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Hypoglycemia clinical trials

View clinical trials related to Hypoglycemia.

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NCT ID: NCT05762107 Recruiting - Clinical trials for Type 1 Diabetes Mellitus With Hypoglycemia

A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes

ZONE
Start date: July 28, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to learn about the effect of the study drug (ZT-01) on low blood sugar (hypoglycemia) in adults with type 1 diabetes (T1D) who have been having low blood sugars ("hypos") at night. ZT-01 increases the amount of a hormone called glucagon during low blood sugar, and this may help prevent the occurrence of hypos. The main questions this trial aims to answer are whether ZT-01 lowers the number of hypos happening at night, and what its effects are on blood sugar levels. The safety of ZT-01 will also be measured. Participants will be asked to wear a study-provided continuous glucose monitor (CGM) during two 4-week periods when they will self-inject the study drug before bed. They will get ZT-01 at one of three dose levels during one period, and placebo (which looks like the study drug but doesn't contain the active ingredient) during the other. Neither the participant nor the study site will know what they are receiving during each treatment period or see data from the CGM. The participant will continue to use their usual methods of measuring blood sugar (including their personal CGM) and giving insulin during the study. The participant will be asked to complete a short diary each evening, and will be asked to upload the CGM data to a study phone every day. If a participant uses their own CGM and is willing to share information on how often they have low blood sugar with the study site at the first visit to see if they meet study entry requirements, they will have 6 study visits, 2 study phone calls, and be in the study for about 16 weeks. If they don't use CGM or don't want to share their information, then they will be asked to wear a study CGM for an extra 4 weeks to find out how many low blood sugars they have, and will have an extra visit. Study participants will be asked to give blood and urine for testing to see whether they meet the requirements to enter the study, and at the start and end of each treatment period to see if the study treatment has any effects. They will also have their blood pressure and temperature taken at each study visit, and have an ECG at 4 visits to measure the electrical activity of their heart. Some participants will be asked to also take part in a sub-study where their blood level of ZT-01 and glucagon is measured, after the first and last dose. They will be asked to stay at the study site overnight for each set of measurements (4 in total).

NCT ID: NCT05728320 Recruiting - Bariatric Surgery Clinical Trials

Glycemic Patterns After Bariatric Surgery and High Glycemic Variability and Hypoglycemia Unawareness Risk Factors

Start date: March 1, 2022
Phase:
Study type: Observational

To study the glycemic patterns of patients undergoing bariatric surgery and what are the risk factors capable of predicting episodes of unnoticed hypoglycemia and high glycemic variability, evaluating patients who underwent reduction gastroplasty with Roux-en-Y reconstruction (GRYR) and sleeve gastrectomy (SG)

NCT ID: NCT05721729 Active, not recruiting - Clinical trials for Postbariatric Hypoglycemia

Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions

Start date: June 23, 2023
Phase: Phase 2
Study type: Interventional

This is a phase 2 crossover, randomized, placebo-controlled, single-blind, repeat dose study in PBH subjects to determine the effect of mizagliflozin on adverse events and postprandial glucose excursions.

NCT ID: NCT05711108 Recruiting - Diabetes Clinical Trials

Continuous Glucose Monitoring (CGM) in Long Term Care (LTC) Facilities

Start date: January 19, 2022
Phase:
Study type: Observational

To prospectively determine the burden of hypoglycemia (minutes spent below 70 mg/dl per day, measured by continuous glucose monitor (CGM)) among residents of long term care facilities (LTC) with a diagnosis of type 1 or type 2 diabetes including key clinical subgroups (living in skilled nursing facility (SNF) or nursing home (NH), on different hypoglycemic medications). This aim will be achieved by recruiting 300 residents with diabetes in 4 LTC facilities. All participants will undergo masked CGM for 10 days.

NCT ID: NCT05700604 Completed - Cystic Fibrosis Clinical Trials

Hypoglycemia and Glucagon Response in CF

Start date: January 1, 2020
Phase:
Study type: Observational

The goal of this clinical trial is to investigate the etiopathogenesis of isolated hypoglycemia and hypoglycemia with abnormal glucose tolerance in children with Cystic Fibrosis (CF) and to evaluate the role of glucagon and pancreatic insufficiency on hypoglycemia in CF. The main questions it aims to answer are: 1. Do isolated hypoglycemia and hypoglycemia with abnormal glucose tolerance have different etiopathogenesis? 2. What is the role of pancreatic insufficiency in these two conditions? Participants were asked to perform 3-h OGTT and to take blood samples. Researchers compared with healthy peers to see if there is isolated hypoglycemia in OGTT and how is the glucagon response to OGTT in healthy peers.

NCT ID: NCT05687500 Recruiting - Preterm Clinical Trials

Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP)

GALOP
Start date: May 20, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to confirm hypothesis that Glibenclamide can be administered orally and is an alternative to insulin therapy in treating transient hyperglycemia of premature newborns.

NCT ID: NCT05687474 Recruiting - Cystic Fibrosis Clinical Trials

Baby Detect : Genomic Newborn Screening

Start date: September 1, 2022
Phase:
Study type: Observational

Newborn screening (NBS) is a global initiative of systematic testing at birth to identify babies with pre-defined severe but treatable conditions. With a simple blood test, rare genetic conditions can be easily detected, and the early start of transformative treatment will help avoid severe disabilities and increase the quality of life. Baby Detect Project is an innovative NBS program using a panel of target sequencing that aims to identify 126 treatable severe early onset genetic diseases at birth caused by 361 genes. The list of diseases has been established in close collaboration with the Paediatricians of the University Hospital in Liege. The investigators use dedicated dried blood spots collected between the first day and 28 days of life of babies, after a consent sign by parents.

NCT ID: NCT05686590 Enrolling by invitation - Hypoglycemia Clinical Trials

Prehospital Provider Training With Augmented Reality (AR)

Start date: December 12, 2022
Phase: N/A
Study type: Interventional

The goal is to evaluate the acceptance of Augmented Reality (AR) simulation as a learning modality for prehospital providers. The simulation itself is grounded in traditional best practices for simulation delivery and design as well as prior literature on simulation training for prehospital providers; the focus of this study is the participants' experiential interaction with AR and the simulation resources.

NCT ID: NCT05676385 Completed - Clinical trials for Postprandial Hypoglycemia

Glucose Response to a Formula for Patients at Risk of Hypoglycaemia

EFFECT
Start date: February 13, 2023
Phase: N/A
Study type: Interventional

This study assesses the glycemic responses to several nutritional products.

NCT ID: NCT05662657 Recruiting - Type 1 Diabetes Clinical Trials

Prevalence of Post Traumatic Stress Disorder Related to Diabetes Diagnosis or Severe Hypoglycaemia in Adult With Type 1 Diabetes

Start date: November 30, 2022
Phase:
Study type: Observational

In France, the adult population living with diabetes in 2016 is estimated at more than 3.3 million patients treated. Type 1 diabetes (T1DM) represents 5.6% of diabetic patients (approximately 185,000 patients). Numerous studies show that patients fear hypoglycemia, with an impact on their quality of life, sleep disorders and depressive symptoms. In addition, there is a metabolic impact with a problem of therapeutic compliance and an alteration of glycemic control. This study examine the relation between Post Traumatic Stress disorder (PTSD) and diabetes diagnosis or severe hypoglycaemia in adults with Type 1 Diabetes. The aim of this study is to evaluate the prevalence of PTSD in this population.