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Type 1 Diabetes clinical trials

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NCT ID: NCT04506216 Completed - Type 1 Diabetes Clinical Trials

Eating Disorders in Type 1 Insulin-dependent Diabetes Patients

Diaboulimia
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the prevalence of eating disorders in type 1 insulin-dependent diabetes patients

NCT ID: NCT04503564 Completed - Type 1 Diabetes Clinical Trials

"FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM)

FEXIS
Start date: November 13, 2019
Phase: N/A
Study type: Interventional

Over 1 million patients globally currently manage their Type 1 Diabetes mellitus using continuous subcutaneous insulin infusion with an infusion set that needs to be changed every 3 days. This study will assess the feasibility and device performance of the study device, the Achilles infusion set over three periods during routine insulin infusion. This study will include 20 participants and has 3 periods: Period 1 (up to 7 days): Trial run with study device with saline infusion. Period 2 (up to 7 days): participants will manage their blood glucose solely with their insulin pump and the Achilles infusion set. Blood glucose will be closely monitored with a continuous glucose monitoring (CGM) device. Period 3 (up to 7 days): Participants will return to study center to receive a fresh Achilles infusion set and continue blood glucose management at home until infusion set failure or 7 days.

NCT ID: NCT04501107 Completed - Type 1 Diabetes Clinical Trials

A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus

Start date: August 3, 2020
Phase: Phase 1
Study type: Interventional

This is a single-centre, randomised, double-blind, 4-way crossover, 4-treatment, euglycaemic clamp study in subjects with Type 1 Diabetes Mellitus (T1DM). Each subject will be randomly allocated to one of four treatment sequences. Each sequence comprises one single dose of each of four IMPs. IMP1 and IMP2 are BioChaperone lispro formulations. They have the same composition and correspond to different development stages of a unique product which is BioChaperone insulin lispro; between them, improvements were made to prepare industrial production. Comparators (IMP3 and IMP4) are US-approved Humalog® and EU-approved Humalog®. All IMPs will be dosed at 0.2 U/Kg of insulin lispro on 4 dosing visits separated by a washout period of 5 to 15 days. The trial will compare the characteristics of BioChaperone insulin lispro fully liquid (IMP2) formulation to US-approved Humalog and EU-approved Humalog.

NCT ID: NCT04492566 Completed - Pregnancy Clinical Trials

Automated Insulin Delivery in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home

Start date: July 27, 2020
Phase: N/A
Study type: Interventional

This clinical trial is a safety and feasibility study to assess the performance of an artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into the iAPS platform for pregnant patients with type 1 diabetes (T1D).

NCT ID: NCT04486547 Completed - Type 1 Diabetes Clinical Trials

Information Motivation Behavioral Skills Model's Effects on Adolescents With Type 1 Diabetes

Start date: October 15, 2018
Phase: N/A
Study type: Interventional

Aim: To evaluate the effects of information-motivation-behavioral skills model interventions given by nurses during home visits on the knowledge levels, personal and social motivation levels, behavioral skills, and HbA1C levels of adolescents with poor glycemic control. Design: Randomized controlled study. Methods: 50 adolescents with type 1 diabetes were equally divided into study and control groups. Socio-Demographic Form, Diabetes Information Evaluation Form, The Child Attitude Toward Illness Scale, The Multidimensional Scale of Perceived Social Support, and Diabetes Management Self-Efficacy Scale were utilized in data collection. The scales were administered at the beginning of the study and six months later. HbA1c levels of adolescents were evaluated in the third and sixth months. Multiple home visits and phone calls were made to each participant in the intervention group. Interventions to improve the information-motivation-behavioral skills model-based knowledge, personal and social motivation, and behavioral skills were applied during the home visits.

NCT ID: NCT04484779 Completed - Type 2 Diabetes Clinical Trials

A Study of an Insulin Management System in Participants With Type 1 or Type 2 Diabetes

Start date: July 14, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the user experience of an integrated insulin management system (IIM) in participants with type 1 or type 2 diabetes. The IIM system is comprised of an insulin injection pen with a data transmission module and blood glucose meter which are connected to a mobile phone application. The application will be used to record and track diabetes-data related information.

NCT ID: NCT04481243 Completed - Type 1 Diabetes Clinical Trials

A Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness in Children With Type 1 Diabetes

Start date: April 30, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if children with type 1 diabetes have adequate immune response to PPSV23 vaccination and to assess factors affecting immune response.

NCT ID: NCT04476433 Completed - Asthma Clinical Trials

Intervention in Chronic Pediatric Patients and Their Families.

FACTORADAPT
Start date: February 4, 2019
Phase: N/A
Study type: Interventional

This project consists of a psychological intervention in patients and their families with different chronic diseases in order to carry out a comparative study between medical pathologies to know which are the protective or risk variables for the adaptation to the disease.

NCT ID: NCT04472962 Completed - Type 1 Diabetes Clinical Trials

The Importance of Meal Composition on Preventing Exercise-induced Hypoglycemia in People With Type 1 Diabetes.

Start date: August 14, 2020
Phase: N/A
Study type: Interventional

This study is a clinical, randomized, crossover study. The study investigates the effect of a low-carbohydrate-high-protein pre-exercise meal on preventing exercise-induced hypoglycemia in people with type 1 diabetes. The hypothesis is that intake of a low-carbohydrate-high-protein meal can reduce the duration and depth of hypoglycemia during and after exercise in people with type 1 diabetes compared with an isocaloric high-carbohydrate-low-protein meal with identical fat content. The study will contribute with new knowledge about importance of meal composition on preventing exercise-induced hypoglycemia.

NCT ID: NCT04450563 Completed - Type 1 Diabetes Clinical Trials

Low Dose Empagliflozin in Adults With Type 1 Diabetes on Closed Loop Insulin System

CL-LoDE
Start date: November 2, 2020
Phase: Phase 1
Study type: Interventional

A closed-loop insulin system, also referred to as the "artificial pancreas" (AP), is made up of an insulin pump, a continuous glucose monitor, and an application communicating between the two to adjust insulin administration based on glucose control. This is meant for the treatment of type 1 diabetes. The McGill Artificial Pancreas (MAP) has been used previously in type 1 diabetes with significant benefits. Though prior studies have shown significant benefit with this system, some challenges still exist. Empagliflozin is used in type 2 diabetes; it allows for glucose to be removed through the urine. Though its use is not approved in type 1 diabetes in North America, it (along with similar drugs) has been used in studies as adjunctive therapy with insulin with benefits on blood sugar control. The purpose of our study is to see if a small dose of empagliflozin (2.5 mg and 5 mg) is enough to help those who cannot achieve adequate glucose control on a closed-loop insulin system. The primary hypotheses of the study are the following: 1. The use of empagliflozin 2.5 mg daily will increase time in range compared to placebo for those on the closed-loop system. 2. The use of empagliflozin 5 mg daily will increase time in range compared to placebo for those on the closed-loop system.