View clinical trials related to Type 1 Diabetes.
Filter by:Diabetic kidney disease and cardiovascular disease remain the leading causes of morbidity and mortality in people with type 1 diabetes and are exacerbated with longer duration of diabetes and time outside goal glycemic range. Yet, type 1 diabetes is a complex disease with pathophysiology that extends beyond beta-cell injury and insulin deficiency to include insulin resistance and renal vascular resistance, factors that accelerate cardiovascular disease risk. We have shown that metformin improved peripheral insulin sensitivity and vascular stiffness in youth with type 1 diabetes on multiple daily insulin injections or standard insulin pumps. However, metformin's effect on kidney and endothelial outcomes, and the effects of type 1 diabetes technologies, with or without metformin, on any cardiovascular or kidney outcome, remains unknown. Automated insulin delivery systems combine an insulin pump, continuous glucose monitor, and control algorithm to modulate background insulin delivery and decrease peripheral insulin exposure while improving time in target range and reducing hypoglycemia. We hypothesize that automated insulin delivery systems, particularly when combined with metformin, may modulate renal vascular resistance and insulin sensitivity, thereby impacting cardiometabolic function. MANATEE-T1D is a randomized, double-blind, placebo-controlled trial of 4 months of metformin 2,000 mg daily in 40 youth aged 12-21 years with type 1 diabetes on automated insulin delivery systems vs. 20 control youth with type 1 diabetes on multiple daily injections plus a continuous glucose monitor or an insulin pump in manual mode plus a continuous glucose monitor which will assess for changes in calculated renal vascular resistance and gold standard measures of whole-body and adipose insulin sensitivity, arterial stiffness, and endothelial function.
Nonalcoholic fatty liver disease (NAFLD) has been extensively studied in the context of type 2 diabetes mellitus (T2D) due to its higher prevalence and its association with obesity and syndrome metabolic, a well-established risk factor for NAFLD. Although several studies have reported the accumulation of liver fat in patients with type 1 diabetes mellitus (T1D), the prevalence, etiology, and the consequences of NAFLD in patients with T1D are poorly characterized, requiring more studies in this field. In addition, liver involvement at the metabolic level in patients with T1D raises the differential diagnosis between NAFLD and glycogen hepatopathy (GH), a rare complication associated with the poorly metabolic control of diabetes and probably underdiagnosed, since the ultrasound pattern is the same than the NAFLD. The investigators have designed a cross-sectional observational study with the objective of describing the prevalence of metabolic liver diseases (NAFLD and GH) in the population of patients with T1D in the healthcare area of Hospital del Mar and Hospital de Vilafranca, as well as studying the relationship of these pathologies with the degree of metabolic control, the presence of metabolic syndrome and the presence of micro and macrovascular complications.
Type 1 diabetes has been poorly characterised, with very sparse information available in the literature about the characteristics of the disease in Africa. Atypical young onset diabetes is often reported by clinicians in sub-Saharan Africa, including patients who have the phenotype of type 1 diabetes but do not appear to have an absolute insulin requirement. The onset of type 1 diabetes in many sub-Saharan African populations seem to occur at later ages (20s to 40s) than what is generally seen in Caucasian populations. The investigators seek to characterise young-onset insulin treated diabetes (clinically diagnosed type 1 diabetes) in sub-Saharan Africa;
This project proposes to use telemedicine-delivered cognitive-behavioral therapy (CBT) enhanced with continuous glucose monitor (CGM) review to target diabetes distress in young adults with type 1 diabetes. The efficacy of CBT for diabetes distress (CBT-DD) will be tested in comparison to commercial FDA-approved CGM only in a randomized controlled clinical trial. The investigators central hypothesis is that the addition of a CBT intervention that targets diabetes distress and self-management directly will yield clinically significant improvements in both diabetes distress and glycemic control relative to CGM alone. The investigators propose to recruit 150 young adults (age 18-35) with type 1 diabetes from a national population for an entirely virtual 6-month study over four years, with targeted recruitment of racial/ethnic minorities. In addition to standard measurement of HbA1c for glycemic control and validated patient-reported outcome (PRO) surveys, the investigators plan to innovatively integrate momentary psychological and behavioral data via smartphone-based ecological momentary assessment with CGM data to assess day-to-day changes in diabetes distress, affect, self-management, and glycemia over the course of the trial.
The investigators aim to estimate the prevalence of functional ovarian hyperandrogenism [idiopathic hyperandrogenism, idiopatic hirsutism, and polycystic ovary syndrome (PCOS)] in adult patients with type 1 diabetes (T1DM) in an observational cross-sectional study. Study population is comprised of premenopausal adult women with a diagnosis of T1DM, consecutively recruited from a Diabetes outpatient clinic at a tertiary hospital in Spain, Europe.
Evidence suggests that prebiotic fibre can correct dysbiosis, reduce intestinal permeability and improve glycemic control. The investigators hypothesize that microbial changes induced by prebiotics contribute to gut and endocrine adaptations that reduce glucose fluctuations, including less hyper- and hypoglycemia in type 1 diabetes (T1D). The primary objective is to compare the change in frequency of hypoglycemia from baseline to 6 months in n=144 newly diagnosed (<12 months) individuals with T1D treated with a 6-month course of prebiotic or placebo as an adjunct to insulin. Secondary objectives will be aimed at understanding the mechanisms by which the prebiotics could affect glycemic control.
The purpose of this study is to evaluate the effectiveness of advanced hybrid-closed loop system, Minimed 780G to glycemic control and safety in children aged 2-6 years with type 1 diabetes. Additionally, the study evaluates the perceived burden of the diabetes treatment to families during the advanced hybrid-closed loop system treatment (diabetes distress). This is a prospective, non-randomized, single-arm study, where primary endpoint is the change in TIR after hybrid-closed loop system initiation. Secondary endpoints are safety (number of severe hypoglycaemias and diabetic ketoacidosis, DKA), HbA1c, time below range (TBR), mean sensor glucose (SG), standard deviation of SG, and coefficient of variation (CV). The inclusion criteria are 1) TDD (total insulin daily dose) ≥ 8 units, 2) HbA1c < 10%, 3) capability to use pump and the CGM, and 4) time from diabetes diagnosis more than 6 months. The exclusion criteria are hemophilia or any other bleeding disorder, a condition, which in the opinion of the investigator would put the participant at risk during the trial.
This research will compare a psychological intervention ("ACT1VATE") versus diabetes self-management education and support (DSME/S; usual care) in improving clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes (T1D) who are experiencing significant diabetes-related emotional distress and poor glycemic control in a real world, healthcare environment.
The objective of the study is to evaluate the differences in the retinal microcirculation measured by OCT-Angiography in patients with type 1 diabetes between the diagnosis of the disease and after 3 months of insulin treatment.
Pilot prospective controlled monocentric open-label, randomized study evaluating the feasibility and safety of the Pancreas4All automated "closed loop" glycemic control system.