Active clinical trials for "Diabetes Mellitus, Type 1"

Children with type 1 diabetes face complex self-management regimens which make adherence challenging and ultimately result in poor blood sugar control. Several common barriers interfere with diabetes control such as limited knowledge or challenges with staying motivated. Efficacious strategies exist to improve diabetes self-management including, but not limited to, diabetes education or family therapy. Patients and families often do not access these strategies, in part due to healthcare systems-based issues such as accessibility, provider availability, or insurance coverage. A family-centered approach has been suggested to tailor diabetes care to provide improved outcomes for each child. Family-centered care engages the family in the decision-making about the child's health and well-being. In this study we will take a family-centered approach to providing diabetes self-management by identifying families' unique self-management barriers through a 10-minute survey tool called PRISM (Problem Recognition in Illness Self-Management). Based upon the results of PRISM, we will provide tailored self-management resources (interventions) to meet the family's needs. We will coordinate group-based delivery of the resources with routine diabetes clinic visits. These group-based resources will be delivered in four 75-minute sessions over a year. The primary goal of this study is to compare the effectiveness of family-centered tailoring of diabetes self-management resources with the untailored approach of usual care. We hypothesize that the family-centered model of care with tailored resources will improve the outcomes of glycemic control and quality of life among children with type 1 diabetes and their parents.

The main objective of this study is to determine whether day and night closed-loop insulin delivery for 12 weeks under free living conditions is superior to addition of real-time continuous glucose monitoring in adults with type 1 diabetes and sub-optimal glucose control on insulin pump therapy. This is an open-label, multi centre, randomised, crossover design study, involving a 6 to 8 week run-in period, during which glucose control will be optimised by a professional pump educator, followed by two 3 months study periods during which glucose levels will be controlled either by an automated closed-loop system or by subjects usual insulin pump therapy augmented with real-time continuous glucose monitoring in random order. A total of up to 42 adults (aiming for 30 completed subjects) aged 18 years and older with T1D on insulin pump therapy will be recruited through diabetes clinics and other established methods in participating centres. Subjects who drop out of the study within the first 6 weeks of the first intervention arm will be replaced. Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. Subjects will be discouraged from international travel during the first two weeks of closed-loop use. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM (adjusted for potential over-estimation) during home stay. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics.

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body)properties of FIAsp (faster-acting insulin aspart) in geriatric and younger adult subjects with type 1 diabetes.

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) response of Faster acting insulin aspart (FIAsp) in subjects with type 1 diabetes.

Patients with type 1 diabetes mellitus (T1DM) are at high risk of developing kidney complications potentially leading to end stage renal disease. Uric acid (UA), the end product of purine metabolism, emerged as an important determinant of renal and vascular injury due to its ability activate the renin-angiotensin-aldosterone system (RAAS) and increase production of harmful reactive oxygen species (ROS). ROS cause progressive endothelial cell dysfunction, inflammation, tissue fibrosis and eventually cell death. These processes are enhanced in DM because of the effect of hyperglycemia. Since existing preventive drug therapies fail to completely prevent kidney damage, an examination of the effect of UA lowering against initiation and progression of renal and vascular complications is therefore of the utmost importance. The purpose of this study is to examine the effect of UA lowering with febuxostat on renal and systemic vascular function in patients with uncomplicated T1DM. It was hypothesized that UA lowering will improve kidney and systemic vascular function through effects on blood vessel function and anti-inflammatory effect. Kidney and blood vessel function will be assessed under conditions of normal and high blood sugar levels before and after 8 weeks of treatment with the UA lowering drug febuxostat in patients with diabetes and during normoglycemia only in health controls. Current treatment for renal and vascular complications in DM patients includes blockade of the RAAS. Unfortunately, angiotensin converting enzyme inhibitors (ACEi) and angiotensin II (AngII) receptor blockers (ARBs) lead to incomplete RAAS suppression, and do not completely prevent renal or vascular complications. Moreover, dual RAAS blockade increases renal and cardiovascular risk. Recent experimental work suggests that UA lowering therapies can block the RAAS, suppress inflammation and promote renal and systemic vascular protection. Therefore, our study is critical in determining the possible role of early UA lowering on renal and systemic hemodynamic dysfunction in young patients with T1DM.

This is a randomized, controlled trial of Unified Safety System (USS) Virginia closed-loop versus sensor-augmented pump (SAP) therapy for hypoglycemia prevention in subjects with type 1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia.

The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

The overall purpose of this trial is to assess the efficacy and safety of using oral verapamil in subjects with recent onset T1D in order to downregulate TXNIP and enhance the patients' endogenous beta cell mass and insulin production. The objectives are therefore to assess parameters of beta cell survival (including new biomarkers), insulin production and glucose control and the feasibility of this approach and thereby provide the basis for future, larger/expanded, longer-term verapamil studies and the off-label use of this approved drug for Type 1 Diabetes (T1D).

This study is a multicenter, double-blind, placebo-controlled, 2:1 randomly assigned, phase 1 clinical trial for individuals with type 1 diabetes. It is a blinded dose-ranging study enrolling patients with new onset type 1 diabetes with documented continued residual C-peptide production. After a 4 week screening and run-in period during which eligibility will be determined and glycemic control optimized, subjects will have a 3-month double-masked treatment period with either DFMO or placebo. After a 3 month wash-out period the durability of effect will be assessed. Subjects will be randomly assigned (6 to DFMO; 3 to placebo in each cohort) to 1 of 4 sequential dose cohorts.

The objective of this study is to assess the efficacy of an Artificial Pancreas system which includes a Control-To-Range algorithm, versus standard Insulin Pump Therapy with Threshold Low glucose Suspend feature. 24 Children aged from 7 to 12 will be recruted in 4 clinical centres. After a 2 week run-in period, they will attend two investigational sessions of 65 hours in home-like settings. During each session, the CTR algorithm or the TLGS feature will be activated, depending on the randomization. The main endpoint is the time spent below 70mg/dL between 22:00 and 07:00.