المؤلفون: Aleppo, Grazia, Ruedy, Katrina J, Riddlesworth, Tonya D, Kruger, Davida F, Peters, Anne L, Hirsch, Irl, Bergenstal, Richard M, Toschi, Elena, Ahmann, Andrew J, Shah, Viral N, Rickels, Michael R, Bode, Bruce W, Philis-Tsimikas, Athena, Pop-Busui, Rodica, Rodriguez, Henry, Eyth, Emily, Bhargava, Anuj, Kollman, Craig, Beck, Roy W

المصدر: Diabetes Care. 40(4)

مصطلحات موضوعية: Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Diabetes, Pediatric, Prevention, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Metabolic and endocrine, Adult, Aged, Blood Glucose, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Insulin Infusion Systems, Male, Middle Aged, Socioeconomic Factors, Young Adult, REPLACE-BG Study Group, Medical and Health Sciences, Endocrinology & Metabolism, Biomedical and clinical sciences, Health sciences

الوصف: ObjectiveTo determine whether the use of continuous glucose monitoring (CGM) without confirmatory blood glucose monitoring (BGM) measurements is as safe and effective as using CGM adjunctive to BGM in adults with well-controlled type 1 diabetes (T1D).Research design and methodsA randomized noninferiority clinical trial was conducted at 14 sites in the T1D Exchange Clinic Network. Participants were ≥18 years of age (mean 44 ± 14 years), had T1D for ≥1 year (mean duration 24 ± 12 years), used an insulin pump, and had an HbA1c ≤9.0% (≤75 mmol/mL) (mean 7.0 ± 0.7% [53 ± 7.7 mmol/mol]); prestudy, 47% were CGM users. Participants were randomly assigned 2:1 to the CGM-only (n = 149) or CGM+BGM (n = 77) group. The primary outcome was time in range (70-180 mg/dL) over the 26-week trial, with a prespecified noninferiority limit of 7.5%.ResultsCGM use averaged 6.7 ± 0.5 and 6.8 ± 0.4 days/week in the CGM-only and CGM+BGM groups, respectively, over the 26-week trial. BGM tests per day (including the two required daily for CGM calibration) averaged 2.8 ± 0.9 and 5.4 ± 1.4 in the two groups, respectively (P < 0.001). Mean time in 70-180 mg/dL was 63 ± 13% at both baseline and 26 weeks in the CGM-only group and 65 ± 13% and 65 ± 11% in the CGM+BGM group (adjusted difference 0%; one-sided 95% CI -2%). No severe hypoglycemic events occurred in the CGM-only group, and one occurred in the CGM+BGM group.ConclusionsUse of CGM without regular use of confirmatory BGM is as safe and effective as using CGM with BGM in adults with well-controlled T1D at low risk for severe hypoglycemia.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/5tm0w2jwTest

المؤلفون: Martens, Thomas, Beck, Roy W, Bailey, Ryan, Ruedy, Katrina J, Calhoun, Peter, Peters, Anne L, Pop-Busui, Rodica, Philis-Tsimikas, Athena, Bao, Shichun, Umpierrez, Guillermo, Davis, Georgia, Kruger, Davida F, Bhargava, Anuj, Young, Laura, McGill, Janet B, Aleppo, Grazia, Nguyen, Quang T, Orozco, Ian, Biggs, William, Lucas, K. Jean, Polonsky, William H, Buse, John B, Price, David, Bergenstal, Richard M

المصدر: Endocrinology Articles

مصطلحات موضوعية: Aged, Blood Glucose, Confidence Intervals, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin A, Glycemic Control, Humans, Hypoglycemic Agents, Insulin, Male, Middle Aged, Patient Satisfaction, Postprandial Period, Sample Size, Time Factors, Treatment Outcome

الوصف: Importance: Continuous glucose monitoring (CGM) has been shown to be beneficial for adults with type 2 diabetes using intensive insulin therapy, but its use in type 2 diabetes treated with basal insulin without prandial insulin has not been well studied. Objective: To determine the effectiveness of CGM in adults with type 2 diabetes treated with basal insulin without prandial insulin in primary care practices. Design, Setting, and Participants: This randomized clinical trial was conducted at 15 centers in the US (enrollment from July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) and included adults with type 2 diabetes receiving their diabetes care from a primary care clinician and treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications. Interventions: Random assignment 2:1 to CGM (n = 116) or traditional blood glucose meter (BGM) monitoring (n = 59). Main Outcomes and Measures: The primary outcome was hemoglobin A1c (HbA1c) level at 8 months. Key secondary outcomes were CGM-measured time in target glucose range of 70 to 180 mg/dL, time with glucose level at greater than 250 mg/dL, and mean glucose level at 8 months. Results: Among 175 randomized participants (mean [SD] age, 57 [9] years; 88 women [50%]; 92 racial/ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, -0.4% [95% CI, -0.8% to -0.1%]; P = .02). In the CGM group, compared with the BGM group, the mean percentage of CGM-measured time in the target glucose range of 70 to 180 mg/dL was 59% vs 43% (adjusted difference, 15% [95% CI, 8% to 23%]; P < .001), the mean percentage of time at greater than 250 mg/dL was 11% vs 27% (adjusted difference, -16% [95% CI, -21% to -11%]; P < .001), and the means of the mean glucose ...

العلاقة: https://scholarlycommons.henryford.com/endocrinology_articles/108Test; https://libkey.io/34077499Test

الإتاحة: https://scholarlycommons.henryford.com/endocrinology_articles/108Test
https://libkey.io/34077499Test

المؤلفون: Beck, Roy W, Riddlesworth, Tonya D, Ruedy, Katrina J, Kollman, Craig, Ahmann, Andrew J, Bergenstal, Richard M, Bhargava, Anuj, Bode, Bruce W, Haller, Stacie, Kruger, Davida F, McGill, Janet B, Polonsky, William, Price, David, Toschi, Elena

المصدر: Endocrinology Articles

مصطلحات موضوعية: Adult, Aged, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 1, Drug Administration Schedule, Female, Humans, Hypoglycemic Agents, Injections, Subcutaneous, Insulin, Insulin Infusion Systems, Male, Middle Aged, Treatment Outcome

الوصف: BACKGROUND: The benefit of initiation of insulin pump therapy (continuous subcutaneous insulin infusion; CSII) in patients with type 1 diabetes using continuous glucose monitoring (CGM) has not been studied. We aimed to assess glycaemic outcomes when switching from multiple daily injections (MDI) to CSII in adults with type 1 diabetes using CGM. METHODS: In this multicentre, randomised controlled trial, 75 adults with type 1 diabetes in the CGM group of the DIAMOND trial were randomly assigned via the study website using a computer-generated sequence to continue MDI or switch to CSII, with continuation of CGM, for 28 weeks. The primary outcome was CGM-measured time in the glucose concentration range of 70-180 mg/dL (3·9-10·0 mmol/L). This study is registered with ClinicalTrials.gov, number NCT02282397. FINDINGS: Between April 14, 2015, and May 5, 2016, 37 participants were randomly assigned to the CGM plus CSII group and 38 participants were randomly assigned to the CGM plus MDI group. The study was completed by 36 (97%) of 37 participants in the CGM plus CSII group and 35 (92%) of 38 participants in the CGM plus MDI group. Mean CGM use was 6·7 days per week (SD 0·8) in the CGM plus CSII group and 6·9 days per week (0·3) in the CGM plus MDI group (p=0·86). No participants in the CGM plus CSII group who completed the trial discontinued CSII. Over the follow-up period, mean time in the glucose concentration range of 70-180 mg/dL (3·9-10·0 mmol/L) was 791 min per day (SD 157) in the CGM plus CSII group and 741 min per day (225) in the CGM plus MDI group (adjusted mean treatment group difference: 83 min, 95% CI 17-149; p=0·01). Participants in the CGM plus CSII group had a greater reduction in CGM-measured mean glucose (p=0·005) and hyperglycaemia (on four metrics: p=0·007 for >180 mg/dL [>10·0 mmol/L], p=0·02 for >250 mg/dL [>13·9 mmol/L], p=0·04 for >300 mg/dL [>16·6 mmol/L], and p=0·02 for the area under the curve for 180 mg/dL [10·0 mmol/L]), but also an increase in CGM-measured hypoglycaemia ...

العلاقة: https://scholarlycommons.henryford.com/endocrinology_articles/33Test; http://sfxhosted.exlibrisgroup.com/hfhs?sid=Entrez:PubMed&id=pmid:28711468Test

الإتاحة: https://scholarlycommons.henryford.com/endocrinology_articles/33Test
http://sfxhosted.exlibrisgroup.com/hfhs?sid=Entrez:PubMed&id=pmid:28711468Test

المؤلفون: Cengiz, Eda, Connor, Crystal G., Ruedy, Katrina J., Beck, Roy W., Kollman, Craig, Klingensmith, Georgeanna J., Tamborlane, William V., Lee, Joyce M., Haller, Michael J.

مصطلحات موضوعية: Glycated Hemoglobin, Male, Adolescent, Incidence, Infant, Kaplan-Meier Estimate, Article, Hypoglycemia, United States, Diabetic Ketoacidosis, Cohort Studies, Diabetes Mellitus, Type 1, Child, Preschool, Hyperglycemia, Humans, Hypoglycemic Agents, Insulin, Female, Prospective Studies, Drug Monitoring, Child, Follow-Up Studies, Proportional Hazards Models

الوصف: There have been few prospective, multicenter studies investigating the natural history of type 1 diabetes (T1D) from the time of diagnosis. The objective of this report from the Pediatric Diabetes Consortium (PDC) T1D New Onset (NeOn) study was to assess the natural history and clinical outcomes in children during the first year after diagnosis of T1D.Clinical measures from the first year following diagnosis were analyzed for 857 participants (mean age 9.1 yr, 51% female, 66% non-Hispanic White) not participating in an intervention study who had a HbA1c result at 12 months.Mean HbA1c ± SD was 102 ± 25 mmol/mol (11.4 ± 2.3%) at diagnosis, 55 ± 12 mmol/mol (7.2 ± 1.1%) at 3 months, 56 ± 15 mmol/mol (7.3 ± 1.3%) at 6 months and 62 ± 16 mmol/mol (7.8 ± 1.5%) at 12 months from diagnosis. A severe hypoglycemic (SH) event occurred in 31 (4%) participants (44 events, 5.2 events per 100 person-years). Diabetic ketoacidosis (DKA) not including diagnosis occurred in 10 (1%) participants (13 events, 1.5 events per 100 person-years).After onset of T1D, mean HbA1c reaches its nadir at 3-6 months with a gradual increase through 12 months. SH and DKA are uncommon but still occur during the first year with T1D. Data from large cohorts, such as the PDC T1D NeOn study, provide important insights into the course of T1D during the first year following diagnosis, which will help to inform the development of models to target future interventions.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=pmid________::2d07411cc26d450bbb94a8ab1898ccd1Test
https://europepmc.org/articles/PMC3844085Test/

المؤلفون: Redondo, Maria J., Connor, Crystal G., Ruedy, Katrina J., Beck, Roy W., Kollman, Craig, Wood, Jamie R., Buckingham, Bruce, Klingensmith, Georgeanna, Silverstein, Janet, Tamborlane, William V.

مصطلحات موضوعية: Glycated Hemoglobin, Male, Adolescent, Blood Glucose Self-Monitoring, Infant, Article, Hypoglycemia, United States, Diabetic Ketoacidosis, Nuclear Family, Cohort Studies, Diabetes Mellitus, Type 1, Socioeconomic Factors, Child, Preschool, Hyperglycemia, Humans, Hypoglycemic Agents, Insulin, Female, Prospective Studies, Child, Follow-Up Studies

الوصف: To identify determinants of hemoglobin A1c (HbA1c) levels 1 yr after the diagnosis of type 1 diabetes (T1D) in participants in the Pediatric Diabetes Consortium (PDC) T1D New Onset (NeOn) Study.Diabetes-specific as well as socioeconomic factors during the first year following diagnosis were analyzed in 857 participants (mean age 9.1 yrs, 51% female, 66% non-Hispanic White) not participating in an intervention study who had an HbA1c value at 12 months.Mean ± SD HbA1c at 1 yr was 62 ± 16 mmol/mol (7.8% ± 1.5). In univariate and multivariate analyses, clinical center, non-Hispanic White race, private health insurance, living with both parents, higher frequency of self-monitoring of blood glucose (SMBG), and lower insulin requirements were associated with lower HbA1c concentrations at 1 yr (p 0.01). No association was found with gender, age, Tanner stage, body mass index (BMI), diabetic ketoacidosis (DKA) at onset, number of positive autoantibodies or HbA1c at onset, or number of visits to diabetes physician during the first year.White race, higher socioeconomic status, two-parent household, more frequent SMBG, and low insulin requirements are associated with lower HbA1c concentration 1 yr after the onset of T1D in children.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=pmid________::e49212008ed81a85ac234fc219e6f68aTest
https://europepmc.org/articles/PMC3858510Test/