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Type 1 Diabetes clinical trials

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NCT ID: NCT04026750 Terminated - Type 1 Diabetes Clinical Trials

Insulin Tolerance Test Study in Patients With Type 1 Diabetes

Start date: September 15, 2019
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes

NCT ID: NCT04020822 Completed - Type 2 Diabetes Clinical Trials

Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices

Start date: July 29, 2019
Phase: N/A
Study type: Interventional

The purpose of Phase 3 Group is to evaluate the impact of acetaminophen on the performance of Guardian Sensor (3) during 11 days of wear (approximately 264 hours) in subjects with insulin requiring diabetes,18-75 years of age.

NCT ID: NCT04016987 Recruiting - Type 1 Diabetes Clinical Trials

Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes

Start date: September 8, 2020
Phase: N/A
Study type: Interventional

In recent years, more and more attention has been paid to diabetes self-management. Glycemic control and self-management skills of patients with type 1 diabetes (T1DM) in China are poor. Artificial intelligence (AI) and the Internet offer a new way to improve the self-management skills of patients with chronic diseases. Few studies have combined AI technology with structured education intervention of type 1 diabetes. This study is innovative in that it compares the effectiveness of smartphone app between usual care, as well as automatic and individualized app education and standardized app education to explore whether the individualized treatment advocated by the latest guideline will bring any additional benefit to T1DM patients. The ultimate goal is to provide an effective and convenient approach for glycemic control of type 1 diabetes and reduce related disease burden in China.

NCT ID: NCT04016558 Completed - Type 1 Diabetes Clinical Trials

Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control

EMBARK
Start date: September 15, 2019
Phase: N/A
Study type: Interventional

This study is comparing three programs to reduce Diabetes Distress (the worries and concerns that people with diabetes may experience as they struggle to keep blood glucose levels in range) in adults with type 1 diabetes. About a third of participants will take part in the TunedIn program, about a third will take part in the FixIt program, and about a third in the StreamLine program.

NCT ID: NCT04014660 Recruiting - Type 1 Diabetes Clinical Trials

Prevention av Autoimmunitet Med Laktobaciller

PAL
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

The incidence of autoimmune diseases (celiac disease, type 1 diabetes, thyroid disease) have increased over the past 30 years. Although most autoimmune diseases have a strong link to different risk genes, the rapid increase is thought to be due to changes in environmental factors. There is currently no cure for autoimmune diseases, but the treatment is lifelong and either involves suppressing the inflammation and / or substituting the organs that are affected to maintain vital functions. Being able to predict who is affected and identifying factors that trigger autoimmunity is necessary for developing new treatment methods that prevent the occurrence of autoimmune diseases. The bacterial flora's composition in the gut can affect both the intestinal barrier properties and the immune system's response to various dietary components. An adverse composition of the intestinal flora can activate parts of the immune system that are involved in chronic inflammation in celiac disease and inflammatory bowel disease. Probiotics are defined as living microorganisms which, when ingested in sufficient amounts, produce a health effect (FAO / WHO). The aim of the study is to investigate whether a daily oral intake of a mixture of L.paracasei and L.plantarum can affect the autoimmune process in children who are screened positive for any of the autoantibodies associated with development of celiac disease, type 1 diabetes and / or thyroid disease. Our hypothesis is that lactobacilli can directly regulate the autoimmune process in the small intestinal mucosa by stimulating regulatory T-cells, but also by affecting the permeability of the small intestinal mucosa by of antigen that stimulates specific T-cells.

NCT ID: NCT04014569 Terminated - Type 1 Diabetes Clinical Trials

Determination of Automated Multiple Insulin Dose Injections Settings Using the MDI/SMBG Advisor for Patients With Type 1 Diabetes -Data Collection, Observational & Proof of Concept Study

Start date: May 2, 2018
Phase: N/A
Study type: Interventional

The MDI (Multiple Daily Injections) plus SMBG |(Self Monitoring Blood Glucose) Advisor (MPSA) is a software product that is designed to assist in insulin dosage decision making for subjects with T1DM using multiple daily injection and SMBG. The study will focus on the development, validation and eventually testing of the MPSA algorithm use. The major objective of the project is to develop an algorithm that will be able to optimize treatment plan parameters of MDI patients who use SMBG as glucose monitoring method. The clinical study has two segments. Segment A is an observational study needed for the development of the algorithm (this segment was already completed at the time of the registration) and Segment B is a proof of concept interventional study to validate the algorithm's Safety and Efficacy. Up to 20 patients using MDI and SMBG or Flash Glucose Monitoring (FGM) without using glucose trends will be enrolled to this proof of concept study. The study will evaluate the algorithm use for a period of 11 weeks. Post screening, patients will undergo a two weeks run-in period while using MDI and SMBG or FGM (patients that do not use FGM will be provided with blinded Libre Flash to be used during the run-in period and 2 weeks prior to arriving to end of study visit). Then, patients will undergo insulin treatment plan changes every week for 7 weeks. At the first 3 weeks insulin dose adjustments will be done for basal insulin dose only, week 4 will be without changes, and in the next 3 weeks the carbohydrate ratio will be amended. No recommendations will be given during the last two weeks of the study. These two weeks will be used for data analysis. Each recommendation of the Advisor will be approved by a physician before implementation. Glucose outcomes will be evaluated comparing the two weeks run-in period to the last two weeks of the study.

NCT ID: NCT04011683 Completed - Type 1 Diabetes Clinical Trials

Hypoglycaemia and Cardiac Arrhythmias in Type 1 Diabetes

Hypo-Heart-1
Start date: December 1, 2018
Phase:
Study type: Observational

The investigators hypothesise that patients with type 1 diabetes have clinically relevant, but often unrecognised, episodes of arrhythmias linked to episodes of hypoglycaemia and/or clinically significant fluctuations in plasma glucose.

NCT ID: NCT04011020 Recruiting - Type 1 Diabetes Clinical Trials

Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

Start date: September 20, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Type 1 diabetes (T1D) is a T cell-mediated autoimmune disease that causes a deficit of pancreatic islet beta cells. Millions of individuals worldwide have T1D, and incidence increases annually. Several recent clinical trials point to the need for an approach that produces comprehensive immune modulation at both the local pancreatic and systemic levels. Stem Cell Educator (SCE) therapy offers comprehensive immune modulation at both the local and systemic levels in T1D by using a patient's own immune cells (including platelets) that are "educated" by cord blood stem cells. Tested clinically in more than 200 patients, SCE therapy has shown lasting reversal in autoimmunity in T1D patients, including improved C-peptide levels, reduced median glycated hemoglobin A1C (HbA1C) values, and decreased median daily usage of insulin. SCE therapy circulates a patient's blood through a blood cell separator, briefly cocultures the patient's immune cells with adherent Cord Blood Stem Cells (CB-SCs) in vitro, and returns the "educated" autologous immune cells to the patient's circulation.

NCT ID: NCT03998475 Completed - Type 1 Diabetes Clinical Trials

Transition Preparation Intervention for Young Adults With Type 1 Diabetes

Start date: July 11, 2019
Phase: N/A
Study type: Interventional

The purpose of this research study is to find out more about how to support young adults (ages 18-22) with type 1 diabetes as they prepare to transition from pediatric and adult endocrinology medical care.

NCT ID: NCT03997409 Completed - Type 1 Diabetes Clinical Trials

Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes

Start date: November 18, 2019
Phase: N/A
Study type: Interventional

Dietary carbohydrate consumption is a key factor influencing postprandial glycemia for patients with type 1 diabetes mellitus (T1DM). Because post-prandial glucose excursions profoundly influence hemoglobin A1c (HbA1c), therapeutic approaches to mitigate post-prandial hyperglycemia are of great importance. The quantity and source of carbohydrates affect post-prandial glycemia more than any other dietary factor. These findings serve as the physiologic basis for a growing interest in carbohydrate-restricted diets in the management of T1DM despite American Diabetes Association (ADA) guidelines that discourage restricting total carbohydrate intake to less than 130 grams per day. Although case series and prospective studies suggest low-carbohydrate diets (LCD) significantly improve HbA1c for adults with T1DM, data in the pediatric T1DM population is limited. The investigators will conduct a randomized prospective pilot study evaluating glycemic control, lipidemia, and quality of life (QOL) in pediatric T1DM patients on a LCD.