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Type1diabetes clinical trials

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NCT ID: NCT06046417 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes

FCL
Start date: November 30, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this clinical trial is to investigate whether a fully automated Lyumjev-and-pramlintide delivery system improves glycemic outcomes in adults with type 1 diabetes. The main question we aim to answer is whether a Lyumjev-pramlintide fully closed loop system improves time in range compared to a hybrid closed loop system with carbohydrate counting. We also aim to find the optimal insulin to pramlintide ratio for glycemic control in the fully automated system. In this cross-over study, patients will undergo the following three interventions in a random order: (i) fully automated Lyumjev insulin-and-pramlintide (8 μg/u) (ii) fully automated Lyumjev insulin-and-pramlintide (10 μg/u) (iii) rapid automated Lyumjev insulin-and-placebo with carbohydrate-matched boluses For all interventions, participants will be required to wear two Ypsomed pumps programmed by our developed EuGlide system.

NCT ID: NCT05973799 Recruiting - Hypoglycemia Clinical Trials

Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes

Start date: October 10, 2019
Phase: N/A
Study type: Interventional

Iatrogenic hypoglycemia is still considered to be the number one barrier to effective glycemic control in patients with type 1 diabetes (T1D). In a previous study, it was observed in people without diabetes that fasting can be detrimental to the hormonal and hepatic responses to insulin-induced hypoglycemia. In the experiments described herein, the impact fasting has on hypoglycemic counterregulation in people with T1D will be determined.

NCT ID: NCT05963152 Recruiting - type1diabetes Clinical Trials

Resistance Exercise and Cognition in People With Type 1 Diabetes

Start date: July 20, 2023
Phase: N/A
Study type: Interventional

The aim of the current study is to determine the effects of resistance exercise on performance of the Paced Auditory Serial Addition Test and the Colour Trails Test.

NCT ID: NCT05958264 Recruiting - Type1diabetes Clinical Trials

Sublingual Microcirculation in Children With Compensated T1D Using the SDF Method

Start date: February 1, 2023
Phase:
Study type: Observational

The main goal of the study is to describe the sublingual microcirculation of children with type 1 diabetes mellitus (T1D) with stable and satisfactory treatment of the disease and to compare it with previously measured parameters of healthy children, NCT05324228.

NCT ID: NCT05823142 Recruiting - Type1diabetes Clinical Trials

Self-Management in Young Adults With Type 1 Diabetes 2023

Start date: December 20, 2023
Phase: N/A
Study type: Interventional

Type 1 diabetes (T1D) affects approximately 2 million Americans, and only 2 in 8 young adults ages 18-31 years achieve glycemic targets (glycated hemoglobin A1C <7.0%). Achieving glycemic targets is associated with reduced risk of micro-and macrovascular complications. Sleep deprivation leads to impaired glucose tolerance and insulin sensitivity in adults without chronic conditions and with T1D. Promoting sleep in laboratory and natural environments contributes to improvements in insulin sensitivity, glucose levels, and distress symptoms in young adults without chronic conditions and more time in range in adolescents with T1D. Multiple dimensions of sleep health (alertness, timing, efficiency, and sleep duration) are associated with better achievement of glycemic targets in adults with T1D. Therefore, sleep health dimensions are appropriate therapeutic targets to improve glucoregulation and other diabetes self-management outcomes in this population. Our primary objective is to evaluate the immediate and short-term effects of a 12-week CB-sleep intervention compared to enhanced usual care (time balanced attention control) on actigraphy- and self-report derived sleep health dimensions and diabetes self-management outcomes (glycemia and distress symptoms) over 9-months (Stage II of the NIH Model for Behavior Change, ORBIT phase III). CB-sleep is guided by principles and practices from motivational interviewing and the Transtheoretical Model of Behavior Change with interactive stage-matched sessions.

NCT ID: NCT05756829 Recruiting - type1diabetes Clinical Trials

Type 1 Diabetes Virtual Self-management Education and Support

T1ME
Start date: May 10, 2023
Phase: N/A
Study type: Interventional

OVERVIEW: People living with type 1 diabetes (T1D) are expected to fit self-management and regular clinical consultations into busy lives. T1D self-management programs that offer frequent contact with care teams are most effective in helping patients achieve optimal glycemic control. However, this is difficult to deliver in the context of current T1D care which involves time-consuming in-person visits during working hours. The proposed study will test a virtual health care intervention to deliver "high frequency, low touch" care aimed at improving metabolic control, while reducing the burden on individuals and their healthcare teams. STUDY DESIGN: A pragmatic multicenter, open-label, randomized trial to evaluate the short-term effectiveness of a multifaceted virtual health care intervention in improving glycemic control in individuals with T1D. Planned recruitment is 580 participants from 10 specialized T1D centres in Ontario. INTERVENTION: Our intervention will include 1) frequent, brief virtual visits between patients with T1D and certified diabetes educators (conducted in real time using a secure telemedicine video interface accessible from any PC, tablet or smart phone) combined with automatic appointment reminders, and 2) a centralized web-based platform to provide educational classes, tools, and resources for diabetes self-management. Virtual visits will be an adjunct to routine in-clinic visits for blood pressure monitoring, foot checks, and surveillance for other complications of diabetes. This approach aims to enable patients to receive more education and support than is feasible in traditional health care models, and in a way that is more seamless (i.e. results in fewer disruptions to their daily life) and tailored to their individual needs based on their stage in life.

NCT ID: NCT05737654 Recruiting - Metabolic Syndrome Clinical Trials

The Effect of Exercise on Metabolic Parameters, Anthropometric Measurement Values and Quality of Life

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

This study was planned as a randomized controlled experimental study to determine the effect of exercise with Augmented Reality Glasses (AR) on metabolic parameters, anthropometric measurement values and quality of life in children with T1DM aged 10-12 years. The research will be carried out with children aged 10-12 with T1DM who are followed up in Erciyes University Health Application and Research Center Fevzi Mercan-Mustafa Eraslan Children's Hospital Pediatric Endocrinology Outpatient Clinic. A total of 30 (AR exercise group=15 and control group=15) children with T1DM between the ages of 10-12 will be included in the sample of the study, according to the sampling calculation. The data of the study, Descriptive Characteristics Form for Children with T1DM and Their Families, Serum and Urine Biochemistry Values Form, Anthropometric Measurement Values Form, Quality of Life Scale for Children with Diabetes Mellitus Child and Parent Form (PedsQL 3.0), Augmented Reality Glasses, Continuous Glucose Tracker, Blood Glucose Meter, Body Composition Analyzer, Caliper, Tape Measure and Digital Height and Weight Meter. Ethics committee approval from "Erciyes University Clinical Research Ethics Committee" and institutional permission from "ERU Health Application and Research Center Mustafa Eraslan Fevzi Mercan Children's Hospital" were obtained in order to conduct the study. Hypothesis tests, correlation and regression analyzes will be applied according to the suitability of the data for normal distribution. As a result of the study; Exercise practice with augmented reality glasses is expected to improve metabolic parameters and anthropometric measurement values and increase the quality of life in children with T1DM. The main question it aims to answer are: Exercise with augmented reality glasses in children with T1DM; - It has an effect on metabolic parameters. - It has an effect on anthropometric measurement values. - It has an effect on the scores of the Quality of Life in Children with Diabetes Mellitus Scale-Child and Parent Form (PedsQL 3.0).

NCT ID: NCT05735340 Recruiting - Type1diabetes Clinical Trials

Type 1 Diabetes Education and Support Study

T1DES
Start date: April 15, 2023
Phase: N/A
Study type: Interventional

Diabetes distress has been identified as one of the largest contributors to the racial disparity in glycemic control that disproportionately burdens Black patients ages 18-30 years with type 1 diabetes (T1D). In order to combat this issue, this study assesses the feasibility of the culturally tailored intervention T1DES and evaluates the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among Black young adults with T1D.

NCT ID: NCT05662267 Recruiting - Clinical trials for End Stage Renal Disease

Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Kidney Transplant Recipient.

KA-IAK
Start date: March 10, 2020
Phase:
Study type: Observational

Islet transplantation is associated with a benefit on glycaemic control compared to optimized insulin therapy in recent clinical trials. However, there is a lack of evidence concerning the long-term impact of islet transplantation on type 1 diabetic kidney transplant recipients' prognosis. The objective of the study is to assess the impact of islet transplantation in patients with type 1 diabetes and a kidney transplantation on the risk of graft failure. Every type 1 diabetic recipient transplanted with a kidney in France between 2000 and 2017 is included. Patients transplanted with pancreatic islets are compared to controls treated with insulin alone according to a matching method based on time-dependent propensity scores which allow to ensure patients comparability at the time of islet transplantation. Time-dependent propensity scores are built according to variables associated with both the probabilities of being transplanted with islets and the outcome of interest. These variables are assessed by a direct acyclic graph. The primary outcome consists in death-uncensored graft survival, defined by death or return to dialysis. Secondary outcomes include the risk of death, or the risk of death-censored graft survival.

NCT ID: NCT05662189 Recruiting - type1diabetes Clinical Trials

Assessment of Pancreatic Beta Cell Mass and Function by Positron Emission Tomography Imaging in Human Diabetes Mellitus

Start date: March 15, 2022
Phase: N/A
Study type: Interventional

The goals of this project are to build an experimental tool to dissect out in vivo pancreatic beta cell mass (BCM) and beta cell function (BCF) and to assess for the first time these two determinants of beta cell functional mass (BCFxM) in obesity and in various stages of type 1 and type 2 diabetes mellitus.