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Hypoglycemia clinical trials

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NCT ID: NCT03130101 Completed - Type 1 Diabetes Clinical Trials

Insulin Management for Exercise in Patients With Type 1 Diabetes

Start date: April 3, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the time spent in glucose target range (4.0-10.0 mmol/L) during exercise and in recovery using three different basal insulin management strategies for prolonged aerobic exercise: A) pump suspension for the duration of the activity, starting at the onset of exercise; B) A 50% basal rate reduction, performed 90-minutes in advance of exercise for the duration of the activity; and C) An 80% basal rate reduction, performed 90-minutes in advance of exercise for the duration of the activity.

NCT ID: NCT03112343 Completed - Diabetes Mellitus Clinical Trials

Information and Communication Technology Based Centralized Clinical Trial Monitoring System for Insulin Dose Adjustment

ICT
Start date: September 26, 2017
Phase: N/A
Study type: Interventional

This is a 24-week, open-label, randomized, multi-center trial conducted in three tertiary hospitals. There are three follow-up measures; at baseline, post-intervention at Week 12, and Week 24. Subjects are diagnosed as type 1 DM, type 2 DM, and/or post-transplant DM, and initiate or currently use insulin therapy. After the given education on insulin dose titration and prevention for hypoglycemia and 1 week of run-in period, subjects are randomized in a 1:1 ratio to either the ICT-based intervention group or the conventional intervention group. Subjects in conventional intervention group will save and send their health information to the server via the PHR app, whereas those in ICT-based intervention group have additional algorithm-based feedback messages. The health information includes levels of blood glucose, insulin dose, details on hypoglycemia, food diary, and number of steps. The primary outcome will be the proportion of patients who reach an optimal insulin dose within 12 weeks of enrolling in the study without severe hypoglycemia or unscheduled clinic visits. This study is based upon work supported by the Ministry of Trade, Industry & Energy (MOTIE, Korea) under Industrial Technology Innovation Program (No. 10059066, 'Establishment of ICT Clinical Trial System and Foundation for Industrialization.")

NCT ID: NCT03107806 Terminated - Hyperglycemia Clinical Trials

Monitoring Glucose Levels in Patients With Myocardial Infarction

COMGAMI
Start date: April 2013
Phase: N/A
Study type: Interventional

To evaluate the OptiScanner® for continuous glucose monitoring as a tool to optimize glucose levels in patients hospitalized for acute coronary syndromes

NCT ID: NCT03103009 Completed - Clinical trials for Hyperinsulinemic Hypoglycemia

Treatment Plan for an Individual Patient With Pasireotide for Hyperinsulinemic Hypoglycemia

Start date: March 22, 2017
Phase: Phase 1
Study type: Interventional

Somatostatin analogues are a last resort for medical intervention in hyperinsulinemic hypoglycemia (HH). The hypoglycemia is very debilitating and can be even life threatening. There is limited experience with pasireotide in hyperinsulinemic hypoglycemia (only one publication); there is more experience with octreotide, both in adults and children successful interventions with octreotide in hyperinsulinemic hypoglycemia have been published. Pasireotide via its different somatostatin receptor binding profile has clear effects on insulin, glucagon and incretin secretion and can ultimately lead to hyperglycemia. This mode of action (especially the effects on insulin and incretin secretion) could be very useful in the setting of hyperinsulinemic hypoglycemia.

NCT ID: NCT03102801 Completed - Clinical trials for Type 2 Diabetes Mellitus With Hypoglycemia

A Study to Identify Biomarkers of Hypoglycaemia in Patients With Type 2 Diabetes

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Glucose is a sugar carried in the blood stream that body uses for energy. If someone has diabetes, blood glucose level can be erratic, sometimes becoming very low this is called Hypoglycaemia (or a "hypo"), and can happen when blood glucose levels drop below 4 mmol/l. So far in order to prove that a hypo happened for a patient, blood glucose level can only be measured at time of the hypo and not after it. In this study we are trying to identify certain chemical substances (biomarkers) in diabetic patients that may be measured in blood tests of the patient up to after 24 hours of the hypo and if we could prove that a hypo has happened we could adjust tablets and or insulin dosage in a way to prevent further hypos. The study will be conducted in the Diabetes Centre in Hull Royal Infirmary and will involve three visits to the diabetes centre. The study can finish in a week time after the first visit. Visit 1 is the screening visit to identify eligibility to take part in the study. Visit 2 insulin infusion will be given to make participants blood sugar level fall lower than normal for a short time and corrected quickly afterward. This is a stress for participant's body and should stimulate certain chemicals that we are trying to identify during hypo. In Visit 3, the main purpose of this visit which is done 24 hours after insulin infusion is to take a blood sample and check how participants is after visit 2. We will recruit 25 Type 2 Diabetic patients and 25 none diabetics to compare both results. Both groups should not have ischemic heart disease, underactive thyroid or seizures and on stable dosage of medications.

NCT ID: NCT03090451 Completed - Clinical trials for Type 1 Diabetes Mellitus

Exercise Physiology Study

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

People with type 1 diabetes often find exercise very difficult to manage, because of the high risk for low blood glucose levels. This can occur very quickly once exercise starts and presents many risks for subjects, such as severe symptoms, confusion, passing out, seizures, and even coma or death in very severe cases. Preventing low blood glucose levels during and after exercise is important because physical exercise is a key component of managing diabetes. It is often hard to correctly adjust insulin infusion rates or doses before exercise as the relationship between exercise and changes in glucose levels in those who have type 1 diabetes is still not fully understood. Therefore, the investigators propose this study to further our understanding in this area. This study is designed to help separate the effects of insulin from those of muscle work (non-insulin effects) on the changes in blood glucose levels during aerobic exercise. The main hypothesis is that the non-insulin effects occur quickly during exercise and account for the rapid change in blood glucose levels once aerobic exercise begins. These effects can be separated from the slower changes in insulin sensitivity that occur because of exercise, and which account for reduced insulin demand even after exercise has stopped. The investigators will investigate the effects of both moderate and intense aerobic exercise at different levels of insulin in the body to help separate the insulin and non-insulin effects. The investigators wish to recruit 26 subjects to take part in this study. Subjects will be randomly divided into two groups, with 13 in each group. Group 1 will undergo moderate aerobic exercise, while group 2 will undergo intense aerobic exercise. Each subject will repeat the exercise study three times on three separate days at least 2 weeks apart, while having insulin infused at a low, a medium, and a high rate. Subjects will have an IV line placed in each arm, one for drawing blood relatively frequently during the study, and another for infusion of insulin, glucose, and a special glucose tracer (non-radioactive). Each study lasts about 9 hours. Information from this study will be used to help develop a mathematical model of how glucose changes during exercise in type 1 diabetes. Such a model of type 1 diabetes and exercise will be very useful for adjusting insulin doses in patients who use multiple daily injections of insulin, and can help to guide an automated insulin delivery system, such as the artificial pancreas.

NCT ID: NCT03079921 Active, not recruiting - Hypoglycemia Clinical Trials

Adrenergic System in Islet Transplantation

Start date: January 20, 2017
Phase: Early Phase 1
Study type: Interventional

To determine the effect of sympathetic neural and hormonal (epinephrine) input on islet cell hormonal responses to insulin-induced hypoglycemia in type 1 diabetic recipients of intrahepatic islet transplantation. We hypothesize that α-adrenergic (neural) blockage will abolish insulin-mediated suppression of C-peptide, attenuating α-cell glucagon secretion during hypoglycemia, and that β-adrenergic (hormonal) blockage will have no effect. Glucose counterregulatory responses will be measured during hyperinsulinemic euglycemic-hypoglycemic clamps on three occasions with randomized, double-blind administration of the α-adrenergic blocker phentolamine, the β-adrenergic blocker propranolol, or placebo. The demonstration of neural rather than hormonal regulation of the transplanted islet cell response to hypoglycemia is critical for understanding the mechanism for protection from hypoglycemia afforded by intrahepatically transplanted.

NCT ID: NCT03078491 Completed - Clinical trials for Type 1 Diabetes Mellitus

Technological Advances in Glucose Management in Older Adults

TANGO
Start date: March 30, 2017
Phase: N/A
Study type: Interventional

This is a study to assess the effectiveness of CGM (Continuous Glucose Monitor), enhanced by a diabetes management platform (DMP), collectively called enhanced CGM (eCGM), in the care of older patients with T1D. The DMP includes an automated data transfer from CGM, insulin-delivery devices, and activity tracker to a clinical decision support system (CDS) that provides dosing adjustment recommendations based on that data to the healthcare team. In addition, the DMP includes on-demand education for patients and caregivers, and an interface for communication between providers, patients, and their caregivers.

NCT ID: NCT03076775 Completed - Clinical trials for Neonatal Hypoglycemia

Euglycemia After Antenatal Late Preterm Steroids, the E-ALPS Study

E-ALPS
Start date: June 8, 2017
Phase: N/A
Study type: Interventional

Annually in the U.S 300,000 neonates are born late preterm, defined as 34 weeks 0 days - 36 weeks 6 days. The Antenatal Late Preterm Steroids (ALPS) Trial demonstrated that maternal treatment with betamethasone in the late preterm period significantly reduces neonatal respiratory complications, but also increases neonatal hypoglycemia, compared to placebo. This research study will attempt to answer the following primary question: Does a management protocol aimed at maintaining maternal euglycemia after ALPS decrease fetal hyperinsulinemia, compared to usual antepartum care?

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.