FreeStyle Libre FGM During Summer Camp for Children With Type 1 Diabetes
Type 1 Diabetes MellitusHypoglycemia1 moreA randomized, double-blinded, single center, parallel design pediatric study, on 45 subjects with type 1 diabetes (T1D), aged six to 15 (inclusive) years, measuring sensor time in glucose values within range 3.9 - 10 mmol/l (70 - 180 mg/dl) achieved using the FreeStyle Libre Flash Glucose Monitoring System (FGM - intervention, Abbott Diabetes Care, California, USA) versus Self-Monitoring Blood Glucose (SMBG - control). Study duration will be two weeks per subject and two weeks overall, it will take place at youth summer camp for children with T1D. Main inclusion criteria include age of six to 15 (inclusive) years, clinical diagnosis of T1D for at least six months, at least three months of current use of insulin pump therapy, HbA1c between 6.3 and 10 % (both inclusive), no other chronic medical conditions (beside treated hypothyroidism and celiac disease) and no current medications (other than insulin) (detailed list of inclusion and exclusion criteria list can be found at section 6). The objectives of this clinical investigation is: 1. to evaluate the efficacy of glucose control using the FreeStyle Libre FGM in children with T1D during two weeks of summer camp.
An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
HypoglycemiaThe purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.
Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
Acquired Hyperinsulinemic HypoglycemiaThe primary goal of this study is to evaluate the safety and efficacy of two different dosing regimens of an investigational drug called Avexitide in treating low blood sugar in patients with Acquired Hyperinsulinemic Hypoglycemia.
Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With...
Type 1 DiabetesHypoglycemiaThe aim of the study is to evaluate the efficacy, safety and feasibility of outpatient-utilization of low-dose dasiglucagon administered via a multi-dose reusable pen injector in preventing and treating mild hypoglycemia in insulin pump-treated people with type 1 diabetes.
Use of Terbutaline or a Reduction in Basal Insulin in the Prevention of Nocturnal Hypoglycemia
Type 1 DiabetesThe investigators hypothesize that the use of an oral dose of Terbutaline or a 20% basal reduction will be able to prevent nocturnal hypoglycemia after an afternoon exercise session. This is a randomized three period cross-over study including treatment with Terbutaline, a 20% basal reduction for six hours, or no treatment (control).
Insulin Analogues and Severe Hypoglycaemia
Type 1 DiabetesSevere hypoglycaemia is hampering the lives of many diabetic patients. The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated. In total, 250 hypoglycaemia prone type 1 diabetic patients will be randomised to receive analogue and human insulin for one year in random order. Outcomes will be number of episodes of severe hypoglycaemia
Insulin Glargine in Type I Diabetes Mellitus> Main Study "AT.LANTUS": A Trial Comparing Lantus Algorithms...
Diabetes MellitusType 1Primary objective: AT.LANTUS main study* To determine the optimal treatment algorithm for insulin glargine based on the incidence of severe hypoglycaemia.(*Target Number of patients for the main study:2346) HALT Sub-study** To test the hypothesis that titration regimens involving insulin glargine are associated with changes in the rate of symptomatic hypoglycaemic episodes together with changes in Fear of Hypoglycaemia as measured by the HFS-98 Questionnaire in Type I diabetes.(**Target Number of patients for the Sub-study: 250) Secondary objectives: AT.LANTUS main study To determine: the incidence of symptomatic, asymptomatic and nocturnal hypoglycaemia with each treatment regimen the difference in glycemic control as measured by HbA1c and fasting blood glucose with each treatment regimen the difference in glycemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment the safety on the use of insulin glargine in each treatment algorithm the change in subject weight with each treatment regimen the change in insulin doses with each treatment regimen the change in Diabetes Treatment Satisfaction (Diabetes Treatment Satisfaction Questionnaire, sub-study only) with each treatment regimen HALT Sub-study (baseline to study end) To estimate the relationship between change in HbA1c and incidence of hypoglycaemia To examine the effect of insulin glargine on Quality of Life (EQ-5D) in relation to incidence of hypoglycaemia To examine the effect of insulin glargine on the Hospital Anxiety and Depression Scale (HADS) in relation to the incidence of hypoglycaemia To examine the use of the Prescription Plan versus standard management (no Prescription Plan)
Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes
Type 2 Diabetes MellitusHypoglycemiaThe maintenance of nearly normal glycemic levels reduces the risk of diabetic complications, but is difficult to achieve, despite the administration of escalating doses of oral antidiabetic drugs, such as metformin, sulfonylureas, and thiazolidinediones. Most patients eventually require insulin which usually is added when glycemic control with a regimen of oral antidiabetic agents becomes suboptimal. The aims of the present study were: 1) To compare the clinical efficacy of insulin glargine and neutral protamine lispro (NPL) insulin when added to ongoing oral therapy in poorly controlled type 2 diabetic patients; 2) to find out the possibility to phenotype the patient who may benefit more by the single treatment. This an open-label, randomized, parallel, 36-week comparative study was performed between January 2007 and March 2008 at a single centre.
Skittles(TM) Effective for Treating Hypoglycemia in Children With Type 1 Diabetes
Type 1 Diabetes MellitusHypoglycemiaThe purpose of this study is to determine the most effective treatment option for managing naturally occurring hypoglycemia in children with type 1 diabetes. Hypotheses: Sucrose and Fructose are equally effective as glucose in the treatment of spontaneous hypoglycemia in children with type 1 diabetes. Children and teens will use a variety of treatment practices for the management of hypoglycemia. Children and teens will prefer the mode of treatment that was most effective in treating hypoglycemia.
Treatment With Erythropoietin and Cognition During Hypoglycaemia
Type 1 DiabetesHypoglycemiaThe purpose of the trial is to determine if erythropoietin (EPO) can enhance cognitive function during hypoglycaemia in patients with type 1 diabetes. Patients with type 1 diabetes will receive one injection of EPO. Hypoglycaemia will be induced 6 days after. Before (1 hour), during and after (1 hour) hypoglycaemia, the cognitive function will be measured.