Active clinical trials for "Diabetes Mellitus, Type 1"

The DIA-LINK Study is a prospective observational study analysing longitudinal associations and mediating links between diabetes distress (DD), depressive symptoms (DS) and glycaemic outcomes in people with type 1 diabetes (T1DM). A total of 200 people with T1DM with different levels of DD and DS are to be enrolled. At baseline, all participants are assessed for DD and DS, psychological and stress-related variables, self-reported self-management, HbA1c and inflammatory markers. This is followed by a 4-week ambulatory assessment period including continuous glucose monitoring (CGM), continuous activity tracking and daily event sampling regarding sleep, stress levels, mood and diabetes-related issues; additionally, cortisol levels are assessed on four days within this period. Three months after baseline, a follow-up assessment covers DD and DS levels, stress-related variables, self-reported self-management, HbA1c and final CGM assessment. The analyses aim to establish risk factors/protective factors regarding DD and DS, their relative impact on glycaemic outcomes and potential mediation of the associations by behavioural (e.g. self-management, physical activity), physical (e.g. heart rate variability, inflammatory activity) and mental variables (subjective stress level) in T1DM.

The objective is to develop a novel system to predict and prevent nocturnal hypoglycemia in type 1 diabetic (T1D) patients, focused in patients with multiple daily injections (MDI) therapy. The general idea is to make use of previous-day information in the moment when patients go to sleep, and then predict if in the next following hours any hypoglycemic event will occur. If the system will have predicted any hypoglycemic event in that moment, it is expected that it will be able to warn the patient to take some action: such as reduce basal insulin dose or to consume a snack before sleep. 10 patients with T1D for more than five years will be included. It is a longitudinal, prospective, interventional study in which every patient will use intermittently scanned Continuous Glucose Monitoring (isCGM) and a physical activity tracker during 12 weeks. Moreover, during this period, patients will store in a mobile application (Freestyle LibreLink) or in a reader information regarding their diabetes management activities, such as insulin delivery doses and meal consumption.

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.

Siblings of those with type 1 diabetes are at an increased risk of developing the disease themselves. Through prior research, the investigators have found that siblings as well as those with type 1 diabetes have a general level of inflammation in the body. The investigators are examining the role that diet plays in this level of inflammation by asking siblings of children with type 1 diabetes to go on a gluten and Amylase Trypsin Inhibitors (ATI)-free diet for 4 weeks. Blood and stool samples will be measured before the diet, after the diet is completed and again 4 weeks after participants resume their normal diet.

This study will examine the impact of a closed-loop insulin delivery system intervention on health and psychological outcomes in families with young children with Type 1 Diabetes (T1D).

Investigators aim to further the understanding of environmental factors that underlie the progression to Type 1 diabetes (T1D). Dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing T1D in those with genetic susceptibility. Dysbiosis may result from modern dietary habits, such as broad consumption of the highly processed Western Diet, or by widespread use of antibiotics. Here, investigators propose to examine the impact of dysbiosis on the endogenous innate inflammation known to exist within families affected by T1D and if probiotic supplementation may beneficially modulate this inflammatory state. Participants will be asked to take the probiotic VSL#3 daily for six weeks. Stool and blood samples will be analyzed before and after the six week course of probiotics.

Use of devices for continuous monitoring of the blood sugar is valuable for people with diabetes to understand their disease and to help prevent low blood sugar. Furthermore, continuous monitoring should be used in drug development to evaluate efficacy and safety. However, the devices have been criticised for being too inaccurate. This investigation sought to reveal the inaccuracies of current devices and to assess the subsequent usability related to the mentioned use cases.

Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting.

Critical power is an important threshold in exercise physiology, and is an important determinant of the ability to tolerate high-intensity exercise. The ability to tolerate such exercise is drastically impaired in certain chronic conditions, such as type 1 diabetes. Whilst the most important physiological factors that determine critical power have yet to be determined, previous work from our laboratory suggests that it is related to the speed of oxygen uptake at the onset of exercise. This study will look to utilise "priming" exercise as an intervention to improve the speed of these oxygen uptake "kinetics", and thus critical power and exercise tolerance in individuals with type 1 diabetes. We hypothesize that oxygen uptake kinetics will be faster and critical power will be higher when exercise is performed with compared to without a prior bout of high-intensity priming exercise in a population of individuals with type 1 diabetes.

The objectives of this clinical study is to evaluate the efficacy continuous glucose monitoring (CGM) use on glucose variability (GV) in preschool children with T1D treated with CSII. Downloads from CGM and CSII saved in pdf from will be retrospectively reviewed and analysed for all preschool children with type 1 diabetes in Slovenia. Glucose variability and other glycemic parameters will be analyzed separately for periods when CGM was used (CGM and SMBG data) and compared to periods when CGM was not used (SMBG only data).