RESUMEN
AIMS: To evaluate physicians' adjustments of insulin pump settings based on continuous glucose monitoring (CGM) for patients with type 1 diabetes and to compare these to automated insulin dose adjustments. METHODS: A total of 26 physicians from 16 centres in Europe, Israel and South America participated in the study. All were asked to adjust insulin dosing based on insulin pump, CGM and glucometer downloads of 15 patients (mean age 16.2 ± 4.3 years, six female, mean glycated haemoglobin 8.3 ± 0.9% [66.8 ± 7.3 mmol/mol]) gathered over a 3-week period. Recommendations were compared for the relative changes in the basal, carbohydrate to insulin ratio (CR) and correction factor (CF) plans among physicians and among centres and also between the physicians and an automated algorithm, the Advisor Pro (DreaMed Diabetes Ltd, Petah Tikva, Israel). Study endpoints were the percentage of comparison points for which there was full agreement on the trend of insulin dose adjustments (same trend), partial agreement (increase/decrease vs no change) and full disagreement (opposite trend). RESULTS: The percentages for full agreement between physicians on the trend of insulin adjustments of the basal, CR and CF plans were 41 ± 9%, 45 ± 11% and 45.5 ± 13%, and for complete disagreement they were 12 ± 7%, 9.5 ± 7% and 10 ± 8%, respectively. Significantly similar results were found between the physicians and the automated algorithm. The algorithm magnitude of insulin dose change was at least equal to or less than that proposed by the physicians. CONCLUSIONS: Physicians provide different insulin dose recommendations based on the same datasets. The automated advice of the Advisor Pro did not differ significantly from the advice given by the physicians in the direction or magnitude of the insulin dosing.
Asunto(s)
Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Sistemas de Infusión de Insulina , Insulina/administración & dosificación , Pautas de la Práctica en Medicina/estadística & datos numéricos , Adolescente , Adulto , Glucemia/efectos de los fármacos , Glucemia/metabolismo , Automonitorización de la Glucosa Sanguínea/métodos , Automonitorización de la Glucosa Sanguínea/normas , Calibración , Niño , Diabetes Mellitus Tipo 1/epidemiología , Relación Dosis-Respuesta a Droga , Europa (Continente)/epidemiología , Femenino , Geografía , Humanos , Sistemas de Infusión de Insulina/normas , Israel/epidemiología , Estudios Longitudinales , Masculino , América del Sur/epidemiología , Adulto JovenRESUMEN
OBJECTIVES: To investigate the safety, tolerability, and pharmacokinetics of liraglutide in adolescents with obesity. STUDY DESIGN: This was a randomized, double-blind, placebo-controlled trial. Twenty-one subjects, aged 12-17 years and Tanner stage 2-5, with obesity (body mass index [BMI] corresponding to both a BMI ≥95th percentile for age and sex and to a BMI of ≥30 kg/m2 for adults; additionally, BMI was ≤45 kg/m2) were randomized (2:1) to receive 5 weeks of treatment with liraglutide (0.6 mg with weekly dose increase to a maximum of 3.0 mg for the last week) (n = 14) or placebo (n = 7). The primary endpoint was number of treatment-emergent adverse events (TEAEs). Secondary endpoints included safety measures, and pharmacokinetic and pharmacodynamic endpoints. RESULTS: All participants receiving liraglutide, and 4 receiving placebo (57.1%), had at least 1 TEAE. The most common TEAEs were gastrointestinal disorders. No severe TEAEs, TEAE-related withdrawals, or deaths occurred. Twelve hypoglycemic episodes occurred in 8 participants receiving liraglutide and 2 in 1 participant receiving placebo. No severe hypoglycemic episodes were reported. Liraglutide exposure in terms of trough concentration increased with dose, although dose proportionality was confounded by unexpectedly low trough concentration values at the 2.4 mg dose. Exposure in terms of model-derived area under the plasma concentration time curve from 0 to 24 hours after dose in steady state was similar to that in adults with obesity. CONCLUSIONS: Liraglutide had a similar safety and tolerability profile compared with adults when administered to adolescents with obesity, with no unexpected safety/tolerability issues. Results suggest that the dosing regimen approved for weight management in adults may be appropriate for use in adolescents. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01789086.
Asunto(s)
Hipoglucemia/inducido químicamente , Liraglutida/farmacocinética , Liraglutida/uso terapéutico , Obesidad Infantil/tratamiento farmacológico , Adolescente , Área Bajo la Curva , Índice de Masa Corporal , Niño , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Esquema de Medicación , Femenino , Estudios de Seguimiento , Humanos , Hipoglucemia/epidemiología , Inyecciones Subcutáneas , Liraglutida/efectos adversos , Masculino , Dosis Máxima Tolerada , Seguridad del Paciente , Obesidad Infantil/diagnóstico , Valores de Referencia , Medición de Riesgo , Resultado del TratamientoRESUMEN
OBJECTIVE: To evaluate the influence of biopsy-proven celiac disease (BPCD) on somatic development and metabolic parameters in children with type 1 diabetes mellitus (T1DM) in a multicenter survey. STUDY DESIGN: Within the Diabetes Patienten Verlaufsdokumentationssystem-Wiss project, data of 41 951 patients with T1DM, aged <20 years (52% males, mean age 13.9 years; mean duration of diabetes 5.5 years) were collected in 297 centers in Germany and Austria from 1995 to 2009. RESULTS: The number of BPCD (0.6% in 1995; 1.3% in 2008) has increased over time. Patients with BPCD were significantly younger at diabetes onset (5.9 vs 8.3 years), had a significantly lower weight standard deviation score (SDS); (0.20 vs 0.43) and height SDS (-0.28 vs -0.03) (P < .001, each) compared with patients without celiac disease. No differences were found in hemoglobin A1c or numbers of severe hypoglycemia. In a subgroup of 9805 patients (183 with BPCD) significantly lower height and weight SDS (P < .001) were still found after a 5-year follow-up. CONCLUSIONS: Screening for celiac disease is important in children with T1DM to prevent persistent growth failure.
Asunto(s)
Enfermedad Celíaca/epidemiología , Diabetes Mellitus Tipo 1/epidemiología , Adolescente , Enfermedad Celíaca/inmunología , Niño , Preescolar , Comorbilidad , Diabetes Mellitus Tipo 1/metabolismo , Femenino , Humanos , Lactante , MasculinoRESUMEN
OBJECTIVE: To investigate the influence of celiac disease (CD) on growth and metabolic control in a nationwide cohort of children and adolescents with type 1 diabetes (T1D). STUDY DESIGN: We analyzed data from 19,796 pediatric patients with T1D in the German pediatric multicenter DPV-database for occurrence of CD. RESULTS: CD-specific antibodies were present in 1326 patients (6.7%). The diagnosis was confirmed in 127 patients (0.6%) by small-bowel biopsy. Female subjects were significantly more predisposed to have T1D and CD. The CD-affected patients in our cohort were significantly younger at diabetes onset. Furthermore, they had significantly lower height-SDS at onset (-0.49 vs -0.06, P < .05), a difference that increased during the course of the disease (-0.80 vs -0.26 after 9 years of diabetes, P < .05). In addition, body mass index-SDS significantly differed between the groups (0.22 vs 0.47, P < .05). Evidence for thyroid disease was more commonly observed in the T1D with CD group (6.3% vs 2.3%, P < .05). HbA1c values were lower in the patients with T1D and CD. CONCLUSIONS: The CD-positive patients were characterized by earlier onset of diabetes and decreased growth and weight gain. These findings emphasize the clinical relevance of celiac disease in patients with autoimmune diabetes.