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Showing 1-9 of 9 trials
NCT06693115
Using a prospective, mixed methods study design, the investigators will assess the feasibility, usefulness, and care team acceptability of CGM in conjunction with FSBG during implementation of the new subQ DKA/HHS protocol at Regions Hospital. This will include evaluating how many patients agree to have a CGM device placed, time to place the CGM devices, CGM impact on length of stay, level of care required, frequency of alerts to changing glucose levels events, and assessing the match between CGM and FSBG readings done in the inpatient setting. Results will help inform cost effective, safe, patient-centered strategies, while gauging care team satisfaction to optimize DKA and HHS management in the future.
NCT07423559
This study aimed to assess intensive care unit stay and relapse among patients of Diabetic ketoacidosis (type 1 diabetes mellitus) maintained basal bolus insulin and patients non maintaining along with intervenors insulin infusion.
NCT05402579
Sodium glucose co-transporter 2 (SGLT2) inhibitors have revolutionized care for people living with type 2 diabetes mellitus (T2DM). They reduce a person's risk of heart failure, renal failure, myocardial infarction, stroke, cardiovascular mortality, and potentially all-cause mortality. Remarkably, some of these benefits also extend to people who do not have T2DM. While the benefits of SGLT2 inhibitors are impressive, there is one life-threatening side effect associated with their use: diabetic ketoacidosis (DKA). The ability to predict which patients are at highest risk of DKA is needed to sufficiently mitigate this risk. Moreover, considering the impressive benefits of SGLT2 inhibitors, identifying patients at the lowest risk of SGLT2 inhibitor-associated DKA is also important so that providers do not overestimate risk in those who stand to benefit most. Advances in genomic technologies and related analyses have provided unprecedented opportunities to bring genomics-driven precision medicine initiatives to the forefront of clinical research. Leading these developments has been the progress made by genome-wide association studies (GWAS) due to decreasing genotyping costs, and consequently, the ability to routinely study large numbers of patients. These approaches allow for systematic screening of the genome in an unbiased manner and have accelerated the discovery of genetic variants and novel biological processes that contribute to the development of adverse treatment outcomes. By using innovative approaches, which harness large cohorts of population controls, sample size limitations that are associated with rare adverse drug reactions such as SGLT2 inhibitor-associated DKA can be overcome. The DANGER study represents a highly innovative new direction wherein partnership among basic science researchers and computational biologists will lead to the application of genomic techniques to identify genetic variants that may be associated with SGLT2 inhibitor-associated DKA.
NCT06955416
A number of scientific papers have been published on the efficacy and safety of adding REAMBERIN® (meglumin sodium succinate), a 1.5% infusion solution, to standard therapy for patients with diabetic ketoacidosis (DKA), which showed that the addition of the medication to DKA therapy at a dose of 10 ml/kg/day or an average of 800.68±151.59 ml on the first day of infusion, leads to a more rapid and successful resolution of DKA, achieving a state of compensation, a more rapid transfer of the patient from the intensive care unit (ICU) and discharge from the hospital. A combined, two-stage, multicenter, randomized, double-blind, phase II/III study with an adaptive design is planned. Stage 1 (phase II) will be a sequential evaluation of 2 doses of the study medication (750 ml and 1500 ml) versus placebo. At the 2nd stage of the study (phase III), additional recruitment of patients will be carried out in two groups in a 1:1 ratio to the experimental group or placebo group, to receive the optimal dose in accordance with the result obtained at stage 1.
NCT06516692
This study will help in determining the impact of assessment of Inferior Vena Cava Collapsibility and Distensibility Index (IVC CI and DI) through Point Of Care Ultra Sound (POCUS), for the fluid management of critically ill patients. This would help in better management of such patients in resource limited countries, where costly equipment for cardiac output monitoring and fluid management are frequently not available. Moreover this study will help in development of future guidelines for fluid resuscitation in critically ill patients.
NCT05867797
Diabetic ketoacidosis (DKA), a severe complication of diabetes mellitus (DM), is the leading cause of hospitalization, morbidity and mortality in patients with DM (1). DKA is associated with hyperglycemic crises and featured by metabolic acidosis, the production of ketoacids, volume depletion, and electrolyte imbalance. Due to glucose-induced osmotic polyuria and even emesis, volume depletion is a major cause of acute kidney injury (AKI) in DKA patients (2).
NCT04656236
The main objective of this clinical trial is to study the metabolic effects of intravenous infusion of the ketone body, 3-hydroxybutyrate (3-OHB), in patients with type 1 diabetes and healthy control subjects. Moreover, the investigators plan to examine regulatory mechanisms of 3-OHB that may be related to diabetic ketoacidosis. The hypotheses are: 1. 3-OHB related inhibition of lipolysis is impaired in patients with type 1 diabetes. 2. Intravenous infusion of 3-OHB affects signaling pathways involved in the metabolic regulation in patients with type 1 diabetes and healthy controls. 3. 3-OHB infusion improves cardiac function in patients with type 1 diabetes and healthy controls. The effects of 3-OHB will be investigated by isotopic tracers examinations, fat and muscle biopsies and blood samples. To evaluate effects on cardiac function echocardiography will be performed.
NCT01753921
This is a research study to understand how diabetic ketoacidosis may affect the brain and learning and to see if these changes are transient or permanent. The investigators hope to learn more about how diabetic ketoacidosis may cause changes in brain compliance (by wearing a non-invasive head band/helmet like device from Jan Medical: The Nautilus Neurowave System™ (NNS), learning, talking, behavior, or development. The investigators will compare those results from those with diabetes mellitus to those age and gendered matched healthy controls. Possible subjects in this study have diabetes mellitus and are between the ages of 10 to less than 17 years old OR do NOT have diabetes and are between the ages of 10 to less than 17 years old.
NCT02130180
Diabetic ketoacidosis (DKA) is a complication of type 1, or "insulin-dependent," diabetes (T1DM) and is defined by a high blood glucose level (over 200 mg/dL) coupled with severe acidosis. In this state the body breaks down fat tissue for adequate energy production. This results in ketone and acid production, and ultimately DKA. Cerebral edema (CE), or "brain swelling," can also occur with severe DKA. Current evaluation for DKA-related CE necessitates a high index of clinical suspicion and often times such patients receive advanced brain imaging such as computed tomography (CT) scans.Ocular sonography (ultrasound) is an alternative imaging technique that can provide immediate diagnostic capability at the bedside and minimize radiation exposure. This technique has been used to rapidly and accurately detect increased brain swelling through measurement of the optic nerve sheath diameter (ONSD) in a number of clinical situations including pediatric head trauma, hydrocephalus and ventriculoperitoneal shunt malfunctions, and altitude sickness in adults. Investigators plan to conduct a prospective study including children aged 7-18 years. The objective of this study is to assess the utility of sonographic measurements of the ONSD as a tool for identification of DKA-related CE.