Active clinical trials for "Diabetes Mellitus"

Pregnancy is a vulnerable period for both a mother and her developing child. The investigator hypothesizes that diet-induced glucose excursions in the pregnant mother are a key contributor to unfavourable brain development and epigenetic marks in the developing child. It is long known that metabolic conditions are influenced by maternal nutrition and that this can impact the unborn infant. The most prominent example is gestational diabetes (GDM). It is unclear at what point unfavourable changes in brain development occur during pregnancy. Unlike many previous trials, we plan to introduce healthy diet early in the first trimester. Comparative analyses of DNA methylation patterns in the offspring of women with or without GDM revealed preferentially methylated genes, particularly in pathways linked to metabolic diseases. NuPreGDM is a randomized, controlled, open label intervention trail. The investigator aims to assess the effect of individual diet counselling combined with CGM compared to regular diet on glucose levels and postprandial glycemic excursions during an OGTT in pregnancy. The investigator wants to assess the effect of dietary counselling combined with continuous glucose monitoring on GDM risk, glycaemia and pregnancy outcome, starting in the first trimester. The investigator further hypothesizes that improved glucose levels by a healthy diet will affect brain activity of the infant and prevent unfavourable epigenetic modifications. The investigator plans to include 50 pregnant women within gestational week 4 and 14 after the last menstruation, with elevated risk for development of (GDM). Participants will be randomized 1:1 to either "diet modification group" (intervention) or to "standard diet group" (control). In the current trial, the investigator aims to modulate maternal metabolism with periodic personalized diet counselling on the basis of continuous glucose monitoring (CGM) compared to regular diet throughout pregnancy. The investigator propose that a reduction in glucose excursions in the mother will lead to a healthy environment for the developing child and prevent altered brain activity in utero, which will be assessed by fMEG (fetal magnetoencephalography) during a 75g OGTT in gestational week 28. The investigator further planned to examine child's leucocytes from cord blood to assess whether a healthy diet of the mother prevented epigenetic alterations due to improved maternal glycaemia, as exploratory endpoint. The development of blood sugar levels of the mother postpartum will be assessed by an further OGTT 6-12 weeks postpartum.

The goal of this clinical trial is to learn about the effect of the study drug (ZT-01) on low blood sugar (hypoglycemia) in adults with type 1 diabetes (T1D) who have been having low blood sugars ("hypos") at night. ZT-01 increases the amount of a hormone called glucagon during low blood sugar, and this may help prevent the occurrence of hypos. The main questions this trial aims to answer are whether ZT-01 lowers the number of hypos happening at night, and what its effects are on blood sugar levels. The safety of ZT-01 will also be measured. Participants will be asked to wear a study-provided continuous glucose monitor (CGM) during two 4-week periods when they will self-inject the study drug before bed. They will get ZT-01 at one of three dose levels during one period, and placebo (which looks like the study drug but doesn't contain the active ingredient) during the other. Neither the participant nor the study site will know what they are receiving during each treatment period or see data from the CGM. The participant will continue to use their usual methods of measuring blood sugar (including their personal CGM) and giving insulin during the study. The participant will be asked to complete a short diary each evening, and will be asked to upload the CGM data to a study phone every day. If a participant uses their own CGM and is willing to share information on how often they have low blood sugar with the study site at the first visit to see if they meet study entry requirements, they will have 6 study visits, 2 study phone calls, and be in the study for about 16 weeks. If they don't use CGM or don't want to share their information, then they will be asked to wear a study CGM for an extra 4 weeks to find out how many low blood sugars they have, and will have an extra visit. Study participants will be asked to give blood and urine for testing to see whether they meet the requirements to enter the study, and at the start and end of each treatment period to see if the study treatment has any effects. They will also have their blood pressure and temperature taken at each study visit, and have an ECG at 4 visits to measure the electrical activity of their heart. Some participants will be asked to also take part in a sub-study where their blood level of ZT-01 and glucagon is measured, after the first and last dose. They will be asked to stay at the study site overnight for each set of measurements (4 in total).

Carbohydrate count marks the cornerstone of Type 1 Diabetes management. Eventhough it is a crucial task, it is burdensome and prone to error. Therefore, the investigators want to explore the effect that SNAQ, a food analyser app would have in glycaemic control by facilitating the task of carbohydrate estimation.

The purpose of this study is to develop and test an 8-week sedentary behavior reduction intervention ("Sit Less" program) for patients with type 2 diabetes. The program aims to reduce and break sitting times among this population using an objective activity monitor and mHealth. The investigators will test the program to help diabetes patients break up sitting time, reduce daily sitting time, and move more. The investigators will also study preliminary effects of the SB reduction intervention on light physical activity, cardiometabolic markers and patient-centered outcomes, and whether diabetes patients like the program and can follow it.

This phase 2 study will include patients suffering from type 2 diabetes mellitus and will first study their response to enteric coated aspirin at a dose of 80 mg per day for a 7-day period. Participants with an incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily will be randomized to a random order of 3 different ASA regimens: EC ASA 162 mg once daily, EC ASA 81 mg twice daily and chewable ASA 40 mg twice daily. The aims are to determine the feasibility of a larger scale trial, and to determine the regimen associated with the lowest proportion of non-responders after randomization. Platelet function will be assessed at baseline and at day 7 of each arms of the study.

The study is being conducted to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with oral antidiabetic drugs compared to insulin Glargine QD for 26+26 weeks.

Diabetes is prevalent in adults admitted to subacute rehab (SAR) and long-term care (LTC) skilled nursing care facilities. Management of diabetes in these facilities is challenging due to number of older adults with higher prevalence of other diseases, functional disability, and altered nutritional intake, which increase the risk of hypoglycemia (low blood sugars). The investigators propose to conduct this randomized controlled trial to determine whether the use of Dexcom CGM with Glucose Telemetry System (CGM-GTS) with hypoglycemia alarm compared to standard of care using capillary POC testing, will facilitate diabetes treatment and reduce the risk of hypoglycemia in patients with T2D in LTC facilities. Participants in the standard of care group will also wear a CGM (blinded one). The results of this study have great potential to impact and facilitate care and to change current clinical guidelines in the management of older adults with diabetes in SAR and LTC facilities.

Investigator initiated, randomised, placebo-controlled, double-blind, multi-centre primary intervention study to assess whether daily administration of B. infantis EVC001 from age 7 days to 6 weeks (+14 days) until age 12 months (+ 14 days) to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies in childhood.

A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System with Enhanced Features. The purpose of this clinical investigation is to evaluate the accuracy of the Eversense 524 Continuous Glucose Monitoring System (Eversense 524 CGM System) and ROME CGM System with next generation feature enhancements compared to reference glucose measurements in adults 18 years of age and older with diabetes. The investigation will also evaluate safety of the Eversense 524 CGM System and ROME CGM System usage. Additionally, the safety and accuracy of the Eversense 524 CGM System will be evaluated in the pediatric population ages 14-17 with Type 1 Diabetes Mellitus.

As more adolescents with type 1 diabetes (T1D) opt to follow very low carbohydrate diets to improve glucose control, it is becoming increasingly important to study the metabolic and neurological changes that occur on these diets and how these effect patient safety. Understanding the impact of dietary changes on metabolic and neurological factors will help guide clinical advice about the overall safety and efficacy of these diets in the pediatric T1D population. This work will be the basis of future studies testing dietary interventions to improve glycemic control and ensure that these dietary interventions are safe for growing youth with T1D.