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Hypoglycemia clinical trials

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NCT ID: NCT03735225 Completed - Hypoglycemia Clinical Trials

Evaluation of the Safety, Tolerability and Bioavailability of Dasiglucagon Following Subcutaneous (SC) Compared to IV Administration

Start date: November 7, 2018
Phase: Phase 1
Study type: Interventional

The purpose of the trial is to characterize the safety and tolerability of dasiglucagon 4 mg/mL following IV administration at increasing doses in healthy volunteers. One cohort of subjects will receive a SC dose of dasiglucagon to characterize the bioavailability of dasiglucagon following SC administration compared to IV administration. Furthermore, the trial aims to assess the potential effect of dasiglucagon on corrected QT interval (QTc) prolongation via a concentrationresponse analysis.

NCT ID: NCT03734718 Completed - Clinical trials for Diabetes Mellitus, Type 1

The Role of Glucose-Dependent Insulinotropic Polypeptide in the Pathological Glucose Homeostasis Of Type 1 Diabetes

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in the daily life of participants with type 1 Diabetes

NCT ID: NCT03726697 Completed - Premature Infant Clinical Trials

Effect of Tahneek on Hypoglycemia in Newborn Infants

THIN
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Tahneek is an Arabic word which means putting something sweet such as dates, in the infant's mouth after the birth. Neonatal hypoglycemia is common in the first few days after birth. Up to 15 % of normal newborn babies will have low blood glucose concentrations. It has been demonstrated that treatment of neonatal hypoglycemia with oral dextrose gel was more effective than feeding alone in reversing the hypoglycemia, and also reduced the rate of NICU admission. investigators study is using dates to asses its effect on hypoglycemia in infants at risk.

NCT ID: NCT03725657 Completed - Exercise Clinical Trials

Correlation Between Exercise and Insulin Dose in a Camp for Pediatric Type 1 Patients

inCamp
Start date: October 29, 2018
Phase:
Study type: Observational

Intense exercise is a major challenge to the management of type 1 diabetes. The management is even more difficult, during a camp, probably due to increased hypoglycemia maybe from increase of intensity of physical activity. The investigators want to evaluate steps, energy expenditure, sleep time and glycemic control and insulin dosage, through use of a wrist accelerometer, in pediatric type 1 patients attending a camp. Finding a correlation between these parameters could be useful not only for educational purposes but also in the development of algorithms for artificial pancreas.

NCT ID: NCT03713060 Completed - Clinical trials for Hypoglycemia Non-Diabetic

Bariatric Surgery and Consequences for Mother and Baby in Pregnancy

BAMBI
Start date: April 17, 2019
Phase: N/A
Study type: Interventional

Background Roux-en-Y gastric bypass (RYGB) is a well-established treatment of obesity, most often performed in women during their reproductive years. Adverse events related to RYGB include hypoglycemia. Though usually attenuated in pregnancy, the incretin response is reinforced in subjects with RYGB and the resulting changes in insulin and glucagon responses together with the resultant weight loss are possible underlying mechanisms for hypoglycemia. The majorities of women who have undergone RYGB conceive shortly after RYGB and have an increased risk for inappropriate gestational weight gain (GWG) and thereby fetal growth restriction. However, studies of hypoglycemia and GWG in pregnant women following RYGB are lacking. Objective In women with previous RYGB we aim to investigate a) glucose level and incretin response during a mixed meal test (MMT) in early and late pregnancy, b) trimester specific incidence of postprandial hypoglycemia and c) fetal growth. Methods 20 women with RYGB and 20 age-, BMI- and parity-matched controls will be studied with a) 2nd and 3rd trimester 4-hour liquid MMTs, b) 6-days Continuous Glucose Monitoring (CGM) once every trimester and post partum and c) maternal and fetal anthropometrics including antenatal ultrasound examinations and neonatal DXA-scans. The primary outcomes are nadir plasma glucose levels during the 4-hour liquid MMT, number of hypoglycemic episodes during CGM and birthweight standard deviation scores. Discussion A better understanding of maternal metabolism and fetal growth in women with RYGB will support risk stratification, patient information and management both before and during pregnancy.

NCT ID: NCT03711656 Completed - Hypoglycemia Clinical Trials

Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes Using Machine Learning Techniques

Start date: October 10, 2018
Phase: N/A
Study type: Interventional

The objective is to develop a novel system to predict and prevent nocturnal hypoglycemia in type 1 diabetic (T1D) patients, focused in patients with multiple daily injections (MDI) therapy. The general idea is to make use of previous-day information in the moment when patients go to sleep, and then predict if in the next following hours any hypoglycemic event will occur. If the system will have predicted any hypoglycemic event in that moment, it is expected that it will be able to warn the patient to take some action: such as reduce basal insulin dose or to consume a snack before sleep. 10 patients with T1D for more than five years will be included. It is a longitudinal, prospective, interventional study in which every patient will use intermittently scanned Continuous Glucose Monitoring (isCGM) and a physical activity tracker during 12 weeks. Moreover, during this period, patients will store in a mobile application (Freestyle LibreLink) or in a reader information regarding their diabetes management activities, such as insulin delivery doses and meal consumption.

NCT ID: NCT03708939 Completed - Glucose Intolerance Clinical Trials

Microbiome and Non-caloric Sweeteners in Humans

Start date: February 19, 2017
Phase: N/A
Study type: Interventional

Non-caloric sweeteners are common food supplements consumed by millions worldwide as means of combating weight gain and diabetes, by retaining sweet taste without increasing caloric intake. While they are considered safe, there is increasing debate regarding their potential role in contributing to metabolic derangements in some humans. The investigators recently demonstrated that non-caloric sweeteners consumption could induce glucose intolerance in mice and, in preliminary experiments, in distinct human subsets, by functionally altering the gut microbiome, and that the gut microbiome plays an important role in mediating differential glucose responses to identical foods. The proportion of the human population that is susceptible to glucose intolerance induced by non-caloric sweeteners, the common factors that are shared between these individuals and whether and how the microbiome promotes the metabolic derangements remain to be addressed.

NCT ID: NCT03704818 Completed - Clinical trials for Type1 Diabetes Mellitus

Dapagliflozin Effects on Hypoglycemia

Start date: October 8, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this research study will be to test and evaluate if dapagliflozin has an effect on the amount of glucagon (a hormone produced by the pancreas and stomach that stimulates liver glucose production) produced by the body and if that change will improve recovery time from hypoglycemia (low blood sugar) in participants with Type 1 Diabetes.

NCT ID: NCT03688711 Completed - Clinical trials for Diabetes Mellitus, Type 1

Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM

Start date: November 1, 2018
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes mellitus (T1DM) compared to placebo

NCT ID: NCT03674281 Completed - Clinical trials for Type 1 Diabetes Mellitus

The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System

Start date: September 24, 2018
Phase: N/A
Study type: Interventional

The objective of this pilot study is (i) to test the use of an Artificial Pancreas (AP) System as a viable therapy treatment for two vulnerable populations: 6 to 10 year-old and adults older ≥65 years old with T1D; (ii) to assess cognitive function in children and older adult patients with T1D and examine whether improved glycemic control defined by stable (more than 70% of the day in glycemic range 70-180 mg/dL) control positively influences cognitive function; and (iii) obtain preliminary data to apply to funds to continue with larger and longer clinical trials.