View clinical trials related to Type1diabetes.
Filter by:The Diabetes registry for biomarker research Graz is a prospective cohort-study including subjects with type 1 and type 2 diabetes, rare types of diabetes, obesity and dyslipidemia, aiming to collect data, blood and urine samples of all subjects on an annual basis.
Paediatric Type 1 Diabetes (T1D) patients are at greater risk for developing severe hypo and hyperglycaemic events due to poor glycaemic control and incorrect Insulin administration. To reduce the risk of adverse events, patients need to achieve the best possible glycaemic control through frequent blood glucose monitoring with finger prick or Continuous Glucose Monitoring (CGM) systems. However, several non-invasive techniques have been proposed aiming at exploiting changes in physiological parameters based on glucose levels. The overall objective of this study is to validate a deep learning algorithm to detect glycaemic events using electrocardiogram (ECG) signals collected through non-invasive device. This observational single-arm study will enrol participants with T1D aged less than 18 years old who already use CGM device. Participants will wear an additional non-invasive wearable device, for recording physiological data (e.g. ECG, breathing waveform, 3-axis acceleration) for three days. ECG variables (e.g. heart rate variability features), respiratory rate, physical activity, posture and glycaemic measurements driven through ECG variables and other physiological signals (e.g. the frequency of hypo or hyperglycaemic events, the time spent in hypo- or hyperglycaemia and the time in range) are the main outcomes. A quality-of-life questionnaire will be administered to collect secondary outcomes. Data collected will be used to design, develop and validate the personalised and generalized classifiers based on a deep-learning artificial intelligence (AI) algorithm developed during the pilot study, able to automatically detect hypoglycaemic events by using few ECG heartbeats recorded with wearable devices. This study is a validation study that will carry out additional tests on a larger diabetes sample population, to validate the previous promising pilot results that were based on four healthy adult subjects. Therefore, this study will provide evidence on the reliability of the deep-learning artificial intelligence algorithms investigators developed, in detecting glycaemic events in paediatric diabetic patients in free-living conditions. Additionally, this study aims to develop the generalized AI model for the automated glycaemic events detection on real-time ECG.
A randomized, open-label, three-arm crossover study will be conducted. The aim of the study is to determine the effect of different isocaloric diet macronutrient compositions (High-carbohydrate-Low-fat-Low-protein (HCLFLP), Low-carbohydrate-High-fat-Low-protein (LCHFLP), Low-carbohydrate-Low-fat-High-protein (LCLFHP)) on plasma glucose dynamics in everyday life and during fasted exercise in persons with type 1 diabetes. Our hypothesis is that a HCLFLP diet reduce the decrease in plasma glucose from start to end of fasted exercise compared with a LCHFLP diet. Secondary a LCHFLP compared with a LCLFHP diet does not reduces the decrease in plasma glucose from start to end of fasted exercise. The current study will contribute with new knowledge about the importance of the compositions of a low-carbohydrate diet on glucose dynamics and the influence on plasma glucose during and after cycling in fasted state.
Type 1 diabetes (T1D) is one of the most common chronic illnesses of childhood. The involved treatment regimen, including daily insulin administration/pump management, frequent blood glucose checks, and careful track-ing of food intake, places a high-stress burden on patients and their families. Adolescence is a particularly risky time for T1D management given a marked decline in treatment adherence and glycemic control. Over 80% of adolescents with T1D have poor glycemic control (A1c >7.5%), and one significant risk factor is the increase in negative affectivity, including depression and anxiety symptoms, that distinguish adolescents with T1D. Elevated depression and anxiety symptoms affect 40% of teens with T1D. Preliminary data support the notion that negative affectivity contributes to diminished treatment adherence and worsening of glycemic control, partially through the effects of negative affectivity on stress-related behavior such as maladaptive eating behavior (e.g., dietary restriction, uncontrolled eating patterns, and insulin omission for weight control). There is no gold-standard approach to address the poor glycemic control seen in adolescents with T1D. The creation of novel, targeted interventions, tailored for the developmental needs of adolescents with T1D and the particular burdens of coping with their chronic illness, are needed. Mindfulness-based interventions delivered to adolescents without T1D, including the team's preliminary work in teens with depression and weight-related disorders, have shown promise in treating negative affectivity, maladaptive eating behavior, and health outcomes. A mindfulness-based approach may be well-suited for adolescents with T1D, but given that the mechanisms of association among negative affectivity, stress-related behavior, and self-care are unique to individuals with T1D, interventions must be specifically tailored for this population. The goal of this study is to, therefore, adapt an existing 6-session mindfulness-based intervention, Learning to BREATHE, for use with adolescents with T1D (BREATHE-T1D). The first specific aim of the study is to adapt BREATHE for adolescents with T1D and to adapt a relevant and credible health education comparison curriculum (HealthEd-T1D). The second aim is to carry out a 2-way pilot randomized controlled trial to evaluate the feasibility and acceptability of BREATHE-T1D and HealthEd-T1D. The result of the current study will be a feasible and acceptable mindfulness intervention and comparison curriculum that can be evaluated in an efficacy trial. The multidisciplinary study team contributes complementary areas of expertise in adolescents with T1D, behavioral intervention development, negative affectivity and maladaptive eating behavior, adolescent mindfulness-based intervention, qualitative data analysis, and delivery of behavioral health interventions via telehealth. The study's innovative approach will enable the investigators to establish a feasible/acceptable intervention tailored for adolescents with T1D, leading to a future proposal for a full-scale efficacy trial.
In clinical practice, women living with type 1 diabetes frequently report that insulin requirements change across the menstrual cycle. Consequently, glycemic fluctuations are observed. This phenomenon could be explained by a decrease in insulin sensitivity during the second half of the menstrual cycle (luteal phase). Overall, despite an important proportion of women reporting glycemic and/or insulin variations across the menstrual cycle, studies to date have involved small sample sizes, and have had inconsistent results. The objective of this study will be to study glycemic fluctuations across the menstrual cycle using CGM data, alongside insulin data, in a large sample of women.
Aims: To investigate early markers of arterial stiffness and nerve dysfunction and the association to an extended glucose metabolic profile comprising glucose control (current and past), glucose variability and insulin sensitivity in children and adolescents with type 1 diabetes (T1D). Background: Most Danish children and adolescents with T1D do not achieve their metabolic target and are at increased risk of developing long-term diabetic complications, reducing their life expectancy and increase their morbidity rate. Hence, improved metabolic control, a better understanding of what optimal metabolic control means, combined with detailed monitoring of the first markers of long-term complications and their reversibility or lack thereof are needed. Methods: A prospectivel study of 400 children, aged 6-18 years old, with T1D>12 months. Early markers of long-term diabetic complications will be investigated as arterial stiffness, nerve dysfunction and nephropathy. Data on T1D onset, duration, treatment modality, self-monitoring-blood-glucose profiles, growth, weight, and pubertal status will be collected. Blood sampling will include routine tests and markers of glucose, lipid, bone, and gastrointestinal metabolism. DXA-scan, Fibroscan, bone-age, eye-examination and physical activity will be measured. Data on retrospective glucose- and lipid-profiles will be collected. The children will be offered a followup every 5 years for the next two decades. Perspectives: This study provides novel insight into the frequency of early markers of long-term diabetic complications and its association to the interplay of the pancreas, adipose, gastrointestinal and bone metabolic axis. Which can assist in identifying subgroups of children and adolescents requiring earlier in-depth screening for early markers of long-term diabetic complications, for putative interventions for prevention, hence reducing morbidity and mortality in T1D.
An experimental mechanistic study. The overall objective is to gain new knowledge about mechanisms involved in adaptation to recurrent hypoglycaemia in diabetes by investigating patients with type 1 diabetes and healthy controls. The knowledge to be obtained may feed into experimental hypoglycaemic clamp studies to further elucidate the effect of the adaptations during acute hypoglycaemia. Ultimately, it may lead to intervention studies aiming at the maintenance of functional capability during hypoglycaemia in patients with type 1 diabetes to reduce their risk of severe hypoglycaemia.
The aim of this study is to investigate the efficacy，safety， and tolerability of the recombinant human insulin patch ZJSRM2021 in healthy subjects, type 1diabetes mellitus and type 2diabetes mellitus patients
The primary aim of this pilot study is to test whether low-carbohydrate diet (LCD) instituted in children/adolescents with type 1 diabetes (T1D) can improve their disease control. The primary objective of the trial is the change in continuous glucose monitoring time in target range 3.9-10.0 mmol/l (TIR) in a 5-week period on LCD as opposed to a 5-week period on recommended carbohydrate diet (RCD). Secondary objectives are: Changes in immune parameters during the LCD period; Differences in fecal microbiome during the LCD period; Differences in fecal, serum and urine metabolome during the LCD period;
This is a combined phase 1 and 2 study in 66 subjects, male or female, between 7-21 years of age that have recently (< 6 months) been diagnosed with type 1 diabetes. The first phase 1 part of the study includes six subjects openly receiving allogeneic Wharton's jelly derived mesenchymal stromal cells as the Advanced Therapy Medicinal Product (ATMP) Protrans, three each in the age ranges 7-11 and 12-18.The second part is a randomized, double-blinded placebo-controlled phase 2 study in parallel design comparing allogeneic Wharton's jelly derived mesenchymal stromal cells treatment (as Protrans) to placebo in children and adolescent subjects (7-21 years of age) diagnosed with type 1 diabetes, The primary objectives of this study will be to investigate the safety, tolerance and efficacy after an allogieneic infusion of Wharton's jelly derived mesenchymal stromal cells.