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Type1diabetes clinical trials

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NCT ID: NCT06318611 Completed - Sleep Clinical Trials

Sleep Patterns and Chronotype in Children With and Without Type 1 Diabetes

Start date: May 1, 2022
Phase:
Study type: Observational

Type 1 diabetes (T1D) is one of the most common chronic childhood diseases. Recent studies have highlighted the strong association between type 1 diabetes and sleep health problems. Sleep problems have been reported to include sleep onset, sleep maintenance, frequent nighttime awakenings, and daytime sleepiness. Studies show that children with T1D sleep significantly less than their peers without diabetes, and that this is associated with poorer glycemic control in type 1 diabetes due to impaired glucose metabolism. This study aimed to compare sleep health composite dimensions and chronotype in children and adolescents with and without T1D, and to explore the relationship between sleep and glycemic variability in T1D. The study was designed as a prospective observational case-control study. The estimated sample size is calculated as 168. The sleep health composite dimensions were measured using actigraphy, sleep diaries, and self- or parental reports. Sleep disturbance will be assessed using the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) Level 2-Sleep Disturbance Scale Short Form, and the Children's Chronotype Questionnaire will be used to determine the chronotype. Sleep/wake patterns were also assessed using sleep diaries. Glycemic variability was assessed using continuous glucose monitoring (CGM) device parameters.

NCT ID: NCT05936203 Completed - Type1diabetes Clinical Trials

Management of Prolonged Aerobic exeRcise in Patients With Type 1 Diabetes on Advanced Technologies

MARTA-walk
Start date: January 11, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to compare three different therapeutic and nutritional approaches during a prolonged aerobic exercise in moderately active type 1 diabetes people using advanced technologies, to identify the best strategy for the management of this type of exercise. Participants will be randomly assigned to different interventions in three different occasions: insulin therapy adjustment; nutritional adjustment; combination of insulin and nutritional adjustment.

NCT ID: NCT05874323 Completed - Type1diabetes Clinical Trials

The Relationship of RAGE Gene Polymorphism With Type I Diabetes in Egyptian Patients

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Type I Diabetes Mellitus (TIDM) is a chronic metabolic disorder caused by the immune-mediated T-cell and macrophages that typically affects insulin-producing β-cells of Langerhans leading to cell destruction and absolute insulin deficiency. This study aimed to investigate the correlation of RAGE gene polymorphism rs1800625 with the incidence of type I diabetes mellitus in the Egyptian patients with the activity and the severity of the disease and to assess their association with inflammatory reactions in TIDM patients (IL-6, TNF-α). Also, this study investigated the relation between MiRNA-34, MiRNA-146, to TID severity and activity

NCT ID: NCT05762783 Completed - Sleep Disturbance Clinical Trials

The Importance of Sleep for Diabetes Associated Tasks and Outcomes

Sleep1child
Start date: March 27, 2023
Phase:
Study type: Observational

Adolescents with type 1 diabetes (T1D) experience more disturbed sleep compared to their healthy peers, especially because they tend to spend less time in deep sleep, the most restoring part of sleep, potentially impacting diabetes management. Disturbed sleep may adversely affect diabetes management which requires day-to-day decision-making, emotional and behavioural regulation, attention, and planning. Despite a massive increase in new technology, more than 50% of adolescents do not reach their glycaemic target. Lack of sleep impairing diabetes management including blood glucose monitoring may play an important role in reaching the goal. For approximately 4000 children and adolescents in Denmark living with T1D, sleep disturbances may therefore account for short and long-term diabetes complications. Our overall aims are to investigate: (1) If and how glycaemic variability (GV) influences sleep quality and sleep stages and (2) if and how poor sleep quality influences time-in-range (TIR), time-above-range (TAR) and time-below-range (TBR) the following day.

NCT ID: NCT05747352 Completed - Type1diabetes Clinical Trials

Safety of Closed-loop Hybrid Insulin Administration During Ramadan Fasting in People Living With Type 1 Diabetes

RAMDAM
Start date: June 5, 2023
Phase:
Study type: Observational

Fasting in Ramadan is not recommended for people with type 1 diabetes. The main risk associated with fasting is dysglycemia (hypoglycemia, hyperglycemia, diabetic ketosis) and dehydration. Nevertheless, whether or not to practice Ramadan remains a personal choice and many people living with diabetes choose to perform this fast with or without their physician's approval. The purpose of this prospective observational study is to evaluate the safety and efficacy of an closed-loop hybrid insulin system on glycemic parameters and the level of hypoglycemia in patients with type 1 diabetes who wished to fast during Ramadan.

NCT ID: NCT05729776 Completed - Type1diabetes Clinical Trials

Evaluation of the Glucose Metrics After Eating Pizza Margherita in Hybrid Closed Loop Users

Start date: December 1, 2022
Phase:
Study type: Observational

In previous study the investigators proved that blood glucose after eating pizza margherita could be managed with a simple wave bolus of insulin in pediatric patients with type 1 diabetes under controlled conditions. Participants in this previous study were Predictive Low Glucose Suspended (PLGS) System users. In this study the investigators want to demonstrate that blood glucose after the meal pizza margherita could also be managed with simple wave bolus of insulin in real life. The investigators will include just the patients with Hybrid Closed Loop (HCL) System.

NCT ID: NCT05708040 Completed - Type1diabetes Clinical Trials

Clinical Trial to Evaluate the Efficacy of the Smart Insulin Pen Compared to a Closed Loop System in Patients With Type 1 Diabetes (EBIACE-1)

EBIACE-1
Start date: August 19, 2022
Phase: N/A
Study type: Interventional

Analysis of glycemic control, frequency of hypoglycemia, glycemic variability, patient satisfaction and patient-perceived quality of life in patients with type 1 diabetes mellitus and continuous real-time glucose monitoring, the use of a smart pen compared to a closed loop system.

NCT ID: NCT05698875 Completed - type1diabetes Clinical Trials

The Breakfast Rise, Education and Knowledge Study

BREAK
Start date: February 14, 2023
Phase: N/A
Study type: Interventional

The study proposes to recruit 90 children and young people who have type 1 diabetes (T1D) and who regularly use Dexcom continuous glucose monitoring (CGM). The participants will be recruited from National Health Service (NHS) sites in the United Kingdom (UK) via their managing dietitian. The dietitian will be asked to provide baseline information about the participants which will include demographic data and information on clinical data, treatment and anthropometrics. Participants will be asked to provide access to Dexcom CGM data throughout the period of recording. Participants will be asked to test three breakfast meals (high glycaemic load, high glycaemic with 10g added protein and medium glycaemic load) plus a control meal (usual breakfast), repeating each meal twice in a randomized order using a Latin square randomisation. The dietitian will be asked to optimise the participants insulin doses prior to commencing test meals. Participants will be asked to complete a questionnaire for each of the postprandial test and control meal periods. This will include questions about their diabetes management, food and fluid intake in addition to questions on activities all of which took place during the three-hour postprandial period. The glycaemic response to the test and control meals will be analysed using the CGM data and the results statistically described using univariate, bivariate and multivariate analysis.

NCT ID: NCT05678712 Completed - Hemodialysis Clinical Trials

Improved Glycemic Control in Diabetic Patients in Hemodialysis Using Continuous Glucose Monitoring (CGM)

Start date: March 9, 2022
Phase: N/A
Study type: Interventional

The 16-week trial is an open-label cross-over trial which includes heamodialysis patients with T2D and T1D on insulin therapy. During one period, patients carry a non-blinded CGM. In the other period they follow standard procedures (the last two weeks with a blinded CGM). The patients and the dialysis staff can use the CGM measures to regulate insulin and food intake during the non-blinded weeks. The research group will collect the CGM-data during the trial.

NCT ID: NCT05620251 Completed - type1diabetes Clinical Trials

Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes

Start date: September 3, 2021
Phase:
Study type: Observational

Adolescents with type 1 diabetes may be at increased risk for severe coronavirus disease-2019 (COVID-19) and are therefore prioritized for access to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination. The pivotal trial that assessed the efficacy of the BNT162b2 vaccine among adolescents demonstrated 100% protection against SARS-CoV-2 infection after a two-dose regimen. However, the research did not include adolescents with type 1 diabetes. In this study, the investigators aimed to assess the humoral immune response of infection-naive adolescents with type 1 diabetes following vaccination with the BNT162b2 vaccine in comparison to that of infection-naive healthy controls and the factors associated with that response.