RESUMEN
OBJECTIVE: The objective of this study was to determine the safety, feasibility, and efficacy of a predictive hyperglycemia and hypoglycemia minimization (PHHM) system compared with predictive low-glucose insulin suspension (PLGS) alone in overnight glucose control. RESEARCH DESIGN AND METHODS: A 42-night trial was conducted in 30 individuals with type 1 diabetes in the age range 15-45 years. Participants were randomly assigned each night to either PHHM or PLGS and were blinded to the assignment. The system suspended the insulin pump on both the PHHM and PLGS nights for predicted hypoglycemia but delivered correction boluses for predicted hyperglycemia on PHHM nights only. The primary outcome was the percentage of time spent in a sensor glucose range of 70-180 mg/dL during the overnight period. RESULTS: The addition of automated insulin delivery with PHHM increased the time spent in the target range (70-180 mg/dL) from 71 ± 10% during PLGS nights to 78 ± 10% during PHHM nights (P < 0.001). The average morning blood glucose concentration improved from 163 ± 23 mg/dL after PLGS nights to 142 ± 18 mg/dL after PHHM nights (P < 0.001). Various sensor-measured hypoglycemic outcomes were similar on PLGS and PHHM nights. All participants completed 42 nights with no episodes of severe hypoglycemia, diabetic ketoacidosis, or other study- or device-related adverse events. CONCLUSIONS: The addition of a predictive hyperglycemia minimization component to our existing PLGS system was shown to be safe, feasible, and effective in overnight glucose control.
Asunto(s)
Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hiperglucemia/tratamiento farmacológico , Hipoglucemia/tratamiento farmacológico , Hipoglucemiantes/administración & dosificación , Sistemas de Infusión de Insulina , Insulina/administración & dosificación , Adolescente , Adulto , Glucemia/metabolismo , Automonitorización de la Glucosa Sanguínea , Método Doble Ciego , Estudios de Factibilidad , Femenino , Humanos , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico , Masculino , Adulto JovenRESUMEN
OBJECTIVE: To compare the frequency of elevated morning blood ketone levels according to age in 4-14 year olds with type 1 diabetes following overnight use of an automated low glucose insulin suspension system, or following control nights when the system was not used. RESEARCH DESIGN AND METHODS: For 28 children ages 4-9 years and 54 youth ages 10-14 years, elevation of morning blood ketone levels was assessed using the Precision Xtra Ketone meter following 1155 and 2345 nights, respectively. Repeated measures logistic regression models were used to compare age groups for blood ketone level elevation following control nights (system not activated) and following intervention nights with and without insulin suspension. RESULTS: Elevated morning blood ketones (≥0.6 mmol/L) were present following 10% of 580 control nights in the 4-9 year olds compared with 2% of 1162 control nights in 10-14 year olds (P < 0.001). Likewise, the frequency was greater following intervention nights in the younger age group (13% of 575 nights vs 2% of 1183 nights, P < 0.001). A longer duration of pump suspension resulted in a higher percentage of mornings with elevated blood ketones in the younger age group (P = 0.002), but not in the older age group (P = 0.63). The presence of elevated morning ketone levels did not progress to ketoacidosis in any subject. CONCLUSIONS: Elevated morning blood ketones are more common in younger children with type 1 diabetes with or without nocturnal insulin suspension. Care providers need to be aware of the differences in ketogenesis in younger age children relative to various clinical situations.
Asunto(s)
Diabetes Mellitus Tipo 1/sangre , Hipoglucemiantes/administración & dosificación , Sistemas de Infusión de Insulina , Insulina/administración & dosificación , Cetonas/sangre , Adolescente , Niño , Preescolar , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Femenino , Humanos , MasculinoAsunto(s)
Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hipoglucemia/prevención & control , Insulina/administración & dosificación , Insulina/efectos adversos , Algoritmos , Humanos , Hipoglucemia/inducido químicamente , Bombas de Infusión Implantables , Sistemas de Infusión de Insulina , Páncreas ArtificialRESUMEN
OBJECTIVE: Nocturnal hypoglycemia can cause seizures and is a major impediment to tight glycemic control, especially in young children with type 1 diabetes. We conducted an in-home randomized trial to assess the efficacy and safety of a continuous glucose monitor-based overnight predictive low-glucose suspend (PLGS) system. RESEARCH DESIGN AND METHODS: In two age-groups of children with type 1 diabetes (11-14 and 4-10 years of age), a 42-night trial for each child was conducted wherein each night was assigned randomly to either having the PLGS system active (intervention night) or inactive (control night). The primary outcome was percent time <70 mg/dL overnight. RESULTS: Median time at <70 mg/dL was reduced by 54% from 10.1% on control nights to 4.6% on intervention nights (P < 0.001) in 11-14-year-olds (n = 45) and by 50% from 6.2% to 3.1% (P < 0.001) in 4-10-year-olds (n = 36). Mean overnight glucose was lower on control versus intervention nights in both age-groups (144 ± 18 vs. 152 ± 19 mg/dL [P < 0.001] and 153 ± 14 vs. 160 ± 16 mg/dL [P = 0.004], respectively). Mean morning blood glucose was 159 ± 29 vs. 176 ± 28 mg/dL (P < 0.001) in the 11-14-year-olds and 154 ± 25 vs. 158 ± 22 mg/dL (P = 0.11) in the 4-10-year-olds, respectively. No differences were found between intervention and control in either age-group in morning blood ketosis. CONCLUSIONS: In 4-14-year-olds, use of a nocturnal PLGS system can substantially reduce overnight hypoglycemia without an increase in morning ketosis, although overnight mean glucose is slightly higher.
Asunto(s)
Glucemia/análisis , Diabetes Mellitus Tipo 1/sangre , Cetoacidosis Diabética/sangre , Cetoacidosis Diabética/prevención & control , Hipoglucemia/sangre , Monitoreo Fisiológico/métodos , Sueño , Automonitorización de la Glucosa Sanguínea/métodos , Niño , Preescolar , Ritmo Circadiano , Diabetes Mellitus Tipo 1/diagnóstico , Femenino , Humanos , Hipoglucemia/diagnóstico , Hipoglucemiantes/uso terapéutico , MasculinoRESUMEN
BACKGROUND: Hypoglycemia remains an impediment to good glycemic control, with nocturnal hypoglycemia being particularly dangerous. Information on major contributors to nocturnal hypoglycemia remains critical for understanding and mitigating risk. MATERIALS AND METHODS: Continuous glucose monitoring (CGM) data for 855 nights were studied, generated by 45 subjects 15-45 years of age with hemoglobin A1c (HbA1c) levels of ≤8.0% who participated in a larger randomized study. Factors assessed for potential association with nocturnal hypoglycemia (CGM measurement of <60 mg/dL for ≥30 min) included bedtime blood glucose (BG), exercise intensity, bedtime snack, insulin on board, day of the week, previous daytime hypoglycemia, age, gender, HbA1c level, diabetes duration, daily basal insulin, and daily insulin dose. RESULTS: Hypoglycemia occurred during 221 of 885 (25%) nights and was more frequent with younger age (P<0.001), lower HbA1c levels (P=0.006), medium/high-intensity exercise during the preceding day (P=0.003), and the occurrence of antecedent daytime hypoglycemia (P=0.001). There was a trend for lower bedtime BG levels to be associated with more frequent nocturnal hypoglycemia (P=0.10). Bedtime snack, before bedtime insulin bolus, weekend versus weekday, gender, and daily basal and bolus insulin were not associated with nocturnal hypoglycemia. CONCLUSIONS: Awareness that HbA1c level, exercise, bedtime BG level, and daytime hypoglycemia are all modifiable factors associated with nocturnal hypoglycemia may help patients and providers decrease the risk of hypoglycemia at night. Risk for nocturnal hypoglycemia increased in a linear fashion across the range of variables, with no clear-cut thresholds to guide clinicians or patients for any particular night.
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Ritmo Circadiano , Diabetes Mellitus Tipo 1/sangre , Hipoglucemia/sangre , Adolescente , Adulto , Factores de Edad , Glucemia/análisis , Automonitorización de la Glucosa Sanguínea , Diabetes Mellitus Tipo 1/complicaciones , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Ejercicio Físico , Femenino , Hemoglobina Glucada/análisis , Humanos , Hipoglucemia/tratamiento farmacológico , Hipoglucemia/etiología , Hipoglucemia/prevención & control , Hipoglucemiantes/administración & dosificación , Insulina/administración & dosificación , Sistemas de Infusión de Insulina , Masculino , Persona de Mediana Edad , Factores de Riesgo , Factores Sexuales , Bocadillos , Adulto JovenRESUMEN
OBJECTIVE: Type 1 diabetes (T1D) results from the inflammatory destruction of pancreatic ß-cells. In this study, we investigated the effect of docosahexaenoic acid (DHA) supplementation on stimulated inflammatory cytokine production in white blood cells (WBC) from infants with a high genetic risk for T1D. RESEARCH DESIGN AND METHODS: This was a multicenter, two-arm, randomized, double-blind pilot trial of DHA supplementation, beginning either in the last trimester of pregnancy (41 infants) or in the first 5 months after birth (57 infants). Levels of DHA in infant and maternal red blood cell (RBC) membranes and in breast milk were analyzed by gas chromatography/mass spectrometry. Inflammatory cytokines were assayed from whole blood culture supernatants using the Luminex multiplex assay after stimulation with high dose lipopolysaccharide (LPS), 1 µg/mL. RESULTS: The levels of RBC DHA were increased by 61-100% in treated compared to control infants at ages 6-36 months. There were no statistically significant reductions in production of the inflammatory cytokines, IL-1ß, TNFα, or IL-12p40 at any of the six timepoints measured. The inflammatory marker, high-sensitivity C-reactive protein (hsCRP), was significantly lower in breast-fed DHA-treated infants compared to all formula-fed infants at the age of 12 months. Three infants (two received DHA) were removed from the study as a result of developing ≥two persistently positive biochemical islet autoantibodies. CONCLUSIONS: This pilot trial showed that supplementation of infant diets with DHA is safe and fulfilled the pre-study goal of increasing infant RBC DHA levels by at least 20%. Inflammatory cytokine production was not consistently reduced.
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Citocinas/metabolismo , Diabetes Mellitus Tipo 1/prevención & control , Ácidos Docosahexaenoicos/uso terapéutico , Autoanticuerpos/sangre , Proteína C-Reactiva/metabolismo , Diabetes Mellitus Tipo 1/inmunología , Suplementos Dietéticos , Ácidos Docosahexaenoicos/análisis , Ácidos Docosahexaenoicos/metabolismo , Método Doble Ciego , Eritrocitos/metabolismo , Femenino , Predisposición Genética a la Enfermedad , Humanos , Lactante , Leucocitos/metabolismo , Masculino , Leche Humana/química , Proyectos Piloto , Embarazo , Vitamina D/sangreRESUMEN
AIMS: Intravenous glucose tolerance testing (IVGTT) is a common test of ß-cell function in which a glucose load is administered and insulin and/or C-peptide responses are monitored. Since the first IVGTT may be more stressful and stress may alter ß-cell secretion or hepatic insulin extraction, we asked whether there was a first test effect. METHODS: Insulin and C-peptide responses were compared from two sequential IVGTTs performed within 6 months during staging for the Diabetes Prevention Trial-Type 1 (DPT-1) in 368 people at high risk for type 1 diabetes. Insulin data (1+3 min) were used because the first phase insulin response (and peak insulin concentration) occurs within this time frame. Areas under the curve (AUC) calculations represent early insulin or C-peptide responses from 0 through 10 min post-glucose challenge. RESULTS: More than half of all subjects were found to have first test values lower than the second. This was true for all measures of both insulin and C-peptide but the frequency was significantly different only for insulin measures corrected for basal and for insulin AUC (p < 0.05). However, for subjects (n = 99) whose 1+3 min insulin response was <10th percentile on the first test, there was a significant increase on the second test (p < 0.05). The C-peptide: insulin ratio did not change significantly between tests, indicating that differences are due to changes in ß-cell secretion rather than hepatic insulin uptake. CONCLUSIONS: A statistically significant first test effect occurs during the IVGTT attributable to variations in insulin secretion rather than hepatic uptake.
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Intolerancia a la Glucosa/diagnóstico , Células Secretoras de Insulina/metabolismo , Insulina/metabolismo , Estrés Psicológico/complicaciones , Adolescente , Adulto , Péptido C/sangre , Niño , Preescolar , Diabetes Mellitus Tipo 1/epidemiología , Salud de la Familia , Glucosa/administración & dosificación , Glucosa/metabolismo , Intolerancia a la Glucosa/sangre , Intolerancia a la Glucosa/complicaciones , Intolerancia a la Glucosa/metabolismo , Prueba de Tolerancia a la Glucosa , Humanos , Infusiones Intravenosas , Insulina/sangre , Secreción de Insulina , Hígado/metabolismo , Persona de Mediana Edad , Reproducibilidad de los Resultados , Riesgo , Adulto JovenRESUMEN
Continuous glucose monitors (CGMs) provide real-time interstitial glucose concentrations that are essential for automated treatment of individuals with type 1 diabetes. Miscalibration, noise spikes, dropouts, or pressure applied to the site (e.g., lying on the site while sleeping) can cause inaccurate glucose signals, which could lead to inappropriate insulin dosing decisions. These studies focus on the problem of pressure-induced sensor attenuations (PISAs) that occur overnight and can cause undesirable pump shut-offs in a predictive low glucose suspend system. The algorithm presented here uses real-time CGM readings without knowledge of meals, insulin doses, activity, sensor recalibrations, or fingerstick measurements. The real-time PISA detection technique was tested on outpatient "in-home" data from a predictive low-glucose suspend trial with over 1125 nights of data. A total of 178 sets were created by using different parameters for the PISA detection algorithm to illustrate its range of available performance. The tracings were reviewed via a web-based analysis tool by an engineer with an extensive expertise on analyzing clinical datasets and ~3% of the CGM readings were marked as PISA events which were used as the gold standard. It is shown that 88.34% of the PISAs were successfully detected by the algorithm, and the percentage of false detections could be reduced to 1.70% by altering the algorithm parameters. Use of the proposed PISA detection method can result in a significant decrease in undesirable pump suspensions overnight, and may lead to lower overnight mean glucose levels while still achieving a low risk of hypoglycemia.
Asunto(s)
Algoritmos , Glucemia/análisis , Páncreas Artificial , Automonitorización de la Glucosa Sanguínea , Humanos , PresiónRESUMEN
BACKGROUND: This study evaluated meal bolus insulin delivery strategies and associated postprandial glucose control while using an artificial pancreas (AP) system. SUBJECTS AND METHODS: This study was a multicenter trial in 53 patients, 12-65 years of age, with type 1 diabetes for at least 1 year and use of continuous subcutaneous insulin infusion for at least 6 months. Four different insulin bolus strategies were assessed: standard bolus delivered with meal (n=51), standard bolus delivered 15 min prior to meal (n=40), over-bolus of 30% delivered with meal (n=40), and bolus purposely omitted (n=46). Meal carbohydrate (CHO) intake was 1 g of CHO/kg of body weight up to a maximum of 100 g for the first three strategies or up to a maximum of 50 g for strategy 4. RESULTS: Only three of 177 meals (two with over-bolus and one with standard bolus 15 min prior to meal) had postprandial blood glucose values of <60 mg/dL. Postprandial hyperglycemia (blood glucose level >180 mg/dL) was prolonged for all four bolus strategies but was shorter for the over-bolus (41% of the 4-h period) than the two standard bolus strategies (73% for each). Mean postprandial blood glucose level was 15.9 mg/dL higher for the standard bolus with meal compared with the prebolus (baseline-adjusted, P=0.07 for treatment effect over the 4-h period). CONCLUSIONS: The AP handled the four bolus situations safely, but at the expense of having elevated postprandial glucose levels in most subjects. This was most likely secondary to suboptimal performance of the algorithm.
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Glucemia/metabolismo , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hiperglucemia/tratamiento farmacológico , Hipoglucemiantes/metabolismo , Sistemas de Infusión de Insulina , Comidas , Páncreas Artificial , Adolescente , Adulto , Algoritmos , Automonitorización de la Glucosa Sanguínea , Niño , Diabetes Mellitus Tipo 1/sangre , Carbohidratos de la Dieta/metabolismo , Femenino , Humanos , Hiperglucemia/prevención & control , Hipoglucemiantes/administración & dosificación , Masculino , Persona de Mediana Edad , Cooperación del Paciente , Periodo Posprandial , Estados UnidosRESUMEN
BACKGROUND: The Control to Range Study was a multinational artificial pancreas study designed to assess the time spent in the hypo- and hyperglycemic ranges in adults and adolescents with type 1 diabetes while under closed-loop control. The controller attempted to keep the glucose ranges between 70 and 180 mg/dL. A set of prespecified metrics was used to measure safety. RESEARCH DESIGN AND METHODS: We studied 53 individuals for approximately 22 h each during clinical research center admissions. Plasma glucose level was measured every 15-30 min (YSI clinical laboratory analyzer instrument [YSI, Inc., Yellow Springs, OH]). During the admission, subjects received three mixed meals (1 g of carbohydrate/kg of body weight; 100 g maximum) with meal announcement and automated insulin dosing by the controller. RESULTS: For adults, the mean of subjects' mean glucose levels was 159 mg/dL, and mean percentage of values 71-180 mg/dL was 66% overall (59% daytime and 82% overnight). For adolescents, the mean of subjects' mean glucose levels was 166 mg/dL, and mean percentage of values in range was 62% overall (53% daytime and 82% overnight). Whereas prespecified criteria for safety were satisfied by both groups, they were met at the individual level in adults only for combined daytime/nighttime and for isolated nighttime. Two adults and six adolescents failed to meet the daytime criterion, largely because of postmeal hyperglycemia, and another adolescent failed to meet the nighttime criterion. CONCLUSIONS: The control-to-range system performed as expected: faring better overnight than during the day and performing with variability between patients even after individualization based on patients' prior settings. The system had difficulty preventing postmeal excursions above target range.
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Glucemia/metabolismo , Diabetes Mellitus Tipo 1/sangre , Hemoglobina Glucada/metabolismo , Hiperglucemia/prevención & control , Hipoglucemia/prevención & control , Hipoglucemiantes/administración & dosificación , Insulina/administración & dosificación , Páncreas Artificial , Adolescente , Adulto , Algoritmos , Automonitorización de la Glucosa Sanguínea , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Carbohidratos de la Dieta , Femenino , Humanos , Hiperglucemia/sangre , Hipoglucemia/sangre , Insulina/metabolismo , Secreción de Insulina , Masculino , Comidas , Monitoreo Fisiológico , Seguridad del Paciente , Proyectos Piloto , Periodo Posprandial , Reproducibilidad de los Resultados , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: To assess the frequency of continuous glucose monitoring (CGM) device use, factors associated with its use, and the relationship of CGM with diabetes outcomes (HbA1c, severe hypoglycemia [SH], and diabetic ketoacidosis [DKA]). RESEARCH DESIGN AND METHODS: Survey questions related to CGM device use 1 year after enrollment in the T1D Exchange clinic registry were completed by 17,317 participants. Participants were defined as CGM users if they indicated using real-time CGM during the prior 30 days. RESULTS: Nine percent of participants used CGM (6% of children <13 years old, 4% of adolescents 13 to <18 years, 6% of young adults 18 to <26 years, and 21% of adults ≥26 years). CGM use was more likely with higher education, higher household income, private health insurance, longer duration of diabetes, and use of insulin pump (P < 0.01 all factors). CGM use was associated with lower HbA1c in children (8.3% vs. 8.6%, P < 0.001) and adults (7.7% vs. 7.9%, P < 0.001). In adults, more frequent use of CGM (≥6 days/week) was associated with lower mean HbA1c. Only 27% of users downloaded data from their device at least once per month, and ≤15% of users reported downloading their device at least weekly. Among participants who used CGM at baseline, 41% had discontinued within 1 year. CONCLUSIONS: CGM use is uncommon but associated with lower HbA1c in some age-groups, especially when used more frequently. Factors associated with discontinuation and infrequent use of retrospective analysis of CGM data should be considered in developing next-generation devices and education on CGM use.
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Diabetes Mellitus Tipo 1/sangre , Hemoglobina Glucada/análisis , Sistemas de Infusión de Insulina , Insulina/administración & dosificación , Insulina/uso terapéutico , Monitoreo Ambulatorio/estadística & datos numéricos , Sistema de Registros , Adolescente , Adulto , Glucemia/metabolismo , Automonitorización de la Glucosa Sanguínea/métodos , Niño , Estudios Transversales , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Cetoacidosis Diabética/epidemiología , Femenino , Humanos , Hipoglucemia/epidemiología , Incidencia , Masculino , Educación del Paciente como Asunto , Estudios Retrospectivos , Factores de Riesgo , Adulto JovenRESUMEN
OBJECTIVE: Overnight hypoglycemia occurs frequently in individuals with type 1 diabetes and can result in loss of consciousness, seizure, or even death. We conducted an in-home randomized trial to determine whether nocturnal hypoglycemia could be safely reduced by temporarily suspending pump insulin delivery when hypoglycemia was predicted by an algorithm based on continuous glucose monitoring (CGM) glucose levels. RESEARCH DESIGN AND METHODS: Following an initial run-in phase, a 42-night trial was conducted in 45 individuals aged 15-45 years with type 1 diabetes in which each night was assigned randomly to either having the predictive low-glucose suspend system active (intervention night) or inactive (control night). The primary outcome was the proportion of nights in which ≥1 CGM glucose values ≤60 mg/dL occurred. RESULTS: Overnight hypoglycemia with at least one CGM value ≤60 mg/dL occurred on 196 of 942 (21%) intervention nights versus 322 of 970 (33%) control nights (odds ratio 0.52 [95% CI 0.43-0.64]; P < 0.001). Median hypoglycemia area under the curve was reduced by 81%, and hypoglycemia lasting >2 h was reduced by 74%. Overnight sensor glucose was >180 mg/dL during 57% of control nights and 59% of intervention nights (P = 0.17), while morning blood glucose was >180 mg/dL following 21% and 27% of nights, respectively (P < 0.001), and >250 mg/dL following 6% and 6%, respectively. Morning ketosis was present <1% of the time in each arm. CONCLUSIONS: Use of a nocturnal low-glucose suspend system can substantially reduce overnight hypoglycemia without an increase in morning ketosis.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hipoglucemia/prevención & control , Hipoglucemiantes/administración & dosificación , Insulina/administración & dosificación , Adolescente , Adulto , Algoritmos , Glucemia/análisis , Glucemia/efectos de los fármacos , Automonitorización de la Glucosa Sanguínea/métodos , Diabetes Mellitus Tipo 1/sangre , Cetoacidosis Diabética/epidemiología , Femenino , Humanos , Hipoglucemia/epidemiología , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico , Sistemas de Infusión de Insulina , Masculino , Persona de Mediana Edad , Adulto JovenRESUMEN
OBJECTIVE: To assess the effect of overnight insulin pump suspension in an automated predictive low glucose suspend system on morning blood glucose and ketone levels in an attempt to determine whether routine measurement of ketone levels is useful when a closed-loop system that suspends insulin delivery overnight is being used. RESEARCH DESIGN AND METHODS: Data from an in-home randomized trial of 45 individuals with type 1 diabetes (age range 15-45 years) were analyzed, evaluating an automated predictive low glucose pump suspension system in which blood glucose, blood ketone, and urine ketone levels were measured on 1,954 mornings. RESULTS: One or more pump suspensions occurred during 744 of the 977 intervention nights (76%). The morning blood ketone level was ≥0.6 mmol/L after 11 of the 744 nights (1.5%) during which a pump suspension occurred and 2 of the 233 nights (0.9%) during which there was no suspension compared with 11 of 977 control nights (1.1%). The morning blood ketone level was ≥0.6 mmol/L after only 2 of 159 nights (1.3%) with a pump suspension exceeding 2 h. Morning fasting blood glucose level was not a good predictor of the presence of blood ketones. CONCLUSIONS: Routine measurement of blood or urine ketones during use of an automated pump suspension system using continuous glucose monitoring, whether threshold based or predictive, is not necessary. Recommendations for checking ketone levels should be no different when a patient is using a system with automated insulin suspension than it is for conventional diabetes self-management.
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Glucemia/metabolismo , Ritmo Circadiano/fisiología , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Sistemas de Infusión de Insulina , Insulina/administración & dosificación , Insulina/uso terapéutico , Cetosis/epidemiología , Adolescente , Adulto , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/fisiopatología , Femenino , Humanos , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/uso terapéutico , Cetonas/sangre , Cetonas/orina , Masculino , Persona de Mediana Edad , Pacientes Ambulatorios , Valor Predictivo de las Pruebas , Prevalencia , Autocuidado , Adulto JovenRESUMEN
Insulin delivery via injection and continuous subcutaneous insulin infusion (CSII) via insulin pump were compared in a cross-sectional study (n = 669) and retrospective longitudinal study (n = 1904) of young children (<6 yr) with type 1 diabetes (T1D) participating in the T1D Exchange clinic registry. Use of CSII correlated with longer T1D duration (p < 0.001), higher parental education (p < 0.001), and annual household income (p < 0.006) but not with race/ethnicity. Wide variation in pump use was observed among T1D Exchange centers even after adjusting for these factors, suggesting that prescriber preference is a substantial determinant of CSII use. Hemoglobin A1c (HbA1c) was lower in pump vs. injection users (7.9 vs. 8.5%, adjusted p < 0.001) in the cross-sectional study. In the longitudinal study, HbA1c decreased after initiation of CSII by 0.2%, on average (p < 0.001). Frequency of a severe hypoglycemia (SH) event did not differ in pump vs. injection users (p = 0.2). Frequency of ≥1 parent-reported diabetic ketoacidosis (DKA) event in the prior year was greater in pump users than injection users (10 vs. 8%, p = 0.04). No differences between pump and injection users were observed for clinic-reported DKA events. Children below 6 yr have many unique metabolic characteristics, feeding behaviors, and care needs compared with older children and adolescents. These data support the use of insulin pumps in this youngest age group, and suggest that metabolic control may be improved without increasing the frequency of SH, but care should be taken as to the possibly increased risk of DKA.