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Showing 1-16 of 16 trials
NCT07422831
The goal of this clinical trial is to learn if periodic use of over-the-counter continuous glucose monitoring (CGM) can support glucose management in people with type 2 diabetes not using insulin being treated in primary care settings. The main questions it aims to answer are: * Is periodic use of CGM every 30 or 90 days for six months associated with reduced A1C compared to usual care at baseline? * Is periodic use of CGM every 30 or 90 days for six months associated with increased time in range and time in tight range compared to usual care at baseline? * Is periodic use of CGM every 90 days over six months associated with non-inferior A1C reduction compared to periodic use of CGM every 30 days? * Are clinician feasibility and acceptability of periodic, OTC CGM higher than for prescription CGM? * How acceptable is periodic, OTC CGM to people with non-insulin-treated type 2 diabetes? Researchers will compare use of periodic CGM every 30 and 90 days to see if less frequent periodic CGM use can support glucose management as effectively as more frequent use. Participants will: * be assigned to one of two groups using the 15-day Dexcom Stelo® glucose biosensor every 30 or 90 days over a six-month period. * receive Stelo devices every 30 or 90 days (as randomized) * complete up to 9 virtual or in-person visits with the study team. * complete 3 fingerstick A1c tests. * wear a blinded CGM device at 3 time points outside of Dexcom Stelo® use. * complete a survey at the end of the study.
NCT07251257
People with diabetes sometimes consider that they are subjected to unfair discrimination in the occupational or work environment. These include safety-critical activities, such as operating machinery and driving 1-3. Some occupations preclude the use of medications that lower blood glucose, particularly insulin. Safety regulators, occupational health physicians and national organisations frequently have to balance the competing priorities of individual rights against public safety. Modern treatment, with advances in insulin therapy and glucose monitoring, combined with rigorous clinical assessment and review, has allowed stereotypical attitudes to be challenged and advocated individual assessment with respect to safety criteria. Along with the UK Driving and Vehicle Licensing Agency (DVLA) and Civil Aviation Authority (CAA), the Maritime and Coastguard Agency (MCA) have accepted that insulin-treated diabetes should not be an absolute contra-indication to partaking in these occupational activities4. However, as the Disability Discrimination Act (1995) recognises that there may be specific employment-related hazards, fitness to work should be assessed on an individual basis. Therefore, each of these transport agencies has established regulatory standards for their respective domains, with the priority of minimising hypoglycaemic incapacitation risks. The CAA, for example, has worked alongside other European countries to use the ARA.MED.330 protocol and require medically certified pilots to check their blood glucose levels regularly before and during flights. In 2010, the UK CAA's expert committee reviewed the knowledge and policies concerning flying and it was decided that Continuous Glucose Monitoring (CGM) systems were not accurate enough and instead used finger prick-blood glucose monitoring (SMBG) as the gold standard. Since then, the protocol has been successfully implemented and there are current works in progress that demonstrate sufficient accuracy in modern CGMs as a viable alternative to SMBG. Similarly, the guidelines devised by the MCA, Approved Doctor's Manual (ADM), place a great emphasis on the type and treatment of diabetes, with the primary concern being risks of cognitive impairment or incapacitation5. Emphasis is placed on the need for able glycaemic control and "full awareness of impending hypos, with no reported or observed significant hypoglycaemic episodes in the last year". The guidance stipulates that certification may be restricted on individuals pending their medication side effects, compliance, and vascular risk factor control. Previous regulations prevented seafaring individuals such as insulin-treated seafarers from partaking in lone watchkeeping/lone-working roles and restricted them to near-coastal duties (150-200 nautical miles) (Appendix 1). Current regulations allows for exemptions for certain vessels, provided that the seafarer's diabetes control remains stable and is subject to blood glucose monitoring. Regardless, an approved medical assessor is needed to conduct these specific medical assessments in line with the statutory standards in MSN 1886 and guidance in the ADM. All seafarers who are insulin-dependent and licenced to undertake seafaring in the UK will be invited to participate in this study.
NCT04225455
To compare glucose control achieved by using real time continuous glucose monitoring (CGMS) Dexcom G6® in combination with self-monitored blood glucose during flight and also with free living in pilots.
NCT06959316
T1D Pregnancy \& Me will partner with pregnant participants living with type 1 diabetes (T1D) in the United States to collect real-world data on management of T1D in pregnancy. This is a remote study where participants can complete online surveys and share device data (continuous glucose monitor (CGM) data and insulin data). Through the collection of CGM, insulin, and pregnancy outcome data, the study will provide important information to understand how diabetes is being managed during pregnancy. These data will provide much needed evidence to guide modern management of diabetes during pregnancy with a goal of improving care and outcomes.
NCT04141891
This Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers. This multi-site trial will (1) test the driving decision aid (DDA) in improving decision making and quality (knowledge, decision conflict, values concordance and behavior intent); and (2) determine its effects on specific subpopulations of older drivers (stratified for cognitive function, decisional capacity, and attitudinally readiness for a mobility transition). The overarching hypotheses are that the DDA will help older adults make high-quality decisions, which will mitigate the negative psychosocial impacts of driving reduction, and that optimal DDA use will target certain populations and settings.
NCT03073343
Betaine (trimethyglycine) is a food supplement that is approved for sale in the United States without a prescription. In this study, betaine will be provided to patients as a powder that can be mixed with aqueous solutions and consumed orally.
NCT05915338
This study was conducted to evaluate the effect of individual insulin use training given to patients with type 2 diabetes using insulin on safe drug administration, pain level and perception of treatment. The study was conducted between October 2022 and March 2023 with a randomized control group.
NCT03345004
The objective of DIAGNODE-2 is to evaluate the efficacy of Diamyd compared to Placebo, upon administration directly into a lymph node in combination with an oral vitamin D/Placebo regimen, in terms of preserving endogenous insulin secretion as measured by C-peptide.
NCT03283566
This will be a pilot, 12-month phase II, open label, randomized, two-arm, single-blinded, placebo-controlled, parallel clinical trial of individuals undergoing TPAIT (Total Pancreatectomy and Autologous Islet Transplantation) for treatment of chronic pancreatitis (CP). The two study arms consist of HCQ-treated (Hydroxychloroquine) and placebo-treated individuals. The purpose of this study is to investigate the effects of HCQ administration compared to placebo on islet cell function post-autologous transplantation.
NCT00640549
The study will investigate the effects of atorvastatin on the concentrations of small, dense LDL and HDL subfractions in patients with diabetes and the underlying mechanisms of these effects.
NCT02158741
The overall purpose of this research is to examine and compare the effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with Type 2 Diabetes Mellitus and multiple chronic conditions and their family caregivers. Once the study is complete, the investigators will be able to determine if there is any measurable difference in self-care management between usual care plus the intervention versus usual care alone.
NCT00835861
Many women come into pregnancy with diabetes that is controlled with either Metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic control, and has been used in pregnancy for other indications without adverse maternal or fetal outcomes. What remains unproven is the ability of Metformin to adequately control glucose in women during pregnancy. Our goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by either diet or an oral agent and women who are found to have an abnormal glucose challenge test at less than 20 weeks to either standard treatment with weight based Regular and neutral protamine Hagedorn (NPH) insulin or Metformin. Our hypothesis is that Metformin will provide glycemic control that is equivalent to insulin in these women.
NCT01980459
In most diabetic patients where low blood magnesium levels occur the important depletion of cellular levels is usually not measured. This study will measure both blood and oral mucosal cell magnesium levels before and after 3 months of supplementation with magnesium tablets (the recommended dietary amount of 336 milligrams per day). These magnesium levels will be correlated with blood levels of indicators of inflammation (eg C reactive protein) to see whether the cellular levels are more reliable than blood levels of magnesium for appropriate treatment of magnesium deficiency in diabetic patients.
NCT02529969
Diabetes mellitus is the most common endocrine disorder, causes many complications such as micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed, but most of them have side effects. Recently, the use of natural plant products has gained more attention among scientists in order to prevent diabetic vascular complications. Curcumin is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory, anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in reducing glycemic index and hyperlipidemia in rodent models and is relatively inexpensive and safe. Most of the studies conducted on animal model, and just a few of them are on human model. The present study was planned to evaluate the effects of curcumin supplementation on serum levels of lipid profile and inflammatory markers in patients with type 2 diabetes
NCT01559025
The primary objective of this study is to evaluate the action of DPP-IV inhibitors in the prevention of progressive beta cell dysfunction in patients with type 1 diabetes mellitus newly diagnosis ( less than 6 months). The secondary objectives are: 1. To define the immune and inflammatory profile 2. To define the secretion of glucagon and GLP-1 3. To assess the glycemic variability
NCT01735253
Surgical treatment for type 2 diabetes has been taken note especially in less obese or non obese patients. In Asian, the nuber of less obses or non obese patients with T2DM is greater than that of the obese. We are trying to do a prospective observational study for the evaluation of the effect of duidenojejunal bypass and gastric bypass on the glycemoc control in those patients. The selection criteria are type 2 diabetess, 20-60 years old, BMI 23-34 or 21-22 with viceral obesity, insulin use less than 10 years and the patients understanding the hypothesis of this study, risks, expecting effects and agreeing this study. We are checking oral GTT, insulin level, C-peptide level, HbA1C, etc. with some anthropometric measurs preoperatively, postoperatively, at 3 month and 12 month. We will compare the clinical factors at each time.