Active clinical trials for "Diabetes Mellitus, Type 1"

Primary Objective: • To compare the immunogenicity of Gan & Lee Insulin Lispro Injection and EU-authorized Humalog following treatment in adult subjects with T1DM Secondary Objectives: To evaluate the safety of Gan & Lee Insulin Lispro Injection in comparison with that of EU authorized Humalog following treatment in adult subjects with T1DM To evaluate the efficacy of Gan & Lee Insulin Lispro Injection in comparison with that of EU authorized Humalog following treatment in adult subjects with T1DM

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. The objective of this pilot study is to inform both the decision whether to conduct a confirmatory study and the design of the larger confirmatory trial. In addition, we want to estimate postprandial glucose levels parameters and confidence interval in an 11-hour in-patient study with standardized conditions in adults with type 1 diabetes, estimate the size and direction of the treatment effect. Faster insulin Aspart (FiAsp) will provide preliminary evidence of efficacy to regulate postprandial glucose levels compared to rapid-acting Aspart in adults with type 1 diabetes using insulin pump therapy.

Randomized, controlled, double-blinded, multicenter, phase I/II clinical trial to evaluate the safety of low-dose IL-2 and determine whether low-dose IL-2 therapy for one year, can prevent further loss of beta-cell function in patients with established T1D, (primary outcome). The study will carefully examine various effects of low-dose IL-2 on the immune system in patients with T1D, including effects on Treg and other cell subsets, and disease-specific autoimmune responses.

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed loop strategy regulates glucose levels through the infusion of two hormones: insulin and glucagon. The objective of this study is to compare, in a randomized multicenter trial, the effectiveness of single-hormone closed-loop, dual-hormone closed-loop, and sensor-augmented pump therapy with low-glucose suspend in regulating day-and-night glucose levels in outpatient settings for 15 weeks in adolescents and adults. The investigators hypothesize that dual-hormone closed-loop will reduce time spent in hypoglycemia compared to single-hormone closed-loop, which in turn will be more effective than sensor-augmented pump therapy with low-glucose suspend.

The research will be carried out in two phases in order to verify the Turkish validity and reliability of the "Feeling Good, Living Life" (FGLL) Scale and to determine the effect of the diary kept using the spiritual writing technique on the anxiety and spiritual well-being level of the children aged 9-12 years who have been diagnosed with Type 1 Diabetes. The first phase of the research was carried out methodologically in Kartal Yavuz Selim Secondary School and Kartal Borsa Imam Hatip Secondary School in Kartal District of Istanbul Province between November-December 2021 for the Turkish validity and reliability study of the FGLL Scale. It has been determined that FGLL can be used as a valid and reliable tool for children aged 9-12 in Turkish society. In the second phase of the study, it was decided to conduct it at Kartal Dr. Lütfi Kırdar City Hospital in order to reach children between the ages of 9 and 12 who were diagnosed with Type 1 Diabetes, and necessary permissions were obtained from the institutions. Istanbul/Kartal Dr. Sample calculations were made with the G*Power 3.1 program in children diagnosed with Type 1 Diabetes, who applied to the Lütfi Kırdar City Hospital Pediatric Endocrinology and Metabolic Diseases Outpatient Clinic. It was calculated that a total of 89 people in three groups, 28/30 people in the groups, should be reached (n=89). The data in the second phase of the study were "Introductory Information Form for Children Diagnosed with Type 1 Diabetes", "Feeling Good-Living Life Scale" and "State-Trait Anxiety Inventory for Children", "What Did You Feel Today? Spiritual Diary" and "What Did You Do Today?Diary" It will be obtained through.

This study aims to test the effectiveness of an evidence-based eating- disorder prevention program specifically targeted for individuals with Type 1 Diabetes (T1D) compared to an educational control group. The Diabetes Body Project (DBP), is an adaptation of the Body Project which is the only eating disorder prevention program to have repeatedly produced effects when evaluated by independent researchers, produced stronger effects than credible alternative interventions, and affected objective outcomes. DBP has been adapted slightly for individuals with T1D who are at ultra-high risk for eating disorders. The study aims to test the effectiveness of the DBP of reducing body image concerns and reducing eating pathology and improving glycemic control.

The purpose of this two-part multiple ascending dose study is to evaluate the safety and tolerability of multiple doses of MHS552 in adults with type 1 diabetes mellitus. Participants will be treated for 4 or 12 weeks followed by an 8 week follow-up period

The purpose of this clinical study is to optimize the measurement algorithm of the Vital USA VitalDetectTM in measuring the microcirculating blood flow. Further optimization and finally the demonstration of the performance of the VitalDetectTM non-invasive monitoring biosensor in monitoring glucose, and heart rate in patients with type 1 and type 2 diabetes and healthy participants, when operated according to the instructions for use.

Type 1 diabetes (T1D) is a lifelong disease which stops the body from producing insulin - an important hormone that controls blood sugar (glucose) levels. People with T1D use insulin replacement therapy, usually in the form of injections, to help control blood glucose levels, however keeping glucose levels within normal ranges is usually a challenge. Mealtime glucose control is fundamental to good diabetes management and are an important contributor to long-term diabetes complications. However, many individuals experience variability in glucose levels around mealtimes. The objective of this study is to establish whether and which parameters are important predictors of mealtime glucose levels in people with T1D. The investigators will monitor glucose levels using the latest glucose monitoring technology and collect blood samples to: Characterise changes in glucose levels in individuals with T1D in response to different meals Determine whether and what food characteristics and personal factors are linked to individual glucose responses to different meals. The investigators will recruit 150 individuals with type 1 diabetes. Firstly participants will attend a preliminary visit, where a blood sample will be donated to study laboratory blood markers of vascular and metabolic health accompanied by a full medical examination in which body composition will be established. During this visit participants will also complete questionnaires about their lifestyle, and be fitted with two wearable devices to monitor glucose levels and physical activity levels under free-living conditions. After 4-weeks of wearing the devices, participants will attend two experimental laboratory visits where breakfast and lunch will be served and blood samples taken. This will enable us to observe glucose and metabolic responses to feeding under controlled conditions.

Objective: to gain experience with in-home use of a modified algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy data. Study Design: randomized controlled trial, with randomization on a night level within subject. Major Eligibility Criteria: clinical diagnosis of type 1 diabetes, daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months; 15.0 to <46.0 years of age; HbA1c < 10.0%; no DKA in last 6 months; no hypoglycemic seizure or loss of consciousness in last 6 months; Living with a significant other or family member ("companion") committed to participating in all study activities, and being present and available to provide assistance when the system is being used at night. Sample Size: 30 subjects. Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in activities followed by up to 90 days spent in clinical trial phase of study; clinic visits at enrollment, following CGM and system assessment run-in phases, at start of clinical trial phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use. Major Efficacy Outcomes: Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight. Secondary: time spent in hypoglycemia (≤70 mg/dl, 3.9 mmol/L) and time spent in hyperglycemia (>180 mg/dl, 10.0 mmol/L) overnight. Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and diabetic ketoacidosis.