Ketoacidosis children rct

The aim of this study was to assess the efficacy and safety of hybrid closed-loop (HCL) systems for insulin delivery in children and adolescents with type 1 diabetes (T1D). We searched Embase, PubMed, and Cochrane Library for randomized controlled trials (RCTs) published until March 2023 comparing the HCL therapy with control therapies for children and adolescents with T1D. We computed weighted mean differences (WMDs) for continuous outcomes and risk ratios (RRs) with 95% confidence intervals (CIs) for binary endpoints...

AIM: To determine the comparative effectiveness of fluid schemes for children with diabetic ketoacidosis (DKA). METHODS: We conducted a systematic review with an attempt to conduct network meta-analysis (NMA). We searched MEDLINE, EMBASE, CENTRAL, Epistemonikos, Virtual Health Library, and gray literature from inception to July 31, 2022. We included randomized controlled trials (RCTs) in children with DKA evaluating any intravenous fluid schemes. We planned to conduct NMA to compare all fluid schemes if heterogeneity was deemed acceptable...

BACKGROUND/OBJECTIVE: The main objective of this study is to evaluate the incremental cost-effectiveness (ICER) of the Cambridge hybrid closed-loop automated insulin delivery (AID) algorithm versus usual care for children and adolescents with type 1 diabetes (T1D). METHODS: This multicenter, binational, parallel-controlled trial randomized 133 insulin pump using participants aged 6 to 18 years to either AID (n = 65) or usual care (n = 68) for 6 months. Both within-trial and lifetime cost-effectiveness were analyzed...

BACKGROUND: This study compared the effectiveness of the traditional and revised one-bag protocols for pediatric diabetic ketoacidosis (DKA) management. METHODS: This single-center retrospective cohort study included children diagnosed with DKA upon admission between 2012 and 2019. Our institution reevaluated and streamlined the traditional one-bag protocol (revised one-bag protocol). The revised one-bag protocol rehydrated all pediatric DKA patients with dextrose (5 g/100 ml) containing 0...

BACKGROUND: Diabetic ketoacidosis (DKA) is a life-threatening complication in children with diabetes mellitus. There are considerable differences in the management approaches for DKA between different countries. One of the main areas of differences between guidelines is the administration of fluid, with most guidelines adopting a restrictive approach. This is based on the concern over cerebral oedema, a lethal sequela allegedly to be caused by excessive fluid administration. However, in recent years, new clinical studies suggest that there is no causal relationship between intravenous fluid therapy and DKA-related cerebral injury...

PURPOSE: Sodium glucose co-transporter-2 inhibitors (SGLT2i) have been evaluated in children with type-2 diabetes (T2DM), Type-1 diabetes (T1DM) and several other non-diabetic conditions. Potential tolerability issues have been preventing us from routinely using SGLT2i in children with diabetes. No meta-analysis till date has evaluated the safety and tolerability of SGLT2i in children. This systematic review and meta-analysis aimed to address this knowledge-gap. METHODS: Databases were searched for randomized controlled trials (RCTs), case-control and cohort studies involving children receiving SGLT2i in intervention-arm...

AIM: This systematic review aims to provide evidence on effectiveness of interventions used in emergency care of hypoglycaemia and diabetic ketoacidosis (DKA). METHODOLOGY: This is a systematic review of randomized controlled trials and analytical studies. We selected studies based on eligibility criteria. The databases Medline, Cochrane library and Embase were searched from their inception till November 2, 2022, using search strategy. We used the term such as "diabetes mellitus", "treatment", "hypoglycaemia", "diabetic ketoacidosis", "low blood sugar", "high blood sugar" and Mesh terms like "disease management", "hypoglycaemia", "diabetic ketoacidosis", and "diabetes mellitus" to form search strategy...

INTRODUCTION: Intravenous fluid therapy is the most common intervention in critically ill children. There is an increasing body of evidence questioning the safety of high-volume intravenous fluid administration in these patients. To date, the optimal fluid management strategy remains unclear. We aimed to test the feasibility of a pragmatic randomised controlled trial comparing a restrictive with a standard (liberal) fluid management strategy in critically ill children. METHODS AND ANALYSIS: Multicentre, binational pilot, randomised, controlled, open-label, pragmatic trial...

BACKGROUND: Closed-loop control systems of insulin delivery may improve glycemic outcomes in young children with type 1 diabetes. The efficacy and safety of initiating a closed-loop system virtually are unclear. METHODS: In this 13-week, multicenter trial, we randomly assigned, in a 2:1 ratio, children who were at least 2 years of age but younger than 6 years of age who had type 1 diabetes to receive treatment with a closed-loop system of insulin delivery or standard care that included either an insulin pump or multiple daily injections of insulin plus a continuous glucose monitor...

UNLABELLED: In children with diabetic ketoacidosis (DKA), insulin infusions are the mainstay of treatment; however, optimal dosing remains unclear. Our objective was to compare the efficacy and safety of different insulin infusion doses for the treatment of pediatric DKA. DATA SOURCES: We searched MEDLINE, EMBASE, PubMed, and Cochrane from inception to April 1, 2022. STUDY SELECTION: We included randomized controlled trials (RCTs) of children with DKA comparing intravenous insulin infusion administered at 0...

Aim: To assess long-term efficacy and safety of open-source automated insulin delivery (AID) in children and adults (7-70 years) with type 1 diabetes. Methods: Both arms of a 24-week randomized controlled trial comparing open-source AID (OpenAPS algorithm within a modified version of AndroidAPS, preproduction DANA-i™ insulin pump, Dexcom G6 continuous glucose monitor) with sensor-augmented pump therapy (SAPT), entered a 24-week continuation phase where the SAPT arm (termed SAPT-AID) crossed over to join the open-source AID arm (termed AID-AID)...

INTRODUCTION: The ketogenic diet is prescribed for seizures in some children with epilepsy. Children with type 1 diabetes are at risk for diabetic ketoacidosis caused by ketosis due to decreased insulin effect. Currently there are no clinical guidelines regarding the safety and efficacy of the ketogenic diet in patients with concurrent epilepsy and type 1 diabetes. OBJECTIVES: This review examines the current literature regarding the association between TID and epilepsy, proposed mechanisms for the observed relationship, risks and benefits of the ketogenic diet, and clinical applications of the ketogenic diet in the context of type 1 diabetes and epilepsy...

Objective: To evaluate safety and effectiveness of MiniMed™ 670G hybrid closed loop (HCL) in comparison with continuous subcutaneous insulin infusion (CSII) therapy for 6 months in persons with type 1 diabetes (T1D). Methods: Adults (aged 18-80 years), adolescents, and children (aged 2-17 years) with T1D who were using CSII therapy were enrolled and randomized (1:1) to 6 months of HCL intervention (n = 151, mean age of 39.9 ± 19.8 years) or CSII without continuous glucose monitoring (n = 151, 35...

Objective: To evaluate a transition from standard-of-care (SC) management of type 1 diabetes (any insulin delivery method including hybrid closed-loop systems plus real-time continuous glucose monitoring [CGM]) to use of the insulin-only configuration of the iLet® bionic pancreas (BP) in 90 adults and children (age 6-71 years). Research Design and Methods: After the SC group completed the randomized controlled trial (RCT) portion of the Insulin-Only BP Pivotal Trial, 90 of the 107 participants participated in a 13-week study using the BP...

IMPORTANCE: Of youths diagnosed with type 2 diabetes, many develop microvascular complications by young adulthood. OBJECTIVE: To review the evidence on benefits and harms of screening children and adolescents for prediabetes and type 2 diabetes to inform the US Preventive Services Task Force (USPSTF). DATA SOURCES: PubMed/MEDLINE, Cochrane Library, and trial registries through May 3, 2021; references; experts; literature surveillance through July 22, 2022...

BACKGROUND: Open-source automated insulin delivery (AID) systems are used by many patients with type 1 diabetes. Data are needed on the efficacy and safety of an open-source AID system. METHODS: In this multicenter, open-label, randomized, controlled trial, we assigned patients with type 1 diabetes in a 1:1 ratio to use an open-source AID system or a sensor-augmented insulin pump (control). The patients included both children (defined as 7 to 15 years of age) and adults (defined as 16 to 70 years of age)...

Objective: To compare the efficacy and safety of low dose insulin infusion (0.05 U/kg/h) against the standard dose insulin infusion (0.1 U/kg/h) in children with diabetic ketoacidosis. Method: Children (age <12 years, n = 30) presenting with diabetic ketoacidosis were enrolled and randomised to receive insulin infusion either as 0.05 U/kg/h (low dose) or 0.1 U/kg/h (standard dose) as an open labelled randomised controlled trial. The rest of the management was identical in both groups...

BACKGROUND: Since there are few treatment options for young people with type 2 diabetes, we aimed to assess the efficacy and safety of dapagliflozin as add-on therapy in children, adolescents, and young adults with type 2 diabetes receiving metformin, insulin, or both. METHODS: This multicentre, placebo-controlled, double-blind, randomised phase 3 study was undertaken at 30 centres in five countries (Hungary, Israel, Mexico, Russia, and the USA). Participants aged 10-24 years with type 2 diabetes and HbA1c concentration of 6·5-11% (48-97 mmol/mol) were randomly assigned 1:1 to oral dapagliflozin 10 mg or placebo during a 24 week double-blind period, which was then followed by a 28 week open-label safety extension in which all participants received dapagliflozin...

AIM: To obtain additional information on the incremental differences between using a sensor-augmented pump (SAP) without automated insulin delivery (AID), using it with predictive low-glucose management (PLGM) or as hybrid closed loop (HCL), in preschool and school children. METHODS: We conducted a monocentric, randomized, controlled, two-phase crossover study in 38 children aged 2-6 and 7-14 years. The primary endpoint was the percentage of time in range (TIR) of 70-180 mg/dl...

AIMS: To assess the safety and efficacy of hybrid closed-loop (HCL) insulin delivery 24/7 vs. only evening and night (E/N), and on extended 24/7 use, in free-living children with T1D. MATERIALS AND METHODS: Pre-pubertal children (n = 122; 49F/73M, age: 8.6 ± 1.6, diabetes duration: 5.2 ± 2.3 years, insulin pump use: 4.6 ± 2.5 years, HbA1c: 7.7 ± 0.7%/61 ± 5 mmol/mol) from 4 centers were randomized for 24/7 vs. E/N activation of the Tandem Control-IQ system for 18 weeks...