MiniMed 780G™ in 2- to 6-Year-Old Children: Safety and Clinical Outcomes After the First 12 Weeks.

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.

Parent-child and spousal relationships in families with a young child with end-stage renal disease.

BACKGROUND: End-stage renal disease (ESRD) leads to the need for dialysis and renal transplantation (Tx). Peritoneal dialysis (PD) of young children is normally performed at home by the parents and affects the whole family. We studied the coping of families with a young child with ESRD by interviewing the parents of 19 children. METHODS: The spousal and parent-child relationships were assessed by using the Psychosocial Assessment of Childhood Experiences (PACE) and the Brief Measure of Expressed Emotion, respectively. A control group of 22 families with a healthy child was used for the parent-child relationship evaluation. RESULTS: The spousal relationship at the start of PD was good or fairly good in most of the families and remained good in half of the families following renal Tx. Lack of support from close relatives and renal Tx were associated with a poorer relationship quality. Almost all parents expressed much or fairly much emotional warmth towards the child throughout the study, but there was a trend towards increased criticism over time. No differences in the degree of expressed warmth or criticism were noted between the index parents and controls. CONCLUSIONS: Overall, the study families appeared to cope well despite the serious illness of their child and the demands of the treatments.

Neurological development in 21 children on peritoneal dialysis in infancy.

Few studies have focused on the neurodevelopment of infants on peritoneal dialysis (PD). Infants are the most demanding patient group on PD and thus are vulnerable to neurological sequelae. We studied 21 patients <2 years of age (mean 0.59 years) at onset of PD. They were evaluated by a neurologist, otologist, physiotherapist, and occupational therapist during PD. Neuropsychological tests were collected from all patients at least 5 years old, and the brain images were reviewed. Eleven patients (52%) had a pre- or neonatal problem or comorbidity as risk factor for their development at onset of PD. All infants tolerated PD well. At the end of the study, 71% had some neurological abnormality, 29% a major impairment (all with predialysis risk factors), and 43% a minor one. Brain infarcts were detected in four patients (19%) and other ischemic lesions in three (14%). Three patients (14%) developed hearing defect. Mortality rate was 5%. PD is a safe treatment modality for end-stage renal failure in infants. Some patients had risk factors for development, but their neurological problems did not progress during PD. Patients without risk factors tolerated PD well without major neurological sequelae.

Normal growth and intravascular volume status with good metabolic control during peritoneal dialysis in infancy.

The most demanding patient population on peritoneal dialysis (PD) consists of children under 2 years of age. Their growth is inferior to that of older children and maintaining euvolemia is difficult, especially in anuric patients. In this prospective study reported here, we enrolled 21 patients <2 years of age (mean 0.59 years) at onset of PD and monitored their uremia parameters and evaluated their nutrition. Since no good instrument currently exists for estimating intravascular volume status, we used traditional blood pressure measurements, echocardiography, and N-terminal atrial natriuretic peptide measurements. Growth was compared with midparental height. Metabolic control was good. Long-term hypertension was seen in 43% of the patients, but left ventricular hypertrophy decreased during the study period. Mean weekly urea Kt/V was 3.38 +/- 0.66 and creatinine clearance was 49 +/- 20 L/week per 1.73 m(2). Catch-up growth was documented in 57% of the patients during PD. However, these children did not attain their midparental height at the end of PD at a mean age of 1.71 years. Although favorable metabolic control and good growth were achieved during PD, these children lagged in term of their midparental height. We conclude that several instruments are needed for determining the management of intravascular volume status and that the control of calcium-phosphorus status is demanding.

Peritoneal dialysis in children under two years of age.

BACKGROUND: Although results of peritoneal dialysis (PD) in small children have improved during recent years, the youngest children have poorer growth, more infections and higher mortality than do older children. METHODS: In this retrospective study, we analysed patient records of all children under age 2 treated with continuous peritoneal dialysis (CPD) between 1995 and 2000 in Finland. Diagnoses leading to renal failure in these 23 children were congenital nephrotic syndrome of the Finnish type (13), polycystic kidney disease (4), a urethral valve (3), renal insufficiency due to neonatal asphyxia (2) and Prune-Belly syndrome (1). Of these 23, 17 (74%) were anuric. RESULTS: The mean age at the onset of PD was 0.4 years and the mean time on dialysis 1.4 years. Hernias were diagnosed in 57%. The peritonitis rate was 1:14.5 patient-months, and 30% were peritonitis-free. Hypertension was common, and 70% had at least one period on antihypertensive medication. None of the patients had pulmonary oedema or dialysis-related seizures. The mean height standard deviation score (hSDS) at the start of PD (n = 16) was -2.0 and after 9 months -1.6. Catch-up growth was documented in 64% of the patients during dialysis. Hospitalization time was 124 days/patient-year. Two patients (9%) died. CONCLUSIONS: Our results are reassuring. Mortality was low, laboratory parameters were acceptable and growth was good. Peritonitis rate was comparable to that in older children. Correction of inguinal hernia should be routinely performed; high blood pressure is still a problem.

Muscular dystonia and athetosis in six patients with congenital nephrotic syndrome of the Finnish type (NPHS1).

Congenital nephrotic syndrome of the Finnish type (NPHS1, CNF) is an autosomal recessively inherited disease occurring due to mutations in the nephrin gene (NPHS1). Two main Finnish mutations exist: Fin-major and minor, which both cause a lack of nephrin and absence of the slit diaphragm between the podocytes. This leads to severe proteinuria, nephrotic syndrome and infections, and without dialysis or renal transplantation, death in infancy. Between 1984 and 2003, six (8.6%) of the 70 NPHS1 patients diagnosed at our institution had, in addition to their renal disease, similar neurological symptoms. All six showed a severe dyskinetic cerebral palsy-like syndrome with dystonic features, athetosis and a hearing defect. The neurological symptoms became apparent during their 1st year of life and were diagnosed before 11 months of age. MRI showed increased signal intensity in T2-weighted images in the globus pallidus area. No mitochondrial gene mutations explaining the neurological symptoms were found, nor did external neurological complications explain them when compared with 29 NPHS1 control patients. Four children died at an early age: two during dialysis and two shortly after renal transplantation. Two are still alive with a functioning graft. Both have severe motor defects, but are mentally active and social.