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Type 1 Diabetes Mellitus clinical trials

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NCT ID: NCT06382350 Not yet recruiting - Clinical trials for Type 1 Diabetes Mellitus

Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems

SAFEDRIVE
Start date: April 2024
Phase:
Study type: Observational

The study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy

NCT ID: NCT06369649 Not yet recruiting - Pain Clinical Trials

Coolsense and Buzzy Use on Pain Score and Anxiety Level During Insulin Injection Application

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

This study aims to determine the effect of using Coolsense, which is created using the proven effect of cold application during insulin injection, and Buzzy, which is a combination of vibration and cold application, in reducing pain and anxiety in children diagnosed with Type 1 diabetes mellitus.This randomized controlled clinical study is planned to be conducted between 05.2024-12.2025 with 147 participants between the ages of 6-12. Participants will be divided into three groups according to the randomization method: buzzy group (n = 49), coolsense group (n = 49) and control group (n = 49). Participants in the Coolsense group will receive a cold application using the coolsense device for 5 seconds before the injection. Participants in the Buzzy group will be subjected to vibration and cold application 30-60 seconds before the procedure. Participants in the control group will continue the clinic's standard procedure. Changes in participants' pain score and fear level, heart rate, blood pressure, respiratory rate and oxygen saturation will be measured at three time points: immediately before and after the procedure. Data descriptive information form, application registration form, Facial Expressions Pain Scale (FPS-R) and Child Fear Scale (CFS) will be used. The collected data will be analyzed using SPSS 15 software. The main questions it aims to answer: - Does buzzy and coolsense application have an effect the pain score of children during the insülin injection? - Does buzzy and coolsense application have an effect the fear score of children during the insülin injection? - Does buzzy and coolsense application have an effect the heart rate of children during the insülin injection? - Does buzzy and coolsense application have an effect the oxygen saturation of children during the insülin injection? - Does buzzy and coolsense application have an effect the blood pressure of children during the insülin injection? - Does buzzy and coolsense application have an effect the respiratory rate of children during the insülin injection?

NCT ID: NCT06361680 Not yet recruiting - Clinical trials for Type 1 Diabetes Mellitus

Effect of Coenzyme Q10 on Diabetic Children

Start date: October 30, 2024
Phase: Early Phase 1
Study type: Interventional

Determine the effect of Coenzyme Q10 on random blood sugar and glycosylated haemoglobin

NCT ID: NCT06280703 Not yet recruiting - Healthy Clinical Trials

A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM)

Start date: May 15, 2024
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to look at the amount of the study drug LY3938577 that gets into the blood stream and how long it takes the body to get rid of it. At a later stage of this study (part B and C) the blood sugar lowering effect and the duration of action of LY3938577 will be evaluated compared to Insulin Degludec. The study will also evaluate the safety and tolerability of LY3938577 and information about any side effects experienced will be collected. The study will be conducted in three parts (A, B, and C). Healthy participants in part A will receive one single dose of LY3938577 or a placebo, whereas participants in Parts B and C with T1DM will receive single doses of either LY3938577 or Insulin Deglude given via intravenous (IV) infusion. The study will last up to approximately 5.5, 10 and 13 weeks for parts A, B, and C, respectively, including screening period.

NCT ID: NCT06180616 Not yet recruiting - Obesity Clinical Trials

Tirzepatide for the Concurrent Treatment of Obesity and Type 1 Diabetes

TZP-T1D
Start date: March 2024
Phase: Phase 2
Study type: Interventional

This study is a 2-arm, double blinded, randomised clinical trial where 72 participants will be assigned 1:1 to insulin treatment alone (control) or insulin treatment and tirzepatide treatment for 32 weeks. The primary objective is to demonstrate that tirzepatide treatment, dose incremented to 15mg QW for 32 weeks adjunctive to insulin treatment can reduce body weight in patients with T1D and obesity when compared to insulin treatment alone. The secondary objective is to demonstrate that tirzepatide treatment, dose incremented to 15mg QW for 32 weeks can improve glycaemic control (measured by hbA1c), improve time in range, reduce insulin requirements, and reduce the severity of comorbidities in people with obesity and T1D.

NCT ID: NCT05566977 Not yet recruiting - Clinical trials for Type 1 Diabetes Mellitus

Autologous Adoptive T Regulatory Cell Transfer in Autoimmune Diseases.

Start date: December 2022
Phase: Phase 1
Study type: Interventional

Investigators aim to develop an effective and safe treatment of autoimmune diseases through adoptive T regulatory cells transfer. Our objectives are to evaluate the safety and efficacy of autologous adoptive Treg (CD4CD25FoxP3 CD127 low regulatory) cell transfer to patients with refractory autoimmune diseases: Refractory lupus Nephritis, and adults' type1 diabetes mellitus. Patients and Methods: This is Non randomized open label phase 1 pilot study including ten patients with refractory lupus nephritis and ten patients with Type 1 diabetic patients. All patients will be subjected to Full history taking, clinical examination and pretreatment investigations according to the type of autoimmune disease then regulatory T cells (Tregs) identification and count, Treg isolation and expansion and finally administration of T reg cells and follow-up of adverse events and outcomes.

NCT ID: NCT04721509 Not yet recruiting - Clinical trials for Type 1 Diabetes Mellitus

Effect of Smartphone Based Telemedicine and Education in Patients With Type 1 Diabetes Mellitus

Start date: February 2021
Phase: N/A
Study type: Interventional

Objective: evaluation of effect of smartphone based telemedicine and education in patients with type 1 diabetes mellitus Outline: Among the patients with type 1 diabetes, the group with telemedicine and education using smartphone set as a experimental group and the group without those set as a control group, respectively. Sample size: experimental group (n=50), control group (n=50) Inclusion criteria: patients with type 1 diabetes with A1c>8.0% Exclusion criteria: chronic disease, psychological disease, children aged under 12 with parents with psychological disease, athletics Method: We divide subjects as an experimental group and a control group by randomization, and they visit outpatient clinic every 12 weeks. We perform telemedicine and education with smartphone application to the experimental group every 2 weeks. We evaluate the effect of smartphone based telemedicine and education in patients with type 1 diabetes mellitus with checking A1c and checklist at baseline, 12 weeks and 24 weeks after starting of the research. Variables: A1c, satisfaction, knowledge, self-confidence, willing to continuing, quality of life, physical activity, drinking, smoking Primary endpoint: Improvement in HbA1c of experimental group Secondary endpoint: No improvement in HbA1c of control group

NCT ID: NCT04698330 Not yet recruiting - Clinical trials for Type 1 Diabetes Mellitus

Effects Of Berberine Plus Inulin On Diabetes Care in Patients With LADA

Start date: May 2022
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to evaluate the effects of oral berberine (BBR) and inulin combined with insulin therapy on diabetes care in patients with LADA.

NCT ID: NCT04129424 Not yet recruiting - Clinical trials for Type 2 Diabetes Mellitus

Preliminary Exploration on the Operational Standards of Insulin Pump Installation in Diabetes Clinic in China

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

Continuous subcutaneous insulin infusion (CSII), known as insulin pump therapy, has been widely used for diabetes patients in recent years. Many clinical studies have proved the priority of CSII to multiple insulin injections including better glycaemic control with lower daily insulin requirement, lower glycated haemoglobin (HbA1c) level and reduced risk of severe hypoglycaemia. The best mode of CSII is a kind of programmed and individualized insulin infusion mode. But at present, the applying of insulin pump is mainly during hospitalization period in China, which is not conformed with daily living scenarios of patients. The outpatient insulin pump treatment is much closer to the real living scenarios of patients. However, lack of management experience and widely accepted formative model of insulin pump applying in clinic restricted use of insulin pumps in clinical in China. The investigators aimed to explore a safe and effective management mode of insulin pump operating to enable a wide population to have access to daily use of CSII, and to maximize the rational use of limited medical resources.

NCT ID: NCT01525784 Not yet recruiting - Clinical trials for Type 1 Diabetes Mellitus

Affect of RT-CGMS as Part of Clinical Care in Type 1 Diabetes Mellitus Patients

Start date: February 2012
Phase: N/A
Study type: Observational

The incidence of Type 1 Diabetes Mellitus is increasing annually, in all pediatric age groups, especially among infants and toddlers.However, only 30% of diabetic children manage to achieve and maintain glycated hemoglobin A1c (HbA1c) levels below 8%, although most are treated by intensive insulin therapy.Recently, devices for real-time continuous glucose monitoring (RT-CGMS) have been introduced to aid self management of glycemic control. These devices enable the patients to see the interstitial glucose levels continuously, the trends of decrement and increment, and to have alarms prior to a severe hypoglycemic episode . The RT-CGMS was approved in Israel for routine usage in the pediatric population, 0-18 years in 2011, indicated for those with recurrent hypoglycemic episodes. So, the aim of the investigators study is to examine prospectively the short and long term effect of the RT-CGMS routine usage, in daily routine life of the diabetic child.