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Hypoglycemia clinical trials

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NCT ID: NCT04824872 Withdrawn - Hypoglycemia Clinical Trials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NCT ID: NCT04192019 Withdrawn - Type 1 Diabetes Clinical Trials

Micro Glucagon During Exercise in Type 1 Diabetes

Start date: April 2023
Phase: Early Phase 1
Study type: Interventional

This proof-of-principle study to assess effects of different doses (mini and micro) of subcutaneous glucagon analog Dasiglucagon (Zealand Pharma, Copenhagen, Denmark) on the change in blood glucose concentration during moderate-intensity exercise in people with T1D.

NCT ID: NCT04147637 Withdrawn - Clinical trials for Type1 Diabetes Mellitus

FreeStyle Libre Plus Bluetooth Transmitter Adjunct: Can This Improve Glucose Accuracy and Reduce Burden of Hypoglycaemia

FSL-M
Start date: October 14, 2020
Phase: N/A
Study type: Interventional

Advanced glucose monitoring systems have revolutionized diabetes care and enabled people with diabetes to achieve better diabetes control with reduced risk of hypoglycaemia. Continuous glucose monitoring (CGM) systems provide real-time glucose monitoring and alarms when glucose approaches extreme readings (hypoglycaemia and hyperglycaemia) or when the change in glucose is rapid. All available CGM systems, except Dexcom G6, require daily calibrations with capillary glucose readings in order to attain accuracy of glucose readings. Decom G6 system is not widely accessible and only available in certain countries. Flash glucose monitoring systems (Flash) provide glucose readings when users actively scan their sensors. FreeStyle Libre (FSL) is the only Flash glucose monitoring system currently available in market. FSL is factory calibrated and sensors are ready to use after placement and initiation. The two main differences between Flash and CGM are user interaction and the alarm facility. While CGM provide real-time glucose readings, Flash is user-dependent for actively scanning and understanding the readings. Moreover, CGM systems provide alarms for low or high glucose and for rapid glucose changes, while Flash does not routinely provide alarms. This is particularly relevant when patients have impaired or lost hypoglycaemia awareness. CGM systems are costlier compared to Flash, which has contributed to the wider adoption of FSL. Several Bluetooth adjuncts have been introduced to market for FSL. These devices attach to Libre sensor and connect to the user's mobile phone via Bluetooth. This enables continuous and real-time feed of glucose readings from the sensor to patient's mobile phone, which enables a wide range of customizable alarms for high and low glucose levels and for rapid glucose changes. This setup also enables calibration of Libre sensor with capillary glucose which, anecdotally, has been reported to improve sensor accuracy. None of these adjuncts have been validated clinically. FSL with Bluetooth adjunct such as MiaoMiao remain cheaper than current CGM options and could be more accessible in some countries than CGM. However, without robust evidence to support effectiveness and safety of such setup it is not possible to recommend this. The Objective of this study is to determine whether FSL with Bluetooth Adjunct is superior to FSL alone in accuracy and reduction of hypoglycaemia burden.

NCT ID: NCT03827434 Withdrawn - Diabetes Mellitus Clinical Trials

CGM/Clarity Use, Glycemic Control and Clinical Outcomes

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

The prevalence of Diabetes Mellitus (DM) is rising and more than 30 million of Americans or 9.4% of the US population has DM. Several large scale randomized clinical trials have found that improved glycemic control reduces the development of complications in patients with DM. However intensive glucose management carries an increased risk of hypoglycemia, a condition that may lead to neurological damage and is associated with increased incidence of cardiovascular events and mortality. Reducing uncontrolled hyperglycemia and hypoglycemia represents therefore an important objective, as may decrease the direct and indirect impact that diabetes has in our health care system. Achieving optimal glycemic control requires frequent blood glucose monitoring by the patients and recurrent clinic visits,which is often difficult to achieve, as access to typical DM clinic is at least sub optimal. m-Health and telemedicine health solutions represent alternative ways to manage patients in the outpatient setting and have been applied in different medical areas, among them in diabetes. However, almost all the telemedicine studies that have been previously performed and recruited DM patients used telemedicine solutions which were based on point of care (POC) finger-stick glucose testing, which are checked infrequently , usually 4-6 times/day. Continuous glucose monitoring (CGM) devices offer additional ways to monitor blood glucose values and can provide numerous glucose measurements (as frequent as every 5 min). By using software applications, such as the Clarity (Dexcom), which highlights glucose patterns, trends and statistics in standardized reports, providers can make safe recommendations of adjusting DM medications, especially insulin titration. In this randomized clinical trial investigators propose to use CGM devices and Clarity software as a telemedicine platform in order to improve glycemic control and improve health outcomes.

NCT ID: NCT03738293 Withdrawn - Prematurity Clinical Trials

Continuous Glucose Monitoring of Late Preterm Birth After Corticosteroids

Start date: December 2019
Phase:
Study type: Observational

Women undergoing late preterm birth are at high risk of delivering a newborn with neonatal hypoglycemia. The investigators plan to monitor interstitial glucose levels prior to delivery in these women in order to develop a better understanding of the relationship between maternal hyperglycemia and neonatal hypoglycemia.

NCT ID: NCT03736083 Withdrawn - Hypoglycemia Clinical Trials

Introducing CGM at Type 1 Diabetes Diagnosis

Start date: September 2019
Phase: N/A
Study type: Interventional

Diabetes technology is changing and has quickly become an integral part of diabetes care and management. The study team plans to study the effects of introducing technology to newly diagnosed type 1 diabetes patients. The investigators hypothesize that early access to continuous glucose monitoring (CGM) technology will potentially improve satisfaction scores, hemoglobin A1c, glycemic control, reduce hypoglycemia, and ease the burden of disease when compared to new onset patients who receive standard of care access to CGM.

NCT ID: NCT03527498 Withdrawn - Cerebral Infarction Clinical Trials

Evaluation of Long-term Neurodevelopment in Neonatal Encephalopathy by Infant Treadmill

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

There is no international application of infant running stimulation system to evaluate the brain injury in children with various stages of nerve and motor development in a large sample of studies. The study of neonatal brain injury is only limited to intraventricular hemorrhage(IVH),periventricular leukomalacia(PVL), Down's syndrome(DS), premature birth of these four conditions, and the number of samples in the single digits, there is no representative of the disease population. Therefore, from the newborn to the infant development of the critical period, the investigator will refer to the previous treadmill parameters set on the research results, optimize the application of neonatal treadmill. The study hypothesized that neonatal treadmill stimulation with brain-injured children could improve his / her staggered gait characteristics and long-term nerve development through large sample data. It is important to preserve and analyze the gait characteristics and the changes of nerve development in every stage of growth and development of neonates with brain injury so as to provide clinical evidence for rehabilitation intervention. It is of great significance to judge whether this technique can be used in the early stage of brain injury in neonates.

NCT ID: NCT03053284 Withdrawn - Hyperinsulinism Clinical Trials

Pasireotide in Hyperinsulinemic Hypoglycemia

Start date: April 2017
Phase: Phase 2
Study type: Interventional

This is a small controlled pilot study to assess the effect of subcutaneous pasireotide on preventing hypoglycemia due to hyperinsulinism, including congenital hyperinsulinism and insulinoma.

NCT ID: NCT02586831 Withdrawn - Diabetes Mellitus Clinical Trials

Diabetes Islet Preservation Immune Treatment

DIPIT
Start date: January 2025
Phase: Phase 1/Phase 2
Study type: Interventional

To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.

NCT ID: NCT02518022 Withdrawn - Clinical trials for Type 1 Diabetes Mellitus

How to be Safe With Alcoholic Drinks in Diabetes

BEER
Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to show that during and after drinking beer a treatment strategy by insulin bolus and reduction of basal rate reduces the rate of hyperglycaemia without an increase of hypoglycaemic events compared to a treatment strategy according to the standard recommendation without insulin Bolus.