View clinical trials related to Hypoglycemia.
Filter by:BIOD-961 is a dry powder formulation of glucagon intended for use in a device that mixes (reconstitutes) the powder with liquid to make it easier for users to treat patients with severe hypoglycemia. The purpose of this study is to evaluate how much BIOD-961 absorbs into the bloodstream, how much it raises glucose concentrations (the intended effect) and compare to two glucagon products already on the market.
Up to fifty (50) children and adolescents with type 1 diabetes (T1D) aged 4 to ˂18 years at time of enrolment will be selected for inclusion in the study. The target is to obtain treatment response and user-experience data following use of Nasal Glucagon (LY900018) in treating episodes of hypoglycemia.
The objective of this pilot trial is to demonstrate the safety and the performance of the Hyposafe hypoglycaemia alarm device before conducting clinical trials in type 1 diabetes patients.
The trial is a single-centre, randomized, double-blind, phase 1b trial of multiple ascending doses of ZP4207 administered s.c. to healthy volunteers (HV) to evaluate the safety, tolerability, pharmakocinetic (PK) and pharmacodynamic (PD). Three cohorts of 8 subjects are planned. Within each cohort, the subjects will be randomly assigned to five repeated doses of ZP4207 or placebo in a 3:1 treatment allocation at trial site.
The trial is a randomized, double-blind First in Human trial to evaluate the safety and tolerability of ZP4207 in healthy volunteers (HV) and in insulin-induced hypoglycemic T1D (type 1 diabetes) subjects as compared to native glucagon. The trial includes two parts. Part 1 includes dose escalation of ZP4207 in cohorts of 8 subjects. In each cohort, subjects will be randomized 3:1 to receive either a single ascending dose of ZP4207 (6 subjects) or a single fixed dose (SD) of native glucagon (2 subjects). The doses will be administered s.c. in 4-5 cohorts and i.m. in 3 cohorts. Part 2 includes two sequence groups of 10 hypoglycemic T1D subjects. The subjects will be treated with fixed single doses of ZP4207 and native glucagon s.c. in a sequential cross-over design in a randomized treatment order.
It is known that hypoglycaemia affects various domains of cognitive function. One aspect of cognitive function is 'social cognition', which is our ability to interpret facial expressions, gestures and speech. It is an approach to understanding human judgement and behaviour. There is anecdotal evidence for negative behavioural responses such as aggressiveness and argumentativeness during hypoglycaemia and while research has shown that hypoglycaemia can cause significant changes in mood, little information exists regarding its effect on social cognition. It is therefore not known whether hypoglycaemia affects this aspect of cognitive function but, if it did, it could explain why people with low blood sugar due to insulin treatment are often resistant to offers of help (for example, they may misinterpret a friendly gesture as being threatening). Knowledge of this effect of hypoglycaemia can be used to educate relatives and carers of people with diabetes who may suffer this problem. Hypoglycaemia is also known to have an effect on the electrical rhythm of the heart. This is thought to be secondary to adrenaline secretion during hypoglycaemia which provokes a fall in the blood level of potassium, a type of electrolyte. Other electrolyte imbalances are known to predispose to heart rhythm abnormalities or arrhythmias in other situations and it is not known if the levels of these other electrolytes are affected during hypoglycaemia. Using specific tests of social cognition and continuous electrocardiographic (ECG) monitoring, this study aims to find out whether social cognition is affected by an hour of hypoglycaemia and how hypoglycaemia affects blood electrolyte levels and the electrophysiology of the heart.
Low blood sugar levels are common in babies after birth. This may be normal as babies can use other sources of energy. However if a baby does not produce these fuels the brain can be starved of energy and be damaged. Measurement of these fuels is not done as part of clinical practice in the newborn. The investigators aim to see whether at the same time as taking the blood sugar level from a heel prick these fuels can be measured in a small drop of blood. At the same time as blood needs to be taken for clinical reasons the study team will to take a drop of blood from 50 babies to see how good the point of care (POC) meters are compared to the laboratory at measuring these fuels. If accurate these POC meters could identifying those at risk from brain damage as well as prevent separation of mothers and babies who are establishing breast feeding.
One of the emerging complications of RNY gastric bypass surgery is mild to severe refractory/ recurrent postprandial hypoglycemia. This complication can lead to a significant reduction in quality of life to severe disability. Unfortunately at this time there are no treatment guidelines or proven therapeutic options for the treatment of this complication. One of the proposed treatment options is the use of fiber supplements to help modify the absorption of glucose, slow the food bolus transit time more toward normal and restore the postprandial (after meal) glucose homeostasis. The investigators are proposing a pilot project for the use of Glucomannan soluble fiber as a treatment option for postprandial hypoglycemia in this cohort. This project will help the investigators to identify if Glucomannan soluble fiber can be used as an effective dietary supplement to eliminate or reduce this condition
The Minimed®640G system (MM640G) consists of a combination of insulin and glucose sensor for continuous glucose monitoring (CGM). Here, the glucose sensor transmits not only the continuous glucose data on the display of insulin pump but, in the case of hypoglycemia also interrupt their insulin delivery of pump. In the currently available system Paradigm®VEO, the interruption takes place at a settled threshold level. In difference in the new system MM640G the shutdown algorithm can already be proactive and help avoid hypoglycemia completely. The so called PLGM algorithm (predictive low glucose management) should be tested in the user evaluation. The main objective is to answer the question of reducing the rate of hypoglycemia by application of the new PLGM algorithm. Included are a total of 24 patients, aged 1-21 years, in three pediatric diabetes centers.
Patients with insulin-dependent diabetes mellitus (DM) and chronic kidney disease (CKD) exhibit an excessive risk for cardiac arrhythmias, in particular sudden cardiac death (SCD). Hypoglycemia is a frequent problem in insulin-treated patients, especially in those with CKD, and various studies have shown that hypoglycemic episodes are strong predictors of cardiovascular mortality in both type 1 and type 2 diabetic patients. Experimental data and small clinical studies link hypoglycemia with ECG changes and SCD, but little is known about the direct association of hypoglycemic events and/or rapid swings in blood glucose with arrhythmias in this high risk population. Ideally, an algorithm should help to identify patients at risk for hypoglycemia-associated arrhythmias and SCD, but hitherto systematic analyses of blood glucose values and 12-channel ECGs are lacking in these patients.