View clinical trials related to Type 1 Diabetes Mellitus.
Filter by:Observational study about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in Type 1 Diabetes Mellitus (T1DM) adult patients in routine clinical practice.
A Phase 3 clinical trial has been completed and demonstrated the safety and efficacy of allogeneic islet transplantation in improving glycemic control in Type 1 diabetic patients using the UIC protocol.The objective in offering expanded access to donislecel (allogeneic islets of Langerhans for transplant; IND BB-11807) for the treatment of brittle T1D is to bridge the gap between completed clinical trials and marketing (i.e. approval by the FDA of a biological license application). Expanded access will allow clinical trial subjects, as well as patients outside a clinical trial, to receive treatment. New patients participating in the expanded access protocol are required to meet exclusion and inclusion criteria.
The primary aim of this study is to measure (residual) beta cell mass in type 1 diabetes (T1D) patients with stable near-normal and unstable glucose control using PET/CT imaging, to improve the understanding of the relation between beta cell mass and glycemic control in T1D.
In patients with type 1 diabetes (T1D) that have undergone islet of Langerhans transplantation or are on the waiting list for transplantation, Ga-68-exendin PET imaging is performed to study the visualization of transplanted islet grafts in patients.
The suggested clinical trial is part of the KidsAP project funded by the European Commission's Horizon 2020 Framework Programme with additional funding by JDRF. The project evaluates the use of the Artificial Pancreas (or closed loop system) in very young children with type 1 diabetes (T1D) aged 1 to 7 years. The suggested trial is an outcome study to determine whether 24/7 automated closed loop glucose control will improve glucose control as measured by time in range compared to sensor augmented pump therapy. In the extension phase, the purpose is to evaluate the effect of long-term home use of 24/7 automated hybrid closed loop insulin delivery on glucose control (UK sites only). The study adopts an open-label, multi-centre, multi-national, randomised, two period, cross-over design study, comparing two 16-week periods during which glucose levels will be controlled either by a closed loop system (intervention period) or by sensor augmented pump therapy (control period). Participants will complete a 2 to 4 week run-in period, followed by two treatment periods that will last 16 weeks each, with a 1 to 4 week washout period in between. The order of the two treatments will be random. A total of up to 80 young children aged 1 to 7 years with T1D on insulin pump therapy (aiming for 72 randomised subjects) will be recruited through paediatric outpatient diabetes clinics of the investigation centres. Prior to the use of study devices, participants and parents/guardians will receive appropriate training by the research team on the safe use of the study pump and continuous glucose monitoring device, and the hybrid closed loop insulin delivery system. Carers at nursery or school may also receive training by the study team if required. During the closed loop study arm, subjects and parents/guardians will use the closed loop system for 16 weeks under free-living conditions in their home and nursery/school environment without remote monitoring or supervision by research staff. During the control study arm, subjects and parents/guardians will use sensor augmented pump therapy for 16 weeks under free-living conditions in their home and nursery/school environment. All subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary endpoint is time spent in target range, between 3.9 and 10.0 mmol/l as recorded by CGM. Secondary outcomes are the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the frequency and severity of hypoglycaemic episodes and diabetic ketoacidosis (DKA). During the extension phase, participants will have follow-up contacts every 3 months. The primary endpoint is time spent in target range, between 3.9 and 10.0 mmol/l as recorded by CGM, over 18 months from the end of the primary phase, as compared to sensor augmented pump therapy during the primary phase. Secondary outcomes as well as safety and utility will be assessed as per primary phase.
In pregnancies associated with diabetes, lowering glucose to the recommended targets to prevent adverse health outcomes often leads to significant hypoglycemia. Hybrid closed-loop (HCL) therapy, automated insulin delivery using an insulin pump getting feedback from a continuous glucose monitor (CGM), may improve outcomes. This exploratory, novel pilot feasibility randomized clinical trial will evaluate pregnant women with type 1 diabetes (T1D) on HCL therapy or Sensor-Augmented Pump Therapy (SAPT, non-communicating pump and CGM) from the 2nd trimester, throughout pregnancy, and 4-6 weeks post-partum. Comparisons will be made on safety (Specific Aim [SA] 1), indices of glycemic variability and fear of hypoglycemia (SA 2), and quality of life and device satisfaction (SA 3) between groups. Exploratory SA 4 will compare maternal and fetal outcomes between groups. Safety data will include episodes of severe hypoglycemia requiring 3rd party assistance, diabetic ketoacidosis, and skin reactions. Glycemic control will be measured by CGM time spent in glucose ranges (<63, 63-140, >140 mg/dL) and other measures of glycemic variability. Subjects will fill out surveys (Fear of Hypoglycemia, a quality of life survey, and 2 questionnaires about device satisfaction) at baseline, throughout gestation, and early post-partum. Data on maternal and fetal outcomes will be collected. Findings will reveal the safety profile and glucose control with a novel therapy for pregnant women with type 1 diabetes.
The DreaMed Advisor Pro is a software which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing. DreaMed Advisor Pro is a decision- support software intended for assisting healthcare professionals in the management of type 1 diabetes patients who use insulin pumps as their insulin delivery therapy and monitor their blood glucose levels using CGM (Continuous Glucose Monitoring) or CGM and self-management blood glucose meter. The main objective of the proposed study is to test the safety, reliability, and efficacy of the DreaMed Advisor Pro algorithm when the recommendation is sent directly to the patient without a physician review. Participants will be randomized in a 1:1 ratio to either the intervention group (DreaMed Advisor Pro) or control group (standard of care). Participants will download the CGM and pump data at no less frequent than every 4 weeks for both groups during the 3 months period of the study. Each time new data is received, the following actions will be performed: In the intervention group, a new algorithm recommendation for pump settings will be issued. The recommendation will be approved by a technical, non-physician to assure that glucose data are not fall within predefined safety criteria which require a physician approval before the recommendation will be sent to the patient, otherwise, recommendation will be sent directly to the patient. In the control group, if no safety criteria is met, it is the responsibility of the patient to contact his/her physician to advise on change of treatment. In case a safety issue has occurred, the physician will contact the patient and change the pump settings. Prior to initiating the interventional phase of the study, we will evaluate the experience of patients in self adjustments of insulin dosing in regular care management and to evaluate their acceptance for using an automated dosing recommendations software. The evaluation will be done by asking patients/caregivers to fill 15 questions survey. 100 patients are anticipated to participate in this phase of the study.
The present study wants to compare the Dexcom G6® continuous glucose monitoring (CGM) system (experimental group) with the FreeStyle Libre flash glucose monitoring (FGM) system (control group). The ALERTT1 trial will have three phases: a baseline, study, and extension phase. During the baseline phase, eligible patients will be screened for in- and exclusion criteria, wear a blinded Dexcom G6® for 28 days, together with their FreeStyle Libre FGM system, and receive a uniform education moment. In the study phase, patients will be randomized into two groups (1:1): the experimental group will use an unblinded Dexcom G6® CGM for 6 months, the control group will keep using the FreeStyle Libre FGM system for 6 months. Before the 6 month time point is reached, patients in the control group will wear a blinded Dexcom G6® CGM for 28 days, together with their FreeStyle Libre FGM. In the extension phase, patients in the initial control group will start using unblinded Dexcom G6® for 30 months. The initial experimental group will keep using the unblinded Dexcom G6® for the next 30 months.
The objective of this randomized crossover clinical trial is to 1) assess the efficacy and safety of an automated insulin delivery (AID) system using a Model Predictive Control (MPC) algorithm versus sensor augmented pump therapy (SAP)/Predictive Low Glucose Suspend (PLGS) in people with type 1 diabetes, and 2) assess the impact of different meal macronutrient content on glucose control when using AID and SAP.
The overall goal of this study is to enroll pregnant women with type 1 diabetes and follow their glycemic outcomes prospectively throughout pregnancy and into the post-partum period. The investigators anticipate that when compared to subjects using an Artificial pancreas system (AP) as part of a future protocol, this comparator group of subjects undergoing usual care will exhibit less time in target continuous glucose monitoring (CGM) glucose range defined as 63-140 mg/dL and an increased duration of hypoglycemia with CGM glucose <63 mg/dL.