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49 active trials for Type1diabetes

Hb A1C Pre and Post Confinement in Latin American Children With Type 1 Diabetes: Dulce Study Group

A multicenter retrospective observational study among children with type 1 diabetes will be performed. The Objective of this study will be to determine a) the association between the increase in Hba1c in children with type 1 diabetes and confinement due to the COVID 19 pandemic. b) the association between the frequency of patient care during social confinement and the Hba1c values. Different centers from Latin America including Argentina, Peru, Panama, Chile, and Ecuador will participate in this study. Children younger than 17 years with a diagnosis of type 1 diabetes prior to 2018 will be included. Data from the medical records of the participating centers will be collected on the Hb A1c value before and after confinement (6 months completed). The initial (base) value will be taken as a value of HbA1c registered in the patient's Clinical History for the year 2018, 2019, and 2020 pre and post quarantine (Sep-Oct-Nov) 2020, considering compliance with six months of quarantine. Hb A1c should have been performed in the same institution or with the same methods in order to avoid bias.

Start: November 2020

Genetics Of Autoimmunity In Type I Diabetes

The purpose of this study is to gain more information about the step-by-step process that causes someone to develop type 1 diabetes. Scientists think that a person's own immune system, directed by genetic and environmental factors play a major role in its development. Participation involves a blood draw, a brief medical history questionnaire and measurements of height and weight. Some participants will be asked to return for annual follow-up visits for 10 years.

Start: August 2001

Phenotypic and Genotypic Characterization of New-onset Type I Diabetes

The goal of DIATAG study is the identification of biomarkers of T1D evolution in a pediatric cohort.

Start: June 2019

Sleep, Glycemic Control, and Insulin Resistance in Adolescents With Type 1 Diabetes

Despite advancements in care, most adolescents with T1D have higher BMI and significantly higher HbA1c than recommended and are markedly IR, placing them at increased risk for CVD1,2. Thus, alternative approaches to improve and maintain glycemic control, IR, and BMI for adolescents with T1D are urgently needed. This proposal moves beyond the current insulin and carbohydrate counting-focused lifestyle change paradigm to focus on sleep and circadian misalignment, which will allow for identification of new mechanisms that can be directly translated into future intervention and prevention trials. The goal of the current study is to utilize multiple objective measures of sleep duration, timing (actigraphy), and circadian rhythm (melatonin) in adolescents with type 1 diabetes (T1D; N = 40) and examine relationships with glycemic control, IR, vascular health, and BMI. Further, qualitative methodology will be used to identify barriers and facilitators to healthy sleep in adolescents with T1D.

Start: December 2019

Covid-19 Infection and New Onset Type 1 Diabetes

Although recognized as an autoimmune disease the etiology of type 1 diabetes remains unknown. Virus infections has been suggested as a possible agent triggering the autoimmune reaction finally resulting in beta-cell destruction and fate of insulin secretion. SARS Cov-2 virus enters the infected cells by binding to the ACE-2 receptor, which is abundant in many tissues including the pancreas. Accordingly, SARS Covid-19 infection may trigger the development of type 1 diabetes either by an activation of the immune system or directly via beta-cell infection and destruction. Our aim is to study the impact of the Covid-19 epidemic on the development of type 1 diabetes. This will be done in two ways: a clinical study and an epidemiological follow up. During the next two years, adult patients with newly diagnosed type 1 diabetes will be asked to participate. Type 1 diabetes will be diagnosed by usual means and a mixed meal tolerance test will be performed at time of diagnosis and after one year to evaluate beta-cell function. People with type 1 diabetes and serologically documented previous SARS Covid-19 will be compared with people with no previous infection regarding beta-cell function and fate of insulin secretion. In addition, we will estimate the number of new diagnosed type 1 diabetes patients compared to previous years.

Start: November 2020

Defining the Role of Management Factors in Outcome Disparity in Pediatric T1D

Type 1 diabetes (T1D), is associated with considerable risk of morbidity and mortality due to chronic hyperglycemia. Despite innovations in management, pediatric patients of African ancestry (AA) have been found to have persistently higher mean blood glucose (MBG) than European ancestry (EA) patients. The investigators hypothesize that an intervention using advanced insulin delivery technology together with home management will sustainably improve MBG to levels comparable to EA patients without increasing hypoglycemia. The investigators will first perform a small "field trial" of the intervention in African American patients having T1D, with 8.5<HbA1c<12% aged 10-17 years. The primary intervention approach will use a combination of an advanced hybrid closed loop (AHCL) pump + enhanced home video management conferencing with study CDE nurse coordinator. Information gained in the "field trial" will be used to more specifically tailor the intervention in a randomized trial. In the second part , the investigators will conduct a randomized trial of the study intervention in participants with the same clinical features as the field trial for a six month pilot period. Participants will be randomized into one of four groups. The special intervention group (AHCL+conferencing) group will be compared with a group using patient's current insulin management+followup, vs AHCL+without conferencing, vs patient's standard insulin management+conferencing. The investigators will compare HbA1c, MBG, time in glycemic range, ability to adhere with home management, satisfaction with management procedures between the groups.

Start: November 2020

The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes

The study is designed to evaluate two different dietitian-led self-management approaches in carbohydrate counting compared to routine dietary care (control) on glycaemic control in adult patients with type 1 diabetes: The basic carbohydrate counting concept aims at improving carbohydrate counting accuracy and day-to-day consistency of carbohydrate intake (the BCC intervention) The advanced carbohydrate counting concept aims at improving prandial insulin dose accuracy using an automated bolus calculator (the ABC-ACC intervention) The main hypothesis is that structured training and education in either the BCC concept or the ABC-ACC concept will reduce HbA1c or the average glucose variability more than routine dietary education.

Start: September 2018

Bridging the Gap to Adult Diabetes Care

Adolescents with type 1 diabetes face particular challenges related to having a chronic illness that requires daily intensive self-management and medical follow-up during a period when their social, developmental, educational, and family situations are in flux. When transitioning from pediatric to adult care, over a third of youth have a care gap of >6 months. During this vulnerable period youth are at risk for acute life-threatening complications such as diabetic ketoacidosis, and for poor glycemic control, which confers an increased risk of chronic diabetes complications. Gaps in care may be a result of deficiencies in transition processes causing some young people to be poorly prepared for adult care and dissatisfied with the transition process. Ineffective transition can lead to decreased frequency of diabetes visits and an increased risk of adverse events in young adulthood. Further, risk factors such as psychiatric comorbidity and behavioural problems in adolescents with type 1 diabetes are associated with poor outcomes in early adulthood. Quality improvement initiatives can be designed to optimize care processes such as referral systems to adult diabetes providers. Our overall objective is to optimize care and outcomes for youth with diabetes as they transition to adult care. Specific Aim 1: To improve glycemic control in youth around the time of transition from pediatric to adult diabetes care Specific Aim 2: To evaluate the fidelity and quality of a quality improvement intervention designed to improve transition care processes and to identify contextual factors associated with variation in outcomes.

Start: June 2019

The Impact of a Predictive Hypoglycaemia Alert Function in Physical Activity for People With T1DM

Observational, within-subject, crossover study To assess the impact of Dexcom G6 RT-CGM with a predictive hypoglycaemia alert function on the frequency, duration and severity of hypoglycaemia occurring before, during and after regular physical activity in people with type 1 diabetes At Imperial College Healthcare NHS Trust have established the multi-disciplinary Imperial Physical Activity and Diabetes (IPAD) clinic to empower, educate and enable people with diabetes to manage their blood glucose when they undertake physical activity. The investigator utilise the skills and expertise of a consultant diabetologist, a diabetes dietitian, a consultant in sports & exercise medicine, and a diabetes specialist nurse with expertise in diabetes technology. The investigator have access to diagnostic & therapeutic radiology, physiotherapy and psychology services.

Start: December 2019

A Trial of Diabetes-educated Psychologist to Improve HbA1c and Reduce Diabetes-related Distress

Type 1 diabetes is associated with a significant increase in mortality, cardiovascular disease, injuries on eyes and kidneys. These risks are largely dependent on glycemic control. Multiple strategies of achieving good glycemic control exist. Despite this, only about 20 % of patients in Sweden reach the target HbA1c of ? 52 mmol/mol. It is well-known that when the motivation is high, a large proportion of patients reach good glycaemic control with current treatments, e.g. most pregnant women reach a much better glycaemic control. The patient is then motivated to a greater extent in managing the disease, e.g. by carefully dosing insulin and more closely monitoring blood glucose levels. Moreover, besides lack of motivation, specific psychiatric conditions are well-known barriers in being compliant with treatments such as depression, eating disorders and attention deficit disorders (ADHD). Further, identified specific diabetes-related psychosocial factors include severe fear of hypoglycaemia, diabetes-burnout, unrealistic treatment goals, poor relationship with physician, feelings of powerlessness and treatment skepticism. These parameters can be measured via a diabetes distress scale where a high score is correlated to higher HbA1c. The majority of outpatient diabetes clinics in Sweden today request the resource of a diabetes-educated psychologist. However, more evidence is needed from randomized multicentre trials whether such a resource would help to improve HbA1c, reduce diabetes-related distress and improve quality of life. The primary aim of the current study is to evaluate whether the assistance of a diabetes-educated psychologist in the diabetes care of patients with type 1 diabetes improves HbA1c. Secondary endpoints include studying its influence on diabetes-related distress and quality of life. The study is a 1 year randomized trial where the intervention group will meet with a diabetes-educated psychologist in addition to conventional care.

Start: January 2019

Study of Acceptability of a New Distance-learning Tool "MyFIT"

The investigators developed an on-line learning tool "MyFIT" enabling to patients with T1D to acquire the knowledge and skills for practicing functional insulin therapy from their home. The aim of the present study is to evaluate the acceptability of this new learning modality via the tool "MyFIT" by the patients and by the health professionnals.

Start: July 2020

Exercise Training and Endothelial Function in Type 1 Diabetes

Endothelial dysfunction and vasoreactivity disorders are early subclinical complications of type 1 diabetes (T1D). In a preventive setting, in T1D patients still free of complications, the research of non-pharmacological interventions to improve endothelial function appears fundamental. In this randomized controlled trial, the effects of exercise training on endothelial function will be evaluated in T1D adults. Secondary objectives are to evaluate the exercise training effects on the micro and macrovascular function and exercise-induced tissue vasoreactivity and their possible neurometabolic consequences. An improvement in vascular function, particularly endothelium-dependent, as well as in neurometabolic profile, through this non-pharmacological strategy is expected

Start: November 2019

Postprandial Gut Hormone Responses in Patients With Type 1 Diabetes Mellitus

The study will compare the postprandial responses to a test meal between subjects with type 1 diabetes and healthy control subjects, in terms of gut hormone levels, meal induced thermogenesis, hunger and satiety perception, as well as futher metabolic parameters.

Start: August 2020

Comparison of Low, Moderate and High Carbohydrate Diet on Insulin Requirements and Metabolic Control in Type 1 Diabetes

The scientific basis for dietary recommendations in type 1 diabetes is almost lacking, with the current recommendations being based on type 2 diabetes studies. Therefore the overall purpose of this study is to improve the current evidence for dietary recommendations to people with type 1 diabetes. Study aim: To compare how a strictly low carbohydrate diet, a moderately low carbohydrate diet and a traditional diabetes diet (with higher amounts of carbohydrates) affect insulin requirements and metabolic control in individuals with type 1 diabetes. Carbohydrate intake is 50-60% of the total energy intake in the traditional diabetes diet, 30-40% in the moderately low carbohydrate diet and 15-20% in the strictly low carbohydrate diet with a minimum of 50 g carbohydrates/day. A diet with less than 50 g carbohydrates/day is usually called very low carbohydrate diet or ketogenic and will not be tested in this study. Recruitment areas are Stockholm and Uppsala. Those who wish to participate and meet the inclusion criteria (and none of the exclusion criteria) will be randomized to one of the three diets. The duration of the intervention is 6 months after which the participants will be able to choose their own diet for another 6 months. The main study visits are at baseline (screening and study start), 3, 6, 9, and 12 months. Shorter visits will be at 3 and 6 weeks. The participants will meet with a study nurse, dietitian and doctor. They will attend two carbohydrate counting courses before the start of the intervention in order to be able to match their insulin to the amount carbohydrates they eat. Participants will receive written materials about their diets with menus and recipes for better adherence to the diet. The primary endpoint is the change in insulin requirements within and between groups (for secondary endpoints please see relevant section). For assessing the different endpoints the participants will provide blood, urine and feces samples for lab analyses as well as register their insulin use, blood glucose, diet, physical activity and any blood ketones or hypoglycemia electronically or in written forms. Continuous/flash glucose monitoring (CGM/FGM) will be also used for 3-7 days before study visits. Dietary assessment and adherence will be based on 3-4 day food diaries before every scheduled study visit.

Start: December 2018

New Insulin Therapy by Multiwave Bolus

The aim of the study is to evaluate the effect of insulin therapy when the bolus dose of insulin is calculated on the basis of protein and fat content in food intake, in addition to that of carbohydrates in T1D patients treated by insulin pump. The study is planned to recruit 150 patients with type1 diabetes already practicing functional insulin therapy based on carbohydrate counting in meals. We will therefore study the effect on continuous glucose measured by subcutaneous sensor, of meal bolus adjustments by comparing two groups of T1D patients: Groupe A takes into account the lipid and protein content in addition to the carbohydrate content Group B takes into account the carbohydrate content only At randomization, all patients receive dietary and adjustment of bolus doses instructions according to the randomization group. They have to apply these instructions for 3 months. At the end of 3 months, the study groups will be under glucose monitoring during two weeks in the Outpatient Clinic but returns to the investigational site in hospital to download data from the continuous measurement of glucose. In addition, we propose a period of extension similar to that of the main period, namely 3 months of application of dietetic and adaptation of bolus doses instructions and 2 weeks of continuous measurement of glucose. During each 2 weeks period will be assessed specific glucose parameters in the post-prandial period over 4hours (glycemic sensor values in the glucose range between 70-140 mg / dl, glycemic sensor values in the glucose range between 140 -180 mg /dl and > 180 mg /dl) after taking each meal during the 13 days of Glucose Continuous Measurement (GCM), average daily glucose per meal, average blood glucose over the 13-day period after each meal.

Start: October 2019

Unannounced Meal Handling of Advanced Closed Loop Insulin Delivery in Monitored Condition

The study will follow participants for the periods of 3 months while using an advanced hybrid closed loop algorithm in free living conditions . Each period will have a different meal handling protocols. The objective is to identify the mitigation of the algorithm with different meal handling approaches.

Start: July 2020

Hybrid Closed Loop Insulin Delivery System in Hypoglycemia

Can a type 1 diabetic adult avoid low glucoses and regain hypoglycemia awareness using a hybrid closed loop insulin delivery system? Involvement is 22 months (13 visits) and includes a 4-week Screening Phase and an 18-month Intervention Phase. Participants will undergo 3 Hyperinsulinemic Clamps done at: Baseline (before starting the device and after completing the screening), 6 months (after using the device 6 months), and after using the device for 18 months. This metabolic testing will allow us to measure improvement in hypoglycemia awareness.

Start: August 2017

Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients

Physical activity, along with proper nutrition, is the basis for the behavioral treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation. The aim of this study is the assessment of physical exercise in normobaric hypoxia condition on metabolic control of diabetes: blood glucose profile, its stability, HbA1c value, hypoglycemia: frequency, level, severity and time of occurrence, insulin demand, maximal muscle strength level, VO2max and anthropometric parameters.

Start: October 2019

Skeletal Fragility in Type 1 Diabetes: Glycemic Control and Bone Strength

The purpose of this research study is to find out how bones are affected in children and adolescents with type 1 diabetes (T1D) as compared to children and adolescents without type 1 diabetes.

Start: January 2020

A Evaluation of Systematic Intensive Therapy Using CGM/FGM in Clinical Diabetes Care

This study aims to analyse if intensive systematic treatment via internet and telephone during 4 months improved HbA1c for persons with type 1 diabetes which are already treated with CGM or FGM, and if the effect continuous for 1-2 years after the intervention stops. Time in Hypoglycaemia, treatment satisfaction, Diabetes distress and hypoglycaemia fear will even be analysed. A randomised, non-blinded, multi-centre, clinical study for persons with type 1 diabetes and hbA1c ? 58mmol/mol and treated with CGM or FGM. The control group continuous its normal diabetes care with study visits at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires. The intervention group will have contact with the study team on a weekly basis, when mean blood glucose levels the previous week are elevated. They will receive help with analysing data and advice on how to improve their glucose values. They will even meet the study team at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.

Start: November 2018