Active clinical trials for "Diabetes Mellitus, Type 1"

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 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 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.

The primary goal is to test the function of the Diabetes Assistant (DiAs) enhanced control-to-range (CTR) controller in a closely monitored diabetes camp setting. The camp setting will allow us to obtain pilot efficacy data.

The addition of Biochaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to a facilitation of the absorption of the insulin after subcutaneous injection. The aim of the trial is to assess the efficacy and safety of BioChaperone insulin lispro in subjects with Type 1 diabetes under a dose of 0.2 U/Kg. This trial is a single-center, randomised, double-blinded, two-treatment, two-period cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone insulin lispro 0.2 U/Kg and a single dose of Humalog® 0.2 U/Kg on 2 separate dosing visits.

Continuous glucose monitoring (CGM) provides up to 288 blood glucose levels per day, updated every 5 minutes and displayed in real-time on the insulin pump, which can be used to enhance delivery of insulin through pump therapy. In addition this real-time CGM data includes "trend arrows" which indicate when the blood glucose is rapidly falling or rising thus enabling the pump user to make immediate adjustments in insulin delivery to prevent subsequent low or high blood sugars. The trend arrows are displayed when the blood glucose is rapidly falling or rising. For example, if the glucose is increasing by 1-2 mmol/L over 20 minutes, a single upward arrow alerts the pump wearer, who can then decide to give a bolus of insulin or increase the meal bolus. Should the glucose level be increasing at a rate greater than 2mmol/L over 20 minutes, 2 upward arrows are displayed and the user could decide to give a larger bolus. The purpose of the bolus adjustment is to add insulin for the predicted rise in glucose to prevent or reduce subsequent hyperglycemia. Similarly, a decrease in the insulin bolus is advised if glucose levels are falling as evidenced by one or two downward arrows. However, effective strategies for adjusting insulin boluses based on CGM trend arrows are lacking. The JDRF CGM Study Group recommended that boluses be adjusted based on trend arrows using a standard 10-20% increase/decrease of the total original recommended bolus dose (10% for one arrow up or down, and 20% for two arrows up or down), with the original bolus dose calculated by the pump calculator (i.e. Bolus Wizard). However, the original recommended bolus dose is dependent on the amount of food to be consumed (grams of carbohydrate) and the current blood glucose (if above or below target range), as well as the amount of active insulin, and therefore increasing or decreasing the total recommended bolus by 10-20% may overcompensate for the trend arrows and result in postprandial hypoglycemia. Attempts to use the10/20% formula within CHEO's large pediatric pump/CGM population resulted in low acceptance and adherence by CGM users. The CGM TIME Trial Study Group develop an innovative tool for adjusting boluses for CGM trend arrows based on the patient's own insulin sensitivity factor (ISF). The Trend Arrow Adjustment Tool formula is: if CGM shows a single arrow up or down: adjust bolus by +/- (1.5/ISF) and for 2 arrows up or down +/- (3/ISF). Use of the Trend Arrow Adjustment Tool within the CGM TIME Trial appears to lead to more appropriate adjustment in bolus dosing, and more effective prevention of subsequent hyper- and hypoglycemia. Furthermore, this tool appears to have excellent uptake amongst the TIME Trial participants, with observations that there is continued usage of the tool throughout the 12 month study, and greater satisfaction with this component of CGM. However, the tool has not been systematically evaluated. The proposed study will evaluate the Trend Arrow Adjustment Tool, to determine its effectiveness in reducing postprandial hyper- and hypoglycemia, as well as parent, child/youth satisfaction, and ease of use of the tool based on self-report measures. Comparison will be made with the 10/20% bolus adjustment & also to no adjustments to meal boluses (i.e. ignoring CGM trend arrows). Should use of the Trend Arrow Adjustment Tool lead to more time spent within the target glucose range, this will have immediate clinical benefit for patients, including improved quality of life, and potentially a reduction in HbA1c and prevention of long-term complications.

This project aims to evaluate the efficacy of autologous mesenchymal stem cell treatment to preserve insulin production and beta-cell mass in recently diagnosed patients with type 1 diabetes mellitus. The hypothesis to be tested is that an increased number of circulating mesenchymal stem cells will provide immune modulatory properties, and thereby stop the immune process in islets causing progressive beta-cell death.

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.

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.