RESUMO
AIMS: To investigate whether the positive effects on glycaemic outcomes of 3-month automated insulin delivery (AID) achieved in 2- to 6-year-old children endure over an extended duration and how AID treatment affects time in tight range (TITR), defined as 3.9-7.8 mmol/L. RESEARCH DESIGN AND METHODS: We analysed 18 months of follow-up data from a non-randomized, prospective, single-arm clinical trial (n = 35) conducted between 2021 and 2023. The main outcome measures were changes in time in range (TIR), glycated haemoglobin (HbA1c), time above range (TAR), TITR, and mean sensor glucose (SG) value during follow-up visits (at 0, 6, 12 and 18 months). The MiniMed 780G AID system in SmartGuard Mode was used for 18 months. Parental diabetes distress was evaluated at 3 and 18 months with the validated Problem Areas in Diabetes-Parent, revised (PAID-PR) survey. RESULTS: Between 0 and 6 months, TIR and TITR increased, and HbA1c, mean SG value and TAR decreased significantly (p < 0.001); the favourable effect persisted through 18 months of follow-up. Between 3 and 18 months, PAID-PR score declined significantly (0 months: mean score 37.5; 3 months: mean score 28.6 [p = 0.06]; 18 months: mean score 24.6 [p < 0.001]). CONCLUSIONS: Treatment with AID significantly increased TITR and TIR in young children. The positive effect of AID on glycaemic control observed after 6 months persisted throughout the 18 months of follow-up. Similarly, parental diabetes distress remained reduced during 18 months follow-up. These findings are reassuring and suggest that AID treatment improves glycaemic control and reduces parental diabetes distress in young children over an extended 18-month follow-up.
Assuntos
Glicemia , Diabetes Mellitus Tipo 1 , Hemoglobinas Glicadas , Hipoglicemiantes , Sistemas de Infusão de Insulina , Insulina , Humanos , Feminino , Masculino , Pré-Escolar , Insulina/administração & dosagem , Insulina/uso terapêutico , Criança , Hemoglobinas Glicadas/análise , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/uso terapêutico , Glicemia/análise , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/sangue , Estudos Prospectivos , Seguimentos , Controle Glicêmico/métodos , Fatores de Tempo , Automonitorização da GlicemiaRESUMO
INTRODUCTION: Intrauterine conditions and accelerating early growth are associated with childhood obesity. It is unknown, whether fetal programming affects the early growth and could alterations in the maternal-fetal metabolome be the mediating mechanism. Therefore, we aimed to assess the associations between maternal and cord blood metabolite profile and offspring early growth. METHODS: The RADIEL study recruited 724 women at high risk for gestational diabetes mellitus (GDM) BMI ≥ 30 kg/m2 and/or prior GDM) before or in early pregnancy. Blood samples were collected once in each trimester, and from cord. Metabolomics were analyzed by targeted nuclear magnetic resonance (NMR) technique. Following up on offsprings' first 2 years growth, we discovered 3 distinct growth profiles (ascending n = 80, intermediate n = 346, and descending n = 146) by using latent class mixed models (lcmm). RESULTS: From the cohort of mother-child dyads with available growth profile data (n = 572), we have metabolomic data from 232 mothers from 1st trimester, 271 from 2nd trimester, 277 from 3rd trimester and 345 from cord blood. We have data on 220 metabolites in each trimester and 70 from cord blood. In each trimester of pregnancy, the mothers of the ascending group showed higher levels of VLDL and LDL particles, and lower levels of HDL particles (p < 0.05). When adjusted for gestational age, birth weight, sex, delivery mode, and maternal smoking, there was an association with ascending profile and 2nd trimester total cholesterol in HDL2, 3rd trimester total cholesterol in HDL2 and in HDL, VLDL size and ratio of triglycerides to phosphoglycerides (TG/PG ratio) in cord blood (p ≤ 0.002). CONCLUSION: Ascending early growth was associated with lower maternal total cholesterol in HDL in 2nd and 3rd trimester, and higher VLDL size and more adverse TG/PG ratio in cord blood. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, http://www. CLINICALTRIALS: com , NCT01698385.
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Diabetes Gestacional , Obesidade Infantil , Criança , Feminino , Humanos , Gravidez , Colesterol , Sangue Fetal/química , Lipoproteínas/análiseRESUMO
BACKGROUND: Between March 18th and May 13th 2020, the COVID-19 pandemic outbreak in Finland resulted in the closure of schools and the limitation of daycare (i.e. lockdown). Social distancing changed the daily routines of children with type 1 diabetes (T1D). Healthcare professionals were forced to adapt to the pandemic by replacing physical outpatient visits with virtual visits. However, the influence of the lockdown on glycemic control in these patients remained unknown. METHODS: In this retrospective register study from a pediatric diabetes outpatient clinic, we analyzed the glycemic data of T1D patients (n = 245; aged 4 to 16 years) before and under the lockdown. All the participants used continuous glucose monitoring (rtCGM or iCGM), two-thirds were on insulin pumps (CSII), and one-third on multiple daily insulin injections (MDI) therapy. RESULTS: In our patient cohort, time in range (TIR, n = 209) and mean glucose levels (n = 214) were similar prior to and under the lockdown (mean change 0.44% [95%CI: -1.1-2.0], p = 0.56 and -0.13 mmol/mol [95%CI: -0.3-0.1], p = 0.17, respectively). However, children treated with CSII improved their glycemic control significantly during the lockdown: TIR improved on average 2.4% [0.6-4.2] (p = 0.010) and mean blood glucose level decreased -0.3 mmol/mol [-0.6-(-0.1)] (p = 0.008). The difference was more pronounced in girls, adolescents and patients using conventional insulin pumps. CONCLUSIONS: The glycemic control in T1D children did not deteriorate under the lockdown, and patients on CSII even improved their control, which suggests that social distancing might have allowed families to use the insulin pump more accurately as out-of-home activities were on hold.
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COVID-19 , Diabetes Mellitus Tipo 1 , Adolescente , Glicemia , Automonitorização da Glicemia , Criança , Controle de Doenças Transmissíveis , Diabetes Mellitus Tipo 1/tratamento farmacológico , Feminino , Controle Glicêmico , Humanos , Hipoglicemiantes/uso terapêutico , Pandemias , Estudos Retrospectivos , SARS-CoV-2RESUMO
OBJECTIVE: The hybrid close-loop system (HCL) is a rapidly emerging treatment method for type 1 diabetes (T1D), but the long-term effectiveness of the system remains unclear. This study investigates the influence of the HCL on glycemic control in children and adolescents with T1D in a real-life setting during the first year on HCL. RESEARCH DESIGN AND METHODS: This retrospective study included all the patients (n = 111) aged 3 to 16 years with T1D who initiated the HCL system between 1st of December 2018 and 1st of December 2019 in the Helsinki University Hospital. Time in range (TIR), HbA1c, mean sensor glucose (SG) value, time below range (TBR), and SG coefficient of variance (CV) were measured at 0, 1, 3, 6, and 12 month. The changes over time were analyzed with a repeated mixed model adjusted with baseline glycemic control. RESULTS: After the initiation of HCL, all measures of glycemic control, except HbA1c, improved and the effect lasted throughout the study period. Between 0 and 12 month, TIR increased (ß = -2.5 [95%CI: -3.6 - (-1.3)], p < 0.001), whereas mean SG values (ß = -0.7 [95%CI: -0.9 - (-0.4)]), TBR (ß = -2.5 [95%CI: -3.6 - (-1.3)]), and SG CV (ß = -4.5 [95%CI: -6.3 - [-2.8]) decreased significantly (p < 0.001). Importantly, the changes occurred regardless of the age of the patient. CONCLUSIONS: Measurements of glycemic control, except HbA1c, improved significantly after the initiation of the HCL system and the favorable effect lasted throughout the follow-up. These results support the view that HCL is an efficacious treatment modality for children and adolescents with T1D of all ages.
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Diabetes Mellitus Tipo 1/tratamento farmacológico , Controle Glicêmico/estatística & dados numéricos , Hipoglicemiantes/administração & dosagem , Sistemas de Infusão de Insulina/estatística & dados numéricos , Insulina/administração & dosagem , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Estudos RetrospectivosRESUMO
Self-care of insulin-tretated diabetes has in recent years become considerably more technical. Continuous glucose sensoring, measuring the glucose level of tissue fluid, has become an important tool for the management of glucose values in the everyday life of the diabetic patient. Detailed guidance to the use of the devices is essential in their utilization. The first glucose sensor requiring no calibration though the measurement of blood glucose level has also entered the market. Numerous smartphone applications for self-monitoring have emerged, and cloud services are being increasingly used for mediating data between the patient and the health facility. The Nightscout system makes remote monitoring of diabetic patients possible with a smart device.
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Automonitorização da Glicemia/instrumentação , Diabetes Mellitus/sangue , Calibragem , Telefone Celular , HumanosRESUMO
Objective: The safety and impact of the advanced hybrid closed-loop (AHCL) system on glycemic outcome in 2- to 6-year-old children with type 1 diabetes and the diabetes distress of caregivers were evaluated. Research Design and Methods: This was an open-label prospective study (n = 35) with historical controls matched by treatment unit, diabetes duration, age, gender, and baseline treatment modality. The inclusion criteria were (1) type 1 diabetes diagnosis >6 months, (2) total daily dose of insulin ≥8 U/day, (3) HbA1c <10% (85 mmol/mol), and (4) capability to use insulin pump and continuous glucose monitoring. The MiniMed 780G™ AHCL in SmartGuard™ Mode was used for 12 weeks. Parental diabetes distress was evaluated with a validated Problem Areas In Diabetes-Parent, revised (PAID-PR) survey. Results: No events of diabetic ketoacidosis or severe hypoglycemia occurred. Between 0 and 12 weeks, HbA1c (mean change = -2.7 mmol/mol [standard deviation 5.7], P = 0.010), mean sensor glucose value (SG) (-0.8 mmol/L [1.0], P < 0.001), and time above range (TAR) (-8.6% [9.5], P < 0.001) decreased and time in range (TIR) (8.3% [9.3], P < 0.001) increased significantly, whereas no significant change in time below range (TBR) was observed. At the same time, PAID-PR score decreased from 37.5 (18.2) to 27.5 (14.8) (P = 0.006). Conclusions: MiniMed 780G™ AHCL is a safe system and 12-week use was associated with improvements in glycemic control in 2- to 6-year-old children with type 1 diabetes. In addition, AHCL is associated with a reduction in parental diabetes distress after 12-week use. ClinicalTrials.gov registration number: NCT04949022.
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Diabetes Mellitus Tipo 1 , Criança , Humanos , Glicemia , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/complicações , Hemoglobinas Glicadas , Hipoglicemiantes/uso terapêutico , Insulina/efeitos adversos , Sistemas de Infusão de Insulina , Estudos Prospectivos , Resultado do TratamentoRESUMO
CONTEXT: Early growth is associated with childhood adiposity, but the influence of lifestyle remains unknown. OBJECTIVE: This work aimed to investigate the association of growth profiles from high-risk pregnancies with adiposity at age 5 years, taking into account lifestyle and several antenatal/postnatal exposures. METHODS: This prospective cohort study. INCLUDED: 609 children born during the Finnish Gestational Diabetes Prevention Study (RADIEL), recruiting women with body mass index (BMI) greater than or equal to 30 and/or prior gestational diabetes mellitus (GDM) (2008-2013). Altogether 332 children attended the 5-year follow-up (2014-2017). Main outcome measures included growth profiles based on ponderal index (PIâ =â weight/height3), investigated using latent class mixed models. Adiposity was assessed with anthropometrics and body composition (InBody720). RESULTS: We identified 3 growth profiles: ascending (nâ =â 82), intermediate (nâ =â 351), and descending (nâ =â 149). Children with ascending growth had a higher body fat percentage, ISO-BMI, and waist circumference (Pâ <â .05) at age 5 years. Ascending (ß 4.09; CI, 1.60-6.58) and intermediate (ß 2.27; CI, 0.50-4.03) profiles were associated with higher fat percentage, even after adjustment for age, sex, gestational age, diet, physical activity, education, and prepregnancy BMI. Similar associations existed with ISO-BMI. After adjusting for age and education, ascending growth was associated with prepregnancy BMI (odds ratio [OR] 1.06; CI, 1.01-1.12), primiparity (OR 3.07; CI, 1.68-5.62), cesarean delivery (OR 2.23; CI, 1.18-4.21), and lifestyle intervention (OR 2.56; CI, 1.44-4.57). However, meeting the intervention goals and exclusive breastfeeding for 3 months or more were associated with lower odds of ascending growth. CONCLUSION: Accelerated early growth was associated with higher adiposity in 5-year-old children from high-risk pregnancies, even when adjusted for lifestyle. Reducing cesarean deliveries and promoting breastfeeding may be beneficial for postnatal growth.
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Tecido Adiposo/patologia , Adiposidade , Diabetes Gestacional/fisiopatologia , Estilo de Vida , Obesidade/fisiopatologia , Adulto , Biomarcadores/análise , Pré-Escolar , Diabetes Gestacional/epidemiologia , Feminino , Finlândia/epidemiologia , Seguimentos , Humanos , Lactente , Recém-Nascido , Masculino , Gravidez , Prognóstico , Estudos ProspectivosRESUMO
A multicenter randomized controlled pilot trial investigated whether motivational interviewing (MI) by diabetes physicians improves glycemic control and variability in the context of follow-up for adolescent patients with poorly controlled type 1 diabetes. Patients (n = 47) aged 12 to 15.9 years who showed poor glycemic control (HbA1c >75 mmol/mol/9.0%) were randomized to standard education (SE) only or MI+SE, with study physicians randomized to employ MI+SE (N = 24 patients) or SE only (N = 23). For one year of follow-up, the main outcome measurements were obtained at three-month visits (HbA1c) or six-monthly: time in range (TIR) and glycemic variability (CV). Mean adjusted 12-month change in HbA1c was similar between the MI+SE and SE-only group (-3.6 vs. -1.0 mmol/mol), and no inter-group differences were visible in the mean adjusted 12-month change in TIR (-0.8 vs. 2.6%; P = 0.53) or CV (-0.5 vs. -6.2; P = 0.26). However, the order of entering the study correlated significantly with the 12-month change in HbA1c in the MI+SE group (r = -0.5; P = 0.006) and not in the SE-only group (r = 0.2; P = 0.4). No link was evident between MI and changes in quality of life. The authors conclude that MI's short-term use by diabetes physicians managing adolescents with poorly controlled type 1 diabetes was not superior to SE alone; however, improved skills in applying the MI method at the outpatient clinic may produce greater benefits in glycemic control.
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Glicemia/análise , Diabetes Mellitus Tipo 1/psicologia , Diabetes Mellitus Tipo 1/terapia , Entrevista Motivacional/métodos , Adolescente , Antropometria , Criança , Diabetes Mellitus Tipo 1/sangue , Feminino , Finlândia , Hemoglobinas Glicadas/biossíntese , Humanos , Masculino , Pacientes Ambulatoriais , Projetos Piloto , Qualidade de Vida , Reprodutibilidade dos Testes , Resultado do TratamentoRESUMO
INTRODUCTION: We studied if motivational interviewing (MI) added to standard educational care (SEC) improves vascular health in adolescents with poorly controlled type 1 diabetes. RESEARCH DESIGN AND METHODS: 47 adolescents with type 1 diabetes of at least 2 years duration and hemoglobin A1c >75 mmol/mol (>9.0%) on two visits were randomized to MI+SEC or SEC. We also compared vascular health parameters of patients with type 1 diabetes at trial baseline with a group of healthy historical controls matched for age and body size. RESULTS: 39 adolescents (20 MI+SEC) completed the vascular health study. At 12 months, parameter changes were not statistically significantly different between MI+SEC and SEC (carotid-femoral pulse wave velocity (cfPWV): mean difference 0.052 m/s (95% CI -0.395 to 0.500, p=0.81); carotid-radial PWV (crPWV): 0.118 m/s (95% to 0.478 to 0.713, p=0.69), carotid intima-media thickness (IMT): 0.002 mm (95% CI -0.37 to 0.40, p=0.93), systolic blood pressure (BP) z-score: 0.495 (95% CI -0.099 to 1.09, p=0.10). At baseline, duration of type 1 diabetes was associated with radial IMT (r=0.430, p=0.007) and cfPWV (r=0.373, p=0.018), and carotid, femoral and brachial IMT were correlated with continuous glucose monitoring (CGM) SD (r=0.440, p=0.017; r=0.377, p=0.048; r=0.387, p=0.038). There was an inverse association between CGM time-in-range (3.9-10.0 mmol/L) and crPWV (r=-0.476, p=0.022) changes. Systolic BP change was associated with body mass index change (r=0.374, p=0.019) and IMT change (r=0.461, p=0.016 for carotid IMT; r=0.498, p=0.010 for femoral IMT). PWVs were higher and common carotid compliance lower among patients with type 1 diabetes at baseline compared with healthy controls, but no other differences were found. CONCLUSION: There was no effect of MI added to SEC on vascular health parameters. Although disease duration and glycemic control were associated with vascular health at baseline, there were only limited associations between glycemic control and vascular health parameter changes. Vascular health parameter changes were interrelated suggesting clustering of cardiovascular risk. TRIAL REGISTRATION NUMBER: NCT02637154.