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Hypoglycemia clinical trials

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NCT ID: NCT01923688 Completed - Diabetes Clinical Trials

Preventing Hypoglycemia

Start date: August 2011
Phase: N/A
Study type: Interventional

The purpose of the project is to improve in-patient safety by lowering the risk of severe hypoglycemia (low blood sugar) for patients with diabetes on insulin therapy and to improve communication between healthcare providers. The procedures of the study are: - the hospital patient information system [Pharmacy Event System,(PES)] will generate for healthcare providers a real-time risk alert of severe hypoglycemia (low blood sugar) - the real-time PES risk alert will be sent via a beeper to the patient's charge nurse - the charge nurse will follow the specific guidelines in the alert for assessment of the patient's care and insulin regimen - the charge nurse will then notify the physician of the patient's assessment and of the recommendation for change/no change in insulin regimen and/or clinical care - the alerted charge nurse and physician will complete a collaboration scale

NCT ID: NCT01922817 Completed - Type 1 Diabetes Clinical Trials

DPP4inhibitors in Type 1 Diabetes

Start date: September 2012
Phase: Phase 3
Study type: Interventional

A small, pilot, randomised, cross over trial that investigates the potential for DPPIVi therapy to reduce insulin requirements in type 1 diabetes was studied. We investigated whether this drug reduces daily insulin doses, leads to weight reduction, reduces blood glucose fluctuation and improves glucose control. Through reduction of blood glucose variability, we want investigated, whether it has the capability of improving the magnitude of epinephrine responses at 2.5mmol/L by performing a hyperinsulinaemic, hypoglycaemia clamp study after each arm. A successful outcome would then lead to an application for funds for a larger, multicentre intervention study. The benefits of this therapeutic advance are clear and this has the potential to make a dramatic improvement to the lives of people with type 1 diabetes in our community.

NCT ID: NCT01919788 Completed - Hypoglycemia Clinical Trials

Intracellular Counter-regulatory Mechanisms Following Low Blood Glucose

Start date: August 2013
Phase: N/A
Study type: Interventional

Diabetes mellitus type I (DMI) is characterized by lack of endogenous insulin and these patients are 100% dependent on insulin substitution to survive. Diabetes mellitus type II (DMII) is characterized by reduced insulin sensitivity and sometimes also reduced insulin production, thus patients with DMII might also be dependent on insulin substitution. Insulin is produced in- and secreted from the pancreas when blood glucose concentration rises during- and after a meal. Insulin increases cellular uptake of glucose leading to lower blood glucose concentration. Substitution with insulin is/can be necessary in DM, but at the same time it induces the risk of hypoglycemia. This makes treatment with insulin a balancing act between hyper- and hypoglycemia. A hypoglycemic episode is a dreaded consequence of insulin overdosing, and also a very frequent reason for hospital admission in patients with DM. Examples of hypoglycemic symptoms may be; shaking, a sense of hunger, sweating, irritability progressing to lack of relevant cerebral responses and eventually coma, convulsions and possibly death. People with diabetes lose the ability to sense of low blood glucose with time, because of a lack of appropriate counter-regulatory responses, hereby increasing the risk of severe hypoglycemia. Understanding normal physiologic counter regulatory mechanisms during hypoglycemia is of major importance to patients with DM and has the potential to change medical treatment in diabetes, to reduce the risk of hypoglycemia. Hypothesis: Hypoglycemia counteracts insulin signaling via hormone-dependent intracellular counter-regulatory mechanisms, involving phosphorylation of specific signaling proteins. Aim: To define counter-regulatory mechanisms in muscle- and fat tissue during hypoglycemia, and to investigate the effect of insulin on lipid metabolism in healthy- and type I diabetic subjects.

NCT ID: NCT01919385 Completed - Type 1 Diabetes Clinical Trials

Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia

Start date: July 2013
Phase: Phase 1
Study type: Interventional

This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type 1 diabetes that are currently using an insulin pump.

NCT ID: NCT01897363 Completed - Hypoglycemia Clinical Trials

Hypoglycemia in Prader-Willi Syndrome

Start date: July 2013
Phase: N/A
Study type: Observational

This project will study whether infants with Prader-Willi Syndrome experience low blood sugars after short periods of fasting. This study will also evaluate metabolic markers in the blood to determine if infants with Prader-Willi Syndrome process energy differently than other children during fasting.

NCT ID: NCT01865760 Completed - Obesity Clinical Trials

Etiology, Assessment and Treatment of Post-gastric Bypass Severe Hypoglycemia

Start date: June 2013
Phase: N/A
Study type: Interventional

With increasing rates of obesity the number of anti-obesity operations performed is increasing; one of the most common is gastric bypass. Anti-obesity surgery ameliorates diabetes and several other serious comorbidities, but bariatric surgery is also associated with medical and nutritional complications. Post-gastric bypass hyperinsulinemic hypoglycemia is a relative rare but serious complication often seen months to years after gastric bypass surgery. The patients experience neuroglycopenic symptoms (eg. inability to concentrate, weakness, altered mental status, loss of consciousness). The purpose of this study is to determine whether glucagon-like peptide-1 (GLP-1)or other enteropancreatic factors (eg. gastric emptying rate) are responsible for the excessed insulin secretion seen in some patients after bariatric surgery.

NCT ID: NCT01852968 Completed - Diabetes Mellitus Clinical Trials

Hippocampal Metabolism and Function in Patients With Type 1 Diabetes

Start date: May 2013
Phase:
Study type: Observational

The hippocampus is an area of brain which plays an essential role in learning and memory processing and is thought to be particularly vulnerable to effects of hypoglycemia (low blood glucose). The goal of this project is to examine hippocampal neurochemistry and metabolism and identify how diabetes and recurrent hypoglycemia alter the hippocampus.

NCT ID: NCT01841359 Completed - Hypoglycemia Clinical Trials

Pramlintide (Symlin) for the Treatment of Hypoglycemia Following Gastric Bypass Surgery

Start date: February 2, 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether pramlintide (Symlin) will help to reduce the frequency and severity of hypoglycemia in individuals who have had gastric bypass surgery.

NCT ID: NCT01823341 Completed - Type 1 Diabetes Clinical Trials

Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children

PSO4
Start date: May 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see whether low blood sugar at night can be reduced by using a system that turns off the insulin pump automatically. The study system includes a continuous glucose monitor (CGM) and an insulin pump. The CGM and pump work with a regular laptop computer. A The system works by (1) measuring the glucose levels under the skin with the CGM, (2) using a computer program on the laptop to predict whether a low blood sugar is likely to occur, and (3) turning off the insulin pump when the computer program predicts that a low blood sugar will occur. We have tested the system in the home environment in individuals with type 1 diabetes age 15 years and older. We have found an indication that the system can decrease the frequency of hypoglycemia. We have not had any serious cases of high blood sugars or other problems. We are now ready to further test the system in the home environment in a younger age group to learn more about its ability to reduce overnight low blood sugar risk. This study has several phases and will take about 3 months for a patient to complete. - First, the patient will use the CGM and pump at home for up to 15 days with the help of a parent/guardian. This is done to determine if the patient meets our study criteria to proceed with the next phase of the study. - If the patient is eligible to continue in the study, the patient will need to use the full study system for at least 5 nights at home with the help of a parent/guardian. This is done to make sure the patient and parent/guardian are able to use the system correctly. The patient may participate in starting and stopping the system at home, but the parent/guardian is responsible for making sure it is used as instructed. - After that, the patient will be asked to use the study system each night for an additional 6 to 8 weeks. The parent/guardian will remain responsible for making sure the system is used as instructed. The study will include about 90 individuals with type 1 diabetes at 3 clinical centers in the United States and Canada. First a study of children 8 to less than 15 years old will be done. Then, a study of children 3 to less than 8 years old will be conducted.

NCT ID: NCT01816893 Completed - Hypoglycemia Clinical Trials

Hypoglycemia and Autonomic Nervous System Function

HypoANS
Start date: June 8, 2004
Phase: N/A
Study type: Interventional

The goals of this proposal are to determine the effects of hypoglycemia on the autonomic nervous system.