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1.
Clin Neuropsychol ; : 1-20, 2024 Feb 21.
Artigo em Inglês | MEDLINE | ID: mdl-38380810

RESUMO

OBJECTIVE:  Individuals with type 1 diabetes (T1D) have increased risk for cognitive dysfunction and high rates of sleep disturbance. Despite associations between glycemia and cognitive performance using cross-sectional and experimental methods few studies have evaluated this relationship in a naturalistic setting, or the impact of nocturnal versus daytime hypoglycemia. Ecological Momentary Assessment (EMA) may provide insight into the dynamic associations between cognition, affective, and physiological states. The current study couples EMA data with continuous glucose monitoring (CGM) to examine the within-person impact of nocturnal glycemia on next day cognitive performance in adults with T1D. Due to high rates of sleep disturbance and emotional distress in people with T1D, the potential impacts of sleep characteristics and negative affect were also evaluated. METHODS:  This pilot study utilized EMA in 18 adults with T1D to examine the impact of glycemic excursions, measured using CGM, on cognitive performance, measured via mobile cognitive assessment using the TestMyBrain platform. Multilevel modeling was used to test the within-person effects of nocturnal hypoglycemia and hyperglycemia on next day cognition. RESULTS:  Results indicated that increases in nocturnal hypoglycemia were associated with slower next day processing speed. This association was not significantly attenuated by negative affect, sleepiness, or sleep quality. CONCLUSIONS:  These results, while preliminary due to small sample size, showcase the power of intensive longitudinal designs using ambulatory cognitive assessment to uncover novel determinants of cognitive fluctuation in real world settings, an approach that may be utilized in other populations. Findings suggest reducing nocturnal hypoglycemia may improve cognition in adults with T1D.

2.
Diabet Med ; 40(8): e15120, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37083018

RESUMO

AIM: Managing type 1 diabetes in young children can cause significant stress for parents. Continuous glucose monitoring (CGM) may reduce parental burden. The Strategies to Enhance CGM Use in Early Childhood (SENCE) trial randomized parents of children (ages 2 to <8 years) with type 1 diabetes to CGM with family behavioural intervention (CGM + FBI), CGM alone (Standard-CGM) or blood glucose monitoring for 26 weeks before receiving CGM + FBI (BGM-Crossover). This report assesses changes in psychosocial outcomes for all groups over 52 weeks. METHODS: CGM + FBI (n = 45), Standard-CGM (n = 42) and BGM-Crossover (n = 44) participants completed psychosocial assessments at baseline, 26 weeks and 52 weeks. Repeated measures linear regression models evaluated change within and between treatment groups. RESULTS: The BGM-Crossover group reported improved diabetes burden (Δ -6.9, 95% CI [-11.3, -2.6], p = 0.003), fear of hypoglycaemia (Δ -6.4, CI [-10.1, -2.6], p = 0.002) and technology satisfaction (Δ 7.3, CI [2.4, 12.2], p = 0.005) from 26 to 52 weeks, similar to published findings in the CGM + FBI group over the first 26 weeks. The Standard-CGM group reported increased technology satisfaction (Δ 7.3, CI [0.6, 14.0], p = 0.027) from baseline to 52 weeks. The CGM + FBI group reported less diabetes burden and fear of hypoglycaemia from baseline to 52 weeks, but changes were not statistically significant. Scores from 26 to 52 weeks did not deteriorate. CONCLUSIONS: Parents demonstrated psychosocial benefits following FBI that appeared to maintain without additional intervention. CGM-focused education with behavioural support likely helps parents of young children with type 1 diabetes reduce burden and worry in the short- and long-term.


Assuntos
Diabetes Mellitus Tipo 1 , Hipoglicemia , Criança , Pré-Escolar , Humanos , Glicemia , Automonitorização da Glicemia , Pais/psicologia
3.
J Diabetes Sci Technol ; : 19322968221149040, 2023 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-36629330

RESUMO

BACKGROUND: The Wireless Innovation for Seniors with Diabetes Mellitus (WISDM) study demonstrated continuous glucose monitoring (CGM) reduced hypoglycemia over 6 months among older adults with type 1 diabetes (T1D) compared with blood glucose monitoring (BGM). We explored heterogeneous treatment effects of CGM on hypoglycemia by formulating a data-driven decision rule that selects an intervention (ie, CGM vs BGM) to minimize percentage of time <70 mg/dL for each individual WISDM participant. METHOD: The precision medicine analyses used data from participants with complete data (n = 194 older adults, including those who received CGM [n = 100] and BGM [n = 94] in the trial). Policy tree and decision list algorithms were fit with 14 baseline demographic, clinical, and laboratory measures. The primary outcome was CGM-measured percentage of time spent in hypoglycemic range (<70 mg/dL), and the decision rule assigned participants to a subgroup reflecting the treatment estimated to minimize this outcome across all follow-up visits. RESULTS: The optimal decision rule was found to be a decision list with 3 steps. The first step moved WISDM participants with baseline time-below range >1.35% and no detectable C-peptide levels to the CGM subgroup (n = 139), and the second step moved WISDM participants with a baseline time-below range of >6.45% to the CGM subgroup (n = 18). The remaining participants (n = 37) were left in the BGM subgroup. Compared with the BGM subgroup (n = 37; 19%), the group for whom CGM minimized hypoglycemia (n = 157; 81%) had more baseline hypoglycemia, a lower proportion of detectable C-peptide, higher glycemic variability, longer disease duration, and higher proportion of insulin pump use. CONCLUSIONS: The decision rule underscores the benefits of CGM for older adults to reduce hypoglycemia. Diagnostic CGM and laboratory markers may inform decision-making surrounding therapeutic CGM and identify older adults for whom CGM may be a critical intervention to reduce hypoglycemia.

4.
J Diabetes Sci Technol ; 17(4): 976-987, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35343269

RESUMO

OBJECTIVES: Achieving optimal glycemic outcomes in young children with type 1 diabetes (T1D) is challenging. This study examined the durability of continuous glucose monitoring (CGM) coupled with a family behavioral intervention (FBI) to improve glycemia. STUDY DESIGN: This one-year study included an initial 26-week randomized controlled trial of CGM with FBI (CGM+FBI) and CGM alone (Standard-CGM) compared with blood glucose monitoring (BGM), followed by a 26-week extension phase wherein the BGM Group received the CGM+FBI (BGM-Crossover) and both original CGM groups continued this technology. RESULTS: Time in range (70-180 mg/dL) did not improve with CGM use (CGM+FBI: baseline 37%, 52 weeks 41%; Standard-CGM: baseline 41%, 52 weeks 44%; BGM-Crossover: 26 weeks 38%, 52 weeks 40%). All three groups sustained decreases in hypoglycemia (<70 mg/dL) with CGM use (CGM+FBI: baseline 3.4%, 52 weeks 2.0%; Standard-CGM: baseline 4.1%, 52 weeks 2.1%; BGM-Crossover: 26 weeks 4.5%, 52 weeks 1.7%, P-values <.001). Hemoglobin A1c was unchanged with CGM use (CGM+FBI: baseline 8.3%, 52 weeks 8.2%; Standard-CGM: baseline 8.2%, 52 weeks 8.0%; BGM-Crossover: 26 weeks 8.1%, 52 weeks 8.3%). Sensor use remained high (52-week study visit: CGM+FBI 91%, Standard-CGM 92%, BGM-Crossover 88%). CONCLUSION: Over 12 months young children with T1D using newer CGM technology sustained reductions in hypoglycemia and, in contrast to prior studies, persistently wore CGM. However, pervasive hyperglycemia remained unmitigated. This indicates an urgent need for further advances in diabetes technology, behavioral support, and diabetes management educational approaches to optimize glycemia in young children.


Assuntos
Diabetes Mellitus Tipo 1 , Hiperglicemia , Hipoglicemia , Humanos , Criança , Pré-Escolar , Glicemia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Automonitorização da Glicemia
5.
Diabetes Technol Ther ; 24(9): 628-634, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35856740

RESUMO

Objective: The German/Austrian Diabetes Patient Follow-up Registry (Diabetes-Patienten-Verlaufsdokumentation or DPV), England/Wales National Pediatric Diabetes Audit (NPDA), and Type 1 Diabetes Exchange (T1DX) in the United States investigated changes in hemoglobin A1c (HbA1c) and diabetes technology use from 2010 to 2018. Methods: Registry/audit data from 2010 to 2018 were analyzed in annual cohorts using linear regression for those <18 years of age with type 1 diabetes diagnosed at age >6 months. Time trends in HbA1c, pump, and continuous glucose monitoring (CGM) use were studied using repeated measurements linear and logistic regression models with an autoregressive covariance structure and with year and data source as independent variables. Results: A total of 1,172,980 visits among 114,264 (54,119 DPV, 43,550 NPDA, 16,595 T1DX) patients were identified. HbA1c remained clinically stable in DPV (7.7% [61 mmol/mol] to 7.6% [60 mmol/mol]), decreased in the NPDA (8.7% [72 mmol/mol] to 7.9% [63 mmol/mol]), and increased in T1DX (8.0% [64 mmol/mol] to 8.5% [69 mmol/mol] from 2010 to 2018). In all registries/audits, insulin pump and CGM use increased over time with greatest pump use in T1DX and lowest uptake reported in NPDA. Conclusions: These data reveal three different longitudinal patterns of change in registry/audit HbA1c from 2010 to 2018. Diabetes technology use increased throughout, at different rates. Quality improvement (QI) programs in DPV have been ongoing for 25 years, began in NPDA in 2009 and T1DX in 2016. We speculate that in England/Wales, development of networks, peer review, and implementation of QI measures contributed to reductions in population HbA1c. Many of these interventions had been implemented in DPV before 2010. Further efforts to understand this improvement, including the role of QI, and continued success within standardized documentation and benchmarking could inform T1DX programs to reduce HbA1c.


Assuntos
Diabetes Mellitus Tipo 1 , Glicemia , Automonitorização da Glicemia , Criança , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/epidemiologia , Hemoglobinas Glicadas/análise , Humanos , Lactente , Estudos Prospectivos , Sistema de Registros , Tecnologia
6.
Pediatr Diabetes ; 23(6): 792-798, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35446449

RESUMO

BACKGROUND: Despite potential glycemic benefits of continuous glucose monitor (CGM) use in young children with type 1 diabetes, psychosocial and behavioral challenges may interfere with sustained use. We developed a 5-session family behavioral intervention (FBI) to support CGM use. OBJECTIVE: We report on the multi-step development of the FBI, training interventionists, implementation in a 14-site clinical trial, and participant satisfaction. METHODS: A multidisciplinary team created the FBI based on mixed-methods (i.e., survey data, qualitative research) preliminary work with parents of young children. Investigators trained non-physician staff to deliver the 5 sessions per an intervention manual. Trial participants received the FBI either during the first (FBI group, n = 50) or second 6-months (Crossover group, n = 44) of the 1-year trial. Investigators listened to session recordings to rate intervention fidelity, and participants rated satisfaction with the FBI. RESULTS: The complete 5-session FBI was delivered to 89% of participants, in-person (73%) or by telephone (23%). Sessions lasted 23 min on average, and fidelity was high across sessions. Over 80% of participants rated very high satisfaction with all aspects of the FBI and offered few recommendations for improvement. CONCLUSIONS: Having been developed based on experiences and input of families of young children with type 1 diabetes, the FBI represented a novel behavioral approach to enhance sustained CGM use during a challenging developmental period. Evidence of strong feasibility and acceptability supports its potential for implementation in research and clinical care. As diabetes technologies evolve, the FBI may continue to be refined to address parents' most relevant concerns.


Assuntos
Diabetes Mellitus Tipo 1 , Terapia Comportamental , Glicemia , Criança , Pré-Escolar , Diabetes Mellitus Tipo 1/psicologia , Diabetes Mellitus Tipo 1/terapia , Humanos , Pais/psicologia , Inquéritos e Questionários
7.
Diabetes Technol Ther ; 24(6): 424-434, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35294272

RESUMO

Objective: To evaluate glycemic outcomes in the Wireless Innovation for Seniors with Diabetes Mellitus (WISDM) randomized clinical trial (RCT) participants during an observational extension phase. Research Design and Methods: WISDM RCT was a 26-week RCT comparing continuous glucose monitoring (CGM) with blood glucose monitoring (BGM) in 203 adults aged ≥60 years with type 1 diabetes. Of the 198 participants who completed the RCT, 100 (98%) CGM group participants continued CGM (CGM-CGM cohort) and 94 (98%) BGM group participants initiated CGM (BGM-CGM cohort) for an additional 26 weeks. Results: CGM was used a median of >90% of the time at 52 weeks in both cohorts. In the CGM-CGM cohort, median time <70 mg/dL decreased from 5.0% at baseline to 2.6% at 26 weeks and remained stable with a median of 2.8% at 52 weeks (P < 0.001 baseline to 52 weeks). Participants spent more time in range 70-180 mg/dL (TIR) (mean 56% vs. 64%; P < 0.001) and had lower hemoglobin A1c (HbA1c) (mean 7.6% [59 mmol/mol] vs. 7.4% [57 mmol/mol]; P = 0.01) from baseline to 52 weeks. In BGM-CGM, from 26 to 52 weeks median time <70 mg/dL decreased from 3.9% to 1.9% (P < 0.001), TIR increased from 56% to 60% (P = 0.006) and HbA1c decreased from 7.5% (58 mmol/mol) to 7.3% (57 mmol/mol) (P = 0.025). In BGM-CGM, a severe hypoglycemic event was reported for nine participants while using BGM during the RCT and for two participants during the extension phase with CGM (P = 0.02). Conclusions: CGM use reduced hypoglycemia without increasing hyperglycemia in older adults with type 1 diabetes. These data provide further evidence for fully integrating CGM into clinical practice. Clinicaltrials.gov (NCT03240432).


Assuntos
Diabetes Mellitus Tipo 1 , Hipoglicemia , Idoso , Glicemia , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemia/prevenção & controle , Hipoglicemiantes/uso terapêutico
8.
Diabetes Technol Ther ; 24(1): 32-41, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34524026

RESUMO

Aims: This study assessed hemoglobin A1c (HbA1c) across the lifespan in people with type 1 diabetes (T1D) in Germany/Austria, Sweden, and the United States between 2011 and 2017 to ascertain temporal and age-related trends. Methods: Data from the Diabetes-Patienten-Verlaufsdokumentation (DPV) (n = 25,651 in 2011, n = 29,442 in 2017); Swedish Pediatric Diabetes Quality Registry (SWEDIABKIDS)/National Diabetes Register (NDR), (n = 44,474 in 2011, n = 53,690 in 2017); and T1D Exchange (n = 16,198 in 2011, n = 17,087 in 2017) registries were analyzed by linear regression to compare mean HbA1c overall and by age group. Results: Controlling for age, sex, and T1D duration, HbA1c increased in the United States between 2011 and 2017, decreased in Sweden, and did not change in Germany/Austria. Controlling for sex and T1D duration, mean HbA1c decreased between 2011 and 2017 in all age cohorts in Sweden (P < 0.001). In the United States, HbA1c stayed the same for participants <6 years and 45 to <65 years and increased in all other age groups (P < 0.05). In Germany/Austria, HbA1c stayed the same for participants <6 to <13 years and 18 to <25 years; decreased for participants ages 13 to <18 years (P < 0.01); and increased for participants ≥25 years (P < 0.05). Conclusions: The comparison of international trends in HbA1c makes it possible to identify differences, explore underlying causes, and share quality improvement processes. National quality improvement initiatives are well accepted in Europe but have yet to be implemented systematically in the United States. However, disparities created by the lack of universal access to health care coverage, unequal access to diabetes technologies (e.g., continuous glucose monitoring) regardless of insurance status, and high out-of-pocket cost for the underinsured ultimately limit the potential of quality improvement initiatives.


Assuntos
Diabetes Mellitus Tipo 1 , Longevidade , Adolescente , Áustria , Glicemia , Automonitorização da Glicemia , Criança , Alemanha/epidemiologia , Hemoglobinas Glicadas/análise , Humanos , Sistema de Registros , Suécia/epidemiologia , Estados Unidos/epidemiologia
9.
Pediatrics ; 148(2)2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34315809

RESUMO

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 (n = 7292), the German-Austrian-Luxembourgian-Swiss diabetes prospective follow-up initiative (Diabetes Patienten Verlaufsdokumentation) (n = 39 226) and the US-based Type 1 Diabetes Exchange Clinic Registry (n = 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 (P ≤ .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.


Assuntos
Diabetes Mellitus Tipo 1/sangue , Hemoglobinas Glicadas/análise , Adolescente , Criança , Pré-Escolar , Diabetes Mellitus Tipo 1/diagnóstico , Feminino , Humanos , Internacionalidade , Masculino , Sistema de Registros , Fatores de Tempo
10.
J Clin Endocrinol Metab ; 106(5): 1294-1302, 2021 04 23.
Artigo em Inglês | MEDLINE | ID: mdl-33567069

RESUMO

CONTEXT: Glycemic control in adolescents with type 1 diabetes is poor; yet, it typically improves during early adulthood. Factors related to improvement of glycemic control are unclear. OBJECTIVE: This work examines how demographic and clinical variables may affect trajectories of glycemic control over time. METHODS: This retrospective, observational study comprised 1775 participants ages 18 to 30 years at enrollment in the T1D Exchange clinic registry. Latent class trajectory modeling was used to determine subgroups following a similar glycated hemoglobin A1c (HbA1c) trajectory over time. RESULTS: Five distinct trajectories of HbA1c classes were identified: "low-decline" and "moderate-decline" groups had low or moderate HbA1c with a gradual decline, the "high-stable" group had high HbA1c and remained stable, and the "very high-rapid decline" and "very high-slow decline" groups had very high HbA1c with rapid or gradual decline. Compared with the "high-stable" group, the "low-decline" and "moderate-decline" groups were more likely to be male (P = .009), White non-Hispanic (P = .02), nonsmokers (P < .001), check self-monitoring blood glucose (SMBG) more frequently (P < .001), and have higher education (P < .001), lower body mass index (P = .02), and lower daily insulin dose (P < .001). Compared with the "very high-rapid decline" and "very high-slow decline" groups, the "low-decline" and "moderate-decline" groups were more likely to be male (P = .02), have higher education (P < .001), use insulin pumps (P = .01), be nonsmokers (P < .001), and have a higher number of SMBG checks per day at enrollment (P < .001). CONCLUSION: We determined 5 distinct patterns of glycemic control from early adulthood into adulthood. Further evaluation into the modifiable factors associated with a declining HbA1c trajectory would aid in the development of targeted interventions.


Assuntos
Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/epidemiologia , Hemoglobinas Glicadas/metabolismo , Adolescente , Adulto , Redes Comunitárias , Diabetes Mellitus Tipo 1/diagnóstico , Feminino , Humanos , Masculino , Prognóstico , Grupos Raciais/estatística & dados numéricos , Estudos Retrospectivos , Fatores Socioeconômicos , Estados Unidos/epidemiologia , Adulto Jovem
11.
J Diabetes Sci Technol ; 15(3): 582-592, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-31867988

RESUMO

BACKGROUND: Knowledge regarding the burden and predictors of hypoglycemia among older adults with type 1 diabetes (T1D) is limited. METHODS: We analyzed baseline data from the Wireless Innovations for Seniors with Diabetes Mellitus (WISDM) study, which enrolled participants at 22 sites in the United States. Eligibility included clinical diagnosis of T1D, age ≥60 years, no real-time continuous glucose monitoring (CGM) use in prior three months, and HbA1c <10.0%. Blinded CGM data from 203 participants with at least 240 hours were included in the analyses. RESULTS: Median age of the cohort was 68 years (52% female, 93% non-Hispanic white, and 53% used insulin pumps). Mean HbA1c was 7.5%. Median time spent in the glucose range <70 mg/dL was 5.0% (72 min/day) and <54 mg/dL was 1.6% (24 min/day). Among all factors analyzed, only reduced hypoglycemia awareness was associated with greater time spent <54 mg/dL (median time of 2.7% vs 1.3% [39 vs 19 minutes per day] for reduced awareness vs aware/uncertain, respectively, P = .03). Participants spent a mean 56% of total time in target glucose range of 70-180 mg/dL and 37% of time above 180 mg/dL. CONCLUSIONS: Over half of older T1D participants spent at least an hour a day with glucose levels <70 mg/dL. Those with reduced hypoglycemia awareness spent over twice as much time than those without in a serious hypoglycemia range (glucose levels <54 mg/dL). Interventions to reduce exposure to clinically significant hypoglycemia and increase time in range are urgently needed in this age group.


Assuntos
Diabetes Mellitus Tipo 1 , Hipoglicemia , Idoso , Glicemia , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Feminino , Hemoglobinas Glicadas/análise , Controle Glicêmico , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/epidemiologia , Hipoglicemiantes , Masculino , Pessoa de Meia-Idade
12.
J Diabetes Complications ; 35(3): 107812, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33280985

RESUMO

BACKGROUND: Studies on acute complications in adult T1D were previously reported from the United States (U.S.) and from Germany. The aim was to compare demographic characteristics and patterns of severe hypoglycaemia (SH) and diabetic ketoacidosis (DKA) between Germany and the U.S. METHODS: Descriptive comparison on individuals aged ≥18 years, with T1D duration ≥2 years were made between the German diabetes-patient registry (DPV) and the U.S. electronic-health-record database (T1PCO). Individuals in both databases were divided into patients with haemoglobin A1c (HbA1c) <7% and HbA1c ≥7%. RESULTS: 5190 (DPV) and 31,430 individuals (T1PCO) fulfilled the inclusion criteria. DPV patients were younger, more often male and had lower body-mass index. In both databases, more males than females had HbA1c <7%. Individuals had higher HbA1c in T1PCO compared to DPV. The relationship between HbA1c and DKA was similar in both databases. SH revealed a U-shaped curve in T1PCO, but no clear pattern was present in DPV. SH events increased with higher age in DPV, but not in T1PCO. CONCLUSION: Patterns of SH differ between Germany and U.S. Differences in capture of SH among the databases cannot be excluded, but differences in health care including patient education and level of care by specialists are likely.


Assuntos
Diabetes Mellitus Tipo 1 , Cetoacidose Diabética , Hipoglicemia , Adolescente , Adulto , Bases de Dados Factuais , Demografia , Complicações do Diabetes/epidemiologia , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 1/epidemiologia , Cetoacidose Diabética/epidemiologia , Feminino , Alemanha/epidemiologia , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemia/epidemiologia , Masculino , Sistema de Registros , Estados Unidos/epidemiologia
13.
JBMR Plus ; 4(9): e10389, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32995692

RESUMO

Type 1 diabetes (T1D) increases fracture risk across the lifespan. The low bone turnover associated with T1D is thought to be related to glycemic control, but it is unclear whether peripheral hyperinsulinemia due to dependence on exogenous insulin has an independent effect on suppressing bone turnover. The purpose of this study was to test the bone turnover marker (BTM) response to acute hyperinsulinemia. Fifty-eight adults aged 18 to 65 years with T1D over 2 years were enrolled at seven T1D Exchange Clinic Network sites. Participants had T1D diagnosis between age 6 months to 45 years. Participants were stratified based on their residual endogenous insulin secretion measured as peak C-peptide response to a mixed meal tolerance test. BTMs (CTX, P1NP, sclerostin [SCL], osteonectin [ON], alkaline phosphatase [ALP], osteocalcin [OCN], osteoprotegerin [OPG], osteopontin [OPN], and IGF-1) were assessed before and at the end of a 2-hour hyperinsulinemic-euglycemic clamp (HEC). Baseline ON (r = -0.30, p = .022) and OCN (r = -0.41, p = .002) were negatively correlated with age at T1D diagnosis, but baseline BTMs were not associated with HbA1c. During the HEC, P1NP decreased significantly (-14.5 ± 44.3%; p = .020) from baseline. OCN, ON, and IGF-1 all significantly increased (16.0 ± 13.1%, 29.7 ± 31.7%, 34.1 ± 71.2%, respectively; all p < .001) during the clamp. The increase in SCL was not significant (7.3 ± 32.9%, p = .098), but the decrease in CTX (-12.4 ± 48.9, p = .058) neared significance. ALP and OPG were not changed from baseline (p = .23 and p = .77, respectively). Baseline ON and SCL were higher in men, but OPG was higher in women (all p ≤ .029). SCL was the only BTM that changed differently in women than men. There were no differences in baseline BTMs or change in BTMs between C-peptide groups. Exogenous hyperinsulinemia acutely alters bone turnover, suggesting a need to determine whether strategies to promote healthy remodeling may protect bone quality in T1D. © 2020 American Society for Bone and Mineral Research © 2020 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

14.
JAMA ; 323(23): 2397-2406, 2020 06 16.
Artigo em Inglês | MEDLINE | ID: mdl-32543682

RESUMO

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.


Assuntos
Automonitorização da Glicemia/métodos , Glicemia/análise , Diabetes Mellitus Tipo 1/sangue , Hemoglobinas Glicadas/análise , Hipoglicemia/prevenção & controle , Idoso , Automonitorização da Glicemia/instrumentação , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/psicologia , Feminino , Humanos , Hiperglicemia/diagnóstico , Hipoglicemia/induzido quimicamente , Hipoglicemia/diagnóstico , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/efeitos adversos , Masculino , Pessoa de Meia-Idade , Monitorização Ambulatorial/instrumentação , Medidas de Resultados Relatados pelo Paciente
15.
JAMA ; 323(23): 2388-2396, 2020 06 16.
Artigo em Inglês | MEDLINE | ID: mdl-32543683

RESUMO

Importance: Adolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated. Objective: To determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes. Design, Setting, and Participants: Randomized clinical trial conducted between January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9%. Interventions: Participants were randomized 1:1 to undergo CGM (CGM group; n = 74) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n = 79). Main Outcomes and Measures: The primary outcome was change in HbA1c from baseline to 26 weeks. There were 20 secondary outcomes, including additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate. Results: Among the 153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study. In the CGM group, 68% of participants used CGM at least 5 days per week in month 6. Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01). Of 20 prespecified secondary outcomes, there were statistically significant differences in 3 of 7 binary HbA1c outcomes, 8 of 9 CGM metrics, and 1 of 4 patient-reported outcomes. The most commonly reported adverse events in the CGM and BGM groups were severe hypoglycemia (3 participants with an event in the CGM group and 2 in the BGM group), hyperglycemia/ketosis (1 participant with an event in CGM group and 4 in the BGM group), and diabetic ketoacidosis (3 participants with an event in the CGM group and 1 in the BGM group). Conclusions and Relevance: Among adolescents and young adults with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks. Further research is needed to understand the clinical importance of the findings. Trial Registration: ClinicalTrials.gov Identifier: NCT03263494.


Assuntos
Automonitorização da Glicemia/métodos , Diabetes Mellitus Tipo 1/sangue , Hemoglobinas Glicadas/análise , Hipoglicemiantes/administração & dosagem , Adolescente , Glicemia/análise , Automonitorização da Glicemia/instrumentação , Diabetes Mellitus Tipo 1/tratamento farmacológico , Cetoacidose Diabética , Feminino , Humanos , Hiperglicemia/diagnóstico , Hiperglicemia/prevenção & controle , Hipoglicemia/induzido quimicamente , Hipoglicemia/diagnóstico , Hipoglicemia/prevenção & controle , Hipoglicemiantes/efeitos adversos , Masculino , Aplicativos Móveis , Monitorização Ambulatorial/instrumentação , Adulto Jovem
16.
Diabetes Obes Metab ; 22(9): 1577-1585, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32329127

RESUMO

AIM: To examine the control of cardiovascular risk factors in type 1 diabetes (T1D) registries from the United States and Germany/Austria. MATERIALS AND METHODS: Data on individuals aged ≥12 years with T1D for ≥1 year, from the T1D Exchange Clinic Network (T1DX, United States) and the Prospective Diabetes Follow-up Registry (DPV, Germany/Austria) from 1 January 2016 to 31 March 2018 were analysed. Linear and logistic regression models adjusted for age groups, sex, duration of diabetes and minority status were used to compare clinical characteristics and achievement of diabetes management targets between registries. RESULTS: The cohort consisted of 47 936 patients (T1DX, n = 19 442; DPV, n = 28 494). Achievement of HbA1c goals (<7.0%, ages 18-65 years; all others, <7.5%) was better in the DPV for those aged <65 years (all P < .001). However, more older adults (aged ≥65 years) in the T1DX achieved an HbA1c goal of <7.5% compared with DPV (70% vs. 50%, P < .001). The frequency of patients with overweight (53% vs. 51%, P < .001) and obesity (19% vs. 9%, P < .001) was higher in T1DX. The frequency of meeting blood pressure goals (84% vs. 66%, P < .001) and lipid goals (73% vs. 62%, P < .001) was higher in T1DX; this was observed across all age groups (all P < .001). Few young adults aged <26 years received antihypertensive and lipid-lowering medications, respectively, despite indications in both registries (T1DX: 5% and 3%, DPV: 3% and 1%). CONCLUSION: A minority of patients with T1D achieve glycaemic targets and the majority are inadequately treated for hypertension and dyslipidaemia. This highlights the need for improved diabetes and cardiovascular risk management strategies in T1D.


Assuntos
Doenças Cardiovasculares , Diabetes Mellitus Tipo 1 , Adolescente , Adulto , Idoso , Áustria , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/epidemiologia , Seguimentos , Alemanha/epidemiologia , Fatores de Risco de Doenças Cardíacas , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros , Fatores de Risco , Estados Unidos/epidemiologia , Adulto Jovem
17.
Diabetes Technol Ther ; 22(9): 697-700, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32077755

RESUMO

There are multiple information sources available to assist families in learning about rapidly advancing diabetes technologies as care options for their children. This study explored where and from whom families of young children with type 1 diabetes get information about diabetes technologies and the valence (positive vs. negative) of that information. Semi-structured interviews were conducted with parents (86% mothers) of 79 youth <8 years old with type 1 diabetes for ≥6 months, ([mean ± standard deviation] age 5.2 ± 1.5 years, diabetes duration 2.4 ± 1.3 years, 77% white, A1c 63 ± 10 mmol/mol [7.9 ± 0.9%], 66% pump-treated, 58% using continuous glucose monitors [CGMs]). Interviews were transcribed and underwent content analysis to derive central themes. Most parents reported learning about new technologies from three direct sources: diabetes care providers, people with diabetes, and caregivers of children with diabetes. Parents also cited three indirect sources of information: online forums, publications, and diabetes-specific conferences. Parents reported hearing primarily positive things about technologies. Families not using pump and/or CGM noted reluctance to use technology due to family-specific concerns (e.g., cost, child's unwillingness to wear device) rather than information from outside sources. In this subset of parents, many still expressed willingness to initiate use once family-specific concerns were resolved. Parents of young children received largely positive information about diabetes technologies, primarily from health care providers and others familiar with using devices personally or for their children. To maximize diabetes technology use in young children, it is incumbent upon providers to ensure families receive balanced realistic information about benefits and barriers.


Assuntos
Diabetes Mellitus Tipo 1 , Sistemas de Infusão de Insulina , Tecnologia , Criança , Pré-Escolar , Tomada de Decisões , Diabetes Mellitus Tipo 1/tratamento farmacológico , Feminino , Humanos , Hipoglicemiantes/uso terapêutico , Masculino , Pais
18.
J Clin Invest ; 130(4): 1850-1862, 2020 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-31895699

RESUMO

BACKGROUNDResidual C-peptide is detected in many people for years following the diagnosis of type 1 diabetes; however, the physiologic significance of low levels of detectable C-peptide is not known.METHODSWe studied 63 adults with type 1 diabetes classified by peak mixed-meal tolerance test (MMTT) C-peptide as negative (<0.007 pmol/mL; n = 15), low (0.017-0.200; n = 16), intermediate (>0.200-0.400; n = 15), or high (>0.400; n = 17). We compared the groups' glycemia from continuous glucose monitoring (CGM), ß cell secretory responses from a glucose-potentiated arginine (GPA) test, insulin sensitivity from a hyperinsulinemic-euglycemic (EU) clamp, and glucose counterregulatory responses from a subsequent hypoglycemic (HYPO) clamp.RESULTSLow and intermediate MMTT C-peptide groups did not exhibit ß cell secretory responses to hyperglycemia, whereas the high C-peptide group showed increases in both C-peptide and proinsulin (P ≤ 0.01). All groups with detectable MMTT C-peptide demonstrated acute C-peptide and proinsulin responses to arginine that were positively correlated with peak MMTT C-peptide (P < 0.0001 for both analytes). During the EU-HYPO clamp, C-peptide levels were proportionately suppressed in the low, intermediate, and high C-peptide compared with the negative group (P ≤ 0.0001), whereas glucagon increased from EU to HYPO only in the high C-peptide group compared with negative (P = 0.01). CGM demonstrated lower mean glucose and more time in range for the high C-peptide group.CONCLUSIONThese results indicate that in adults with type 1 diabetes, ß cell responsiveness to hyperglycemia and α cell responsiveness to hypoglycemia are observed only at high levels of residual C-peptide that likely contribute to glycemic control.FUNDINGFunding for this work was provided by the Leona M. and Harry B. Helmsley Charitable Trust, the National Center for Advancing Translational Sciences, and the National Institute of Diabetes and Digestive and Kidney Diseases.


Assuntos
Glicemia/metabolismo , Peptídeo C/sangue , Diabetes Mellitus Tipo 1/sangue , Células Secretoras de Glucagon/metabolismo , Hiperglicemia/sangue , Células Secretoras de Insulina/metabolismo , Adolescente , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
19.
Diabetes Technol Ther ; 22(9): 645-650, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-31905008

RESUMO

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


Assuntos
Diabetes Mellitus Tipo 1 , Hemoglobinas Glicadas , Classe Social , Adolescente , Adulto , Idoso , Glicemia , Automonitorização da Glicemia , Criança , Pré-Escolar , Diabetes Mellitus Tipo 1/sangue , Hemoglobinas Glicadas/análise , Humanos , Pessoa de Meia-Idade , Sistema de Registros , Tecnologia , Adulto Jovem
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