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Showing 1-15 of 15 trials
NCT03956927
The benefits of Therapeutic Patient Education (TPE) have long been proven, but its implementation remains insufficient. It is only accessible to a part of the population and is too often limited to the acquisition of knowledge. TPE consists of supporting the patient in making decisions about his or her health, managing his or her life with the disease and treatment through the acquisition or maintenance of skills. Simulation is a pedagogical method of creating fictional or reconstructed environments in order to develop skills, know-how and abilities for which direct instruction is impossible for ethical, economic or technical reasons. To date, it is recommended for the development of caregiver skills, and has been the subject of two studies among family caregivers. It seems likely that simulation will add value to the methods currently used in TPE. To our knowledge, no studies have been conducted on simulation-based TPE (S-TPE) with patients. A consensus conference, which is a rigorous method of comparing the opinions of experts in TPE, simulation, patient experts and caregivers, was held in order to determine the learning that could be developed through simulation and the conditions of use. However, since the patient is a specific type of learner, we hypothesize that there may be some additional conditions for the use of S-TPE. And the value of this approach remains to be demonstrated. Since the use of S-TPE has never been studied with patients, a feasibility test would make it possible to evaluate, in the context of care, the possibility of its use and its acceptance by both patients and caregivers. This is necessary before considering a multicenter trial that demonstrates an interest in developing patient skills. It was decided to carry out this study in patients with diabetes, a condition for which TPE is a precursor. Caregivers will be able to objectify the advantages and limitations of using S-TPE.
NCT05168657
This is a study assessing the feasibility of using the insulin-only configuration of the iLet bionic pancreas with initiation in pump-naïve people with type 1 diabetes in a primary care practice with either in-person training and follow-up (PC-IP) or with training and follow-up via telehealth (PC-TH). As a comparison, the iLet will be initiated by an academic endocrinology practice with either in-person training and follow-up (EN-IP) or with training and follow-up via telehealth (EN-TH).
NCT04043260
A multi center, open label, prospective study that will include up to 100 subjects with Type 1 Diabetes treated with Multiple Daily Injections (MDI) of insulin according to a predefined sliding scale plan or carbohydrate ratio (CR) and correction factor (CF) plan, and Self-Monitoring of Blood Glucose (SMBG) or Continuous Glucose Monitoring (CGM). The study will include screening, a 3-4 weeks run-in period and a 6 weeks intervention period. Subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps and/or connected pens) and their daily activities (meals, physical activity etc.) using electronic log (implemented on Dedicated Apps), for a total period of 9-10 weeks.
NCT01781975
Type 1 diabetes mellitus (T1DM) results from the autoimmune destruction of insulin-producing ß cells. Although exogenous insulin is widely available, it is not possible for affected individuals to consistently achieve euglycemia with current technology, and thus they are at risk for devastating long-term complications. This phase II study is designed to evaluate the safety and efficacy of imatinib mesylate as a novel therapy for new-onset T1DM. Imatinib is a first-in-class tyrosine kinase inhibitor. This study will explore the potential role of short-term therapy with imatinib to induce tolerance and possibly lead to a durable long-term remission of T1DM.
NCT04239586
The purpose of this study is to switch from insulin to oral sulfonylurea in patients with apparent type 1 diabetes or maturity onset diabetes in the young that are insulin treated. The molecular cause will be DNA variants in the HNF1A, HNF4A, or HNF1B genes that are of unknown significance (VUS, class 3) or known to be pathogenic (class 4 and 5).
NCT03355040
A french study published in 2015 (DAME) showed a decrease of shoulder dystocia and an increase of spontaneous vaginal delivery when the non insulin-treated diabetes patients with large-for-date fetus were induced. This new protocole was introduced in Montpellier University Hospital delivery room. The aim of this study is to evaluate the protocole in Montpellier hospital and to compare our results with the DAME results.
NCT03112343
This is a 24-week, open-label, randomized, multi-center trial conducted in three tertiary hospitals. There are three follow-up measures; at baseline, post-intervention at Week 12, and Week 24. Subjects are diagnosed as type 1 DM, type 2 DM, and/or post-transplant DM, and initiate or currently use insulin therapy. After the given education on insulin dose titration and prevention for hypoglycemia and 1 week of run-in period, subjects are randomized in a 1:1 ratio to either the ICT-based intervention group or the conventional intervention group. Subjects in conventional intervention group will save and send their health information to the server via the PHR app, whereas those in ICT-based intervention group have additional algorithm-based feedback messages. The health information includes levels of blood glucose, insulin dose, details on hypoglycemia, food diary, and number of steps. The primary outcome will be the proportion of patients who reach an optimal insulin dose within 12 weeks of enrolling in the study without severe hypoglycemia or unscheduled clinic visits. This study is based upon work supported by the Ministry of Trade, Industry \& Energy (MOTIE, Korea) under Industrial Technology Innovation Program (No. 10059066, 'Establishment of ICT Clinical Trial System and Foundation for Industrialization.")
NCT03411460
The aim of the study is to establish whether routine usage of the FreeStyle Libre™ system (Abbott) improves satisfaction and quality of sleep in patients hospitalized for poor glycemic control with an indication for external insulin pump treatment.
NCT00057499
Insulin dependent diabetes mellitus (also called type 1 diabetes mellitus or T1DM) is caused by the destruction of insulin-producing cells in the pancreas. People with T1DM do not produce enough insulin, which is necessary for proper regulation of blood sugar levels. T1DM is an autoimmune disease. An autoimmune disease is a disease in which the body's immune system attacks the body itself. In addition to regulating blood sugar, insulin may have the ability to protect cells in the pancreas from attack by the immune system. This study will evaluate whether an insulin-based vaccine can protect cells from autoimmune destruction. Study hypothesis: IFA-enhanced human insulin B-chain vaccination will lead to the arrest or slowing of the ongoing autoimmunity, and this will result in an appreciable difference in functioning B cell mass compared to the placebo treated group by the end of the study.
NCT02114554
Mitochondrial diseases are multisystem disorders that present with a wide range of clinical manifestations. Mitochondrial DNA nt3243A\>G mutation is one of the most common mutations seen in mitochondrial diseases. Syndromes associated with this mutation include mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes (MELAS), maternally inherited diabetes and deafness (MIDD), myoclonic epilepsy with ragged red fibers (MERRF), and chronic progressive external ophthalmoplegia (CPEO). Clinical analyses of mitochondrial DNA nt3243A\>G mutation from Taiwan remain scarce. The present study aims to investigate the clinical features and prognostic factors of patients with mt3243A\>G mutation in Taiwan.
NCT00024518
This study will see if interferon-alpha given early in the disease can stop or slow the immune attack on insulin-producing cells. In addition, the study will examine the safety and efficacy of interferon-alpha (given by mouth) to protect beta cell function. Patients between 3 and 25 years of age with Type 1 Diabetes Mellitus less then six weeks may be eligible for this study. All study-related tests and medications at the NIH Clinical Center are provided at no cost.
NCT01582282
A double-blind, randomized, placebo-controlled, multi-dose clinical study consisting of 2 phases; 1) an 8-week lead-in period during which patients followed a diet judged to be within the acceptable guidelines of the ADA, and 2) a 12-week treatment period, at the beginning of which, Subjects are randomly assigned to 1 of the 3 treatment groups: placebo, 3.4 g psyllium BID for a total of 6.8 g/day (10.4g Metamucil) or 6.8g psyllium BID for a total of 13.6 g/day (20.8g Metamucil). For 12 weeks, Subjects took Metamucil or the fiber-free placebo BID, just prior to breakfast and dinner. Patients visited the clinic 10 times during the 20-week period at Screening, Weeks -8, -6, -4, 0, Day 3, and Weeks 2, 4, 8 and 12, fasting at least 12 hours prior to each visit where a blood sample was taken (all visits except Week -6 and Day 3) for analysis of fasting serum glucose and lipid levels, and HbA1c. Clinical chemistry, hematology and urinalysis were done at Weeks -8, 0 and 12. The completed 7-day food diaries were reviewed by the study dietician at each visit and discussed with the patient to ensure compliance with the recommended diet and the patients' body weights were recorded
NCT00006160
A controlled trial to assess the potential benefit of a home based worker in improving control in African-American children with insulin dependent diabetes.
NCT00359112
This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.
NCT00156897
The purpose of this study is to investigate whether ATL-962 induces weight loss in diabetic patients and whether its safety and tolerability profile is superior to that of orlistat in such patients