Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus
Type 1 Diabetes MellitusEvaluating the use of Liraglutide in patients with Type 1 Diabetes.
Evaluating Safety of NovoPen® 3 and/or FlexPen® Devices in Routine Clinical Practice
DiabetesDiabetes Mellitus4 moreThis study is conducted in Asia. The aim of of this study is to evaluate the safety of NovoPen® 3 and/or FlexPen® devices (if available on the market) measured by the number of adverse events and technical complaints in patients with type 1 and type 2 diabetes in routine clinical practice.
Special Survey of Production of Insulin Aspart Specific Antibody
DiabetesDiabetes Mellitus3 moreThis study is conducted in Japan. The aim of this study is to collect data of production of insulin aspart specific antibody under normal clinical practice conditions.
A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use...
Type 1 Diabetes MellitusType 2 Diabetes MellitusThe purpose of this study is to demonstrate the performance of the Enlite Sensor over an entire calibration and wear period of 146 hours (6 days) when inserted in the abdomen and buttock and used with the Revel 2.0 Pumps in subjects age 18 - 75 years.
Hypoglycemia Prevention After Exercise in Adolescent T1DM Patients Using a Control to Range System...
Type 1 Diabetes MellitusIn this protocol the investigators plan to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). The protocol is designed to challenge the insulin management system with meals and mild exercise, so as to demonstrate its capacity to avoid large glucose excursion with changing metabolic state. This system is designed to both monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections; predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection. The investigators plan to enroll 12 adolescent T1DM patients (expected retention 10/12) and compare glucose control performances under two treatments: standard vs. the new insulin management system. The protocol will include a total of 5 admissions per subject (3 out-patients and 2 in-patients): screening, CGM insertion 1, CGM insertion 2, inpatient 1 and inpatient 2. During the 24h inpatient admissions the patients will be challenged with 30 minutes of mild exercise and 3 meals, insulin coverage of these events will vary depending on the chosen treatment, each subject will be exposed to both studied treatments (repeated measure design). The order of treatment during the inpatient admissions will be randomized.
Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes
DiabetesHypoglycemiaThe study examines whether DPP-4 inhibition by vildagliptin affects the glucagon counterregulatory response to hypoglycemia in type 1 diabetes.
Surveillance Study of NovoRapid® for New Drug Re-examination
DiabetesDiabetes Mellitus3 moreThis study is conducted in Asia. The aim of this study is to observe the safety and efficacy of insulin aspart (NovoRapid®) administered via vial and three different devices.
Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System in Children...
Diabetes MellitusThe purpose of this study is to evaluate the safety and effectiveness of the G4 System when worn for up to 7-days by children and adolescent subjects (6 to <18 years-old) with type 1 diabetes mellitus.
Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia
Type 1 Diabetes MellitusThe purpose of the study is to compare the glycemic control during and following aerobic exercise using either an open or closed-loop insulin delivery system.
An Observational Study on Efficacy and Safety in Subjects Using Levemir® for the Treatment of Insulin...
DiabetesDiabetes Mellitus3 moreThis observational study is conducted in Africa. The aim of this observational study is to evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions.