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1.
J Diabetes Sci Technol ; : 1932296820905904, 2020 Feb 17.
Artigo em Inglês | MEDLINE | ID: mdl-32064911

RESUMO

OBJECTIVE: The aim of these analyses was to characterize the effect of exercise and meals on glucose concentrations in healthy individuals without diabetes. METHODS: Healthy individuals without diabetes (age ≥6 years) with nonobese body mass index were enrolled at 12 centers within the T1D Exchange Clinic Network. Participants wore a blinded Dexcom G6 for up to ten days. Throughout this sensor wear, participants completed a daily log indicating times and type of any exercise and start times of meals and snacks. RESULTS: A total of 153 participants (age 7-80 years) were included in the analyses. Exercise induced a mean change of -15 ± 18 mg/dL from baseline to nadir sensor glucose level. Mean nadir glucose concentration during nights following exercise days was 82 ± 11 mg/dL compared with 85 ± 11 mg/dL during nights following nonexercise days (P = .05). Mean change from baseline to nadir sensor glucose level during aerobic exercise was -15 ± 18 and -9 ± 12 mg/dL for resistance exercise (P = .25). Overnight nadir glucose during nights following aerobic and resistance exercise was 83 ± 12 and 76 ± 14 mg/dL, respectively (P = .25). Overall mean peak postprandial glucose per participant increased from 93 ± 10 mg/dL premeal to 130 ± 13 mg/dL with an average time to peak glucose per participant of 97 ± 31 minutes. Consumption of alcohol on the day prior did not impact overnight mean or nadir glucose. CONCLUSION: The present analysis provides important data characterizing the effect of exercise and meals on glucose in healthy individuals without diabetes. These data provide a repository to which future therapies, whether pharmacologic or technologic, can be compared.

2.
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.

3.
Pediatr Diabetes ; 21(2): 377-383, 2020 Mar.
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.

4.
Diabetes Technol Ther ; 22(4): 330-336, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31859529

RESUMO

Background: Completing phase 3 trials of new drugs for youth with type 2 diabetes is challenging. The Pediatric Diabetes Consortium (PDC) of U.S. pediatric treatment centers developed a Consortium model to improve the efficiency of successfully completing these trials. Aims and Innovations: An aim of the PDC model is to utilize the resources of the PDC Coordinating Center and Executive Committee to improve study protocols, centralize interactions with sponsors, and oversee the performance of PDC Clinical Centers. Key features include a Consulting Group to improve protocol design; Master Service Agreements between the Coordinating Center and Clinical Centers covering confidentiality agreements and contract language; negotiation of a standard Site Budget with Contract Research Organizations (CROs)/Sponsors that reflect actual Clinical Center costs; Weekly Conference Calls with CROs/sponsors to track progress of Clinical Center launches, Monthly Oversight Calls with investigators and study Coordinators to track Clinical Center performance, discuss enrollment strategies, and identify emerging problems. Successes and Challenges: The Consortium model played a key role in the completion of the pivotal trial of liraglutide for treatment of youth with type 2 diabetes. PDC centers also played a pivotal role in exceeding the projected number of randomized subjects needed by two ongoing studies that are nearing completion. Conclusions: While the Consortium model is still a work in progress, PDC has assisted in the successful launch of new type 2 diabetes studies, and negotiations are in underway for PDC participation in pediatric type 1 diabetes and other diabetes-related studies.

5.
PLoS Med ; 16(12): e1002979, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31815939

RESUMO

BACKGROUND: Optimal glycemic control is particularly difficult to achieve in children and adolescents with type 1 diabetes (T1D), yet the influence of dysglycemia on the developing brain remains poorly understood. METHODS AND FINDINGS: Using a large multi-site study framework, we investigated activation patterns using functional magnetic resonance imaging (fMRI) in 93 children with T1D (mean age 11.5 ± 1.8 years; 45.2% female) and 57 non-diabetic (control) children (mean age 11.8 ± 1.5 years; 50.9% female) as they performed an executive function paradigm, the go/no-go task. Children underwent scanning and cognitive and clinical assessment at 1 of 5 different sites. Group differences in activation occurring during the contrast of "no-go > go" were examined while controlling for age, sex, and scan site. Results indicated that, despite equivalent task performance between the 2 groups, children with T1D exhibited increased activation in executive control regions (e.g., dorsolateral prefrontal and supramarginal gyri; p = 0.010) and reduced suppression of activation in the posterior node of the default mode network (DMN; p = 0.006). Secondary analyses indicated associations between activation patterns and behavior and clinical disease course. Greater hyperactivation in executive control regions in the T1D group was correlated with improved task performance (as indexed by shorter response times to correct "go" trials; r = -0.36, 95% CI -0.53 to -0.16, p < 0.001) and with better parent-reported measures of executive functioning (r values < -0.29, 95% CIs -0.47 to -0.08, p-values < 0.007). Increased deficits in deactivation of the posterior DMN in the T1D group were correlated with an earlier age of T1D onset (r = -0.22, 95% CI -0.41 to -0.02, p = 0.033). Finally, exploratory analyses indicated that among children with T1D (but not control children), more severe impairments in deactivation of the DMN were associated with greater increases in hyperactivation of executive control regions (T1D: r = 0.284, 95% CI 0.08 to 0.46, p = 0.006; control: r = 0.108, 95% CI -0.16 to 0.36, p = 0.423). A limitation to this study involves glycemic effects on brain function; because blood glucose was not clamped prior to or during scanning, future studies are needed to assess the influence of acute versus chronic dysglycemia on our reported findings. In addition, the mechanisms underlying T1D-associated alterations in activation are unknown. CONCLUSIONS: These data indicate that increased recruitment of executive control areas in pediatric T1D may act to offset diabetes-related impairments in the DMN, ultimately facilitating cognitive and behavioral performance levels that are equivalent to that of non-diabetic controls. Future studies that examine whether these patterns change as a function of improved glycemic control are warranted.


Assuntos
Glicemia/metabolismo , Encéfalo/fisiopatologia , Diabetes Mellitus Tipo 1/fisiopatologia , Função Executiva/fisiologia , Adolescente , Criança , Diabetes Mellitus Tipo 1/sangue , Feminino , Humanos , Imagem por Ressonância Magnética/métodos , Masculino , Testes Neuropsicológicos
7.
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.

8.
Pediatr Diabetes ; 20(7): 997-1006, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31271239

RESUMO

BACKGROUND: This randomized, controlled trial evaluated a monetary-based reinforcement intervention for increasing self-monitoring of blood glucose (SMBG) among youth with poorly controlled type 1 diabetes. METHODS: After a 2-week baseline, 60 participants were randomized to enhanced usual care (EUC) or Reinforcers. The Reinforcers group earned monetary rewards for SMBG and associated behaviors such as uploading glucose meters. Reinforcers were withdrawn at 24 weeks. A follow-up evaluation occurred at 36 weeks. RESULTS: Participants in the reinforcers group increased the proportion of days they completed ≥4 SMBG from 14.6% at baseline to 64.4%, 47.5%, and 37.8% at 6, 12, and 24 weeks, respectively. In contrast, EUC participants declined from 22.7% at baseline to 17.5%, 10.5%, and 11.1% (Ps < .01 vs EUC at all time points). Group differences were attenuated but remained significant after withdrawal of reinforcers. Effect sizes for SMBG were very large during reinforcement and large after withdrawal of reinforcers. In the reinforcers group, mean A1c dropped from 9.5% ± 1.2% at baseline to 9.0% ± 1.3% at week 6 and 9.0% ± 1.4% at week 12. For EUC, A1c was 9.2% ± 0.2% at baseline and ranged from 9.2% ± 1.5% to 9.6% ± 1.6% throughout the study (P < .05 vs EUC). Group differences in A1c were no longer significant at weeks 24 and 36. Effect sizes for A1c were small during reinforcement and also after withdrawal of reinforcement. CONCLUSIONS: Monetary-based reinforcement of adolescents with type 1 diabetes caused durable increases in SMBG. Modification of the reinforcement structure may be needed to sustain improved metabolic control in this challenging age group.

9.
J Diabetes Complications ; 33(10): 107400, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31279735

RESUMO

AIMS: Diabetic kidney disease (DKD) is a major complication of type 1 diabetes (T1D). To better understand the development of DKD in modern clinical practice, we evaluated risk factors in participants from the T1D Exchange Registry who completed 5-years of longitudinal follow-up. METHODS: Participants had T1D duration ≥ 1 year, age ≥ 10 years, eGFR ≥ 60 ml/min and no albuminuria at enrollment, and at least two serum creatinine and urine albumin measurements recorded during follow-up. Adverse kidney outcomes were defined as eGFR ≪ 60 ml/min and/or albuminuria (ALB) defined by as two consecutive albumin/creatinine ratios or two out of the past three measurements ≫ 30 µg/mg at any follow-up data collection. Associations of baseline characteristics with adverse kidney outcomes were assessed. RESULTS: Among 3940 participants (mean age 41 ±â€¯15 yrs, T1D duration 21 ±â€¯13 yrs), 653 (16.6%) experienced an adverse kidney outcome: 268 (6.8%) experienced incident ALB only, 322 (8.2%) had eGFR decline to ≪60 ml/min without ALB, and 63 (1.6%) experienced eGFR ≪ 60 ml/min with ALB. In a multivariable analysis, higher HbA1c, higher SBP, lower DBP, older age and lower education level were associated with the development of adverse kidney outcomes (all p values ≤ 0.03). CONCLUSIONS: Improving modifiable risk factors, including glucose and blood pressure control, remain important to reduce the risk of DKD in T1D.

10.
Pediatr Diabetes ; 20(6): 743-749, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31206973

RESUMO

Case series and registry data suggest that diabetic retinopathy requiring treatment is rare in youth with type 1 diabetes (T1D) prior to 18 years of age. We evaluated this question in the standardized clinical trial setting by retrospectively reviewing diabetic retinopathy examinations from participants in the Diabetes Control and Complications Trial (DCCT) who were 13 to <18 years of age at randomization. Standardized stereoscopic 7-field fundus photographs were obtained every 6 months during DCCT (1983-1993). Photographs were graded centrally using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. Transitions in diabetic retinopathy status over time were described. A total of 195 participants with median baseline glycated hemoglobin (HbA1c) of 9.3% (103 in the conventional and 92 in the intensive treatment groups) had an average of 5.3 diabetic retinopathy assessments during 2.3 years of follow-up (range 1-11) while under 18 years of age during the DCCT. No participant developed severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and only one participant (in the intensive group) reached clinically significant macular edema (CSME) while less than 18 years of age. In this incident case, baseline characteristics included diabetes duration 9.3 years, HbA1c 10.3%, LDL 131 mg/dL, and mild non-proliferative diabetic retinopathy (35/35 ETDRS scale); CSME resolved without treatment. Similar analyses using age cut-offs of <19, 20, or 21 years showed a slight rise in diabetic retinopathy requiring treatment over late adolescence. Clinical trial evidence suggests that frequent eye exams may not be universally necessary in youth <18 years of age with T1D.

11.
J Diabetes Sci Technol ; 13(6): 1123-1128, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31067999

RESUMO

BACKGROUND: In type 1 diabetes (T1D), closed-loop systems provide excellent overnight fasting blood glucose control by adjusting the insulin infusion rate based on corresponding changes in sensor glucose levels. In patients on multiple daily insulin (MDI) injections, such control in overnight glucose levels has not been possible due to the inability to alter the absorption rate of long-acting insulin after injection. In this study, we tested the hypothesis that increases/decreases of fasting glucose levels could be achieved by cooling/warming the skin around the injection site, which would result in lower/higher Glargine absorption rates from its subcutaneous depot. METHODS: Fourteen subjects with T1D (4 females; age 39.6 ± 16.7 years, HbA1c 7.8 ± 1.1%, BMI 25.4 ± 2.8 kg/m2) on MDI therapy underwent fasting pharmacokinetic and pharmacodynamic studies that started at ~8 am and lasted 240 min on 3 separate days in random order: a control day without warming or cooling of the injection site and two experimental days, one day with injection site warming and the other with cooling. RESULTS: Cooling the skin around the glargine injection site reduced insulin concentrations by >40% (P < .01 versus the warming study, P = .21 versus the control study), accompanied by a 55 mg/dL increase in serum glucose (P < .01 versus the control study). Conversely, skin warming prevented the fall in serum insulin (P = .2 versus the control study; P < .01 versus the cooling study), resulting in a 40 mg/dL reduction in serum glucose (P < .001 versus the cooling study, P = .11 versus the control study). CONCLUSIONS: This proof of concept study has shown that cooling and warming the skin around the injection site provides a means to decrease and increase the rate of absorption and action of insulin glargine from its subcutaneous depot.

12.
J Clin Endocrinol Metab ; 104(10): 4356-4364, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31127824

RESUMO

CONTEXT: Use of continuous glucose monitoring (CGM) is increasing for insulin-requiring patients with diabetes. Although data on glycemic profiles of healthy, nondiabetic individuals exist for older sensors, assessment of glycemic metrics with new-generation CGM devices is lacking. OBJECTIVE: To establish reference sensor glucose ranges in healthy, nondiabetic individuals across different age groups using a current generation CGM sensor. DESIGN: Multicenter, prospective study. SETTING: Twelve centers within the T1D Exchange Clinic Network. PATIENTS OR PARTICIPANTS: Nonpregnant, healthy, nondiabetic children and adults (age ≥6 years) with nonobese body mass index. INTERVENTION: Each participant wore a blinded Dexcom G6 CGM, with once-daily calibration, for up to 10 days. MAIN OUTCOME MEASURES: CGM metrics of mean glucose, hyperglycemia, hypoglycemia, and glycemic variability. RESULTS: A total of 153 participants (age 7 to 80 years) were included in the analyses. Mean average glucose was 98 to 99 mg/dL (5.4 to 5.5 mmol/L) for all age groups except those over 60 years, in whom mean average glucose was 104 mg/dL (5.8 mmol/L). The median time between 70 to 140 mg/dL (3.9 to 7.8 mmol/L) was 96% (interquartile range, 93 to 98). Mean within-individual coefficient of variation was 17 ± 3%. Median time spent with glucose levels >140 mg/dL was 2.1% (30 min/d), and median time spent with glucose levels <70 mg/dL (3.9 mmol/L) was 1.1% (15 min/d). CONCLUSION: By assessing across age groups in a healthy, nondiabetic population, normative sensor glucose data have been derived and will be useful as a benchmark for future research studies.

13.
N Engl J Med ; 381(7): 637-646, 2019 08 15.
Artigo em Inglês | MEDLINE | ID: mdl-31034184

RESUMO

BACKGROUND: Metformin is the regulatory-approved treatment of choice for most youth with type 2 diabetes early in the disease. However, early loss of glycemic control has been observed with metformin monotherapy. Whether liraglutide added to metformin (with or without basal insulin treatment) is safe and effective in youth with type 2 diabetes is unknown. METHODS: Patients who were 10 to less than 17 years of age were randomly assigned, in a 1:1 ratio, to receive subcutaneous liraglutide (up to 1.8 mg per day) or placebo for a 26-week double-blind period, followed by a 26-week open-label extension period. Inclusion criteria were a body-mass index greater than the 85th percentile and a glycated hemoglobin level between 7.0 and 11.0% if the patients were being treated with diet and exercise alone or between 6.5 and 11.0% if they were being treated with metformin (with or without insulin). All the patients received metformin during the trial. The primary end point was the change from baseline in the glycated hemoglobin level after 26 weeks. Secondary end points included the change in fasting plasma glucose level. Safety was assessed throughout the course of the trial. RESULTS: Of 135 patients who underwent randomization, 134 received at least one dose of liraglutide (66 patients) or placebo (68 patients). Demographic characteristics were similar in the two groups (mean age, 14.6 years). At the 26-week analysis of the primary efficacy end point, the mean glycated hemoglobin level had decreased by 0.64 percentage points with liraglutide and increased by 0.42 percentage points with placebo, for an estimated treatment difference of -1.06 percentage points (P<0.001); the difference increased to -1.30 percentage points by 52 weeks. The fasting plasma glucose level had decreased at both time points in the liraglutide group but had increased in the placebo group. The number of patients who reported adverse events was similar in the two groups (56 [84.8%] with liraglutide and 55 [80.9%] with placebo), but the overall rates of adverse events and gastrointestinal adverse events were higher with liraglutide. CONCLUSIONS: In children and adolescents with type 2 diabetes, liraglutide, at a dose of up to 1.8 mg per day (added to metformin, with or without basal insulin), was efficacious in improving glycemic control over 52 weeks. This efficacy came at the cost of an increased frequency of gastrointestinal adverse events. (Funded by Novo Nordisk; Ellipse ClinicalTrials.gov number, NCT01541215.).


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Liraglutida/uso terapêutico , Metformina/uso terapêutico , Adolescente , Glicemia/análise , Criança , Diabetes Mellitus Tipo 2/sangue , Relação Dose-Resposta a Droga , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Gastroenteropatias/induzido quimicamente , Hemoglobina A Glicada/análise , Humanos , Hipoglicemiantes/efeitos adversos , Insulina/uso terapêutico , Liraglutida/administração & dosagem , Liraglutida/efeitos adversos , Masculino , Metformina/efeitos adversos
14.
Expert Rev Clin Pharmacol ; 12(5): 471-479, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30892094

RESUMO

INTRODUCTION: The expanding variety of insulins, including biosynthetic human insulin and rapid and long-acting insulin analogs, have dramatically transformed the management of type 1 diabetes (T1D) over the past 25 years. Moreover, increasing interest in the use of novel drugs developed for the treatment of type 2 diabetes (T2D) as adjunctive therapies for T1D remains a work in progress. Areas Covered: We reviewed articles published up to December 2018 in PubMed and ClinicalTrials.gov for recent developments in the pharmacologic treatment of T1D, including inhaled insulin, ultrafast and ultralong-acting insulins and adjunctive therapies including pramlintide, metformin, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2, and SGLT1/2 inhibitors. Expert Opinion: With the creation of ultrafast-acting insulin analogs and very prolonged duration of action of basal insulins, it is possible to more closely mimic physiologic insulin secretion. Adjunctive therapies, likewise, may also overcome some of the abnormal physiology that is a hallmark of T1D. Therefore, individualized consideration of the efficacy of these agents must be measured alongside the potential adverse effects when choosing an adjunctive therapy.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Insulinas/administração & dosagem , Administração por Inalação , Animais , Preparações de Ação Retardada , Desenvolvimento de Medicamentos/métodos , Humanos , Hipoglicemiantes/efeitos adversos , Insulinas/efeitos adversos
15.
Endocr Pract ; 25(3): 226-229, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30913005

RESUMO

OBJECTIVE: Many youth with diabetes struggle to meet glycemic targets. The new ultralong duration of action of insulin degludec (iDeg) holds potential to ameliorate missed doses of basal insulin and improve glycemic control in youth with diabetes. METHODS: A retrospective chart review was undertaken of youth age 13 to <24 years in our practice with type 1 diabetes (T1D) or type 2 diabetes (T2D) who had been switched from glargine or detemir to iDeg to evaluate the impact of this transition on glycemic control. RESULTS: Glycated hemoglobin A1c (HbA1c) in youth with T1D (n = 82) remained stable during 6 months of treatment with iDeg (10.1 ± 2.11% [87 ± 23 mmol/mol] at start of iDeg compared to 10.1 ± 2.12% [87 ± 23 mmol/mol] at 6 months of treatment), whereas in youth with T2D (n = 16), HbA1c significantly declined from 10.6 ± 2.3% (92 ± 25 mmol/mol) to 8.3 ± 2.2% (67 ± 24 mmol/mol) ( P = .0024). CONCLUSION: In youth switched to iDeg, which in our practice is commonly due to ineffectiveness of the patient's current regimen, the outcome differences we saw may be due to preserved beta-cell function in youth with T2D. It remains to be seen whether there are benefits of transition to iDeg in youth with T1D beyond glycemic outcomes, such as reduction in ketosis and episodes of diabetic ketoacidosis. ABBREVIATIONS: DKA = diabetic ketoacidosis; DPV = Diabetes-Patienten-Verlaufsdokumentation (German/Austrian Prospective Diabetes Follow-Up Registry); HbA1c = glycated hemoglobin A1c; iDeg = insulin degludec; T1D = type 1 diabetes; T2D = type 2 diabetes.


Assuntos
Diabetes Mellitus Tipo 2 , Hipoglicemia , Insulina de Ação Prolongada/uso terapêutico , Hemoglobina A Glicada , Humanos , Hipoglicemiantes , Insulina Glargina , Estudos Prospectivos , Estudos Retrospectivos
16.
Diabetes Care ; 42(6): 1147-1154, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30728224

RESUMO

Sodium-glucose cotransporter (SGLT) inhibitors are new oral antidiabetes medications shown to effectively reduce glycated hemoglobin (A1C) and glycemic variability, blood pressure, and body weight without intrinsic properties to cause hypoglycemia in people with type 1 diabetes. However, recent studies, particularly in individuals with type 1 diabetes, have demonstrated increases in the absolute risk of diabetic ketoacidosis (DKA). Some cases presented with near-normal blood glucose levels or mild hyperglycemia, complicating the recognition/diagnosis of DKA and potentially delaying treatment. Several SGLT inhibitors are currently under review by the U.S. Food and Drug Administration and European regulatory agencies as adjuncts to insulin therapy in people with type 1 diabetes. Strategies must be developed and disseminated to the medical community to mitigate the associated DKA risk. This Consensus Report reviews current data regarding SGLT inhibitor use and provides recommendations to enhance the safety of SGLT inhibitors in people with type 1 diabetes.


Assuntos
Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Cetoacidose Diabética , Inibidores do Transportador 2 de Sódio-Glicose , Consenso , Glucose , Humanos , Hipoglicemiantes , Gestão de Riscos , Sódio
17.
Diabetes Technol Ther ; 21(3): 101-104, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30688521

RESUMO

OBJECTIVE: We have shown that "euglycemic DKA" in patients with type 1 diabetes receiving a sodium-glucose cotransporter 2-inhibitor (SGLT2i) is due to normal increases in rates of ketogenesis but blunted increases in plasma glucose levels. In this analysis, we assessed whether rescue treatment of early ketoacidosis with insulin is altered by SGLT2i use. RESEARCH DESIGN AND METHODS: Participants received 0.2 U/kg of aspart insulin after two 6-h interruptions of basal insulin that increased beta-hydroxybutyrate (BHB) by 1.2 ± 0.7 mmol/L before and by 1.5 ± 0.2 mmol/L during canagliflozin treatment. BHB and free fatty acid (FFA) were monitored every 30 min for 120 min after receiving a 0.2 U/kg subcutaneous injection of aspart insulin. RESULTS: Ten adults (23 ± 5 years) were studied. During the 120 min after rescue therapy with insulin, the reductions in BHB and FFA were nearly identical between the pre- and during canagliflozin treatment studies, respectively (-1.27 ± 0.76 and -1.13 ± 0.69, P = 0.671 for BHB and -0.50 ± 0.35 vs. -0.41 ± 0.41, P = 0.603 for FFA). CONCLUSION: These data indicate that turning ketogenesis off, as well as on, does not appear to be affected by SGLT2i use.


Assuntos
Canagliflozina/administração & dosagem , Diabetes Mellitus Tipo 1/complicações , Cetoacidose Diabética/tratamento farmacológico , Insulina Aspart/administração & dosagem , Inibidores do Transportador 2 de Sódio-Glicose/administração & dosagem , Ácido 3-Hidroxibutírico/sangue , Adulto , Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Cetoacidose Diabética/sangue , Ácidos Graxos não Esterificados/sangue , Feminino , Humanos , Masculino , Resultado do Tratamento
18.
Diabetes Technol Ther ; 21(2): 66-72, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30657336

RESUMO

OBJECTIVE: To provide a snapshot of the profile of adults and youth with type 1 diabetes (T1D) in the United States and assessment of longitudinal changes in T1D management and clinical outcomes in the T1D Exchange registry. RESEARCH DESIGN AND METHODS: Data on diabetes management and outcomes from 22,697 registry participants (age 1-93 years) were collected between 2016 and 2018 and compared with data collected in 2010-2012 for 25,529 registry participants. RESULTS: Mean HbA1c in 2016-2018 increased from 65 mmol/mol at the age of 5 years to 78 mmol/mol between ages 15 and 18, with a decrease to 64 mmol/mol by age 28 and 58-63 mmol/mol beyond age 30. The American Diabetes Association (ADA) HbA1c goal of <58 mmol/mol for youth was achieved by only 17% and the goal of <53 mmol/mol for adults by only 21%. Mean HbA1c levels changed little between 2010-2012 and 2016-2018, except in adolescents who had a higher mean HbA1c in 2016-2018. Insulin pump use increased from 57% in 2010-2012 to 63% in 2016-2018. Continuous glucose monitoring (CGM) increased from 7% in 2010-2012 to 30% in 2016-2018, rising >10-fold in children <12 years old. HbA1c levels were lower in CGM users than nonusers. Severe hypoglycemia was most frequent in participants ≥50 years old and diabetic ketoacidosis was most common in adolescents and young adults. Racial differences were evident in use of pumps and CGM and HbA1c levels. CONCLUSIONS: Data from the T1D Exchange registry demonstrate that only a minority of adults and youth with T1D in the United States achieve ADA goals for HbA1c.


Assuntos
Glicemia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Adolescente , Adulto , Idoso , Criança , Pré-Escolar , Diabetes Mellitus Tipo 1/sangue , Gerenciamento Clínico , Feminino , Humanos , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem , Sistemas de Infusão de Insulina , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Estados Unidos , Adulto Jovem
19.
Pediatr Diabetes ; 19(8): 1379-1384, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30175440

RESUMO

BACKGROUND/OBJECTIVE: Restrictive eligibility criteria have hampered enrollment into trials for new drugs for youth with type 2 diabetes (T2D). We utilized Pediatric Diabetes Consortium (PDC) T2D Registry enrollment data to estimate the percentage of patients who would be excluded from current T2D trials based on out-of-range HbA1c levels. We also examined whether well-controlled patients could be included because baseline HbA1c would rise during a 6 to 12-month study if assigned to control group. METHODS: Clinical characteristics and HbA1c levels were collected from 956 T2D patients aged 10 to <18 years upon Registry enrollment. HbA1c levels were also analyzed in 6-month intervals during the first 30 months of T2D duration. RESULTS: There was an approximately 2:1 ratio of females to males; the majority were obese and from economically disadvantaged minority families. On enrollment in the Registry, 53% of patients would be excluded from current trials because HbA1c levels were either <6.5% (<48 mmol/mol) (37%) or >10.5% (>91 mmol/mol) (16%). Furthermore, in patients with HbA1c levels <6.5% (<48 mmol/mol) and T2D duration between 6 and 30 months, mean HbA1c levels increased by 0.6% (6 mmol/mol) and 0.9% (10 mmol/mol) over the subsequent 6 and 12 months, respectively. CONCLUSIONS: Eligibility criteria for current clinical trials still exclude a large proportion of pediatric T2D patients because of HbA1c levels. Including patients with HbA1c <6.5% (<48 mmol/mol) would enhance recruitment and allow comparisons of the investigational treatment with placebo-assigned subjects in whom HbA1c levels would on average increase during the 6 to 12 months of the trial.


Assuntos
Ensaios Clínicos como Assunto/estatística & dados numéricos , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/terapia , Seleção de Pacientes , Sistema de Registros/estatística & dados numéricos , Adolescente , Idade de Início , Criança , Feminino , Acesso aos Serviços de Saúde/organização & administração , Acesso aos Serviços de Saúde/estatística & dados numéricos , Humanos , Masculino , Pediatria/organização & administração , Projetos de Pesquisa
20.
Diabetes Educ ; 44(6): 510-518, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30203721

RESUMO

PURPOSE: The purpose of the study was to evaluate frequency of use and problem use of psychoactive substances in adults with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: Standardized instruments for assessing tobacco, alcohol, and other psychoactive substance use were emailed to 4311 adult participants at 69 T1D Exchange Registry Exchange Registry centers. A total of 936 respondents (61% female, 90% non-Hispanic white, age 38 ± 16 years) completed the survey. RESULTS: In the sample, 166 (18%) reported past-year use of tobacco and 51 (5%) reported daily use. Past-year alcohol use was reported by 742 (79%) participants, past-month use by 592 (63%), and daily/near-daily use by 87 (9%); 174 (19%) were classified as binge drinkers and 93 (11%) as problem drinkers. Nonprescription use of another psychoactive substance in the past year was reported by 228 (24%), with 167 (18%) indicating they used marijuana, 67 (7%) opioids, 45 (5%) sedatives, and 37 (4%) stimulants. Past-year problem use of these substances was noted in 31 (3%) respondents. CONCLUSIONS: Adults with T1D in the United States use substances at rates that meet or exceed the general population; problematic use occurs at rates similar to the general population. These data delineate the need to inquire about regular, intermittent, and problematic use of nicotine and other substances in individuals with T1D. A better understanding of the impact of moderate and occasional use of substances on T1D management and clinical outcomes is needed.


Assuntos
Consumo de Bebidas Alcoólicas/epidemiologia , Diabetes Mellitus Tipo 1/psicologia , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Uso de Tabaco/epidemiologia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Inquéritos e Questionários , Estados Unidos/epidemiologia
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