Active clinical trials for "Diabetes Mellitus, Type 1"

Intense exercise is a major challenge to the management of type 1 diabetes. The management is even more difficult, during a camp, probably due to increased hypoglycemia maybe from increase of intensity of physical activity. The investigators want to evaluate steps, energy expenditure, sleep time and glycemic control and insulin dosage, through use of a wrist accelerometer, in pediatric type 1 patients attending a camp. Finding a correlation between these parameters could be useful not only for educational purposes but also in the development of algorithms for artificial pancreas.

This study will use ultrasound to characterise lipohypertrophy(LH) and assess the impact of LH on glucose variability in adults with type 1 diabetes. LH is a condition that occurs with repeated exposure to insulin at injection sites, resulting in the development of subcutaneous fatty lumps that impede the absorption of insulin. LH can lead to glucose variability, increased risk of severe hypoglycaemia and diabetes distress. In the long term it can therefore lead to increased risk of diabetes complications and increased insulin costs.

The aim of this study was to assess accuracy, satisfaction and usability of the FGM among children and adolescents with T1DM. The primary outcome was to assess the accuracy of the FGM system. Secondary outcomes included satisfaction and usability of the device as well as assessment of sensor-related issues.

The main purpose of this study is to estimate missed bolus insulin doses in diabetics. This is a 12-week, single-arm, outpatient, exploratory study with two study periods in Type 1 or Type 2 diabetics, with an investigational reusable injection pen, insulin, and a Continuous Glucose Monitoring (CGM) device.

Background: Type 1 diabetes is one of the most common chronic illnesses among children and adolescents. Although, intensive medical care is provided for these patients, some of them have poor metabolic control. For example, only 21% of adolescents with type 1 diabetes in the USA achieve the recommended average blood sugar concentration (HbA1c<7.5%). This is a major problem, since chronic hyperglycemia is the primary cause of morbidity and mortality in type 1 diabetes and causes several serious complications, for example kidney failure, blindness, and stroke. Therefore, the International Society for Pediatric and Adolescent Diabetes (ISPAD) declared psychosocial factors, to be the most important risk factors of poor type 1 diabetes Management. Therefore, an instrument is needed to identify children and adolescents with poor metabolic control in their course of disease as soon as possible. With an early identification of such risk patients, better support can be provided. However, there is no such instrument yet for pediatric patients with type 1 diabetes. To fill this gap, a questionnaire (FEPB) based on the PAT 2.0© (Psychosocial Assessment Tool; an instrument used in oncology) was developed for this project. Aim: The aim of this project is to evaluate and validate a new instrument (FEPB) for an early identification of children and adolescents with poor metabolic control in their course of disease in a longitudinal design. Method: The sample consists of children and adolescents (age: 5-18 years), who were newly diagnosed with type 1 diabetes (2-4 weeks ago), and who are in care at the University Children's Hospital of Zurich. Structured interviews are conducted with the patients and the parents are asked to fill out some questionnaires at two times: first, 2-4 weeks after the diagnosis (T1) and second 6 month later (T2). With the new instrument (FEPB) a risk score can be calculated for each patient at T1. Statistical analysis will be performed to determine whether that risk score can predict which patients have poor metabolic control (HbA1c > 7.5%) at T2.

AIMS: Determining the clinical features and prevalence of peripheral artery disease (PAD) in asymptomatics patients with type 1 diabetes mellitus (T1DM) and checking the validity of the current recommendations regarding for PAD screening in T1DM. METHODOLOGY: An observational and cross-sectional prevalence study. The whole group of patients (sample size calculated: 299 patients) will make the Edinburgh Questionnaire for detecting classic symptoms of intermittent claudication, and after verifying the absence of symptoms and exclusion criteria, they will be included in the study. All patients will undergo assessment of clinical parameters related to T1DM and classic cardiovascular risk factors, as well as, an analytical assessment of the lipid profile, HbA1c level, proinflammatory profile and oxidative stress status. They will also undergo a comprehensive anthropometric assessment including office blood pressure (BP) monitoring and ambulatory 24-hours BP monitoring in patients with an indication as routine clinical practice, assessment of cardioautonomic function, and lastly an ankle-brachial index (ABI) by Doppler ultrasound, in the context of routine clinical practice in patients with clinical indication, or as an extraordinary procedure for participating in the study in patients who do not meet criteria for screening according to current recommendations.

The investigators have identified a support group on social media with ~1500 members (children and adults), the majority of whom have T1DM and follow a carbohydrate-restricted diet. Many participants report exceptionally low HbA1C and insulin requirements. If these anecdotal reports are reflective of a large group of people with type 1 diabetes, a clinical trial would be warranted. The investigators propose to survey the above-mentioned group and their professional diabetes care providers to characterize glycemic control and explore associated dietary and diabetes care factors.

HbA1c is currently the only metric of glucose control showing an association with chronic complications of type 1 diabetes mellitus (T1D). Time in range (TIR, 70-180 mg/dL) measured by real-time continuous glucose monitoring (CGM) might be a better marker. In this study, the investigators studied the clinical significance of a 10% increase of TIR over two years.

To evaluate Tandem Control-IQ compared with rtCGM and insulin pen respectively rtCGM and insulin pump treatment in children and adolescents regarding glucose control, sleep and health economics for 18 months.

The aim of this project is to document the use of insulin pump therapy (CSII), including sensor augmented pump therapy (SAP), before, during and after pregnancy in women with type 1 Diabetes Mellitus benefiting from the Orchestra donation of Paradigm REAL-Time and Paradigm Veo pumps in Poland.