Ketoacidosis children rct

IMPORTANCE: Hybrid closed-loop (HCL) therapy has improved glycemic control in children and adolescents with type 1 diabetes; however, the efficacy of HCL on glycemic and psychosocial outcomes has not yet been established in a long-term randomized clinical trial. OBJECTIVE: To determine the percentage of time spent in the target glucose range using HCL vs current conventional therapies of continuous subcutaneous insulin infusion or multiple daily insulin injections with or without continuous glucose monitoring (CGM)...

BACKGROUND: Although intravenous insulin administration is the standard of care in diabetic ketoacidosis (DKA), subcutaneous insulin administration could be a suitable alternative in resource-limited settings, but pain caused by hourly insulin applications are limiting factors for using it, especially in children. We aimed to assess whether the use of a flexible subcutaneous catheter improves comfort in patients with DKA compared with the usual hourly injections' treatment. We also compared the evolution of metabolic variables in patients with DKA using both insulin administration systems...

OBJECTIVE: To compare the efficacy of insulin infusion of 0.05 Unit/kg/hour vs 0.1 Unit/kg/hour in the management of pediatric diabetic ketoacidosis (DKA). DESIGN: Randomized, double-blind controlled clinical trial. SUBJECT: Pediatric critical care division of a tertiary care hospital from October, 2014 to July, 2018. PARTICIPANTS: Children aged 12 years or younger with a diagnosis of DKA. Children with septic shock and those who had received insulin before enrollment were excluded...

OBJECTIVE: To study the MiniMed Advanced Hybrid Closed-Loop (AHCL) system, which includes an algorithm with individualized basal target set points, automated correction bolus function, and improved Auto Mode stability. RESEARCH DESIGN AND METHODS: This dual-center, randomized, open-label, two-sequence crossover study in automated-insulin-delivery-naive participants with type 1 diabetes (aged 7-80 years) compared AHCL to sensor-augmented pump therapy with predictive low glucose management (SAP + PLGM)...

OBJECTIVE: To further evaluate the safety and efficacy of the Control-IQ closed-loop control (CLC) system in children with type 1 diabetes. RESEARCH DESIGN AND METHODS: After a 16-week randomized clinical trial (RCT) comparing CLC with sensor-augmented pump (SAP) therapy in 101 children 6-13 years old with type 1 diabetes, 22 participants in the SAP group initiated use of the CLC system (referred to as SAP-CLC cohort), and 78 participants in the CLC group continued use of CLC (CLC-CLC cohort) for 12 weeks...

BACKGROUND: Multiple daily injections (MDI) therapy for type 1 diabetes involves basal and bolus insulin doses. Non-optimal insulin doses contribute to the lack of satisfactory glycemic control. We aimed to evaluate the feasibility of an algorithm that optimizes daily basal and bolus doses using glucose monitoring systems for MDI therapy users. METHODS: We performed a pilot, non-inferiority, randomized, parallel study at a diabetes camp comparing basal-bolus insulin dose adjustments made by camp physicians (PA) and a learning algorithm (LA), in children and adolescents on MDI therapy...

BACKGROUND: Acute kidney injury (AKI) is an important complication encountered during the course of diabetic ketoacidosis (DKA). Plasma-Lyte with lower chloride concentration than saline has been shown to be associated with reduced incidence of AKI in adults with septic shock. No study has compared this in DKA. METHODS: This double-blind, parallel-arm, investigator-initiated, randomized controlled trial compared 0.9% saline with Plasma-Lyte-A as initial fluid in pediatric DKA...

The optimal fluid treatment protocol for children with diabetic ketoacidosis (DKA) has long been a subject of controversy. Until recently, there was no high-quality evidence from randomized clinical trials to support an optimal guideline, and recommendations were mainly based on theoretical considerations. As a consequence, fluid treatment protocols for children with DKA vary between institutions (and countries). In June 2018, the results from the Fluid Therapies Under Investigation in DKA Trial conducted in the Pediatric Emergency Care Applied Research Network were published...

INTRODUCTION: The optimal fluid therapy in children with DKA is a matter of debate, especially if we take into account its association with cerebral edema, the most important complication. Hypertonic Saline Solution is used in the treatment of cerebral edema, and also has been used for volume resuscitation in children with shock. AIM OF STUDY: To compare the effects of 3% saline and 0.9% saline solutions on changes in vital parameters, sodium and chloride levels, lactate and pH; time needed for the correction of hyperglycemia; time needed for the control of ketoacidosis and incidence of cerebral edema...

BACKGROUND: The risk of developing long-term complications of type 1 diabetes (T1D) is related to glycaemic control and is reduced by the use of intensive insulin treatment regimens: multiple daily injections (MDI) (≥ 4) and continuous subcutaneous insulin infusion (CSII). Despite a lack of evidence that the more expensive treatment with CSII is superior to MDI, both treatments are used widely within the NHS. OBJECTIVES: (1) To compare glycaemic control during treatment with CSII and MDI and (2) to determine safety and cost-effectiveness of the treatment, and quality of life (QoL) of the patients...

BACKGROUND: Type 1 diabetes (T1D) is one of the most common chronic diseases in childhood. Daily diabetes management poses a major challenge for parents. Intensive insulin therapy using continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI) are recommended for patients with T1D, but evidence for their effectiveness on parental quality of life (QOL) and glycemic control among children with T1D is inconclusive. OBJECTIVES: A systematic review was conducted to determine the best available evidence regarding the effectiveness of CSII compared to MDI on parental QOL and glycemic control among children with T1D...

Objective: This meta-analysis was performed to evaluate the efficacy and safety of continuous subcutaneous insulin infusion (CSII) vs. multiple daily injections (MDI) in children with type 1 diabetes. Methods: A literature search was conducted on databases including PubMed and Embase up to June 2017. The pooled weighted mean difference or risk ratio as well as 95% confidence intervals were calculated using RevMan 5.3 software. Results: Eight studies involving 310 children with type 1 diabetes were included...

BACKGROUND: Diabetic ketoacidosis in children may cause brain injuries ranging from mild to severe. Whether intravenous fluids contribute to these injuries has been debated for decades. METHODS: We conducted a 13-center, randomized, controlled trial that examined the effects of the rate of administration and the sodium chloride content of intravenous fluids on neurologic outcomes in children with diabetic ketoacidosis. Children were randomly assigned to one of four treatment groups in a 2-by-2 factorial design (0...

OBJECTIVES: To evaluate glycemic control among children and adults with type 1 diabetes mellitus (T1DM) who consume a very low-carbohydrate diet (VLCD). METHODS: We conducted an online survey of an international social media group for people with T1DM who follow a VLCD. Respondents included adults and parents of children with T1DM. We assessed current hemoglobin A1c (HbA1c) (primary measure), change in HbA1c after the self-reported beginning of the VLCD, total daily insulin dose, and adverse events...

PURPOSE: To compare one vs. two bag system with respect to blood glucose variability (BGV), time for resolution of acidosis and incidence of hypoglycemia, hypokalemia, and cerebral edema in children with diabetic ketoacidosis (DKA). MATERIAL AND METHODS: In an open labelled randomized controlled trial, thirty consecutive patients ≤12years with DKA were randomized to either one (n=15) or two bag (n=15) system of intravenous fluid delivery. The two bags had similar electrolyte but differing dextrose concentration (none vs...

CONTEXT: Children with type 1 diabetes have vascular dysfunction preceding atherosclerosis. Early interventions are needed to reduce cardiovascular disease. OBJECTIVE: To evaluate the effect of metformin on vascular function in children with type 1 diabetes. DESIGN: Twelve-month double-blind, randomized, placebo-controlled trial. SETTING: Tertiary pediatric diabetes clinic. PARTICIPANTS: Ninety children (8 to 18 years of age), >50th percentile body mass index (BMI), with type 1 diabetes...

We aimed to assess the effectiveness of adding metformin to insulin in type 1 diabetes mellitus (T1DM) children for improving metabolic outcomes. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) conducted on children age 6 to 19 years who are diagnosed with T1DM, and examined the effect of adding Metformin to standard insulin therapy. We performed literature searches on Ovid Midline, Ovid Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) from the date of inception of the database to February 15, 2016...

BACKGROUND: The optimal rate of fluid administration in pediatric diabetic ketoacidosis (DKA) is unknown. OBJECTIVE: Our aim was to determine whether the volume of fluid administration in children with DKA influences the rate of metabolic normalization. METHODS: We performed a randomized controlled trial conducted in a tertiary pediatric emergency department from December 2007 until June 2010. The primary outcome was time to metabolic normalization; secondary outcomes were time to bicarbonate normalization, pH normalization, overall length of hospital treatment, and adverse outcomes...

BACKGROUND: Diabetic ketoacidosis (DKA) is an acute, life-threatening complication of uncontrolled diabetes that mainly occurs in individuals with autoimmune type 1 diabetes, but it is not uncommon in some people with type 2 diabetes. The treatment of DKA is traditionally accomplished by the administration of intravenous infusion of regular insulin that is initiated in the emergency department and continued in an intensive care unit or a high-dependency unit environment. It is unclear whether people with DKA should be treated with other treatment modalities such as subcutaneous rapid-acting insulin analogues...

BACKGROUND: Treatment of diabetic ketoacidosis (DKA) requires hourly controls of blood glucose, which define changes in the intravenous glucose and insulin administration. Every change requires preparing a new solution, wasting time and allowing errors. The two bag system (same electrolytes composition, but one with and the other without glucose) allows immediate changes in glucose administration rate, just by changing the solutions drip. OBJECTIVE: To compare the time needed to reach stabilization of patients with DKA using two different hydration systems: the traditional one (1 glucose/electrolyte solution) vs...