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

Обзор

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.

Подробное 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.

Вмешательства

• Устройство t:slim X2 insulin pump with Control-IQ technology (Control-IQ System)
  Participants enrolled in the study will start use of the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with Dexcom G6 or Dexcom G7, and be followed for 12 months.

Первичные конечные точки

• Rate of diabetic ketoacidosis (DKA). [Срок оценки: 12 months]
• Rate of severe hypoglycemia (SH) [Срок оценки: 12 months]

Вторичные конечные точки (10)

• Time in Range 70-180 mg/dL (TIR) [Срок оценки: 12 months]
• Time above 180 mg/dL [Срок оценки: 12 months]
• Time above 250 mg/dL [Срок оценки: 12 months]
• Time less than 70 mg/dL [Срок оценки: 12 months]
• Time less than 54 mg/dL [Срок оценки: 12 months]
• Treatment Satisfaction [Срок оценки: 12 months]
• System Usability [Срок оценки: 12 months]
• Quality of Life Change [Срок оценки: 12 months]
• Fear of Hypoglycemic Events Change [Срок оценки: 12 months]
• Rate of use of the system [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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 :

• use Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment.
• 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.
• complete questionnaires per the study protocol.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 21 центр

• 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
• GHEF Meaux — Meaux
• CHR Metz-Thionville — Metz
• CHU de Montpellier — Montpellier
• … и ещё 13 центров

Идентификаторы

NCT: NCT07211126 · TP-0018999

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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