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Hypoglycemia clinical trials

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NCT ID: NCT01980914 Completed - Type 2 Diabetes Clinical Trials

Hypoglycemia (Low Blood Sugar) and the Heart

Start date: March 2015
Phase: N/A
Study type: Interventional

The risk of hypoglycemia (low blood sugar) associated with the treatment of diabetes increases with age. Hypoglycemia is a common reason for admission to hospital for older patients with diabetes. Older patients are often unaware that their blood sugar is low and asymptomatic hypoglycemia, as assessed by continuous blood sugar monitoring, is frequent in the elderly. There is also evidence that older people with diabetes are more likely to develop cardiovascular events such a heart attack and more likely to die suddenly when compared to older people without diabetes. It is possible that low blood sugar levels contribute to the increased frequency of these events, but this possibility has never been studied. The purpose of this study is to assess how frequently low blood sugar occurs in older patients with diabetes and to see if low blood sugars adversely affect heart function in these patients.

NCT ID: NCT01972152 Completed - Hypoglycemia Clinical Trials

Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of G-Pen(TM) (Glucagon Injection) to Treat Severe Hypoglycemia

Start date: October 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a complication of diabetes.

NCT ID: NCT01942239 Completed - Hypoglycemia Clinical Trials

Real-time Continuous Glucose Monitoring in Very Low Birth Weight Neonates

Start date: December 2008
Phase: N/A
Study type: Interventional

Hypoglycemia is frequent in very low birth weight (VLBW) neonates and compromises their neurological outcome. The aim of this study was to compare real-time continuous glucose monitoring system (RT-CGMS) to standard method by intermittent capillary blood glucose testing in detecting and managing hypoglycemia. The investigators calculated a number of 48 neonates to be randomized between 2 ways of glucose level monitoring for their 3 first days of life : either by RT-CGMS (CGM-group), or by intermittent capillary glucose testing (IGM-group) associated with a blind-CGMS to detect retrospectively missed hypoglycemia. The investigators' hypothesis is that in the CGM group number and duration of hypoglycemia will be lower.

NCT ID: NCT01941238 Completed - Type 1 Diabetes Clinical Trials

Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi Dose Injection

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

Managing patients with type1 diabetes when fasting Ramadan is very challenging. Insulin pump offers the advantage of flexibility and precision to administering insulin and has been proven to reduce severe hypoglycemia compared to multi-dose injection (MDI). However, there are extremely limited studies on the difference between insulin pump compared to MDI on the incidence of hypoglycemia and other acute complications during fasting Ramadan The investigators hypothesized that insulin pump would be associated with less hypoglycemic events during fasting Ramadan compared to MDI without deterioration in glycemic control. Results of this study are descriptive but will fill a current gap in knowledge and may contribute to development of future guidelines for the management of type1DM during Ramadan.

NCT ID: NCT01933490 Completed - Clinical trials for Hyperinsulinemic Hypoglycemia

Post-Gastric Bypass Hypoglycemia

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

Post-gastric bypass hyperinsulinemic hypoglycemia is a recently described disorder occurring in some patients after gastric bypass surgery for obesity. The pathogenesis is incompletely understood but involves a robust insulin response to ingested carbohydrate. The resultant hyperinsulinemia sometimes produces hypoglycemia with neuroglycopenia, confusion and even loss of consciousness. Various treatments have been recommended including low carbohydrate diets, coingestion of the medication acarbose with carbohydrate containing meals, partial pancreatectomy and even total pancreatectomy. None is completely satisfactory. We propose to test two new potential treatments. Using a design with random assignment of three conditions we plan to compare, in 10 patients with post-gastric bypass hyperinsulinemic hypoglycemia, a high carbohydrate test meal (control condition), a high carbohydrate test meal after pre-treatment with rapid acting aspart insulin (insulin condition), and a high fructose, low glucose test meal with carbohydrate and caloric content similar to the control meal (fructose condition).

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: NCT01916148 Available - Insulinoma Clinical Trials

18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia

Start date: n/a
Phase:
Study type: Expanded Access

This purpose of this study is to determine the ability of an 18F-fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET (Positron Emission Tomography) scan to detect a focal lesion of hyperinsulinism and determine the location in patients with congenital hyperinsulinism, Beckwith Wiedemann Syndrome and suspected insulinoma. Safety data will be collected.