1c) targets in children with type 1 diabetes. Details about the Diabetes Control and Complications Trial (DCCT), the Epidemiology of Diabetes Interventions and Complications (EDIC), and the Hvidoere Childhood Diabetes Study Group Centre Differences Study are provided. Some research findings are given related to the adverse effects of hypoglycemia and the association of lower HbA1c targets with benchmarking results.
- Published
- 2015
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45. Reducing Hypoglycemia in Type 1 Diabetes: An Incremental Step Forward.
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Hirsch, Irl B.
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HYPOGLYCEMIA , *TYPE 1 diabetes , *INSULIN pumps , *BLOOD sugar monitoring , *DIABETIC acidosis , *PREVENTION - Abstract
The author focuses on reducing hypoglycemia in diabetes. Topics include continuous subcutaneous insulin infusion (CSII) insulin pump allowing more consistent insulin absorption, continuous glucose monitoring (CGM) reducing overall hypoglycemic exposure in type 1 diabetes, and applying threshold levels of insulin with sensor-augmented pump (SAP) reduces nocturnal hypoglycemic exposure. It mentions minimum basal insulinemia is reduced without resulting in hyperglycemia or diabetic ketoacidosis.
- Published
- 2013
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46. What's in a name: latent autoimmune diabetes of adults, type 1.5, adult-onset, and type 1 diabetes.
- Author
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Palmer, Jerry P and Hirsch, Irl B
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AGE factors in disease , *TYPE 1 diabetes , *TYPE 2 diabetes , *TERMS & phrases - Published
- 2003
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47. Type 1 Diabetes in the Hospital: What Do We Know About Glucose Control?
- Author
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Hirsch, Irl B.
- Subjects
- *
TREATMENT of diabetes , *TYPE 1 diabetes , *GLYCEMIC control , *HOSPITAL patients , *BLOOD sugar , *BLOOD sugar monitoring , *HOSPITALS , *TYPE 2 diabetes - Abstract
The article focuses on the management of type 1 diabetes, and discusess controlling of blood glucose and glycemic availability in the patients; analysis of glycemic variability in hospitalized patients; and role of healthcare professionals in bringing out patient outcome.
- Published
- 2017
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48. The First Hybrid Closed-Loop Insulin Pump: Will It Meet Its Potential?
- Author
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Hirsch, Irl B.
- Subjects
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INSULIN pumps , *BLOOD sugar monitors , *MEDICAL equipment , *BLOOD sugar analysis , *HYPERGLYCEMIA prevention , *HYPOGLYCEMIA , *TREATMENT of diabetes , *ARTIFICIAL organs , *CLINICAL trials , *COMBINED modality therapy , *ECONOMIC aspects of diseases , *TYPE 1 diabetes , *QUALITY of life , *ACTIVITIES of daily living , *PREVENTION - Abstract
An introduction is presented in which the editor discusses the potential benefits of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM).
- Published
- 2017
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49. International Comparison of Smoking and Metabolic Control in Patients With Type 1 Diabetes.
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Hofer, Sabine E., Miller, Kellee, Hermann, Julia M., DeSalvo, Daniel J., Riedl, Michaela, Hirsch, Irl B., Karges, Wolfram, Beck, Roy W., Holl, Reinhard W., Maahs, David M., DPV Initiative, and T1D Exchange Clinic Network
- Subjects
METABOLIC regulation ,SMOKING ,TYPE 1 diabetes ,VASCULAR diseases ,WILCOXON signed-rank test - Abstract
The article discusses the international comparison between smoking and metabolic control in type 1 diabetes patients (T1D), which may increase the risks of vascular complication of T1D. Topics discussed include the utilization of the Wilcoxon signed-rank test, T1D Exchange Registry (T1DX) in the U.S., and the Prospective Diabetes Follow-up Registry (DPV) in Germany.
- Published
- 2016
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50. Managing New-Onset Type 1 Diabetes During the COVID-19 Pandemic: Challenges and Opportunities.
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Garg, Satish K., Rodbard, David, Hirsch, Irl B., and Forlenza, Gregory P.
- Subjects
- *
COVID-19 pandemic , *TYPE 1 diabetes , *CHILD patients , *MEDICAL care , *ADULTS , *TYPE 2 diabetes - Abstract
Background: The current COVID-19 pandemic provides an incentive to expand considerably the use of telemedicine for high-risk patients with diabetes, and especially for the management of type 1 diabetes (T1D). Telemedicine and digital medicine also offer critically important approaches to improve access, efficacy, efficiency, and cost-effectiveness of medical care for people with diabetes. Methods: Two case reports are presented where telemedicine was used effectively and safely after day 1 in person patient education. These aspects of the management of new-onset T1D patients (adult and pediatric) included ongoing diabetes education of the patient and family digitally. The patients used continuous glucose monitoring with commercially available analysis software (Dexcom Clarity and Glooko) to generate ambulatory glucose profiles and interpretive summary reports. The adult subject used multiple daily insulin injections; the pediatric patient used an insulin pump. The subjects were managed using a combination of e-mail, Internet via Zoom, and telephone calls. Results: These two cases show the feasibility and effectiveness of use of telemedicine in applications in which we had not used it previously: new-onset diabetes education and insulin dosage management. Conclusions: The present case reports illustrate how telemedicine can be used safely and effectively for new-onset T1D training and education for both pediatric and adult patients and their families. The COVID-19 pandemic has acutely stimulated the expansion of the use of telemedicine and digital medicine. We conclude that telemedicine is an effective approach for the management of patients with new-onset T1D. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
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