Active clinical trials for "Diabetes Mellitus, Type 1"

A closed-loop insulin system, also referred to as the "artificial pancreas" (AP), is made up of an insulin pump, a continuous glucose monitor, and an application communicating between the two to adjust insulin administration based on glucose control. This is meant for the treatment of type 1 diabetes. The McGill Artificial Pancreas (MAP) has been used previously in type 1 diabetes with significant benefits. Though prior studies have shown significant benefit with this system, some challenges still exist. Empagliflozin is used in type 2 diabetes; it allows for glucose to be removed through the urine. Though its use is not approved in type 1 diabetes in North America, it (along with similar drugs) has been used in studies as adjunctive therapy with insulin with benefits on blood sugar control. The purpose of our study is to see if a small dose of empagliflozin (2.5 mg and 5 mg) is enough to help those who cannot achieve adequate glucose control on a closed-loop insulin system. The primary hypotheses of the study are the following: The use of empagliflozin 2.5 mg daily will increase time in range compared to placebo for those on the closed-loop system. The use of empagliflozin 5 mg daily will increase time in range compared to placebo for those on the closed-loop system.

Multi-centric open-label randomized controlled trial (RCT) with 11 Belgian centers and one Dutch center in pregnant women with type 1 diabetes to assess safety, efficacy, feasibility and cost-effectiveness of 780 MiniMed Medtronic hybrid closed-loop insulin system (intervention group) compared to standard of care therapy (control group).

This study will evaluate the effects of 3 intra-nodal injections of GAD-alum (Diamyd), together with oral vitamin D supplementation. Safety and feasibility of the treatment will be evaluated and also effects on the immune system and on the preservation of endogenous insulin production.

This is a prospective randomized parallel two group pharmacist-led interventional study. The study will involve introduction of the mobile game to pediatric diabetic patients to improve their blood glucose level. The outcomes to be measured are diabetes control and behavioral change in pediatric patients with type1 diabetes mellitus

It is crucial to understand the social and economic context in which children and youth live; their social determinants of health (SDH). Although this is well recognized, many health care providers do not address SDH because of the lack of easily accessible resources once social needs are identified. Social workers (SW) have the ability to support families once a social need has been identified. However, not every clinic has a SW, and even those that do often struggle to meet the needs of all the families requiring support. The use of social navigators (SN) is an innovative solution for an unmet need. SN models have been successful in primary care settings, but, to date, have not been adapted to address the SDH needs of children and their families receiving care in pediatric specialty care settings. We will implement the first of its kind pediatric SN clinic at the Children's Hospital of Eastern Ontario (CHEO): "Navigating Social Resources for Children's Health" (NSRCH). Our study will evaluate NSRCH - an innovative, transferable, and low-cost pediatric-specific SN model. Our goal is to support families with SDH needs to access timely, appropriate supports and resources via NSRCH.

Adolescents and young adults with type 1 diabetes often have a difficult time achieving good glucose control, which is so important in reducing the risk for diabetes complications. Despite the use of multiple daily injections or insulin pumps and glucose sensors, there is still a need for many individuals to further improve glucose levels without causing low blood glucose levels (hypoglycemia) or adding to the daily burden of living with diabetes. Today an insulin pump can receive glucose readings from a continuous glucose monitor and adjust the insulin delivery in an attempt to keep glucose levels in a more optimal range. These systems are called hybrid closed loop (HCL). This means that much of the insulin delivery is automated, yet the patient still interacts regularly with the system, particularly to help determine the insulin dose to deliver to cover a meal. Results of early studies using HCL systems in adolescents and adults with type 1 diabetes are encouraging. The objective of this study is to compare the efficacy and safety of the automated insulin delivery (AID) system with proportional integral-derivative (PID) algorithm (Minimed 670G 3.0 HCL) to an AID system with combined PID and Fuzzy Logic Algorithm (Minimed 670G 4.0 Advanced Hybrid Closed-Loop (AHCL)). The trial will test the hypothesis that the Minimed AHCL can reduce daytime hyperglycemia, currently the biggest challenge for AID systems, without increasing hypoglycemia. Up to 124 adolescents and young adults (ages 14-<30) will be recruited to test each system for three months in a randomized crossover trial. Investigators will compare how effective each hybrid closed loop system is at preventing high blood glucose readings during the day. The investigators will also evaluate the safety of each system and how participants adjust to the daily use of the technology.

This feasibility/pilot study has three purposes. First, the investigators will determine the feasibility of collecting saliva to measure stress biomarkers over three days at home in youth. Second, the investigators will conduct a pilot study of the Teens.Connect Internet program for youth with type 1 diabetes to determine whether changes in stress biomarkers associate with self-reported perceived stress and HbA1c. Third, the investigators will examine the gene-environment interaction of the top 14 targeted candidate genes and epi-genome wide effects of teens' stress biomarkers and its influence on blood glucose levels over time.

The DreaMed Advisor Pro is a software which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing. The DreaMed Advisor Pro uses information gathered from glucose monitoring (sensor readings or capillary blood glucose measurements), insulin dosing and meal data during daily routine home care. Following a 5-minute data collection and analysis, the algorithm learns and suggests pump-setting changes for optimization of glucose control The algorithm is designed as an advisory tool and has three main components: A statistical analysis of the insulin pump and sensor data: insulin delivery, bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemia patterns. Practical recommendations, alert messages based on aforementioned data Recommendation for new insulin pump settings: including basal intervals and rate, different carbohydrate ratio according to time of day, correction factor and insulin sensitivity time. The main goal of the DreaMed Advisor Pro is to improve diabetes management for subjects with Type 1 Diabetes (T1D) by using an innovative Advisor to determine insulin dosing for pump users. The main objective of the proposed study is to evaluate the safety and efficacy of using the DreaMed Advisor Pro algorithm versus medical guided recommendation to determine insulin dosing for sub-optimal controlled subjects with type 1 diabetes using pump therapy.

The study is an open label single centre randomised cross over study to evaluate the impact of a sensor augmented pump (SAP) with a predictive algorithm to suspend temporarily insulin administration (640G® with the Smart Guard feature) versus the use of the same pump for insulin administration with 'only' continuous glucose measurements (not interacting with the pump, Freestyle Libre ® ) on the time in glucose target , in hypo- and hyperglycemia. Exploratory endpoints are the effect on sleep and quality of life in children with type 1 diabetes and their caregivers.

This clinical study proposes to assess the impact of Libre on frequency, duration and severity of hypoglycaemia, compared with the Dexcom G5 realtime CGM and will focus on people with impaired awareness of hypoglycaemia.