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1.
Endocrinol Metab Clin North Am ; 49(1): 19-35, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31980118

RESUMO

The current era has witnessed an explosion of advanced diabetes technologies. Young people with diabetes and their families require detailed, structured diabetes education in order to optimize use of such devices. There is need for youth and their families to participate in the selection of particular devices for personal use and comprehensive education regarding the safe and effective use of such technologies. The education process should ensure that youth and their families receive realistic expectations of what the advanced technologies can and cannot do to avoid disappointment and the premature discontinuation of such systems.

2.
Diabetes Care ; 2020 Jan 14.
Artigo em Inglês | MEDLINE | ID: mdl-31937608

RESUMO

OBJECTIVE: Assess the efficacy of inControl AP: a mobile closed-loop control (CLC) system. RESEARCH DESIGN AND METHODS: This protocol, NCT02985866, is a 3-month parallel group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA1c <10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L. RESULTS: Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC (n = 65) versus SAP (n = 62); 125 participants completed the study. CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference -1.7% [95% CI -2.4, -1.0%]; P < 0.0001 for superiority). CGM time above 10 mmol/L was 40% at baseline and 34% during follow-up in the CLC group vs. 43% and 39%, respectively, in the SAP group (mean difference -3.0% [95% CI -6.1, +0.1%]; P < 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device. CONCLUSIONS: In meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable.

3.
Pediatr Diabetes ; 21(1): 53-60, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31603620

RESUMO

BACKGROUND: The demands of diabetes care can place substantial burden on youth with type 1 diabetes (T1D), who must manage their treatment in conjunction with the developmentally typical tasks of adolescence. How diabetes affects the normative task of identity development deserves further exploration. METHODS: A sample of 83 participants (ages 13-21) completed a qualitative interview about life with diabetes and a battery of validated psychosocial measures. Individual interviews were analyzed using content analysis to create criteria for whether a teen had incorporated their T1D in relation to their identity. Convergent validity was assessed by comparing identity groups on various validated measures of psychosocial characteristics and health-related outcomes. Analysis of covariances (ANCOVAs) were used to determine whether identity status had a significant relationship to health outcomes. RESULTS: Results indicated that youth who were categorized as incorporating their T1D into their identities demonstrated significantly greater perceived social competency (P = .014), greater diabetes-specific self-esteem (P < .001), better self-care (P = .002), and more life satisfaction (P = .001) than those who had not incorporated T1D. Incorporation was also associated with better glycemic control (P = .003). Identity remained significantly associated with the above psychosocial and health-related outcomes even when controlling for covariates of gender and method of insulin delivery (Ps < .01). CONCLUSIONS: Successful incorporation of diabetes is associated with better biomedical and psychosocial outcomes in teens with T1D. Further research is warranted to assess influences on identity as well as how to encourage and support incorporation in this at-risk population.

4.
Diabetes Care ; 43(1): 22-28, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31308020

RESUMO

OBJECTIVE: To evaluate glycemia and metrics of glucose variability in youth with type 1 diabetes, and to assess patterns of 24-h glucose variability according to pubertal status. RESEARCH DESIGN AND METHODS: Metrics of glycemia, glucose variability, and glucose patterns were assessed by using 4 weeks of continuous glucose monitoring (CGM) data from 107 youth aged 8-17 years with type 1 diabetes for ≥1 year. Glucose values per hour were expressed as percentages relative to the mean glucose over 24 h for a 4-week period. Glucose data were compared on the basis of pubertal status-prepubertal (Tanner stage [T] 1), pubertal (T2-4), and postpubertal (T5)-and A1C categories (<7.5% [<58 mmol/mol], ≥7.5% [≥58 mmol/mol]). RESULTS: Youth (50% female, 95% white) had a mean ± SD age of 13.1 ± 2.6 years, diabetes duration of 6.3 ± 3.5 years, and A1C of 7.8 ± 0.8% (62 ± 9 mmol/mol); 88% were pump treated. Prepubertal youth had a higher mean glucose SD (86 ± 12 mg/dL [4.8 ± 0.7 mmol/L]; P = 0.01) and coefficient of variation (CV) (43 ± 5%; P = 0.06) than did pubertal (SD 79 ± 13 mg/dL [4.4 ± 0.7 mmol/L]; CV 41 ± 5%) and postpubertal (SD 77 ± 14 mg/dL [4.3 ± 0.8 mmol/L]; CV 40 ± 5%) youth. Over 24 h, prepubertal youth had the largest excursions from mean glucose and the highest CV across most hours compared with pubertal and postpubertal youth. Across all youth, CV was strongly correlated with the percentage of time with glucose <70 mg/dL (<3.9 mmol/L) (r = 0.79; P < 0.0001). CONCLUSIONS: Prepubertal youth had greater glucose variability independent of A1C than did pubertal and postpubertal youth. A1C alone does not capture the full range of glycemic parameters, highlighting the added insight of CGM in managing youth with type 1 diabetes.

5.
Pediatr Diabetes ; 2019 Dec 05.
Artigo em Inglês | MEDLINE | ID: mdl-31808586

RESUMO

BACKGROUND: Across all age groups, management of type 1 diabetes (T1D) places substantial responsibility and emotional burden upon families. This study explored parent perceptions of the burdens of caring for very young children with T1D. METHODS: Semi-structured qualitative interviews were conducted with parents (85% mothers) of 79 children with T1D, aged 1 to <8 years old, from four diverse pediatric diabetes clinical centers. Interviews were transcribed, coded, and analyzed using hybrid thematic analysis to derive central themes. RESULTS: Youth (77% White) had T1D for ≥6 months: age (M ± SD) 5.2 ± 1.5 years, diabetes duration 2.4 ± 1.3 years, and A1c 63 ± 10 mmol/mol (7.9 ± 0.9%); 66% used an insulin pump and 61% used CGM. Three major themes emerged related to diabetes burdens: (a) the emotional burden of diabetes on themselves and their children, (b) the burden of finding, training, and trusting effective secondary caregivers to manage the child's diabetes, and (c) suggestions for how more comprehensive, personalized diabetes education from healthcare providers for parents and secondary caregivers could help reduce parent burden and worry. CONCLUSIONS: In families with very young children with T1D, parental perceptions of the burden of managing diabetes are common and could be mitigated by tailored education programs that increase parent knowledge, bolster parents' confidence in themselves, and increase trust in their secondary caregivers to manage diabetes. Reduced parental burden and increased caregiver knowledge may positively impact child's glycemic control, as well as improve parent and child quality of life.

6.
Diabetes Obes Metab ; 2019 Dec 19.
Artigo em Inglês | MEDLINE | ID: mdl-31858718

RESUMO

AIM: To confirm the observed reduction in HbA1c for the 2.5 mg dose in EASE-3 by modelling and simulation analyses. MATERIALS AND METHODS: Independent of data from EASE-3 that tested 2.5 mg, we simulated the effect of a 2.5 mg dose through patient-level, exposure-response modelling in the EASE-2 clinical study. A primary semi-mechanistic model evaluated efficacy considering clinical insulin dose adjustments made after treatment initiation that potentially limited HbA1c reductions. The model was informed by pharmacokinetic, insulin dose, mean daily glucose and HbA1c data, and was verified by comparing the simulations with the observed HbA1c change in EASE-3. One of two empagliflozin phase 3 trials in type 1 diabetes (EASE-3 but not EASE-2) included a lower 2.5 mg dose. A placebo-corrected HbA1c reduction of 0.28% was demonstrated without the increased risk of diabetic ketoacidosis observed at higher doses (10 mg and 25 mg). Since only one trial included the lower dose, we aimed to confirm the observed reduction in HbA1c for the 2.5 mg dose by modelling and simulation analyses. RESULTS: The simulated 26-week mean HbA1c change was -0.41% without insulin dose adjustment and -0.29% at 26 weeks with insulin dose adjustment. A simplified (descriptive) model excluding insulin dose and mean daily glucose confirmed the -0.29% HbA1c change that would have been observed had the EASE-2 population received a 2.5 mg dose for 26/52 weeks. CONCLUSIONS: The HbA1c benefit of low-dose empagliflozin directly observed in the EASE-3 trial was confirmed by two modelling and simulation approaches.

7.
N Engl J Med ; 381(18): 1707-1717, 2019 10 31.
Artigo em Inglês | MEDLINE | ID: mdl-31618560

RESUMO

BACKGROUND: Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes. METHODS: In this 6-month randomized, multicenter trial, patients with type 1 diabetes were assigned in a 2:1 ratio to receive treatment with a closed-loop system (closed-loop group) or a sensor-augmented pump (control group). The primary outcome was the percentage of time that the blood glucose level was within the target range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter), as measured by continuous glucose monitoring. RESULTS: A total of 168 patients underwent randomization; 112 were assigned to the closed-loop group, and 56 were assigned to the control group. The age range of the patients was 14 to 71 years, and the glycated hemoglobin level ranged from 5.4 to 10.6%. All 168 patients completed the trial. The mean (±SD) percentage of time that the glucose level was within the target range increased in the closed-loop group from 61±17% at baseline to 71±12% during the 6 months and remained unchanged at 59±14% in the control group (mean adjusted difference, 11 percentage points; 95% confidence interval [CI], 9 to 14; P<0.001). The results with regard to the main secondary outcomes (percentage of time that the glucose level was >180 mg per deciliter, mean glucose level, glycated hemoglobin level, and percentage of time that the glucose level was <70 mg per deciliter or <54 mg per deciliter [3.0 mmol per liter]) all met the prespecified hierarchical criterion for significance, favoring the closed-loop system. The mean difference (closed loop minus control) in the percentage of time that the blood glucose level was lower than 70 mg per deciliter was -0.88 percentage points (95% CI, -1.19 to -0.57; P<0.001). The mean adjusted difference in glycated hemoglobin level after 6 months was -0.33 percentage points (95% CI, -0.53 to -0.13; P = 0.001). In the closed-loop group, the median percentage of time that the system was in closed-loop mode was 90% over 6 months. No serious hypoglycemic events occurred in either group; one episode of diabetic ketoacidosis occurred in the closed-loop group. CONCLUSIONS: In this 6-month trial involving patients with type 1 diabetes, the use of a closed-loop system was associated with a greater percentage of time spent in a target glycemic range than the use of a sensor-augmented insulin pump. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; iDCL ClinicalTrials.gov number, NCT03563313.).


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Pâncreas Artificial , Adolescente , Adulto , Idoso , Glicemia/análise , Diabetes Mellitus Tipo 1/sangue , Desenho de Equipamento , Feminino , Hemoglobina A Glicada/análise , Humanos , Hipoglicemiantes/efeitos adversos , Insulina/efeitos adversos , Sistemas de Infusão de Insulina/efeitos adversos , Masculino , Pessoa de Meia-Idade , Pâncreas Artificial/efeitos adversos , Adulto Jovem
8.
Lancet ; 394(10205): 1265-1273, 2019 10 05.
Artigo em Inglês | MEDLINE | ID: mdl-31533908

RESUMO

Technological advances have had a major effect on the management of type 1 diabetes. In addition to blood glucose meters, devices used by people with type 1 diabetes include insulin pumps, continuous glucose monitors, and, most recently, systems that combine both a pump and a monitor for algorithm-driven automation of insulin delivery. In the next 5 years, as many advances are expected in technology for the management of diabetes as there have been in the past 5 years, with improvements in continuous glucose monitoring and more available choices of systems that automate insulin delivery. Expansion of the use of technology will be needed beyond endocrinology practices to primary-care settings and broader populations of patients. Tools to support decision making will also need to be developed to help patients and health-care providers to use the output of these devices to optimise diabetes management.


Assuntos
Tecnologia Biomédica , Diabetes Mellitus Tipo 1/terapia , Glicemia/análise , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/tratamento farmacológico , Humanos , Insulina/administração & dosagem , Insulina/uso terapêutico , Sistemas de Infusão de Insulina , Monitorização Fisiológica/instrumentação
9.
J Am Med Inform Assoc ; 26(12): 1627-1631, 2019 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-31529065

RESUMO

Effective diabetes problem solving requires identification of risk factors for inadequate mealtime self-management. Ecological momentary assessment was used to enhance identification of factors hypothesized to impact self-management. Adolescents with type 1 diabetes participated in a feasibility trial for a mobile app called MyDay. Meals, mealtime insulin, self-monitored blood glucose, and psychosocial and contextual data were obtained for 30 days. Using 1472 assessments, mixed-effects between-subjects analyses showed that social context, location, and mealtime were associated with missed self-monitored blood glucose. Stress, energy, mood, and fatigue were associated with missed insulin. Within-subjects analyses indicated that all factors were associated with both self-management tasks. Intraclass correlations showed within-subjects accounted for the majority of variance. The ecological momentary assessment method provided specific targets for improving self-management problem solving, phenotyping, or integration within just-in-time adaptive interventions.

10.
Pediatr Diabetes ; 20(7): 871-879, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31418516

RESUMO

OBJECTIVE: To understand the factors associated with glycemic control after starting insulin in youth with type 2 diabetes following glycemic failure (persistent HbA1c ≥8%) with metformin alone, metformin + rosiglitazone or metformin + lifestyle in the TODAY study. METHODS: Change in HbA1c after add-on insulin therapy and the factors predictive of glycemic response were evaluated. At 1-year postinsulin initiation, 253 youth had a mean of 3.9 ± 1.0 visits since the time of insulin initiation. Participants were divided into three groups according to glycemic control: consistent decrease in HbA1c by ≥0.5%, change <0.5%, or consistent increase in HbA1c ≥0.5%, at 75% or more of the visits. RESULTS: Within 1-year postinsulin initiation, 33.2% of participants had a consistent HbA1c decrease of ≥0.5%, 46.2% changed HbA1c <0.5%, and 20.6% had an increase ≥0.5%. At randomization into TODAY and at time of insulin initiation, the three glycemia groups were similar in age, sex, race-ethnicity, pubertal stage, BMI z-score, diabetes duration, and insulin secretion indices. Consistent HbA1c improvement was associated with higher insulin sensitivity (1/fasting insulin) at randomization and at time of failure, higher adiponectin at randomization, and was not associated with indices of ß-cell function. CONCLUSIONS: Response to add-on insulin was highly variable among youth in TODAY. Greater insulin sensitivity and higher adiponectin concentrations at randomization were associated with improved glycemic control after initiation of insulin. Due to limited information on adherence to insulin injections, the roles of adherence to the prescribed insulin regimen or psychosocial factors are unknown.

11.
Pediatr Diabetes ; 20(7): 1025-1034, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31369191

RESUMO

OBJECTIVE: Grounded in Self-Determination Theory, this study examines the role of parental expectations and communication style (ie, in an autonomy-supportive vs controlling way) in the prediction of adolescent motivation (ie, internalization or defiance) to adhere to self-management for type 1 diabetes. METHODS: Structural Equation Modeling was used in a cross-sectional, multi-informant study of 129 adolescents (Mage = 14.43; 54.4% girls), 110 mothers, and 98 fathers. Adolescents reported on self-motivation, treatment adherence, and parental expectations and communication styles; parents reported on their own expectations, communication style, and perceptions of adolescent treatment adherence. Medical record review provided HbA1c values. RESULTS: Across adolescent and parent reports, parental communication of diabetes-specific expectations and an autonomy-supportive style of communicating expectations related positively to adolescents' internalization of diabetes self-management and negatively to defiance against diabetes self-management. In contrast, a controlling parental communication style showed the opposite patterns of associations. Higher adolescent defiance was related to poorer treatment adherence and worse glycemic control. CONCLUSIONS: Parental communication styles related to adolescent motivation, which in turn, related to adolescent treatment adherence and glycemic control. Future longitudinal research can address the long-term impact of both maternal and paternal communication styles on adolescent motivation to adhere to treatment and their subsequent glycemic control.

12.
Diabetes Technol Ther ; 21(9): 493-498, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31287721

RESUMO

Background: Continuous glucose monitoring (CGM) has potential to address challenges of type 1 diabetes (T1D) management for young children. CGM use is increasing, yet remains underutilized. Characterizing parents' experiences with CGM can inform clinical strategies to help parents make decisions about diabetes management, overcome obstacles to initiating and sustaining CGM use, and maximize benefits of CGM use in their children's diabetes care. Methods: Transcripts from semistructured qualitative interviews with 55 parents of children aged 1 to <8 years, with T1D duration ≥6 months, and whose child currently or previously used CGM were coded and analyzed to derive themes about their experiences with CGM. Results: Participants were 88% mothers and the mean child age was 5.0 ± 1.5 years. Parents described benefits of CGM use: decreased worry about glucose excursions, improved sleep, increased sense of safety with children who cannot recognize or express symptoms of hypo- or hyperglycemia, and greater comfort with other caregivers, especially using remote monitoring functionality when away from children. Challenges included painful insertions, wearing multiple devices on small bodies, disruptive alerts, data gaps due to lost signals, skin/adhesive problems, and difficulty interpreting the amount of information generated by CGM. For some, the challenges outweighed potential benefits and they stopped CGM use. Conclusions: CGM may address unique challenges of T1D in young children and increase parental comfort with diabetes management, yet there are multiple barriers to initiating or maintaining CGM use. Education and behavioral support to address these benefits and barriers may equip caregivers with skills to address challenges of CGM use.

13.
Diabetes Care ; 42(9): 1716-1723, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31177179

RESUMO

OBJECTIVE: While sodium-glucose cotransporter inhibitor (SGLTi) therapy has been evaluated in type 1 diabetes (T1D) trials, patient reactions to benefits and risks are unknown. Using established methodology, we evaluated patient preferences for different adjunct-to-insulin therapy options in T1D. RESEARCH DESIGN AND METHODS: An online survey, completed by 701 respondents with T1D (231 U.S., 242 Canada, and 228 Germany), used conjoint analysis to present six hypothetical, masked, pairwise drug profile choices composed of different benefit-risk attributes and effect ranges. Data used in analyses were derived from actual phase 3 trials of a low-dose SGLTi (comparable to oral empagliflozin 2.5 mg q.d.), a high-dose SGLTi (comparable to oral sotagliflozin 400 mg q.d.), and an available adjunct-to-insulin therapy (comparable to subcutaneous pramlintide 60 µg t.i.d.). RESULTS: Conjoint analysis identified diabetic ketoacidosis risk as most important to patients (23% relative score; z test, P < 0.05); ranked second were HbA1c reduction (14%), risk of severe hypoglycemia (13%), oral versus injectable treatment (12%), and risk of genital infection (12%). Next was risk of nausea (11%), followed by weight reduction (8%) and the risk of diarrhea (7%). A low-dose SGLTi drug profile was identified by conjoint analysis as the top patient preference (83% of participants; z test, P < 0.05) versus high-dose SGLTi (8%) or pramlintide (9%). Separate from conjoint analysis, when respondents were asked to choose their preferred adjunct-to-insulin therapy (masked to drug name/dose), 69%, 17%, 6%, and 9% of respondents chose low-dose SGLTi, high-dose SGLTi, pramlintide, and insulin therapy alone, respectively. CONCLUSIONS: Low-dose SGLTi profile was the favored adjunct-to-insulin therapy by persons with T1D.

14.
Pediatr Diabetes ; 20(6): 702-711, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31119838

RESUMO

The economic issues related to medical treatments in youth with type 2 diabetes (T2D) are rarely reported and thus not fully understood. The Treatment Options for type 2 Diabetes in Adolescents and Youth clinical trial of youth recently diagnosed with T2D collected healthcare and related cost information from the largest cohort studied to date. Costs related to medical treatments and expenses faced by caregivers were identified over a 2-year period from 496 participants. Data were collected by surveys and diaries to document frequency of use of diabetes care (excluding study laboratory tests), non-diabetes care services and treatments, caregiver time, and expenses related to exercise and dietary activities recommended for patients. Economic costs were derived by applying national cost values to the reported utilization frequency data. Annual medical costs in the first year varied by the treatment group, averaging $1798 in those assigned to metformin alone (M), $2971 to combination drug therapy with metformin + rosiglitazone (M + R), and $2092 to metformin + an intensive lifestyle and behavior change program (M + L). Differences were primarily due to costs related to combination drug therapy. Adult caregiver support costs were higher for participants in the lifestyle program, which was delivered in weekly sessions in the first 6 months. Expenses for purchases to enhance diet and exercise change did not vary by treatment assignment. In year 2, medication costs increased in M and M + L due to the initiation of insulin in subjects who failed to maintain glycemic control on the assigned treatment. Data are reported for use by researchers and those providing healthcare to this vulnerable patient population.

15.
Diabetes Care ; 42(7): 1255-1262, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31076415

RESUMO

OBJECTIVE: To confirm efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp), both with basal insulin degludec, in a pediatric population with type 1 diabetes. RESEARCH DESIGN AND METHODS: After a 12-week run-in, this treat-to-target, 26-week, multicenter trial randomized participants (1 to <18 years) to double-blind mealtime faster aspart (n = 260), mealtime IAsp (n = 258), or open-label postmeal faster aspart (n = 259). The primary end point was change from baseline in glycated hemoglobin (HbA1c) after 26 weeks of treatment. All available information regardless of treatment discontinuation was used for the evaluation of treatment effect. RESULTS: At week 26, mealtime and postmeal faster aspart were noninferior to IAsp regarding change from baseline in HbA1c (P < 0.001 for noninferiority [0.4% margin]), with a statistically significant difference in favor of mealtime faster aspart (estimated treatment difference -0.17% [95% CI -0.30; -0.03], -1.82 mmol/mol [-3.28; -0.36]; P = 0.014). Change from baseline in 1-h postprandial glucose increment significantly favored mealtime faster aspart versus IAsp at breakfast, main evening meal, and over all meals (P < 0.01 for all). No statistically significant differences in the overall rate of severe or blood glucose-confirmed hypoglycemia were observed. Mean total daily insulin dose was 0.92 units/kg for mealtime faster aspart, 0.92 units/kg for postmeal faster aspart, and 0.88 units/kg for mealtime IAsp. CONCLUSIONS: In children and adolescents with type 1 diabetes, mealtime and postmeal faster aspart with insulin degludec provided effective glycemic control with no additional safety risks versus IAsp. Mealtime faster aspart provided superior HbA1c control compared with IAsp.

16.
Diabetes Care ; 42(5): 903-909, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30833375

RESUMO

OBJECTIVE: To determine whether self-monitoring of blood glucose (SMBG) is associated with lower HbA1c in youth with type 2 diabetes taking oral medications only or after starting insulin for persistently elevated HbA1c. RESEARCH DESIGN AND METHODS: Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study participants (n = 699) taking oral medications were asked to perform SMBG twice daily. After reaching primary outcome (PO) (HbA1c ≥8% [64 mmol/mol]) over 6 months or an inability to wean from temporary insulin because of metabolic decompensation), insulin glargine was started. HbA1c and percent of SMBG (SMBG%) (percent days when the meter was used one or more times) before and after PO were analyzed. RESULTS: SMBG declined over time and was inversely related to HbA1c (P < 0.0001). Of 298 youth who reached PO and started insulin, 282 had SMBG data. At PO, mean ± SD age was 15.8 ± 2.3 years, BMI 35.5 ± 7.9 kg/m2, and HbA1c 9.6 ± 2.0% (81 ± 21.9 mmol/mol); 65.3% were female. Median SMBG% was 40% at PO, which increased to 49% after 6 months and fell to 41% after 1 year on insulin. At PO, 22% of youth checked ≥80% of days, which increased to 25% and fell to 19% after 6 and 12 months using insulin, respectively. At PO, compared with those who checked <80%, youth who checked ≥80% were younger and with a lower BMI, HbA1c, and blood pressure. SMBG ≥80% was associated with ≥1% reduction in HbA1c at 6 and 12 months after insulin initiation. CONCLUSIONS: Low SMBG adherence was common and associated with higher HbA1c. Optimal SMBG frequency in youth using or not using insulin, and whether less frequent SMBG is a marker for overall worse self-care, require further study.


Assuntos
Glicemia/análise , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/terapia , Adolescente , Idade de Início , Glicemia/metabolismo , Automonitorização da Glicemia/métodos , Criança , Diabetes Mellitus Tipo 2/epidemiologia , Quimioterapia Combinada , Feminino , Hemoglobina A Glicada/metabolismo , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Insulina Glargina/uso terapêutico , Masculino , Metformina/administração & dosagem , Metformina/efeitos adversos , Cooperação do Paciente/estatística & dados numéricos , Comportamento de Redução do Risco , Rosiglitazona/administração & dosagem , Rosiglitazona/efeitos adversos , Autocuidado/normas , Autocuidado/estatística & dados numéricos , Resultado do Tratamento
17.
Pediatr Diabetes ; 20(2): 210-216, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30209870

RESUMO

Hypertension and dyslipidemia are often suboptimally managed in teens with type 1 diabetes (T1D). Teen and parent perspectives on hypertension and dyslipidemia management need further study to enhance the development of cardiovascular disease (CVD) risk factor management plans. We sought to describe barriers to and strategies for CVD risk factor management. Teens with T1D with and without dyslipidemia and parents of teens with T1D with and without dyslipidemia underwent one-on-one semi-structured interviews conducted by trained personnel at a diabetes center; interviews continued until thematic saturation was reached. Teens and parents of teens described their knowledge, attitudes, and beliefs regarding heart health and CVD risk factors (hypertension and dyslipidemia). Researchers undertook a content analysis and categorized central themes as strategies and barriers. In total, 22 teens and 25 parents completed interviews. Teens were 17.4 ± 1.7 years old with T1D duration 9.7 ± 4.0 years; 45% had dyslipidemia. Parents were between 41 and 60 years old, 84% were mothers, and 40% had teens with dyslipidemia. Barriers to heart health included an obesity-promoting environment, parental distrust of medications, and limited teen knowledge about hypertension and dyslipidemia. Strategies included specific and realistic guidance from providers, family support of teen lifestyle management, and having exercise partners. While teen and parent perspectives were often similar, some themes applied only to teens or parents. Central themes provide actionable guidance to enhance hypertension and dyslipidemia management. Providers should consider teen and parent perspectives when managing CVD risk factors to enhance engagement with CVD risk management.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 1/terapia , Angiopatias Diabéticas/prevenção & controle , Dislipidemias/complicações , Dislipidemias/terapia , Conhecimentos, Atitudes e Prática em Saúde , Adolescente , Adulto , Doenças Cardiovasculares/psicologia , Diabetes Mellitus Tipo 1/psicologia , Angiopatias Diabéticas/psicologia , Dislipidemias/psicologia , Feminino , Comportamentos Relacionados com a Saúde , Humanos , Hipertensão/complicações , Hipertensão/psicologia , Hipertensão/terapia , Entrevistas como Assunto , Masculino , Relações Pais-Filho , Pais/psicologia , Percepção , Fatores de Risco , Inquéritos e Questionários , Adulto Jovem
18.
J Clin Endocrinol Metab ; 104(1): 74-82, 2019 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-30346541

RESUMO

Context: Assessment of pubertal change is important for the management of chronic pediatric diseases, such as type 1 diabetes. Physical and/or laboratory assessments of pubertal status are often unavailable, impractical, or costly. Objective: To develop and validate a practical and objective method to assess pubertal status using longitudinal linear growth in youths with type 1 diabetes. Design, Participants, and Outcome Measurements: Participants (n = 123) were part of a 2-year study assessing continuous glucose monitoring in youths with type 1 diabetes at a tertiary diabetes center. Pubertal status at visits was assigned by a tiered approach using clinical Tanner staging or indicators of pubertal maturation from the electronic medical record when available. For other visits, independent evaluations of height velocities and growth chart trajectories provided data for pubertal status assignments. Sensitivity analysis confirmed the validity of the pubertal status assignments. Results: The sample (50% female, 95% white) had a mean ± SD age of 12.7 ± 2.7 years, diabetes duration of 6.0 ± 3.6 years, and hemoglobin A1c of 7.9 ± 0.8%. Of 985 study visits, 50% received a pubertal status assignment based on clinical Tanner staging, 29% on additional medical record review, and 22% on an evaluation of height velocity and growth chart trajectory. For the sensitivity analysis, pubertal status assignments based on height velocity and growth chart trajectory matched clinical Tanner staging in 87% of visits. Conclusions: Our practical and objective method to assess pubertal status based on height velocity and growth chart trajectory highlights growth as a reliable and objective bioassay for pubertal onset, status, and progression.


Assuntos
Estatura , Diabetes Mellitus Tipo 1/patologia , Gráficos de Crescimento , Crescimento/fisiologia , Puberdade , Adolescente , Glicemia/análise , Criança , Diabetes Mellitus Tipo 1/sangue , Feminino , Hemoglobina A Glicada/análise , Humanos , Masculino , Padrões de Referência , Sensibilidade e Especificidade , Maturidade Sexual
19.
Diabetes Care ; 41(12): 2560-2569, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30287422

RESUMO

OBJECTIVE: To evaluate the safety and efficacy of empagliflozin 10- and 25-mg doses plus a unique lower dose (2.5 mg) as adjunct to intensified insulin in patients with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: The EASE (Empagliflozin as Adjunctive to inSulin thErapy) program (N = 1,707) included two double-blind, placebo-controlled phase 3 trials: EASE-2 with empagliflozin 10 mg (n = 243), 25 mg (n = 244), and placebo (n = 243), 52-week treatment; and EASE-3 with empagliflozin 2.5 mg (n = 241), 10 mg (n = 248), 25 mg (n = 245), and placebo (n = 241), 26-week treatment. Together they evaluated empagliflozin 10 mg and 25 mg, doses currently approved in treatment of type 2 diabetes, and additionally 2.5 mg on 26-week change in glycated hemoglobin (primary end point) and weight, glucose time-in-range (>70 to ≤180 mg/dL), insulin dose, blood pressure, and hypoglycemia. RESULTS: The observed largest mean placebo-subtracted glycated hemoglobin reductions were -0.28% (95% CI -0.42, -0.15) for 2.5 mg, -0.54% (-0.65, -0.42) for 10 mg, and -0.53% (-0.65, -0.42) for 25 mg (all P < 0.0001). Empagliflozin 2.5/10/25 mg doses, respectively, reduced mean weight by -1.8/-3.0/-3.4 kg (all P < 0.0001); increased glucose time-in-range by +1.0/+2.9/+3.1 h/day (P < 0.0001 for 10 and 25 mg); lowered total daily insulin dose by -6.4/-13.3/-12.7% (all P < 0.0001); and decreased systolic blood pressure by -2.1/-3.9/-3.7 mmHg (all P < 0.05). Genital infections occurred more frequently on empagliflozin. Adjudicated diabetic ketoacidosis occurred more with empagliflozin 10 mg (4.3%) and 25 mg (3.3%) but was comparable between empagliflozin 2.5 mg (0.8%) and placebo (1.2%). Severe hypoglycemia was rare and frequency was similar between empagliflozin and placebo. CONCLUSIONS: Empagliflozin improved glycemic control and weight in T1D without increasing hypoglycemia. Ketoacidosis rate was comparable between empagliflozin 2.5 mg and placebo but increased with 10 mg and 25 mg. Ketone monitoring for early ketoacidosis detection and intervention and lower empagliflozin doses may help to reduce this risk.


Assuntos
Compostos Benzidrílicos/administração & dosagem , Diabetes Mellitus Tipo 1/tratamento farmacológico , Glucosídeos/administração & dosagem , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem , Adulto , Idoso , Compostos Benzidrílicos/efeitos adversos , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Diabetes Mellitus Tipo 1/sangue , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Glucosídeos/efeitos adversos , Hemoglobina A Glicada/análise , Humanos , Hipoglicemiantes/efeitos adversos , Insulina/efeitos adversos , Masculino , Pessoa de Meia-Idade , Placebos , Resultado do Tratamento , Perda de Peso
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