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Diabetes Type 1 - ClinicalTrials.gov

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Last Updated: 28 June 2022

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Efficacy and Safety of Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes. A 26-week, Randomised, Multicentre, Open-label, Active-controlled, Parallel Group, Two Armed, Treat-to-target Trial Investigating the Effect on Glycaemic Control and Safety of Treatment With Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec, Both in Combination With Insulin Aspart in Adults With Type 1 Diabetes, With a 26-week Extension Investigating Long Term Safety

Insulin icodec is compared to insulin degludec in people with type 1 diabetes, according to this report. The trial will explore how insulin icodec taken weekly regulates blood sugar levels in comparison to insulin degludec taken daily. Participants will either get insulin icodec that participants will need to inject once a week on the same day of the week, or insulin degludec that participants will have to inject once a day at the same time every day. The treatment participants' name is chosen at random. A mealtime insulin will also be given to participants. Participants will have 28 clinic visits and 28 phone calls with the study scientist. Blood samples will be collected during 11 clinic visits. For 8 hours before the visit, participants of six clinic visits are unable to eat or drink for 8 hours. All participants will be required to wear a sensor that monitors your blood sugar levels on a daily basis.

Source link: https://clinicaltrials.gov/ct2/show/NCT04848480


Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes

Published Phase I results on repeat BCG vaccinations in long-term diabetics showed specific death of some of the disease-causing poor white blood cells in some of the disease, as well as a short and small pancreas effect of restored insulin secretion. The investigators predict that every BCG vaccination will eliminate more of the disease-causing white blood cells, providing protection to the pancreas for increased longevity and recovery of insulin secretion from the pancreas. These double blinded type 1 diabetic subjects receiving either BCG or placebo injections are also being tested for COVID-19.

Source link: https://clinicaltrials.gov/ct2/show/NCT02081326


Consortium for Identification of Environmental Triggers of Type 1 Diabetes

Hypotheses: Beginning of persistent beta-cell autoimmunity and diabetes are accelerated with exposure to a trigger factor during pregnancy, such as infections, preeclampsia, blood incompatibility, or birth weight. When stratifying for the HLA DR-DQ genotype and environmental triggers, the risk of persistent beta-cell autoimmunity in children from the general population is lower in children from the general population than in offspring or siblings of T1DM patients. The interaction of HLA DR-DQ genotype with exposure to dietary or infectious causes contributes to an elevated risk of beta-cell autoimmunity and T1DM.

Source link: https://clinicaltrials.gov/ct2/show/NCT00279318


Targeting Inflammation With Salsalate in Type 1 Diabetes Neuropathy-TINSAL -T1DN

Diabetic neuropathy is the most common chronic disease of diabetes, affecting up to half of those with type 1 diabetes. Cardiovascular autonomic neuropathy has the same morbidity as DN, with patients suffering orthostasis, arrhythmias, and premature death. Despite the high morbidity associated with DN, most randomized clinical trials investigating drugs for established DN have been disappointing. The Diabetes Control and Complications Trial (DCCT) found that intensive monitoring designed to achieve near-normal glycemia was vital in lowering the risk of DN formation in type 1 diabetes 8, 9. Salicylate therapy has been shown to be safe in treating diabetic low grade inflammation in diabetes by blocking the enzyme involved in diabetes's inductor of the NF-u03b2/NF-u03bb pathway, according to both in vitro and in vitro studies and human trials. Numero studies have shown that salsalate causes no greater intestinal occult blood loss than placebo and has no suppressive effects on renal prostaglandin production in comparison to aspirin or NSAIDs. After 48 weeks patients with type 2 diabetes, the recently reported "Target Inflammation Using Salsalate in Type 2 Diabetes TINSAL-T2D" trial reported the salutary effects of 3. 5 gram/day salsalate in Type 2 Diabetes TINSAL-T2D" trial. The investigators' initial NIDDK funded R03 DK 094499 grant demonstrated the safety and effectiveness of treating inflammation with salsalate therapy in T1DM patients with DN. The investigators' latest report builds on and expands their initial promising findings and will either confirm or refute salsalate's therapeutic value in a larger T1DM population.

Source link: https://clinicaltrials.gov/ct2/show/NCT02936843


Characterisation of the Immune Response to SARS-CoV-2 Infection in Type 1 Diabetes

In these individuals, the primary goal is to determine whether people with T1D following SARS-CoV-2 infection have the HLA A*0201 and HLA*2402 genes that are linked to T1D, and to demonstrate that SARS-CoV-2-specific killer T-cells are capable of directly killing insulin-producing pancreatic beta cells. Using peptide-HLA multimers, it will be investigated if SARS-CoV-2-specific T-cell epitopes can be identified diabetogenic T-cell epitopes. Methodology will determine if convalescent COVID-19 patients who experience T1D are predominantly expressed the human leukocyte antigens HLA A*02 and HLA*24 by staining a small portion of the sample with antibodies for these HLAs. T-cell libraries [3] and peptide-HLA multimer [4-6] methods will be used to isolate T-cells from SARS-CoV-2 epitopes by peptide-HLA A*02 and HLA*24. Consultant Paediatric Endocrinologists from The Department of Child Health, Cardiff and St, Mary's Hospital, London, are among the clinical research team and the direct clinical care team, which are all part of the Cwm University Health Board, the Department of Child Health, Cardiff, and the Department of Child Health, Cardiff and the Vale health board, The Department of Child Health, Cardiff, and the Department of Child Health, Cardiff, and the Department of Child Health, Cardiff and the Pediatric Endouni In the case of paediatric participants on a consent form or a Parent/Guardian consent form, informed consent would be obtained in writing on a consent form or in the case of paediatric participants on an assent form and a Parent/Guardian consent form. On the day of recruitment, we will need peripheral blood mononuclear cells from of blood. The T-cell clones that are produced will be tested for cross-reactivity with established diabetogenic T-cell epitopes. The white blood cell layer, or PBMCs, is isolated from other parts of the blood and retained and stored. Cells will die during this process, which takes place on the day cells are cultured in the lab. Participants' positive SARS-CoV-2 blood sample data will be recorded and traced to the participant study record using the unique study number provided by a member of the academic team in the direct clinical care teams These results will be stored on a secure NHS server and in a fireproof container at each hospital site.

Source link: https://clinicaltrials.gov/ct2/show/NCT05171998


Cohort Study of Patients With Type 1 Diabetes Registered With Mobile Application in China

The mobile health platform's innovation for the last decade has opened new avenues for disease control for the first decade. Previous studies have shown that health management services based on smartphone devices for diabetic patients can enhance patients' glucose control, self-management skills, and quality of life. Patients who have Type 1 diabetes mellitus due to its particulars need long-term involvement in all aspects of their life cycle. This review's primary aim is to determine T1DM patient blood glucose control outcomes.

Source link: https://clinicaltrials.gov/ct2/show/NCT05163054


The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children

T1D Group 1: Obese or overweight children under the age of 3 years in four groups will be determined by the investigators, according to T1D Group 1: Normal weight children without T1D Group 2: Obese or overweight children within three years of diagnosis of T1D Group 2: Obese or overweight children under the age of 3 years, as well as the presence of pancreatic autoantibodies. All animals will be tested for one-time stool and the first morning urine sample.

Source link: https://clinicaltrials.gov/ct2/show/NCT02938806


Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes: the GLYMETY Study

Women living with type 1 diabetes often report that insulin needs change throughout the menstrual cycle in clinical practice. In a large sample of women, the aim of this study will be to investigate glycemic fluctuations during the menstrual cycle using CGM results and insulin results.

Source link: https://clinicaltrials.gov/ct2/show/NCT05258292


DiaBetter Together: A Strengths-based, Peer Mentor Transition RCT for Young Adults With Type 1 Diabetes

DiaBetter Together is a strengths-based peer support service delivered to young adults by Peer Mentors during the transition between pediatric and adult diabetes care. The research aims to enhance transition in T1D by leveraging and enhancing young adults' diabetes risk, self-management skills, and social services.

Source link: https://clinicaltrials.gov/ct2/show/NCT04247620

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions