Publications by authors named "David M Maahs"

304 Publications

Hemoglobin A1c Patterns of Youth With Type 1 Diabetes 10 Years Post Diagnosis From 3 Continents.

Pediatrics 2021 Jul 27. Epub 2021 Jul 27.

Division of Child and Adolescent Health, The University of Sydney, Sydney, Australia.

Objectives: Distinct hemoglobin A1c (HbA1c) trajectories during puberty are identified in youth with established type 1 diabetes (T1D). We used data from 3 international registries to evaluate whether distinct HbA1c trajectories occur from T1D onset.

Methods: Participants were <18 years old at diagnosis with at least 1 HbA1c measured within 12 months post diagnosis, along with ≥3 duration-year-aggregated HbA1c values over 10 years of follow-up. Participants from the Australasian Diabetes Data Network ( = 7292), the German-Austrian-Luxembourgian-Swiss diabetes prospective follow-up initiative (Diabetes Patienten Verlaufsdokumentation) ( = 39 226) and the US-based Type 1 Diabetes Exchange Clinic Registry ( = 3704) were included. With group-based trajectory modeling, we identified unique HbA1c patterns from the onset of T1D.

Results: Five distinct trajectories occurred in all 3 registries, with similar patterns of proportions by group. More than 50% had stable HbA1c categorized as being either low stable or intermediate stable. Conversely, ∼15% in each registry were characterized by stable HbA1c >8.0% (high stable), and ∼11% had values that began at or near the target but then increased (target increase). Only ∼5% of youth were above the target from diagnosis, with an increasing HbA1c trajectory over time (high increase). This group differed from others, with higher rates of minority status and an older age at diagnosis across all 3 registries ( ≤ .001).

Conclusions: Similar postdiagnostic HbA1c patterns were observed across 3 international registries. Identifying the youth at the greatest risk for deterioration in HbA1c over time may allow clinicians to intervene early, and more aggressively, to avert increasing HbA1c.
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http://dx.doi.org/10.1542/peds.2020-048942DOI Listing
July 2021

50 Years Ago in TheJournalofPediatrics: Neonatal Hypoglycemia: Progress and Predicaments.

J Pediatr 2021 Aug;235:82

Divisions of Pediatric Endocrinology, Stanford University School of Medicine, Stanford, California.

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http://dx.doi.org/10.1016/j.jpeds.2021.05.001DOI Listing
August 2021

ONBOARD: A feasibility study of a telehealth-based continuous glucose monitoring adoption intervention for adults with type 1 diabetes.

Diabetes Technol Ther 2021 Jul 16. Epub 2021 Jul 16.

Stanford University School of Medicine, 10624, Pediatrics, Stanford, California, United States.

Background: Continuous glucose monitoring (CGM) can improve glycemic control for adults with Type 1 diabetes but certain barriers interfere with consistent use including: cost; data overload; alarm fatigue; physical discomfort; and unwanted social attention. This pilot study aimed to examine feasibility and acceptability of a behavioral intervention, ONBOARD (Overcoming Barriers and Obstacles to Adopting Diabetes Devices) to support adults with type 1 diabetes in optimizing CGM use.

Methods: Adults (18-50) with type 1 diabetes in their first year of CGM use were invited to participate in a tailored, multicomponent telehealth-based intervention delivered over four 60-minute sessions every 2-3 weeks. Participants completed surveys (demographics; diabetes distress, T1-DDS; satisfaction with program) and provided CGM data at baseline and post-intervention (3 months). Data were analyzed using paired t-tests and Wilcoxon signed-rank tests.

Results: Twenty-two participants (age=30.95±8.32; 59% female; 91% Non-Hispanic; 86% White, 5% Black, 9% other; 73% pump users) completed the study. ONBOARD demonstrated acceptability and a high rate of retention. Moderate effect sizes were found for reductions in diabetes distress (p=.01, r=-.37) and increases in daytime spent in target range (70-180 mg/dL: p=.03, r=-.35). There were no significant increases in hypoglycemia.

Conclusions: Findings show preliminary evidence of feasibility, acceptability, and efficacy of ONBOARD for supporting adults with type 1 diabetes in optimizing CGM use while alleviating diabetes distress. Further research is needed to examine ONBOARD in a larger sample over a longer period.
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http://dx.doi.org/10.1089/dia.2021.0198DOI Listing
July 2021

Clinically serious hypoglycemia is rare and not associated with time-in-range in youth with new-onset type 1 diabetes.

J Clin Endocrinol Metab 2021 Jul 15. Epub 2021 Jul 15.

Division of Endocrinology, Department of Pediatrics, Stanford University, School of Medicine, Stanford, CA.

Objective: Early initiation of continuous glucose monitoring (CGM) is advocated for youth with type 1 diabetes (T1D). Data to guide CGM use on time-in-range (TIR), hypoglycemia, and the role of partial clinical remission (PCR) are limited. Our aims were to assess whether: 1) an association between increased TIR and hypoglycemia exists, and 2) how time in hypoglycemia varies by PCR status.

Methods: We analyzed 80 youth who were started on CGM shortly after T1D diagnosis and were followed for up to 1-year post-diagnosis. TIR and hypoglycemia rates were determined by CGM data and retrospectively analyzed. PCR was defined as (visit-HbA1c)+(4*units/kg/day) <9.

Results: Youth were started on CGM 8.0 (IQR 6.0-13.0) days post-diagnosis. Time spent <70mg/dL remained low despite changes in TIR (highest TIR 74.6±16.7%, 2.4±2.4% hypoglycemia at 1 month post-diagnosis; lowest TIR 61.3±20.3%, 2.1±2.7% hypoglycemia at 12 months post-diagnosis). No events of severe hypoglycemia occurred. Hypoglycemia was rare and there was minimal difference for PCR versus non-PCR youth (54-70mg/dL: 1.8% vs 1.2%, p=0.04; <54mg/dL: 0.3% vs 0.3%, p=0.55). Approximately 50% of the time spent in hypoglycemia was in the 65-70mg/dL range.

Conclusions: As TIR gradually decreased over 12 months post-diagnosis, hypoglycemia was limited with no episodes of severe hypoglycemia. Hypoglycemia rates did not vary in a clinically meaningful manner by PCR status. With CGM being started earlier, consideration needs to be given to modifying CGM hypoglycemia education, including alarm settings. These data support a trial in the year post-diagnosis to determine alarm thresholds for youth who wear CGM.
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http://dx.doi.org/10.1210/clinem/dgab522DOI Listing
July 2021

Democratizing type 1 diabetes specialty care in the primary care setting to reduce health disparities: project extension for community healthcare outcomes (ECHO) T1D.

BMJ Open Diabetes Res Care 2021 Jul;9(1)

Department of Pediatrics and Division of Pediatric Endocrinology and Diabetes, Stanford University, Palo Alto, California, USA.

Introduction: Project ECHO (Extension for Community Healthcare Outcomes) is a tele-education outreach model that seeks to democratize specialty knowledge to reduce disparities and improve health outcomes. Limited utilization of endocrinologists forces many primary care providers (PCPs) to care for patients with type 1 diabetes (T1D) without specialty support. Accordingly, an ECHO T1D program was developed and piloted in Florida and California. Our goal was to demonstrate the feasibility of an ECHO program focused on T1D and improve PCPs' abilities to manage patients with T1D.

Research Design And Methods: Health centers (ie, spokes) were recruited into the ECHO T1D pilot through an innovative approach, focusing on Federally Qualified Health Centers and through identification of high-need catchment areas using the Neighborhood Deprivation Index and provider geocoding. Participating spokes received weekly tele-education provided by the University of Florida and Stanford University hub specialty team through virtual ECHO clinics, real-time support with complex T1D medical decision-making, access to a diabetes support coach, and access to an online repository of diabetes care resources. Participating PCPs completed pre/post-tests assessing diabetes knowledge and confidence and an exit survey gleaning feedback about overall ECHO T1D program experiences.

Results: In Florida, 12 spoke sites enrolled with 67 clinics serving >1000 patients with T1D. In California, 11 spoke sites enrolled with 37 clinics serving >900 patients with T1D. During the 6-month intervention, 27 tele-education clinics were offered and n=70 PCPs (22 from Florida, 48 from California) from participating spoke sites completed pre/post-test surveys assessing diabetes care knowledge and confidence in diabetes care. There was statistically significant improvement in diabetes knowledge (p≤0.01) as well as in diabetes confidence (p≤0.01).

Conclusions: The ECHO T1D pilot demonstrated proof of concept for a T1D-specific ECHO program and represents a viable model to reach medically underserved communities which do not use specialists.
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http://dx.doi.org/10.1136/bmjdrc-2021-002262DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8268922PMC
July 2021

Engineering Insulin Cold Chain Resilience to Improve Global Access.

Biomacromolecules 2021 Jul 2. Epub 2021 Jul 2.

Department of Bioengineering, Stanford University, Stanford California 94305, United States.

There are 150 million people with diabetes worldwide who require insulin replacement therapy, and the prevalence of diabetes is rising the fastest in middle- and low-income countries. The current formulations require costly refrigerated transport and storage to prevent loss of insulin integrity. This study shows the development of simple "drop-in" amphiphilic copolymer excipients to maintain formulation integrity, bioactivity, pharmacokinetics, and pharmacodynamics for over 6 months when subjected to severe stressed aging conditions that cause current commercial formulation to fail in under 2 weeks. Further, when these copolymers are added to Humulin R (Eli Lilly) in original commercial packaging, they prevent insulin aggregation for up to 4 days at 50 °C compared to less than 1 day for Humulin R alone. These copolymers demonstrate promise as simple formulation additives to increase the cold chain resilience of commercial insulin formulations, thereby expanding global access to these critical drugs for treatment of diabetes.
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http://dx.doi.org/10.1021/acs.biomac.1c00474DOI Listing
July 2021

Improved individual and population-level HbA1c estimation using CGM data and patient characteristics.

J Diabetes Complications 2021 08 17;35(8):107950. Epub 2021 May 17.

Department of Management Science and Engineering, Stanford School of Engineering, Stanford, CA, USA; Division of Pediatric Endocrinology, Stanford School of Medicine, Stanford, CA, USA; Lucile Packard Children's Hospital, Stanford, CA, USA; Stanford Diabetes Research Center, Stanford School of Medicine, Stanford, CA, USA; Clinical Excellence Research Center, Stanford School of Medicine, Stanford, CA, USA. Electronic address:

Machine learning and linear regression models using CGM and participant data reduced HbA1c estimation error by up to 26% compared to the GMI formula, and exhibit superior performance in estimating the median of HbA1c at the cohort level, potentially of value for remote clinical trials interrupted by COVID-19.
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http://dx.doi.org/10.1016/j.jdiacomp.2021.107950DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8316291PMC
August 2021

Diabetes Technology and Therapy in the Pediatric Age Group.

Diabetes Technol Ther 2021 Jun;23(S2):S113-S130

Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.

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http://dx.doi.org/10.1089/dia.2021.2508DOI Listing
June 2021

50 Years Ago in TheJournalofPediatrics: Progress in Pediatric Diabetes Prediction, Management, and Outcomes.

J Pediatr 2021 Jun;233:131

Division of Pediatric Endocrinology, Stanford University School of Medicine, Stanford, CA.

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http://dx.doi.org/10.1016/j.jpeds.2021.02.033DOI Listing
June 2021

Barriers to Technology Use and Endocrinology Care for Underserved Communities With Type 1 Diabetes.

Diabetes Care 2021 May 17. Epub 2021 May 17.

Division of Endocrinology and Diabetes, Department of Pediatrics, Stanford University, Stanford, CA.

Objective: Disparities in type 1 diabetes related to use of technologies like continuous glucose monitors (CGMs) and utilization of diabetes care are pronounced based on socioeconomic status (SES), race, and ethnicity. However, systematic reports of perspectives from patients in vulnerable communities regarding barriers are limited.

Research Design And Methods: To better understand barriers, focus groups were conducted in Florida and California with adults ≥18 years old with type 1 diabetes with selection criteria including hospitalization for diabetic ketoacidosis, HbA >9%, and/or receiving care at a Federally Qualified Health Center. Sixteen focus groups were conducted in English or Spanish with 86 adults (mean age 42 ± 16.2 years). Transcript themes and pre-focus group demographic survey data were analyzed. In order of frequency, barriers to diabetes technology and endocrinology care included: 1) provider level (negative provider encounters); 2) system level (financial coverage); and 3) individual level (preferences).

Results: Over 50% of participants had not seen an endocrinologist in the past year or were only seen once including during hospital visits. In Florida, there was less technology use overall (38% used CGMs in FL and 63% in CA; 43% used pumps in FL and 69% in CA) and significant differences in pump use by SES ( = 0.02 in FL; = 0.08 in CA) and race/ethnicity ( = 0.01 in FL; = 0.80 in CA). In California, there were significant differences in CGM use by race/ethnicity ( = 0.05 in CA; = 0.56 in FL) and education level ( = 0.02 in CA; = 0.90 in FL).

Conclusions: These findings provide novel insights into the experiences of vulnerable communities and demonstrate the need for multilevel interventions aimed at offsetting disparities in diabetes.
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http://dx.doi.org/10.2337/dc20-2753DOI Listing
May 2021

Full closed loop open-source algorithm performance comparison in pigs with diabetes.

Clin Transl Med 2021 Apr;11(4):e387

Division of Endocrinology, Department of Pediatrics, Stanford University, Stanford, California, USA.

Understanding how automated insulin delivery (AID) algorithm features impact glucose control under full closed loop delivery represents a critical step toward reducing patient burden by eliminating the need for carbohydrate entries at mealtimes. Here, we use a pig model of diabetes to compare AndroidAPS and Loop open-source AID systems without meal announcements. Overall time-in-range (70-180 mg/dl) for AndroidAPS was 58% ± 5%, while time-in-range for Loop was 35% ± 5%. The effect of the algorithms on time-in-range differed between meals and overnight. During the overnight monitoring period, pigs had an average time-in-range of 90% ± 7% when on AndroidAPS compared to 22% ± 8% on Loop. Time-in-hypoglycemia also differed significantly during the lunch meal, whereby pigs running AndroidAPS spent an average of 1.4% (+0.4/-0.8)% in hypoglycemia compared to 10% (+3/-6)% for those using Loop. As algorithm design for closed loop systems continues to develop, the strategies employed in the OpenAPS algorithm (known as oref1) as implemented in AndroidAPS for unannounced meals may result in a better overall control for full closed loop systems.
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http://dx.doi.org/10.1002/ctm2.387DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8087942PMC
April 2021

Provider Implicit Bias Impacts Pediatric Type 1 Diabetes Technology Recommendations in the United States: Findings from The Gatekeeper Study.

J Diabetes Sci Technol 2021 Apr 15:19322968211006476. Epub 2021 Apr 15.

Department of Pediatrics, Division of Endocrinology, Stanford University, Stanford, CA, USA.

Background: Diabetes technology use is associated with favorable type 1 diabetes (T1D) outcomes. American youth with public insurance, a proxy for low socioeconomic status, use less diabetes technology than those with private insurance. We aimed to evaluate the role of insurance-mediated provider implicit bias, defined as the systematic discrimination of youth with public insurance, on diabetes technology recommendations for youth with T1D in the United States.

Methods: Multi-disciplinary pediatric diabetes providers completed a bias assessment comprised of a clinical vignette and ranking exercises ( = 39). Provider bias was defined as providers: (1) recommending more technology for those on private insurance versus public insurance or (2) ranking insurance in the top 2 of 7 reasons to offer technology. Bias and provider characteristics were analyzed with descriptive statistics, group comparisons, and multivariate logistic regression.

Results: The majority of providers [44.1 ± 10.0 years old, 83% female, 79% non-Hispanic white, 49% physician, 12.2 ± 10.0 practice-years] demonstrated bias ( = 33/39, 84.6%). Compared to the group without bias, the group with bias had practiced longer (13.4±10.4 years vs 5.7 ± 3.6 years,  = .003) but otherwise had similar characteristics including age (44.4 ± 10.2 vs 42.6 ± 10.1, p = 0.701). In the logistic regression, practice-years remained significant (OR = 1.47, 95% CI [1.02,2.13];  = .007) when age, sex, race/ethnicity, provider role, percent public insurance served, and workplace location were included.

Conclusions: Provider bias to recommend technology based on insurance was common in our cohort and increased with years in practice. There are likely many reasons for this finding, including healthcare system drivers, yet as gatekeepers to diabetes technology, providers may be contributing to inequities in pediatric T1D in the United States.
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http://dx.doi.org/10.1177/19322968211006476DOI Listing
April 2021

'I was ready for it at the beginning': Parent experiences with early introduction of continuous glucose monitoring following their child's Type 1 diabetes diagnosis.

Diabet Med 2021 Aug 21;38(8):e14567. Epub 2021 Apr 21.

Division of Endocrinology, Department of Pediatrics, School of Medicine, Stanford University, Stanford, CA, USA.

Aim: This study aimed to capture the experience of parents of youth with recent onset Type 1 diabetes who initiated use of continuous glucose monitoring (CGM) technology soon after diagnosis, which is a new practice.

Methods: Focus groups and individual interviews were conducted with parents of youth with Type 1 diabetes who had early initiation of CGM as part of a new clinical protocol. Interviewers used a semi-structured interview guide to elicit feedback and experiences with starting CGM within 30 days of diagnosis, and the benefits and barriers they experienced when adjusting to this technology. Groups and interviews were audio recorded, transcribed and analysed using content analysis.

Results: Participants were 16 parents (age 44.13 ± 8.43 years; 75% female; 56.25% non-Hispanic White) of youth (age 12.38 ± 4.15 years; 50% female; 50% non-Hispanic White; diabetes duration 10.35 ± 3.89 months) who initiated CGM 11.31 ± 7.33 days after diabetes diagnosis. Overall, parents reported high levels of satisfaction with starting CGM within a month of diagnosis and described a high level of reliance on the technology to help manage their child's diabetes. All participants recommended early CGM initiation for future families and were committed to continue using the technology for the foreseeable future, provided that insurance covered it.

Conclusion: Parents experienced CGM initiation shortly after their child's Type 1 diabetes diagnosis as a highly beneficial and essential part of adjusting to living with diabetes.
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http://dx.doi.org/10.1111/dme.14567DOI Listing
August 2021

50 Years Ago in TheJournalofPediatrics: Advances in Neonatal Thyrotoxicosis.

J Pediatr 2021 04;231:199

Division of Pediatric Endocrinology, School of Medicine, Stanford University, Palo Alto, California.

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http://dx.doi.org/10.1016/j.jpeds.2020.11.030DOI Listing
April 2021

50 Years Ago in TheJournalofPediatrics: Association of Type 1 Diabetes Mellitus and Celiac Disease: Then and Now.

J Pediatr 2021 03;230:70

Division of Pediatric Endocrinology, School of Medicine, Stanford University, Palo Alto, California.

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http://dx.doi.org/10.1016/j.jpeds.2020.10.050DOI Listing
March 2021

The Evolution of Hemoglobin A Targets for Youth With Type 1 Diabetes: Rationale and Supporting Evidence.

Diabetes Care 2021 Feb 11;44(2):301-312. Epub 2021 Jan 11.

Division of Pediatric Endocrinology and Diabetology and Wells Center for Pediatric Research, Indiana University School of Medicine, Indianapolis, IN.

The American Diabetes Association 2020 (Standards of Care) recommends a hemoglobin A (A1C) of <7% (53 mmol/mol) for many children with type 1 diabetes (T1D), with an emphasis on target personalization. A higher A1C target of <7.5% may be more suitable for youth who cannot articulate symptoms of hypoglycemia or have hypoglycemia unawareness and for those who do not have access to analog insulins or advanced diabetes technologies or who cannot monitor blood glucose regularly. Even less stringent A1C targets (e.g., <8%) may be warranted for children with a history of severe hypoglycemia, severe morbidities, or short life expectancy. During the "honeymoon" period and in situations where lower mean glycemia is achievable without excessive hypoglycemia or reduced quality of life, an A1C <6.5% may be safe and effective. Here, we provide a historical perspective of A1C targets in pediatrics and highlight evidence demonstrating detrimental effects of hyperglycemia in children and adolescents, including increased likelihood of brain structure and neurocognitive abnormalities, microvascular and macrovascular complications, long-term effects, and increased mortality. We also review data supporting a decrease over time in overall severe hypoglycemia risk for youth with T1D, partly associated with the use of newer insulins and devices, and weakened association between lower A1C and severe hypoglycemia risk. We present common barriers to achieving glycemic targets in pediatric diabetes and discuss some strategies to address them. We aim to raise awareness within the community on Standards of Care updates that impact this crucial goal in pediatric diabetes management.
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http://dx.doi.org/10.2337/dc20-1978DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7818324PMC
February 2021

Multimethod, multidataset analysis reveals paradoxical relationships between sociodemographic factors, Hispanic ethnicity and diabetes.

BMJ Open Diabetes Res Care 2020 11;8(2)

Division of Pediatric Endocrinology, Stanford University School of Medicine, Stanford, California, USA

Introduction: Population-level and individual-level analyses have strengths and limitations as do 'blackbox' machine learning (ML) and traditional, interpretable models. Diabetes mellitus (DM) is a leading cause of morbidity and mortality with complex sociodemographic dynamics that have not been analyzed in a way that leverages population-level and individual-level data as well as traditional epidemiological and ML models. We analyzed complementary individual-level and county-level datasets with both regression and ML methods to study the association between sociodemographic factors and DM.

Research Design And Methods: County-level DM prevalence, demographics, and socioeconomic status (SES) factors were extracted from the 2018 Robert Wood Johnson Foundation County Health Rankings and merged with US Census data. Analogous individual-level data were extracted from 2007 to 2016 National Health and Nutrition Examination Survey studies and corrected for oversampling with survey weights. We used multivariate linear (logistic) regression and ML regression (classification) models for county (individual) data. Regression and ML models were compared using measures of explained variation (area under the receiver operating characteristic curve (AUC) and R).

Results: Among the 3138 counties assessed, the mean DM prevalence was 11.4% (range: 3.0%-21.1%). Among the 12 824 individuals assessed, 1688 met DM criteria (13.2% unweighted; 10.2% weighted). Age, gender, race/ethnicity, income, and education were associated with DM at the county and individual levels. Higher county Hispanic ethnic density was negatively associated with county DM prevalence, while Hispanic ethnicity was positively associated with individual DM. ML outperformed regression in both datasets (mean R of 0.679 vs 0.610, respectively (p<0.001) for county-level data; mean AUC of 0.737 vs 0.727 (p<0.0427) for individual-level data).

Conclusions: Hispanic individuals are at higher risk of DM, while counties with larger Hispanic populations have lower DM prevalence. Analyses of population-level and individual-level data with multiple methods may afford more confidence in results and identify areas for further study.
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http://dx.doi.org/10.1136/bmjdrc-2020-001725DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7684662PMC
November 2020

Children and youth with diabetes are not at increased risk for hospitalization due to COVID-19.

Pediatr Diabetes 2021 03 26;22(2):202-206. Epub 2020 Nov 26.

Division of Endocrinology, Department of Pediatrics, Stanford University, Stanford, California, USA.

The severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), responsible for the coronavirus disease COVID-19, was first identified in Wuhan, China in December 2019. Diabetes, as well as other cardiovascular comorbidities, has been recognized as a major risk factor for outcomes and mortality in adults with COVID-19, particularly in the elderly with type 2 diabetes. Based on these conclusions, COVID-19 data on adults have been generalized to youth with diabetes. Nevertheless, experience from pediatric diabetes practices in China (Wuhan), Italy, Spain (Catalonia), and the United States (San Francisco Bay Area) consistently report only a single severe case of COVID-19 in a 20-year-old female youth with type 1 diabetes (T1D) that was hospitalized for bilateral pneumonia and was subsequently discharged without complications. In Italy, information on COVID-19 in all children with diabetes is collected on a weekly basis and those with positive swab test or infection-related symptoms reported to a dedicated national registry. Of a total of 15 500 children tested, 11 subjects with T1D (age 8-17y) tested positive for COVID-19; 6/11 were asymptomatic and the rest presented with mild symptoms. In the rest of locations, youths with T1D diagnosed with COVID-19 were based on clinical suspicion and a confirmatory PCR test (Wuhan:0; Catalonia-HSJD:3; California-Stanford:2). All of them were asymptomatic or had a mild course. We suggest that COVID-19 data from adults should not be generalized to children, adolescents, and youth with diabetes as their outcomes and prognosis seem to be similar to their non-diabetic-peers and consistently milder than adults with diabetes.
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http://dx.doi.org/10.1111/pedi.13158DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7753354PMC
March 2021

Sensitive detection of multiple islet autoantibodies in type 1 diabetes using small sample volumes by agglutination-PCR.

PLoS One 2020 13;15(11):e0242049. Epub 2020 Nov 13.

Enable Biosciences Inc., South San Francisco, CA, United States of America.

Islet autoantibodies are predominantly measured by radioassay to facilitate risk assessment and diagnosis of type 1 diabetes. However, the reliance on radioactive components, large sample volumes and limited throughput renders radioassay testing costly and challenging. We developed a multiplex analysis platform based on antibody detection by agglutination-PCR (ADAP) for the sample-sparing measurement of GAD, IA-2 and insulin autoantibodies/antibodies in 1 μL serum. The assay was developed and validated in 7 distinct cohorts (n = 858) with the majority of the cohorts blinded prior to analysis. Measurements from the ADAP assay were compared to radioassay to determine correlation, concordance, agreement, clinical sensitivity and specificity. The average overall agreement between ADAP and radioassay was above 91%. The average clinical sensitivity and specificity were 96% and 97%. In the IASP 2018 workshop, ADAP achieved the highest sensitivity of all assays tested at 95% specificity (AS95) rating for GAD and IA-2 autoantibodies and top-tier performance for insulin autoantibodies. Furthermore, ADAP correctly identified 95% high-risk individuals with two or more autoantibodies by radioassay amongst 39 relatives of T1D patients tested. In conclusion, the new ADAP assay can reliably detect the three cardinal islet autoantibodies/antibodies in 1μL serum with high sensitivity. This novel assay may improve pediatric testing compliance and facilitate easier community-wide screening for islet autoantibodies.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0242049PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7665791PMC
December 2020

Weight Management in Youth with Type 1 Diabetes and Obesity: Challenges and Possible Solutions.

Curr Obes Rep 2020 Dec 27;9(4):412-423. Epub 2020 Oct 27.

Division of Endocrinology, Department of Pediatrics, Stanford University, School of Medicine, Stanford, CA, USA.

Purpose Of Review: This review highlights challenges associated with weight management in children and adolescents with type 1 diabetes (T1D). Our purpose is to propose potential solutions to improve weight outcomes in youth with T1D.

Recent Findings: A common barrier to weight management in T1D is reluctance to engage in exercise for fear of hypoglycemia. Healthcare practitioners generally provide limited guidance for insulin dosing and carbohydrate modifications to maintain stable glycemia during exercise. Adherence to dietary guidelines is associated with improved glycemia; however, youth struggle to meet recommendations. When psychosocial factors are addressed in combination with glucose trends, this often leads to successful T1D management. Newer medications also hold promise to potentially aid in glycemia and weight management, but further research is necessary. Properly addressing physical activity, nutrition, pharmacotherapy, and psychosocial factors while emphasizing weight management may reduce the likelihood of obesity development and its perpetuation in this population.
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http://dx.doi.org/10.1007/s13679-020-00411-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8087153PMC
December 2020

Glucose Control During Physical Activity and Exercise Using Closed Loop Technology in Adults and Adolescents with Type 1 Diabetes.

Can J Diabetes 2020 Dec 8;44(8):740-749. Epub 2020 Jun 8.

School of Kinesiology and Health Science, York University, Toronto, Ontario, Canada; LMC Manna Research, Toronto, Ontario, Canada.

Guidelines for safe exercise strategies exist for both pediatric and adult patients living with type 1 diabetes. The management of type 1 diabetes during exercise is complex, but making insulin dosing adjustments in advance of activity can yield positive outcomes and reduce the likelihood of hypoglycemia. Closed loop (also known as automated insulin delivery) systems are able to partially automate insulin delivery and can assist in exercise and overall management of type 1 diabetes. Current exercise guidelines, however, focus primarily on management strategies for patients using multiple daily injections or open loop insulin pump therapy. Closed loop systems require strategic approaches to type 1 diabetes management, including appropriate timing and duration of exercise targets and carbohydrates around exercise that have yet to be standardized. This review aims to showcase how closed loop technology has evolved over the last decade and summarizes a number of closed loop and exercise studies both in free-living conditions and clinical trials. This review also highlights strategies and approaches for exercise and type 1 diabetes management using closed loop systems. Some differences in closed loop strategies for exercise include the importance of pump suspension if disconnecting during exercise, fewer grams of uncovered carbohydrates before exercise and these should be taken close to exercise onset to avoid a rise in automated insulin delivery. A primary goal for future closed loop systems is to detect exercise without user input, so that patients are not required to preset exercise targets well in advance of activity, as are the current recommendations.
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http://dx.doi.org/10.1016/j.jcjd.2020.06.003DOI Listing
December 2020

Dietary intake on days with and without hypoglycemia in youth with type 1 diabetes: The Flexible Lifestyle Empowering Change trial.

Pediatr Diabetes 2020 12 5;21(8):1475-1484. Epub 2020 Oct 5.

Department of Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, USA.

Objective: To address a common perception that hypoglycemia is associated with increased dietary intake, we examined calorie and carbohydrate consumption on days with and without hypoglycemia among adolescents with type 1 diabetes (T1D).

Methods: Days (N = 274) with 24-hour dietary recalls and continuous glucose monitoring were available for 122 adolescents with T1D in the Flexible Lifestyle Empowering Change trial (age 13-16 years, diabetes duration >1 year, hemoglobin A1c 8%-13%). Days with no hypoglycemia, clinical hypoglycemia (54-69 mg/dL) or clinically serious hypoglycemia (<54 mg/dL) were further split into night (12-5:59 am) and day (6 am-11:59 pm). Mixed models tested whether intake of calories or carbohydrates was greater on days with than without hypoglycemia.

Results: Fifty-nine percent, 23% and 18% of days had no hypoglycemia, clinical hypoglycemia and clinically serious hypoglycemia, respectively. Intake of calories and carbohydrates was not statistically significantly different on days with clinical hypoglycemia (57.2 kcal [95% CI -126.7, 241.5]; 12.6 g carbohydrate [95% CI -12.7, 38.0]) or clinically serious hypoglycemia (-74.0 kcal [95% CI -285.9, 137.9]; (-7.8 g carbohydrate [95% CI -36.8, 21.1]), compared to days without hypoglycemia. Differences by day and night were not statistically significant.

Conclusions: Among adolescents with T1D, daily intake of calories and carbohydrates did not differ on days with and without hypoglycemia. It is possible that hypoglycemic episodes caused by undereating relative to insulin dosing, followed by overeating, leading to a net neutral difference. Given the post-hoc nature of these analyses, larger studies should be designed to prospectively test the hypoglycemia-diet relationship.
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http://dx.doi.org/10.1111/pedi.13132DOI Listing
December 2020

Estimating Dynamic Treatment Regimes in Mobile Health Using V-learning.

J Am Stat Assoc 2020 17;115(530):692-706. Epub 2019 Apr 17.

Department of Biostatistics, University of North Carolina at Chapel Hill.

The vision for precision medicine is to use individual patient characteristics to inform a personalized treatment plan that leads to the best possible health-care for each patient. Mobile technologies have an important role to play in this vision as they offer a means to monitor a patient's health status in real-time and subsequently to deliver interventions if, when, and in the dose that they are needed. Dynamic treatment regimes formalize individualized treatment plans as sequences of decision rules, one per stage of clinical intervention, that map current patient information to a recommended treatment. However, most existing methods for estimating optimal dynamic treatment regimes are designed for a small number of fixed decision points occurring on a coarse time-scale. We propose a new reinforcement learning method for estimating an optimal treatment regime that is applicable to data collected using mobile technologies in an out-patient setting. The proposed method accommodates an indefinite time horizon and minute-by-minute decision making that are common in mobile health applications. We show that the proposed estimators are consistent and asymptotically normal under mild conditions. The proposed methods are applied to estimate an optimal dynamic treatment regime for controlling blood glucose levels in patients with type 1 diabetes.
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http://dx.doi.org/10.1080/01621459.2018.1537919DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7500510PMC
April 2019

A Decade of Disparities in Diabetes Technology Use and HbA in Pediatric Type 1 Diabetes: A Transatlantic Comparison.

Diabetes Care 2021 Jan 16;44(1):133-140. Epub 2020 Sep 16.

University of Ulm, Institute of Epidemiology and Medical Biometry, ZIBMT, Ulm, Germany.

Objective: As diabetes technology use in youth increases worldwide, inequalities in access may exacerbate disparities in hemoglobin A (HbA). We hypothesized that an increasing gap in diabetes technology use by socioeconomic status (SES) would be associated with increased HbA disparities.

Research Design And Methods: Participants aged <18 years with diabetes duration ≥1 year in the Type 1 Diabetes Exchange (T1DX, U.S., = 16,457) and Diabetes Prospective Follow-up (DPV, Germany, = 39,836) registries were categorized into lowest (Q1) to highest (Q5) SES quintiles. Multiple regression analyses compared the relationship of SES quintiles with diabetes technology use and HbA from 2010-2012 to 2016-2018.

Results: HbA was higher in participants with lower SES (in 2010-2012 and 2016-2018, respectively: 8.0% and 7.8% in Q1 and 7.6% and 7.5% in Q5 for DPV; 9.0% and 9.3% in Q1 and 7.8% and 8.0% in Q5 for T1DX). For DPV, the association between SES and HbA did not change between the two time periods, whereas for T1DX, disparities in HbA by SES increased significantly ( < 0.001). After adjusting for technology use, results for DPV did not change, whereas the increase in T1DX was no longer significant.

Conclusions: Although causal conclusions cannot be drawn, diabetes technology use is lowest and HbA is highest in those of the lowest SES quintile in the T1DX, and this difference for HbA broadened in the past decade. Associations of SES with technology use and HbA were weaker in the DPV registry.
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http://dx.doi.org/10.2337/dc20-0257DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8162452PMC
January 2021

COVID-19 and Children With Diabetes-Updates, Unknowns, and Next Steps: First, Do No Extrapolation.

Diabetes Care 2020 11 4;43(11):2631-2634. Epub 2020 Sep 4.

Division of Pediatric Endocrinology, Stanford Diabetes Research Center, and Department of Health Research and Policy (Epidemiology), Stanford University School of Medicine, Stanford, CA.

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http://dx.doi.org/10.2337/dci20-0044DOI Listing
November 2020

Characterization of youth goal setting in the self-management of type 1 diabetes and associations with HbA1c: The Flexible Lifestyle Empowering Change trial.

Pediatr Diabetes 2020 11 1;21(7):1343-1352. Epub 2020 Sep 1.

Department of Nutrition, University of North Carolina, Chapel Hill, North Carolina, USA.

Introduction: Youth with type 1 diabetes (T1D) commonly do not meet HbA1c targets. Youth-directed goal setting as a strategy to improve HbA1c has not been well characterized and associations between specific goal focus areas and glycemic control remain unexplored.

Objective: To inform future trials, this analysis characterized intended focus areas of youth self-directed goals and examined associations with change in HbA1c over a 18 months.

Methods: We inductively coded counseling session data from youth in the Flexible Lifestyle Empowering Change Intervention (n = 122, 13-16 years, T1D duration >1 year, HbA1c 8-13%) to categorize intended goal focus areas and examine associations between frequency of goal focus areas selected by youth and change in HbA1c between first and last study visit.

Results: We identified 13 focus areas that categorized youth goal intentions. Each session where youth goal setting concurrently incorporated blood glucose monitoring (BGM), continuous glucose monitoring (CGM), and insulin dosing was associated with a 0.4% (95% CI: -0.77, -0.01; P = .03) lower HbA1c at the end of intervention participation. No association was observed between HbA1c and frequency of sessions where goal intentions focused on BG only (without addressing insulin or CGM) (β: 0.07; 95% CI: -0.07, 0.21; P = .33) nor insulin dosing only (without addressing BGM or CGM) (β: 0.00; 95% CI: -0.11, 0.10; P = .95).

Conclusions: Findings exemplify how guiding youth goal development and combining multiple behaviors proximally related to glycemic control into goal setting may benefit HbA1c among youth with T1D. More research characterizing optimal goal setting practices in youth with T1D is needed.
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http://dx.doi.org/10.1111/pedi.13099DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7855488PMC
November 2020

Markers of cholesterol synthesis are elevated in adolescents and young adults with type 2 diabetes.

Pediatr Diabetes 2020 11 15;21(7):1126-1131. Epub 2020 Sep 15.

Division of Endocrinology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

Background: Changes in cholesterol absorption and cholesterol synthesis may promote dyslipidemia and cardiovascular disease in individuals with type 2 diabetes mellitus (T2DM).

Objective: To assess cholesterol synthesis and absorption in lean individuals, obese individuals, and individuals with T2DM.

Methods: We measured lathosterol and lanosterol (markers of cholesterol synthesis) as well as campesterol and β-sitosterol (markers of cholesterol absorption) in the serum of 15 to 26 years old individuals with T2DM (n = 95), as well as their lean (n = 98) and obese (n = 92) controls.

Results: Individuals with T2DM showed a 51% increase in lathosterol and a 65% increase in lanosterol compared to lean controls. Similarly, obese individuals showed a 31% increase in lathosterol compared to lean controls. Lathosterol and lanosterol were positively correlated with body mass index, fasting insulin and glucose, serum triglycerides, and C-reactive protein, and negatively correlated with HDL-cholesterol. In contrast, campesterol and β-sitosterol were not altered in individuals with T2DM. Moreover, campesterol and β-sitosterol were negatively correlated with body mass index, fasting insulin, and C-reactive protein and were positively correlated with HDL-cholesterol.

Conclusions: Adolescents and young adults with T2DM show evidence of increased cholesterol synthesis compared to non-diabetic lean controls. These findings suggest that T2DM may promote cardiovascular disease by increasing cholesterol synthesis, and provide additional rationale for the use of cholesterol synthesis inhibitors in this group.
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http://dx.doi.org/10.1111/pedi.13097DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7855867PMC
November 2020

Improving Clinical Outcomes in Newly Diagnosed Pediatric Type 1 Diabetes: Teamwork, Targets, Technology, and Tight Control-The 4T Study.

Front Endocrinol (Lausanne) 2020 9;11:360. Epub 2020 Jul 9.

Division of Endocrinology, Department of Pediatrics, Stanford University, Stanford, CA, United States.

Many youth with type 1 diabetes (T1D) do not achieve hemoglobin A1c (HbA1c) targets. The mean HbA1c of youth in the USA is higher than much of the developed world. Mean HbA1c in other nations has been successfully modified following benchmarking and quality improvement methods. In this review, we describe the novel 4T approach-teamwork, targets, technology, and tight control-to diabetes management in youth with new-onset T1D. In this program, the diabetes care team (physicians, nurse practitioners, certified diabetes educators, dieticians, social workers, psychologists, and exercise physiologists) work closely to deliver diabetes education from diagnosis. Part of the education curriculum involves early integration of technology, specifically continuous glucose monitoring (CGM), and developing a curriculum around using the CGM to maintain tight control and optimize quality of life.
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http://dx.doi.org/10.3389/fendo.2020.00360DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7363838PMC
May 2021
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