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Набира участници NCT07211126

The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France

Заболявания: Diabetes Mellitus, Type 1

Спонсор: Tandem Diabetes Care, Inc.

Налично на: БГ
Обобщение
This post-market surveillance study is primarily designed to demonstrate the ongoing safety of the Control-IQ system, the ongoing performance of glycemic control and quality of life with Control-IQ system use, and the rate of use of the Control-IQ system. The system will be assessed in all approved populations during the first 12 months of use.
Описание
This post-market surveillance study is a single-arm, prospective cohort study. It is designed to: 1. Demonstrate, in the post-approval setting, the safety of the Control-IQ System for the management of type 1 diabetes by assessing the rate of severe metabolic complications (severe hypoglycemia and/or diabetic ketoacidosis). 2. Determine glycemic outcomes during real-world use of the Control-IQ System over 12 months post-initiation. 3. Demonstrate patient-reported satisfaction with the device, trust in the Control-IQ System, usability of the system, and improved quality of life. 4. Describe the real-world use of the Control-IQ System.
Кой може да участва
Inclusion Criteria: * Clinician-confirmed type 1 diabetes and for whom the site has initiated the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with a Dexcom G6 or G7 CGM sensor. * Age ≥ 6 years at enrollment. * Using an insulin approved for use in the pump. * Ability for patient or parent/guardian to respond to alerts and alarms, and to provide basic diabetes self-management. * Reside full-time in mainland France. * Have an email address and mobile phone number * Participant or participant's parent/guardian has read and understood the information notice and has agreed to participate in the study. This includes agreeing to : 1. use Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment. 2. the reuse of their clinical data including HbA1c results, obtained at most 4 months prior to enrollment, and as available according to the standard of care during the next 12 months. 3. complete questionnaires per the study protocol. Exclusion Criteria: * A medical or other condition, or medications being taken that, in the investigator's judgement would be a safety concern for participation in the study. * Patients considered vulnerable under French law.
Интервенции
t:slim X2 insulin pump with Control-IQ technology (Control-IQ System)
DEVICE
Места на провеждане 17
Франция (17)
CH Agen-Nérac
Agen
CHU d'Angers
Angers
CHU Lyon HFME
Bron
Centre du Diabète - Diab-e-Care Hospices Civils de Lyon (HCL)
Lyon
Hôpital Européen (APHM)
Marseille
CHR Metz-Thionville
Metz
CHU de Montpellier
Montpellier
Clinique Saint Jean de Védas
Montpellier
Institut St-Pierre
Palavas-les-Flots
Hôpital Lariboisière
Paris
GH Paris Saint-Joseph
Paris
Hôpital Robert Debré
Paris
CH de Périgueux
Périgueux
MSP Les Belles Fleurs
Saint-Cyr-sur-Loire
Clinique Pasteur Toulouse
Toulouse
CHU Toulouse
Toulouse
CHU Tours
Tours
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
6 Years
Здрави доброволци
Не
Начална дата
03.03.2026
Крайна дата
01.12.2027
Регистрационен номер
NCT07211126
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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