Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life
Type 1 DiabetesEvaluation of Long-Term Implanted Sensor in Patients on Quality of life
Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device...
Diabetes Mellitus Type 1Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic goal that can be achieved with a true non-invasive device offering the likelihood of continuous glucose monitoring. Currently, glucose is best monitored by measuring capillary blood from the fingertips, from venous/arterial line blood samples and from a daily calibrated Subcutaneous Blood Glucose Monitor (SBGM) which is a source of severe inconvenience and hence, a lack of compliance. Thus, the need for non-invasive and easy to operate glucose monitoring in DM patients for strict glycemic control cannot be overemphasized. The Glucometer CGM-305 blood glucose readings are accurate and measure blood glucose with an acceptable mean relative error when compared to acceptable invasive blood glucose measurements. The primary objectives of the trial are to determine: The safety of the Glucometer CGM-305 in evaluating blood glucose levels The accuracy of the Glucometer CGM-305 in evaluating blood glucose levels
A Randomized Control Trial in People With Type 1 Diabetes Who Will Fast Ramadan: Does Insulin Timing...
Type 1 Diabetes MellitusFasting Ramadan is one of the five pillars of Islam and requested only from healthy adults to abstain from eating and drinking from sunrise to sunset. People with type 1 diabetes mellitus (TIDM) are exempted from fasting, as their chronic condition could be adversely affected by fasting. Nevertheless, many insist on fasting and it has been experienced and advocated that with proper education and follow-up with health care providers, people with uncomplicated T1DM could safely fast Ramadan. Adopted IDF-DAR guidelines for people with diabetes planning to fast Ramadan are available but are based on opinions and largely untested. These current guidelines recommend a significant reduction in insulin doses and a change of the timing of basal insulin and highlight the increased risk of hypoglycemia. Our local DAFNE patient's experience with fasting during the past years points towards no significant changes in insulin timing with minor reductions of insulin without a significant increase in the risk of hypoglycemia. There is no randomized control trial to test the efficacy of the IDF-DAR guidelines specifically looking at changing basal insulin timing This study aims to assess whether insulin doses require reduction and change of timing during Ramadan. We aim to compare the effectiveness and safety of two management strategies. This will help to provide robust guidelines to help both health care professionals and people with type 1 diabetes
The ELG Analysis of Glucose a Correlational to Blood Glucose Assay
Diabetes MellitusType 12 moreThis study is an investigational study of the ELG medical device to monitor glucose blood level in diabetes mellitus Type 1 and 2 without blood samples in comparison to blood testing methods."Investigational" means the ELG medical device is subjected by the FDA (Food and Drug Administration) for premarket testing requirements. The purpose of this study is to collect data comparison values between ELG testing device to current blood testing methods.
Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type...
Type 1 DiabetesThe primary objective of this trial is to assess whether functional insulinotherapy decreases blood glucose variability at 3 months and 6 months, compared to initial values in type 1 diabetes patients. So, this study measures the impact of functional insulinotherapy on several blood glucose variability indicators in patients with type 1 diabetes. This trial also has a secondary objective: to measure the effect of functional insulinotherapy on oxidative stress and inflammation.
Assessment of Individual Follow-up by Coaching Program for Type 1 Diabetes Children
Diabetes type1The purpose of this project is to assess the introduction of an individual follow-up distance coaching (phone and messages on a secure line platform) in order to optimize the health care of type 1 diabetes children with therapy adjustment difficulties. It is a personalized, multi-disciplinary, medical et paramedical. It will consist of an individual coaching for the children and families with therapy adjustment difficulties. The hypothesis is that the proposed coaching would allow to improve the patient glycemic control not only during this coaching, but also, to bring long lasting improvement following the coaching.
QoL and Stress in Parents of Children With Developmental Disabilities and Chronic Disease
Developmental DisabilityChronic Disease9 moreThe aim of this cross-sectional study is to investigate the level of stress and quality of life in parents of children with developmental disabilities (Down syndrome, autism spectrum disorder, pervasive developmental disorder, cerebral palsy) and parents of children chronic diseases (diabetes mellitus type 1, epilepsy, asthma) compared to parents of healthy children. The investigators will analyze the level of stress, quality of life, self-esteem, optimism, resilience, happiness, stigmatization, depression, anxiety, sleep quality, parenting challenges and some physiological indicators of the stress such as level of cortisol and heart rate variability. Also, the investigators will measure Advanced Glycation End products (AGEs) in the skin. The investigators assume that parents of children with developmental disabilities and chronic diseases have higher level of stress and lower quality of life compared to the parents of healthy children.
T1DM Clinical Onset and Progression in Paediatric Population
Type 1 Diabetes MellitusDiabetes Mellitus Type I is the chronic metabolic disease of childhood with the highest incidence in developed countries. Over the past 10 years the incidence of diabetes has been increased especially in immigrants children. The objective of the investigator's project is to evaluate factors that influence the T1DM course in immigrant and Italian children through an analysis of the relationship between socio-cultural determinants, lifestyles and metabolic control. The study population will consist of 100 children with first diagnosis of T1DM divided into two cohorts (Italian and immigrant children). The project consists in a follow-up of 18 months from first visit and will include laboratory tests, two questionnaires and determination of a microbiological indicator of the microbiota and levels of 25-hydroxyvitamin D. The research hypothesis is that the two groups of study population show a different metabolic control of diabetes due to differences in access to care, compliance to therapy and type of nutrition.
Study to Evaluate a Prototype Non-Invasive BG Measurement System
Diabetes MellitusType 22 moreDiabetes mellitus is a chronic disease currently affecting more than 425 million people, of which one-third are people older than 65 years. In the UK, the number of people currently diagnosed with diabetes surpassed 3.8 million in 2019, with someone being diagnosed with the illness every two minutes (Diabetes.org figures). The prototype device being tested is a non-invasive blood glucose measurement system worn on the wrist. This would help people with diabetes manage their condition better and help prevent complications. The main objectives of the research are: To determine how accurate and effective the Afon prototype non-invasive blood glucose measurement system is, as compared to a gold standard invasive method. To chart the Afon device's predicted blood glucose levels over time. The study will be done with 30-50 patients. Eligible patients will have been diagnosed with diabetes (type 1 or 2) at least one year prior, be between 18 and 80 years old, and with a BMI between 18-35 kg/m2. For details of the full list of inclusion and exclusion criteria, see accompanying documentation. The trial will be conducted at the Joint Clinical Research Facility (JCRF), Institute of Life Science 2, Swansea University, SA2 8PP. Participants will attend the site for a total of 5 visits, one for screening, and four study visits, no more than 7 days apart. The study will run for one year.
The Diabetes Transition Study for Young People Aged Between 16-20 Years of Age.
Type 1 Diabetes MellitusStudy into the use of a diabetes specialist transition nurse in the care of young people aged 16-20 years, with type 1 diabetes; undergoing transition from the paediatric to the adult diabetes services at the Northampton General Hospital