Adaptation and Validation Protocol for the Clinical Use of a Non-invasive Sensor for Blood Glucose...
Diabetes Mellitus Type 1 and 2This study is an Observational, prospective, single center, controlled, single-arm, non-randomized, open label clinical study clinical investigation designed to evaluate the performance of igluco invincit in the monitoring and measurement of the blood glucose compared to the standard glucometer in a group of controlled diabetic subjects. The evaluation of the clinical performance including sensitivity, specificity, and accuracy will be also carried out. The clinical investigation has been designed to involve as little pain, discomfort, fear, and any other foreseeable risk as possible for subjects.
Is Real-time CGM Superior to Flash Glucose Monitoring
Diabetes MellitusType 1The aim of the investigator's study is to compare real-time continuous glucose monitoring and flash glucose monitoring in adult patients with Type 1 Diabetes during 4-day training program focused on physical activity and over 4 weeks of follow-up.
The Effect of Gluten-free Diet on New Onset Type 1 Diabetes (T1D)
Type 1 DiabetesThe primary aim of this pilot study is to test whether gluten-free diet (GFD) instituted in children shortly after onset of Type 1 Diabetes (T1D) can decelerate the decline in beta cell function as compared to age matched controls. Primary objective of the trial is the change in C-peptide area under the curve measured by mixed-meal tolerance test (MMTT) between group on GFD and standard gluten-containing diet. Secondary objectives are: Changes in immune parameters between gluten-free diet group and control group; Differences in fecal microbiome between children on normal diet and children on GFD;
Constructed Intervention by Home and School Diabetes Nurse Visits on Diabetic Control of Children...
Type 1 Diabetes MellitusThe investigators assume that an intervention program that includes home visits and trainings of diabetes' nurse and dietitian will lead to an improvement of the patients' metabolic balance, a decrease in complications' rate, a reduction of hospitalizations and an economic streamlining.
Hypoglycemia at Initiation of Pump Therapy in Children With Type 1 Diabetes
Type 1 DiabetesThe purpose of this study is to determine if patients have more hypoglycemic episodes the first 3 days following pump start compared to their usual number of hypoglycemias with our actual pump initiation protocol.
DKA Optic Ultrasound
Diabetic KetoacidosisUncontrolled Type 1 Diabetes MellitusDiabetic ketoacidosis (DKA) is a complication of type 1, or "insulin-dependent," diabetes (T1DM) and is defined by a high blood glucose level (over 200 mg/dL) coupled with severe acidosis. In this state the body breaks down fat tissue for adequate energy production. This results in ketone and acid production, and ultimately DKA. Cerebral edema (CE), or "brain swelling," can also occur with severe DKA. Current evaluation for DKA-related CE necessitates a high index of clinical suspicion and often times such patients receive advanced brain imaging such as computed tomography (CT) scans.Ocular sonography (ultrasound) is an alternative imaging technique that can provide immediate diagnostic capability at the bedside and minimize radiation exposure. This technique has been used to rapidly and accurately detect increased brain swelling through measurement of the optic nerve sheath diameter (ONSD) in a number of clinical situations including pediatric head trauma, hydrocephalus and ventriculoperitoneal shunt malfunctions, and altitude sickness in adults. Investigators plan to conduct a prospective study including children aged 7-18 years. The objective of this study is to assess the utility of sonographic measurements of the ONSD as a tool for identification of DKA-related CE.
The Impact of Continuous Glucose Monitoring Use on Sleep in Parents of Children With Type 1 Diabetes...
Type 1 DiabetesThe purpose of this prospective exploratory study is to compare sleep quality and sleep-wake patterns in parents of children with type 1 diabetes (T1D) before and several weeks after initiating using real-time continuous glucose monitoring (RT-CGM) of their children.
Insulin Resistance in Type I Diabetes in Pediatric Care
Type 1 Diabetes24 children (12 African-American, Hispanic, or American Indian, 12 Caucasian) previously diagnosed with type 1 diabetes mellitus will participate in this pilot study to evaluate the presence of hepatic and peripheral insulin resistance. The investigators will use this pilot information to test the hypothesis that insulin resistance occurs in some children with type 1 DM, is secondary to underlying risk factors, and is responsible for increased insulin needs. Methods will include a "step-up" hyperinsulinemic euglycemic clamp and infusion of the stable isotope 6,6-[2H2]-glucose. Patient and parent interviews will be conducted to gather information about nutritional intake, ethnicity, family history, and socioeconomic status. The investigators will also measure inflammatory cytokines and free fatty acids to determine whether they are associated with differences in insulin resistance among type 1 diabetes mellitus patients.
Autoimmune Diabetes: Markers of the Disease and Treatment of Latent Autoimmune Diabetes in Adults...
Autoimmune DiabetesAutoimmunity is the main cause of diabetes type 1 and an important factor as cause of Latent Autoimmune Diabetes in Adults (LADA). Recently, research has found that being deficient of T-reg cells is an important cause of autoimmunity. The study hypothesis are: Patients with newly found diabetes type 1 have less T-reg than healthy. Patients with newly found diabetes type 1 have less T-reg than patients with long duration of the illness. The number of T-reg is negative associated with HLA-risk-haplotype. The number of T-reg is negative associated with LADA. Differences relating to inflammatory cytokines will be seen among patients with newly found diabetes type 1, but not among others.
Assessment of Quality of Life and Satisfaction With Medical Care of Pediatric Type 1 Diabetes Mellitus...
Type 1 Diabetes MellitusThe purpose of this study is to evaluate the change score for the PedsQL short form Diabetes and Core Modules and the Patient Assessment of Chronic Illness Care measured at baseline (before changing care delivery models) and 12 months after transitioning to the team model of care delivery.