Type 2 Diabetes (T2D) Clinical Trials

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Omnipod 5 - A French Prospective Multicentric Study in Real World

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:

• Patient with T1D aged ≥ 2 years.

• Patient prescribed a commercially available configuration of the Omnipod 5 System using a Dexcom sensor (Dexcom G6 or Dexcom G7).

• Patient has never used the Omnipod 5 System prior to inclusion.

• Patient has not objected to the use of their personal data for this study.

• Patient or legal guardian has an email address and mobile phone number.

• Patient (and legal guardians if the patient is a minor) is able to understand study information and Non-Opposition form.

• Patient (and legal guardians if the patient is a minor) is able to understand and complete questionnaires in French.

• Patient is covered by the local social security system.

Locations
Other Locations
France
CHU Angers
RECRUITING
Angers
CHU Besançon - Hôpital de Jean Minjoz
RECRUITING
Besançon
APHP Hopital Avicenne
RECRUITING
Bobigny
CHU Bordeaux - Hôpital Pellegrin
RECRUITING
Bordeaux
CHU Bordeaux - Hôpital St-André
RECRUITING
Bordeaux
CHU BresCHU Brest - Hôpital de la Cavale Blanchet - Hôpital de la Cavale Blanche
RECRUITING
Brest
Hôpital Femme Mère Enfant
RECRUITING
Bron
Centre Hospitalier Sud Francilien
RECRUITING
Corbeil-essonnes
CHU Dijon - Hôpital François MitterrandCHU Dijon - Hôpital François Mitterrand
RECRUITING
Dijon
GH La Rochelle-Ré-Aunis - Hôpital Saint Louis
RECRUITING
La Rochelle
APHP Hôpital Bicêtre
RECRUITING
Le Kremlin-bicêtre
Diab-eCare
RECRUITING
Lyon
Institut de Diabétologie et de Nutrition du Centre
RECRUITING
Mainvilliers
Fondation Ambroise Paré - Hôpital Européen de Marseille
RECRUITING
Marseille
CHU Montpellier - Hôpital Arnaud de Villeneuve
RECRUITING
Montpellier
CHU Montpellier - Hôpital Lapeyronie
RECRUITING
Montpellier
CHU Orléans
RECRUITING
Orléans
APHP Hôpital Lariboisière
RECRUITING
Paris
APHP Hopital Robert Debré
RECRUITING
Paris
APHP La Pitié Salpêtrière
RECRUITING
Paris
Hôpital NECKER
NOT_YET_RECRUITING
Paris
CH Périgueux
RECRUITING
Périgueux
Cabinet Médical Saint-Cyr sur Loire
RECRUITING
Saint-cyr-sur-loire
CHRU Strasbourg
RECRUITING
Strasbourg
Contact Information
Primary
Trang Ly, MBBS, PhD
APClinical@insulet.com
978-600-7000
Backup
Bonnie Dumais Dumais, RN
APClinical@insulet.com
978-600-7000
Time Frame
Start Date: 2025-07-23
Estimated Completion Date: 2027-10
Participants
Target number of participants: 304
Treatments
Omnipod 5 User
Participation of each patient begins at inclusion and continues until the end-of-study visit, 12 months (± 1 month) following first initiation of automated mode of the Omnipod 5 System
Sponsors
Leads: Insulet Corporation

This content was sourced from clinicaltrials.gov