Active clinical trials for "Diabetes Mellitus, Type 1"

The ultimate T1D treatment tool is a closed-loop glucose control system, i.e. a fully automated system for intensive insulin treatment. Such system will ease the burden of constant treatment decision-making and at the same time it has the potential to safely intensify insulin therapy such that more patients can reach treatment goals. Currently, no off-the-shelf closed-loop system exists but research efforts in this field have been intensified and resulted in great progress in recent years. Most closed-loop systems consist of an insulin pump, a CGM, and a control algorithm residing on a mobile computer that continuously (every 5-15 min) computes the optimal insulin dosage from the CGM values. For daytime blood glucose control, however, we believe that the system needs to be further advanced. Consequently, we have extended our single-hormone closed-loop system such that it now includes a second pump for glucagon delivery and correspondingly we have further developed our control algorithm to compute both insulin and glucagon dosages. We hypothesize that we have developed a safe and effective dual-hormone closed-loop system for patients with type 1 diabetes and that this system is superior to single-hormone closed-loop therapy. The aims of this two-phase project are to 1) demonstrate proof-of-concept and 2) to compare dual-hormone with single-hormone closed-loop glucose control.

A dose with proven drug bioavailability to the immune system for use in a phase II/III primary T1DM (type 1 diabetes) vaccination trial (POINT study) in genetically at risk subjects. Study Design Randomized, placebo-controlled, double-blind/double-masked, multi-center, dose escalation primary intervention pilot study. Accrual Objective 25 (3:2 randomization to active and control arms)

The purpose of this study is to determine whether use of blood pressure lowering drugs, Angiotensin converting enzyme inhibitors (ACEIs) and blood fat (lipid) lowering drugs (statins) may have a place in the treatment of adolescents with diabetes and can help reduce serious long-term health problems in this population.

Background Type 1 diabetes mellitus is a chronic metabolic disorder that presents a significant set of challenges to the patient, their family and the physician. Near normoglycemia is associated with a reduced risk of microvascular and macrovascular complications in type 1 diabetes mellitus but is difficult to achieve despite considerable effort from patients and healthcare providers . Furthermore, episodes of hypoglycemia are frequent and may endanger life acutely. Subcutaneous glucose monitoring systems (CGMS), also called sensors that continuously measure interstitial fluid glucose levels have become available recently, and approved for use in children. CGMS has made it possible to assess the patterns and trends of blood glucose and the substantial variability in glucose excursions in the population of type 1 diabetes, and to prevent severe hypoglycemic episodes. The benefits of this technology are most apparent with near continuous wear of the sensors and is incorporated into the day to day management of the individual's diabetes . These devices provide patients with information regarding postprandial and overnight glucose profiles that are rarely, if ever, obtained with conventional self monitoring of blood glucose using home glucose meters . Skin reactions CGM systems measure the glucose content of interstitial fluid , using an electrochemical enzymatic sensor, which is accessed by a needle sensor inserted subcutaneously. The CGMS is compromised of a disposable subcutaneous glucose-sensing catheter connected by a cable to a pager sized glucose monitor . Problems related associated to skin irritation and sensor adhesiveness in these young children presents challenges to daily use of the CGMS. In the study conducted by Englert et al, for the Diabetes Research in Children (Directnet) Study Group - three primary factors that contributed to reduced CGM use were identified: the limited body surface area in smaller children, ambient temperature and humidity, as well as the type and duration of physical activity. A study conducted in Israel, by our group, demonstrated only 30% consistant use of the system, partly due to skin reactions . In our cohort, thirty participants of the CGMS group (36.1 %) had signs of local reaction to the RT-CGMS insertion. Mild-to severe local redness was reported in 19 % of patients and hyperpigmentation in 17 %. Skin reactions were among the reasons for discontinuation of CGMS (2/51 participants, 3.9 %). The use of Local Fluticasone for dermatological use Fluticasone propionate - the first carbothioate corticosteroid - has been classified as a potent anti-inflammatory drug for dermatological use. It is available as cream and ointment formulations for the acute and maintenance treatment of patients with dermatological disorders such as atopic dermatitis, psoriasis and vitiligo. This glucocorticoid is characterized by high lipophilicity, high glucocorticoid receptor binding and activation, and a rapid metabolic turnover in skin. Several clinical trials demonstrate a low potential for cutaneous and systemic side-effects . Even among paediatric patients with atopic dermatitis, fluticasone propionate proved to be safe and effective. These pharmacological and clinical properties are reflected by the high therapeutic index of this glucocorticoid. The same drug is also available as a nasal spray ,for cases of allergic rhinitis. The use of fluticasone in spray, sprayed on the location of CGMS insertion, prior to insertion to prevent adverse skin reactions in patients with type 1 DM using CGMS devices has not been addressed in the literature. Hypothesis : Minimizing skin irritation may significantly improve duration of use and tolerability of CGM devices by young children, as well a in young adults. The Investigators assumed that the simple use of a spray, which will not decrease the adhesiveness of the sensor, may improve use . Methods Children whose parents had difficulty with CGMS due to irritation, redness were offered to use Flixonase (FLUTICASONE PROPIONATE), with an approval form 29ג, indicating it is not approved for this specific diagnosis . The investigators followed those patients for improvement and possible local side effects. Study population Every patient, treated by the pediatric and adolescents diabetes mellitus interdisciplinary service , Assaf Haroffe Medical Center , who experienced local reaction at the site of CGMS was offered this medical option . Charts were reviewed for response . total participants - 15

Diabetes technology is changing and has quickly become an integral part of diabetes care and management. The study team plans to study the effects of introducing technology to newly diagnosed type 1 diabetes patients. The investigators hypothesize that early access to continuous glucose monitoring (CGM) technology will potentially improve satisfaction scores, hemoglobin A1c, glycemic control, reduce hypoglycemia, and ease the burden of disease when compared to new onset patients who receive standard of care access to CGM.

This study is evaluating how to encourage teens to engage in heart healthy behaviors such as being more active or eating in a healthy way. Teens will be randomly assigned to either the usual care group or the group with education, goal-setting, and lifestyle challenges with teammates.

The purpose of this clinical investigation is to evaluate the accuracy of the Eversense® continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared with reference standard measurements up to 180 days of sensor use. The investigation will also evaluate safety of the Eversense® 180 CGM System usage.

People with Type 1 diabetes (T1DM), type 2 diabetes (T2DM) and healthy volunteers will undergo a hypoglycaemic clamp to to investigate the effect of hypoglycaemia on cardiovascular and inflammatory responses.

The purpose of the study is to assess the accuracy of the Dexcom G6 CGM system and the Abbott FreeStyle Libre flash system compared to the reference standard YSI (Yellow Spring Instruments) glucose in people with diabetes undergoing haemodialysis. The Dexcom G6 is a continuous glucose monitoring system that gives blood glucose values in real-time and includes alarms if the glucose is very low or high. The Abbott FreeStyle ibre flash system is an intermittent glucose monitor that shows the blood glucose values when it is waved near the sensor and does not include alarms. The YSI glucose analysis will take place as a normal part of haemodialysis, by testing blood glucose levels during the haemodialysis session. The study will last 28 days per participant

We propose conducting a pilot randomized study to assess the feasibility of using the automated insulin dose adjustment (AIDA) system to assist the parents of children with Type 1 Diabetes to make insulin dose adjustments between visits with their diabetes provider. Study results will be used to inform a larger RCT with an anticipated primary outcome of change in HbA1c in patients managed with either standard care (changes in therapy settings effected at regularly scheduled patients visits) or AIDA guided care.