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Type 1 Diabetes clinical trials

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NCT ID: NCT06466967 Not yet recruiting - Type 1 Diabetes Clinical Trials

Clinical Utility of Tight Objectives of Advanced Hybrid Closed-loop Systems Among Type 1 Diabetes Patients (TightT1AHCL)

TightT1AHCL
Start date: June 15, 2024
Phase:
Study type: Observational [Patient Registry]

Diabetes is a chronic disease with a relevant public health burden. Maintaining blood glucose levels as close to normal as possible is essential to avoid the associated microvascular and macrovascular complications. Therefore, the key to prevent and/or reduce the development of these chronic complications lies in an adequate and strict glycemic control. This study consist of a prospective analytical clinical study in patients with type 1 diabetes (T1D). The main objective is to analyze the effect on time in range (TIR, 70-180 mg/dL) of interstitial glucose after switching to a tighter glucose objective in advanced hybrid closed-loop (AHCL) treated adult T1D patients previously treated with multiple dose insulin injection (MDI) or other AHCL systems without tighter glucose objective function.

NCT ID: NCT06455319 Not yet recruiting - Type 1 Diabetes Clinical Trials

Precision Administration of Anti-thymocyte Globulin With or Without Verapamil

Start date: April 2025
Phase: Phase 2
Study type: Interventional

T cell directed therapy, anti-thymocyte globulin (ATG), in low doses, has been shown to lower HbA1c and preserve endogenous insulin production (measured by C-peptide) in individuals with recently diagnosed type 1 diabetes (T1D). However, not all individuals who received ATG responded to the therapy (i.e., non-responders). Additionally, use of ATG alone does not address inherent beta cell stress. A calcium channel blocker, verapamil, has demonstrated C-peptide preservation in newly diagnosed T1D. Investigators will identify those mostly likely to respond to ATG using an ex vivo predictive biomarker of response to ATG. In addition, Investigators will use sequential therapies to increase efficacy (ATG followed by verapamil) and explore synergistic mechanisms. This will be assessing with in depth immunophenotyping and quantify biomarkers of beta cell stress, cell death, and abnormal prohormone processing. Finally, novel clinical trial endpoints will be assessed for their ability to predict treatment efficacy earlier than the standard endpoint at 1 year.

NCT ID: NCT06453434 Not yet recruiting - Type 1 Diabetes Clinical Trials

Diabetes Self-management With Continuous Glucose Monitoring

DIASELF
Start date: July 1, 2024
Phase:
Study type: Observational

The overall goal of this observational study is to investigate the interaction between people with type 1 diabetes and continuous glucose monitoring (CGM) and the impact of this interaction on quality of life, particularly the level of diabetes distress, and glycaemic metrics. Participants will: - Visit the clinic twice with a 14-day interval - Fill out a survey before the first and at the last visit - Use CGM as usual and use smart insulin pens and an activity tracker - Register food intake - Answer two-three questions twice a day in REDCap

NCT ID: NCT06448338 Not yet recruiting - Type 1 Diabetes Clinical Trials

UK MyREMEDY Clinical Trial

UK-MyREMEDY
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The UK MyREMEDY study investigates whether MyDiaMate, an online self-help program, can effectively improve the mental health of adults with type 1 diabetes compared to those receiving care as usual.

NCT ID: NCT06435156 Not yet recruiting - Heart Failure Clinical Trials

Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes

SOPHIST
Start date: July 2024
Phase: Phase 2
Study type: Interventional

People with type 1 diabetes sometimes develop heart failure which can cause symptoms like breathlessness, tiredness or ankle swelling, reduced quality of life and lead to being admitted to hospital or suffering potential fatal consequences. This trial is investigating if a tablet called sotagliflozin, can improve quality of life in people with type 1 diabetes and heart failure. In addition, this trial will also assess the safety and tolerability of sotagliflozin in this population. In previous trials that included people with type 2 diabetes and heart failure sotagliflozin was shown to improve patients' symptoms of heart failure, quality of life and reduce the chance of people with heart failure being admitted to hospital or dying. However, people with type 1 diabetes and heart failure were not included in these trials meaning that it is not known if these benefits also apply to this population. This trial aims to recruit 320 people with type 1 diabetes and heart failure symptoms in multiple sites in the United Kingdom (UK). This trial will compare the health and quality of life of participants who take sotagliflozin tablets with participants who take placebo tablets, which is a dummy tablet that looks the same as sotagliflozin. Participants will be randomly allocated to one of two groups (i.e. one taking sotagliflozin and the other the placebo) and both the medical team and participants will not know in which group each participant is until the end of the study. Participants will be in the trial for approximately 6 months and will be given sotagliflozin or placebo tablets to take 1 per day for 4 months. The trial is expected to run for a total of 26 months.

NCT ID: NCT06427421 Not yet recruiting - Type 1 Diabetes Clinical Trials

Characterization of Autoreactive Regulatory and Conventional CD4 T Cells in Recent Onset Type 1 Diabetes and Control Individuals

CARegT1D
Start date: June 2024
Phase: N/A
Study type: Interventional

Type 1 diabetes (T1D) is caused by an autoimmune response leading to the destruction of pancreatic beta cells. The disease association with particular HLA class II alleles, particularly HLA-DQ8, indicates the implication of CD4 T cells in its aetiology. The hypothesis is therefore that T1D starts by the loss of tolerance in autoreactive CD4 T cells. This might result from alterations in conventional autoreactive CD4 T cells (Tcons), which drive disease, or autoreactive regulatory CD4 T cells expressing the transcription factor FOXP3 (Tregs), which normally maintain immune tolerance. The investigators expect that the characterization of HLA-DQ8-restricted Tcons and Tregs in recent onset HLA-DQ8+ T1D patients shall shed light on the molecular mechanisms underpinning T1D development. This knowledge will guide the development of novel cell therapies harnessing the power of genetically engineered Tregs expressing the relevant antigen receptor to restore immune homeostasis upon cell transfer. The ultimate goal is to reach a curative effect

NCT ID: NCT06422325 Not yet recruiting - Type 1 Diabetes Clinical Trials

Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to test how well a new investigational closed loop system manages your blood sugar with the ability to deliver insulin and pramlintide. Pramlintide is a drug that is used with mealtime insulin to control blood sugar in people who have diabetes. It works by slowing down the movement of food through the stomach which prevents blood sugar from rising too high after a meal. The closed loop system will receive glucose values from the Dexcom G6 CGM and automatically send commands to one Omnipod for insulin and one Omnipod for pramlintide delivery.

NCT ID: NCT06420661 Not yet recruiting - Type 1 Diabetes Clinical Trials

School Partnered Collaborative Care (SPACE) Intervention for Children With Type 1 Diabetes

SPACE
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

This is a pilot trial of a school-partnered collaborative care (SPACE) model for pediatric type 1 diabetes. The trial will investigate the feasibility and acceptability of SPACE for children with type 1 diabetes in the school setting. SPACE is adapted from a collaborative care model used to treat depression and other mental health care conditions in adolescents and adults.

NCT ID: NCT06418880 Not yet recruiting - Type 2 Diabetes Clinical Trials

Automated Insulin Delivery for Inpatients With Dysglycemia

AIDING
Start date: July 1, 2024
Phase: Phase 3
Study type: Interventional

This randomized controlled trial will test the efficacy and safety of automated insulin delivery (AID) in hospitalized patients with diabetes (type 1 or type 2) requiring insulin therapy who are admitted to general medical/surgical floors. The main objectives of this study are: - To test the efficacy and safety of AID versus multiple daily insulin injections (MDI) + CGM in the inpatient setting - To determine differences in CGM-derived metrics between AID and MDI plus CGM in the hospital and explore differences in treatment effect according to individual characteristics. Participants will be: - Randomized to AID + remote CGM (intervention) or multiple daily insulin injections (MDI) + CGM (control group) - Followed for a total of 10 days or until hospital discharge (if less than 10 days).

NCT ID: NCT06415097 Not yet recruiting - Type 1 Diabetes Clinical Trials

Benefits of Smart Pens in Type 1 Diabetes

Start date: July 2024
Phase:
Study type: Observational

This study aims to address persistent challenges in achieving recommended control goals for patients with type 1 diabetes through innovative interventions. Specifically, the research focuses on assessing the effectiveness of smart insulin pens combined with glucose monitoring devices as a promising treatment option for individuals on multiple daily insulin injections. The study will analyze electronic health records from adults (≥ 18 years) attending the Diabetes Unit of the University Clinical Hospital of Valencia. Participants who are or have used smart insulin pens will be compared with a control group matched for age, sex, duration of diabetes, and HbA1c value at baseline (1:1). Data will be collected on participant characteristics, smart pen usage, glycemic control parameters, and daily insulin doses. The study also aims to identify adverse events associated with the use of smart pens. Ethical considerations include ensuring the anonymity of participant data, and the study is designed to comply with European (EU) data protection regulations. The retrospective nature ensures no interference with physicians' prescription habits.