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Hypoglycemia clinical trials

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NCT ID: NCT04841304 Active, not recruiting - Diabetes Mellitus Clinical Trials

Cardiac Arrhythmia in Patients With End-Stage Renal Disease

CADDY
Start date: June 1, 2021
Phase:
Study type: Observational

The study will examine the presence of cardiac arrhythmias in patients receiving hemodialysis and the role of diabetes, hypoglycemia and parameters related to uremia and the dialysis procedure. The study is designed as a prospective cohort study with 18 months follow-up. 70 patients receiving chronic hemodialysis will be recruited and equipped with implantable loop recorders (ILR): 35 patients with diabetes and 35 patients without diabetes. Data collection during the follow-up includes continuous monitoring of the heart rhythm by the ILR for the entire follow-up period, continuous glucose monitoring for 10 days every second month, and monthly collection of blood samples and dialytic parameters.

NCT ID: NCT04836273 Completed - Clinical trials for Postprandial Hypoglycemia

Treatment of Post-bariatric Hypoglycaemia

SHERRY
Start date: August 20, 2021
Phase: Phase 2
Study type: Interventional

This is an investigator-initiated, proof-of-concept, randomised, double-blind, placebo-controlled, single-centre phase II study aiming to evaluate the efficacy, safety and tolerability of self-administered subcutaneous 120 µg dasiglucagon with an investigational trial device (i.e. a multi-dose reusable pen) for the treatment of postprandial hypoglycaemia after Roux-en-Y gastric bypass (RYGB) surgery. The study is divided into an in-patient and out-patient part. The primary aim of the study is to compare the effects of self-administered 120 µg dasiglucagon versus placebo on continuous glucose monitoring (CGM)-assessed time spent in hypoglycaemia in RYGB-operated individuals in an out-patient setting.

NCT ID: NCT04826627 Recruiting - Child, Only Clinical Trials

Impact of Preoperative Fasting on Intraoperative Glycemic Homeostasis and Enhanced Recovery in Children

GLYNEMCaen
Start date: July 15, 2021
Phase:
Study type: Observational [Patient Registry]

In 2018, the main societies of anesthesia (European Society Anaesthesiology, European Society Pediatric Anesthesia, and Association des Anesthésistes Réanimateurs Pédiatriques d'Expression Française) changed the current recommendations for preoperative fasting time in children, reducing the time to last intake of clear liquids from two to one hour before anesthetic induction. Prolonged fasting may have a deleterious impact on blood glucose homeostasis. The consequences of intraoperative hypoglycemia in children can be serious in the short term, but also in the long term. The objective of multicenter prospective, observational cohort study is to investigate- in children younger than 24 months of age undergoing scheduled conventional inpatient surgery- a correlation between the duration of preoperative fasting, glycemic intraoperative homeostasis and the criteria of enhanced recovery after surgery, which are the hospital length of stay (main outcome), postoperative pain and postoperative nausea-vomiting (secondary outcomes). By identifying non-adherence to fasting rules as one of the causes of prolonged hospitalization, this study will highlight the need to develop effective strategies to promote adherence to fasting rules in pediatric surgery and minimize the potential deleterious impact on intraoperative glycemic control.

NCT ID: NCT04825366 Recruiting - Type 1 Diabetes Clinical Trials

Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training

FEEL-HIIT
Start date: August 3, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to investigate if the addition of a 12-week program of home-based high intensity interval training to a standard educational program aiming at preventing hypoglycemia episodes will restore hypoglycemia awareness in people living with type 1 diabetes and impaired awareness of hypoglycemia to a further extent than a standard educational program alone. Participants will be randomized for 12 weeks to the standard educational program with or without high intensity interval training. The Gold method will be used to identify people with impaired awareness of hypoglycemia. The educational program will consist of two education sessions on avoidance of hypoglycemia, causes of hypoglycemia, treatment (e.g. glucagon) of hypoglycemia, how to better recognize hypoglycemia symptoms, understand how to use a CGM/Flash-GM and understand CGM/Flash-GM reports to adjust insulin doses. Participants randomized to the training program will be asked to train three times per week for 12 weeks following the home-based program that will be provided to them. Participants will be asked to perform at least 2 training sessions per week (ideally all 3 sessions) with the exercise specialist on a virtual platform.

NCT ID: NCT04824872 Withdrawn - Hypoglycemia Clinical Trials

Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults

Start date: February 2023
Phase: Phase 2
Study type: Interventional

The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects

NCT ID: NCT04811612 Not yet recruiting - Clinical trials for Neonatal Hypoglycemia

Comparing Heel Stick Glucoses in Neonates

CHECK IN
Start date: May 2021
Phase: N/A
Study type: Interventional

Newborn babies can develop low blood sugar (glucose) which can lead to brain injury and poor developmental outcomes. Therefore, it is important to accurately measure the blood glucose in babies. One way to measure the blood glucose is to test blood from the baby's heel with a bedside device called a point of care glucometer. This method is very common and easy; however, multiple factors can lead to an inaccurate reading. A false low reading may require additional blood testing and admission to the NICU. A false high reading could result in the medical provider missing the diagnosis of low blood glucose. Our team wants to know if there is a difference between blood glucose measurements taken from warmed and un-warmed heels of infants. Blood flow farther away from the heart, such as in the feet and heels, may be less than the rest of the body, and might move more slowly. This could cause the glucose level to be lower in the feet and heels. Therefore, sampling blood from an un-warmed heel may result in a falsely low glucose reading. There is some research that suggests warming the heel increases blood flow to the area; however, only one study that we know of has evaluated differences in blood glucose readings from warmed and un-warmed heels. They found significantly higher blood glucose readings from warmed heels compared to un-warmed heels in 57 babies. However, these babies were part of a larger study comparing different diets on blood glucose levels, and the heels were warmed using warm water which is no longer a current practice. The goal of this study is to compare the capillary blood glucose levels from warmed and un-warmed heels in about 100 infants who are breast and/or formula fed using the current practice of warming heels with gel heat packs. The null hypothesis is that there will be no difference between capillary blood glucose levels sampled from an infants warmed and un-warmed heel. The alternative hypothesis is that capillary blood glucose levels sampled from warmed heels will be higher than those samples from un-warmed heels.

NCT ID: NCT04797208 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Remote Glucose Monitoring in Hospital Settings

REMOTE-CGM
Start date: January 9, 2023
Phase: N/A
Study type: Interventional

Use of real-time continuous glucose monitoring (RT-CGM) systems in inpatient settings especially during the COVID-19 pandemic, may allow hospital staff to remotely monitor glucose while reducing viral exposure and preserving use of PPE. RT-CGM may be of benefit to inpatients with unstable glycaemia and at risk of severe hypoglycaemia, as it can automatically alert the treating clinical team of hypo and hyperglycaemia. This is of clinical relevance as up to 45% of inpatients with diabetes were found to have asymptomatic hypoglycaemia events in hospital, especially overnight. It may therefore provide a safer method of monitoring glycaemia in hospital compared to conventional bedside capillary glucose testing, by minimising the likelihood of hyper- and hypoglycaemic events and their known associated worse outcomes. The aim of this pilot study is to to demonstrate that use of Dexcom G6 RT-CGM may provide a safer and effective method of monitoring glycemia in hospital. Data from this pilot study will be used to design and implement a larger multi-centre pivotal trial.

NCT ID: NCT04786262 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

Start date: March 29, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

NCT ID: NCT04770636 Enrolling by invitation - Clinical trials for Neonatal Hypoglycemia

Glucose Disturbances in Premature Infants and Quality of Life

Start date: August 1, 2013
Phase:
Study type: Observational

The aim of this study is to investigate the correlation between preterm birth, glucose level in the first two hours of life and health related quality of life in the age of 8 months and 7 years

NCT ID: NCT04764968 Completed - Type 1 Diabetes Clinical Trials

Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes

Start date: April 27, 2021
Phase: Phase 2
Study type: Interventional

The aim of the study is to evaluate the efficacy, safety and feasibility of outpatient-utilization of low-dose dasiglucagon administered via a multi-dose reusable pen injector in preventing and treating mild hypoglycemia in insulin pump-treated people with type 1 diabetes.