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  • 1
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    Effect of Tight Glycemic Control on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes : A Randomized Clinical Trial
    American Medical Association (AMA) ; 2023
    In:  JAMA Vol. 329, No. 12 ( 2023-03-28), p. 980-
    Details
    In: JAMA, American Medical Association (AMA), Vol. 329, No. 12 ( 2023-03-28), p. 980-
    Abstract: Near normalization of glucose levels instituted immediately after diagnosis of type 1 diabetes has been postulated to preserve pancreatic beta cell function by reducing glucotoxicity. Previous studies have been hampered by an inability to achieve tight glycemic goals. Objective To determine the effectiveness of intensive diabetes management to achieve near normalization of glucose levels on preservation of pancreatic beta cell function in youth with newly diagnosed type 1 diabetes. Design, Setting, and Participants This randomized, double-blind, clinical trial was conducted at 6 centers in the US (randomizations from July 20, 2020, to October 13, 2021; follow-up completed September 15, 2022) and included youths with newly diagnosed type 1 diabetes aged 7 to 17 years. Interventions Random assignment to intensive diabetes management, which included use of an automated insulin delivery system (n = 61), or standard care, which included use of a continuous glucose monitor (n = 52), as part of a factorial design in which participants weighing 30 kg or more also were assigned to receive either oral verapamil or placebo. Main Outcomes and Measures The primary outcome was mixed-meal tolerance test–stimulated C-peptide area under the curve (a measure of pancreatic beta cell function) 52 weeks from diagnosis. Results Among 113 participants (mean [SD] age, 11.8 [2.8] years; 49 females [43%]; mean [SD] time from diagnosis to randomization, 24 [5] days), 108 (96%) completed the trial. The mean C-peptide area under the curve decreased from 0.57 pmol/mL at baseline to 0.45 pmol/mL at 52 weeks in the intensive management group, and from 0.60 to 0.50 pmol/mL in the standard care group (treatment group difference, −0.01 [95% CI, −0.11 to 0.10] ; P  = .89). The mean time in the target range of 70 to 180 mg/dL, measured with continuous glucose monitoring, at 52 weeks was 78% in the intensive management group vs 64% in the standard care group (adjusted difference, 16% [95% CI, 10% to 22%]). One severe hypoglycemia event and 1 diabetic ketoacidosis event occurred in each group. Conclusions and Relevance In youths with newly diagnosed type 1 diabetes, intensive diabetes management, which included automated insulin delivery, achieved excellent glucose control but did not affect the decline in pancreatic C-peptide secretion at 52 weeks. Trial Registration ClinicalTrials.gov Identifier: NCT04233034
    Type of Medium: Online Resource
    ISSN: 0098-7484
    URL: Article
    DOI: 10.1001/jama.2023.2063
    RVK:
    XA 10000
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2023
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  • 2
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    Effect of Verapamil on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes : A Randomized Clinical Trial
    American Medical Association (AMA) ; 2023
    In:  JAMA Vol. 329, No. 12 ( 2023-03-28), p. 990-
    Details
    In: JAMA, American Medical Association (AMA), Vol. 329, No. 12 ( 2023-03-28), p. 990-
    Abstract: In preclinical studies, thioredoxin-interacting protein overexpression induces pancreatic beta cell apoptosis and is involved in glucotoxicity-induced beta cell death. Calcium channel blockers reduce these effects and may be beneficial to beta cell preservation in type 1 diabetes. Objective To determine the effect of verapamil on pancreatic beta cell function in children and adolescents with newly diagnosed type 1 diabetes. Design, Setting, and Participants This double-blind, randomized clinical trial including children and adolescents aged 7 to 17 years with newly diagnosed type 1 diabetes who weighed 30 kg or greater was conducted at 6 centers in the US (randomized participants between July 20, 2020, and October 13, 2021) and follow-up was completed on September 15, 2022. Interventions Participants were randomly assigned 1:1 to once-daily oral verapamil (n = 47) or placebo (n = 41) as part of a factorial design in which participants also were assigned to receive either intensive diabetes management or standard diabetes care. Main Outcomes and Measures The primary outcome was area under the curve values for C-peptide level (a measure of pancreatic beta cell function) stimulated by a mixed-meal tolerance test at 52 weeks from diagnosis of type 1 diabetes. Results Among 88 participants (mean age, 12.7 [SD, 2.4] years; 36 were female [41%] ; and the mean time from diagnosis to randomization was 24 [SD, 4] days), 83 (94%) completed the trial. In the verapamil group, the mean C-peptide area under the curve was 0.66 pmol/mL at baseline and 0.65 pmol/mL at 52 weeks compared with 0.60 pmol/mL at baseline and 0.44 pmol/mL at 52 weeks in the placebo group (adjusted between-group difference, 0.14 pmol/mL [95% CI, 0.01 to 0.27 pmol/mL] ; P  = .04). This equates to a 30% higher C-peptide level at 52 weeks with verapamil. The percentage of participants with a 52-week peak C-peptide level of 0.2 pmol/mL or greater was 95% (41 of 43 participants) in the verapamil group vs 71% (27 of 38 participants) in the placebo group. At 52 weeks, hemoglobin A 1c was 6.6% in the verapamil group vs 6.9% in the placebo group (adjusted between-group difference, −0.3% [95% CI, −1.0% to 0.4%]). Eight participants (17%) in the verapamil group and 8 participants (20%) in the placebo group had a nonserious adverse event considered to be related to treatment. Conclusions and Relevance In children and adolescents with newly diagnosed type 1 diabetes, verapamil partially preserved stimulated C-peptide secretion at 52 weeks from diagnosis compared with placebo. Further studies are needed to determine the longitudinal durability of C-peptide improvement and the optimal length of therapy. Trial Registration ClinicalTrials.gov Identifier: NCT04233034
    Type of Medium: Online Resource
    ISSN: 0098-7484
    URL: Article
    DOI: 10.1001/jama.2023.2064
    RVK:
    XA 10000
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2023
    detail.hit.zdb_id: 2958-0
    detail.hit.zdb_id: 2018410-4
    SSG: 5,21
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  • 3
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    The Contemporary Prevalence of Diabetic Neuropathy in Type 1 Diabetes: Findings From the T1D Exchange
    American Diabetes Association ; 2020
    In:  Diabetes Care Vol. 43, No. 4 ( 2020-04-01), p. 806-812
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 43, No. 4 ( 2020-04-01), p. 806-812
    Abstract: To evaluate the contemporary prevalence of diabetic peripheral neuropathy (DPN) in participants with type 1 diabetes in the T1D Exchange Clinic Registry throughout the U.S. RESEARCH DESIGN AND METHODS DPN was assessed with the Michigan Neuropathy Screening Instrument Questionnaire (MNSIQ) in adults with ≥5 years of type 1 diabetes duration. A score of ≥4 defined DPN. Associations of demographic, clinical, and laboratory factors with DPN were assessed. RESULTS Among 5,936 T1D Exchange participants (mean ± SD age 39 ± 18 years, median type 1 diabetes duration 18 years [interquartile range 11, 31], 55% female, 88% non-Hispanic white, mean glycated hemoglobin [HbA1c] 8.1 ± 1.6% [65.3 ± 17.5 mmol/mol]), DPN prevalence was 11%. Compared with those without DPN, DPN participants were older, had higher HbA1c, had longer duration of diabetes, were more likely to be female, and were less likely to have a college education and private insurance (all P & lt; 0.001). DPN participants also were more likely to have cardiovascular disease (CVD) (P & lt; 0.001), worse CVD risk factors of smoking (P = 0.008), hypertriglyceridemia (P = 0.002), higher BMI (P = 0.009), retinopathy (P = 0.004), reduced estimated glomerular filtration rate (P = 0.02), and Charcot neuroarthropathy (P = 0.002). There were no differences in insulin pump or continuous glucose monitor use, although DPN participants were more likely to have had severe hypoglycemia (P = 0.04) and/or diabetic ketoacidosis (P & lt; 0.001) in the past 3 months. CONCLUSIONS The prevalence of DPN in this national cohort with type 1 diabetes is lower than in prior published reports but is reflective of current clinical care practices. These data also highlight that nonglycemic risk factors, such as CVD risk factors, severe hypoglycemia, diabetic ketoacidosis, and lower socioeconomic status, may also play a role in DPN development.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc19-1583
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2020
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  • 4
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    Longitudinal Changes in Continuous Glucose Monitoring Use Among Individuals With Type 1 Diabetes: International Comparison in the German and Austrian DPV and U.S. T1D Exchange Registries
    American Diabetes Association ; 2020
    In:  Diabetes Care Vol. 43, No. 1 ( 2020-01-01), p. e1-e2
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 43, No. 1 ( 2020-01-01), p. e1-e2
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc19-1214
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2020
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  • 5
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    Management of Hypertension and Hyperlipidemia in Youth with T2D
    American Diabetes Association ; 2018
    In:  Diabetes Vol. 67, No. Supplement_1 ( 2018-07-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 67, No. Supplement_1 ( 2018-07-01)
    Abstract: Introduction: Youth with T2D are at risk for additional cardiovascular (CVD) diseases such as hypertension (HT) and hyperlipidemia (HLD). We examined healthcare provider (HCP) self-reported practices regarding management and treatment of HT and HLD in youth with T2D. Methods: An electronic survey collected information from prescribing HCPs from Pediatric Diabetes Consortium sites regarding their usual treatment of and barriers related to treatment of HT and HLD in youth with T2D. Results: Respondents (N=70) were predominately female (67%) from urban (77%) academic centers (70%). HT and HLD treatment recommendations focused on lifestyle modifications including healthy eating, weight loss, physical activity, dietitian/nutritionist referral, and improving glycemic control. Medication was recommended initially more than half of time to treat HT and HLD (51% and 62%, respectively). If HT or HLD persisted for an additional 6-12 months, & gt;80% of HCPs would choose to add additional treatment. Less than half of HCPs reported that treatment of HT and HLD is generally effective most/all of the time (42% and 34%, respectively). HCPs reported that obstacles to treatment from the patient’s perspective included lack of support to make lifestyle changes (78%), difficulty following-through with lifestyle changes (80%), lack of motivation to control diseases (68%), socioeconomic challenges (62%), and transportation difficulties (54%). Concerns regarding patient adherence (50%) and inability to focus on both diabetes and HT/HDL due to shortness of visits (42%) were the most commonly cited barriers by HCPs. Conclusion: Given that youth with T2D have high risk of developing CVD complications, HCP approaches to treat both HT and HLD are important. Notably, the majority report their recommendations are ineffective. Patient-related barriers are the biggest challenge to effective treatment; future research should explore ways to mitigate these barriers. Disclosure L.C. Beaulieu: Research Support; Self; Novo Nordisk Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Development Center Americas, Inc.. P. Cheng: None. M. Katz: None. L.M. Laffel: Consultant; Self; Eli Lilly and Company, Novo Nordisk Inc., Sanofi US, MannKind Corporation, Roche Diagnostics Corporation, Dexcom, Inc., Insulet Corporation, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Johnson & Johnson Diabetes Institute, LLC. W.V. Tamborlane: Consultant; Self; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, Medtronic MiniMed, Inc., Novo Nordisk Inc., Sanofi, Takeda Pharmaceuticals U.S.A., Inc.. M.A. Van Name: None. N. Bansal: None. C. Kollman: Research Support; Self; JDRF, Bigfoot Biomedical, Dexcom, Inc., Tandem Diabetes Care, Inc., Medtronic MiniMed, Inc., Helmsley Charitable Trust. R.L. Gal: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Development Center Americas, Inc., Novo Nordisk Inc..
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db18-1342-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2018
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  • 6
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    Real‐world use of glucagon‐like peptide‐1 receptor agonists in youth with type 2 diabetes is associated with short‐term improvements in HbA1c
    Wiley ; 2024
    In:  Diabetes, Obesity and Metabolism
    Details
    In: Diabetes, Obesity and Metabolism, Wiley
    Abstract: To assess the short‐term, real‐world use and effectiveness of glucagon‐like peptide‐1 receptor agonist (GLP‐1RA) medications in the management of type 2 diabetes (T2D) in a diverse cohort of youth. Methods This multicentre retrospective study analysed youth prescribed a GLP‐1RA for the management of T2D at two academic paediatric diabetes centres prior to June 2022. Change in HbA1c and insulin use from baseline to first (median 91 days) and second (median 190 days) follow‐up were evaluated for those taking a GLP‐1RA. Multivariable linear mixed effects models adjusting for baseline sex, age, race/ethnicity, insurance, insulin regimen, metformin regimen, GLP‐1RA dosing frequency and the body mass index Z‐score (BMI‐Z) examined the change in HbA1c for participants for up to 6 months after baseline. Results A total of 136 patients with T2D (median age 16.1 [interquartile range 13.9‐18.0] years, 54% female, 56% non‐Hispanic Black, 24% Hispanic, 77% with public insurance) were prescribed GLP‐1RAs and taking them at first or second follow‐up. Median HbA1c decreased from 7.9% to 7.6% ( P 〈 .001) at a median follow‐up of 91 days ( n = 109) and, among those with HbA1c available at baseline and second follow‐up ( n = 83), from 8.4% to 7.4%. The proportion of patients prescribed insulin decreased from baseline to the first follow‐up visit (basal 69% to 60% [ P = .008], prandial 46% to 38% [ P = .03]). In multivariable analysis, there was a mean decrease in HbA1c by 0.09 percentage points per month ( P = .005, 95% confidence interval −0.15, −0.03). Conclusions Real‐world use of GLP‐1RAs in youth with T2D is associated with decreased HbA1c levels, despite challenges with access and adherence. GLP‐1RA treatment may reduce insulin doses for youth with T2D.
    Type of Medium: Online Resource
    ISSN: 1462-8902 , 1463-1326
    URL: Article
    DOI: 10.1111/dom.15430
    Language: English
    Publisher: Wiley
    Publication Date: 2024
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  • 7
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    908-P: A Self-Assessment: Understanding Perceptions of New-Onset Type 1 Diabetes (T1D) Education in a Pediatric Tertiary Care Center
    American Diabetes Association ; 2021
    In:  Diabetes Vol. 70, No. Supplement_1 ( 2021-06-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 70, No. Supplement_1 ( 2021-06-01)
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db21-908-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2021
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  • 8
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    Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes
    American Diabetes Association ; 2021
    In:  Diabetes Care Vol. 44, No. 7 ( 2021-07-01), p. 1630-1640
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 44, No. 7 ( 2021-07-01), p. 1630-1640
    Abstract: 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 & lt; 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 & lt; 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 & lt; 0.0001). This was accomplished with a reduction in time in hypoglycemia & lt;70 mg/dL among adults (median [interquartile range]: 2.00% [0.63, 4.06] to 1.09% [0.46, 1.75], P & lt; 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.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc21-0172
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2021
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  • 9
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    A Randomized Clinical Trial Assessing Continuous Glucose Monitoring (CGM) Use With Standardized Education With or Without a Family Behavioral Intervention Compared With Fingerstick Blood Glucose Monitoring in Very Young Children With Type 1 Diabetes
    American Diabetes Association ; 2021
    In:  Diabetes Care Vol. 44, No. 2 ( 2021-02-01), p. 464-472
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 44, No. 2 ( 2021-02-01), p. 464-472
    Abstract: This study evaluated the effects of continuous glucose monitoring (CGM) combined with family behavioral intervention (CGM+FBI) and CGM alone (Standard-CGM) on glycemic outcomes and parental quality of life compared with blood glucose monitoring (BGM) in children ages 2 to & lt;8 years with type 1 diabetes. RESEARCH DESIGN AND METHODS This was a multicenter (N = 14), 6-month, randomized controlled trial including 143 youth 2 to & lt;8 years of age with type 1 diabetes. Primary analysis included treatment group comparisons of percent time in range (TIR) (70–180 mg/dL) across follow-up visits. RESULTS Approximately 90% of participants in the CGM groups used CGM ≥6 days/week at 6 months. Between-group TIR comparisons showed no significant changes: CGM+FBI vs. BGM 3.2% (95% CI −0.5, 7.0), Standard-CGM vs. BGM 0.5% (−2.6 to 3.6), CGM+FBI vs. Standard-CGM 2.7% (−0.6, 6.1). Mean time with glucose level & lt;70 mg/dL was reduced from baseline to follow-up in the CGM+FBI (from 5.2% to 2.6%) and Standard-CGM (5.8% to 2.5%) groups, compared with 5.4% to 5.8% with BGM (CGM+FBI vs. BGM, P & lt; 0.001, and Standard-CGM vs. BGM, P & lt; 0.001). No severe hypoglycemic events occurred in the CGM+FBI group, one occurred in the Standard-CGM group, and five occurred in the BGM group. CGM+FBI parents reported greater reductions in diabetes burden and fear of hypoglycemia compared with Standard-CGM (P = 0.008 and 0.04) and BGM (P = 0.02 and 0.002). CONCLUSIONS CGM used consistently over a 6-month period in young children with type 1 diabetes did not improve TIR but did significantly reduce time in hypoglycemia. The FBI benefited parental well-being.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc20-1060
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2021
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  • 10
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    1100-P: Real-World Use of GLP-1 Agonists in Youth with Type 2 Diabetes Is Associated with Improvements in Hemoglobin A1c—A Multicenter Analysis
    American Diabetes Association ; 2023
    In:  Diabetes Vol. 72, No. Supplement_1 ( 2023-06-20)
    Details
    In: Diabetes, American Diabetes Association, Vol. 72, No. Supplement_1 ( 2023-06-20)
    Abstract: Background: Despite the high risk of diabetes complications at an early age in youth with type 2 diabetes (T2D), there are limited pharmacologic options to manage T2D in youth. The first Glucagon-like-peptide-1 agonist (GLP-1a) was approved for pediatric T2D treatment in 2019. However, little is known on the real-world use and effectiveness of GLP-1a for management of T2D in the pediatric population. Objectives: To assess the real-world use and effectiveness of GLP-1a (exenatide, dulaglutide, liraglutide, semaglutide) in managing T2D in a diverse cohort of youth. Methods: This multicenter retrospective analysis included adolescents and young adults (ages 11-25y) from two academic pediatric diabetes centers who were prescribed a GLP-1a for management of T2D. Patient HbA1c, weight, and BMI within 12 months of follow-up after GLP-1a prescription were compared to baseline using Signed Rank tests. Secondary outcomes included insulin and metformin use after GLP-1a initiation and were compared using McNemar's test. Results: A total of 153 patients (median age 16.1 years (IQR 13.9-17.8), 57% female, 59% non-Hispanic Black, 23% Hispanic or Latino, 76% with public insurance) were prescribed GLP-1a and 36 patients discontinued the GLP-1a. At a median follow-up of 8.2 months, 117 patients were taking GLP-1a and were included in pre-post analyses. From baseline to follow-up, HbA1c decreased from 8.3% to 7.5% (p & lt;0.007), while weight and BMI remained stable. At baseline, 48% of patients were taking prandial insulin, compared to 36% at follow-up (p=0.001), 71% were taking basal insulin compared to 62% at follow-up (p = 0.025), and 85% were prescribed metformin at baseline compared to 74% at follow-up (p=0.005). Conclusion: Real-world use of GLP-1a in youth with T2D is associated with decreased HbA1c levels. GLP-1a treatment may reduce doses of insulin and other medications for diabetes in youth, which can mitigate the burden of daily diabetes management. Disclosure S.Samuels: None. A.Chajecki: None. P.Hu: None. M.Kayser: None. K.Weyman: None. B.Pan: None. E.A.Brown: None. M.A.Van name: Research Support; Provention Bio, Inc. R.M.Wolf: Research Support; Dexcom, Inc., Boehringer Ingelheim Inc. Funding American Diabetes Association (7-22-JDFN-03 to S.S.); National Institutes of Health (R01DK134955)
    Type of Medium: Online Resource
    ISSN: 0012-1797
    URL: Article
    DOI: 10.2337/db23-1100-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2023
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