Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Diabetes; Type 1 Diabetes
• Intervention / Treatment: Device: Omnipod 5

Detailed Description

Twelve-month, real-world, non-interventional, prospective follow-up of adult and pediatric patients aged more than 2 years old, prescribed the commercially available FreeStyle Libre 2 Plus configuration of the Omnipod 5 Automated Insulin Delivery System in France.

OPTIMAL-B study (Omnipod 5 - A French Prospective Multicentric Study in Real World), aims to provide the requisite real-world data on the glycemic control, quality of life, safety, and device usage profiles of users of the Omnipod 5 System during the 12 months after starting using Omnipod 5 in automated mode.

• Study Type: Observational
• Enrollment (Estimated): 152

Contacts and Locations

• Study Contact: Name: Trang Ly, MBBS, PhD; Phone Number: 978-600-7000; Email: APClinical@insulet.com
• Study Contact Backup: Name: Bonnie Dumais; Phone Number: 978-600-7000; Email: APClinical@insulet.com

Study Locations

• France
  • Angers, France, 49100
    • Recruiting
    • CHU Angers
    • Principal Investigator: Regis COUTANT
    • Contact: Lucie DUFOUR
  • Besançon, France, 25000
    • Recruiting
    • CHU Besançon - Hôpital de Jean Minjoz
    • Principal Investigator: Sophie BOROT
    • Contact: Julie GUCCIARDI
  • Bobigny, France, 93000
    • Not yet recruiting
    • APHP Hopital Avicenne
    • Principal Investigator: Emmanuel COSSON
    • Contact: Sarah YAHIAOUI
  • Bordeaux, France, 33000
    • Recruiting
    • CHU bordeaux - Hopital Pellegrin
    • Principal Investigator: Sandra POCHELU
    • Contact: Caroline BOUYSSOU
  • Bordeaux, France, 33000
    • Recruiting
    • CHU Bordeaux - Hôpital St-André
    • Contact: Bogdan CATARGI
    • Principal Investigator: Bogdan CATARGI
  • Brest, France, 29200
    • Recruiting
    • CHU Brest - Hôpital de la Cavale Blanche
    • Principal Investigator: Emmanuel SONNET
    • Contact: Pascale Quiniou
  • Bron, France, 39500
    • Recruiting
    • Hopital Femme Mere Enfant
    • Principal Investigator: Kevin PERGE
    • Contact: Karima RENDJA
  • Corbeil-Essonnes, France, 91100
    • Recruiting
    • Centre Hospitalier Sud Francilien
    • Principal Investigator: Alfred PENFORNIS
    • Contact: Catherine PETIT
  • Dijon, France, 21000
    • Recruiting
    • CIRDIA
    • Contact: Sylvie PICARD
    • Principal Investigator: Sylvie PICARD
  • Dijon, France
    • Recruiting
    • CHU Dijon - Hôpital François Mitterrand
    • Principal Investigator: Bruno VERGES
    • Contact: Isabelle SIMONEAU
  • La Rochelle, France, 17019
    • Recruiting
    • GH La Rochelle-Ré-Aunis - Hôpital Saint Louis
    • Principal Investigator: Didier GOUET
    • Contact: Harivola ANDRIANTAOLO
  • Le Kremlin-Bicêtre, France, 94270
    • Not yet recruiting
    • APHP Hôpital Bicêtre
    • Contact: Marie-Agathe TROUVIN
    • Principal Investigator: Marie-Agathe TROUVIN
  • Mainvilliers, France, 28300
    • Recruiting
    • Institut de Diabétologie et de Nutrition du Centre
    • Principal Investigator: Said BEKKA
    • Contact: Eva BRIAND
  • Marseille, France
    • Recruiting
    • Fondation Ambroise Paré - Hôpital Européen de Marseille
    • Principal Investigator: Pauline SCHAEPELYNCK
    • Contact: Audrey OLIVETTI
  • Montpellier, France, 34090
    • Recruiting
    • CHU Montpellier - Hôpital Lapeyronie
    • Principal Investigator: Eric RENARD
    • Contact: Manal AL MASRI-SHBAT
  • Palavas-les-Flots, France, 34250
    • Recruiting
    • Institut Saint Pierre
    • Principal Investigator: Fabienne DALLA VALE
    • Contact: Chrystel LEPERCHOIS
  • Paris, France, 75010
    • Not yet recruiting
    • APHP Hôpital Lariboisière
    • Principal Investigator: Jean-Pierre RIVELINE
    • Contact: Charline POTIER
  • Paris, France, 75019
    • Not yet recruiting
    • APHP Hopital Robert Debré
    • Principal Investigator: Elise BISMUTH
    • Contact: Caroline ARNAUD-SARTHOU
  • Périgueux, France, 24000
    • Recruiting
    • CH Périgueux
    • Principal Investigator: Christine COFFIN
    • Contact: Aude ANGELESCU
  • Saint-Jean-de-Védas, France, 34430
    • Recruiting
    • Clinique Saint Jean de Védas
    • Contact: Mérédith MERCIER
    • Principal Investigator: Elizabeth BONNEMAISON
  • Strasbourg, France, 67098
    • Recruiting
    • CHRU Strasbourg
    • Principal Investigator: Nathalie JEANDIDIER
    • Contact: Samir CHENAF
  • Tours, France, 37000
    • Recruiting
    • CHU Tours
    • Contact: Sophie GOUNIN
    • Principal Investigator: Yannis CHARTIER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population contains patients (age ≥ 2 years) with T1DM initiating a commercially available configuration of the Omnipod 5 System using a FreeStyle Libre 2Plus in France.

Description

Inclusion Criteria:

• Patient with T1D aged ≥ 2 years.
• Patient prescribed, less than a year ago, a commercially available confi guration of the Omnipod 5 System using a FreeStyle Libre 2 Plus sensor.
• 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

Exclusion Criteria:

• Patient is currently pregnant.
• Patient presents an allergy to the materials of the Omnipod 5 System (patch, cannula, CGM).
• Patient is unable to be followed by the same investigation site for the duration of the study or is unwilling or unable to maintain contact with the healthcare professional.
• Patient is already participating in a clinical trial or in another study precluding their participation in other studies.
• Adult under guardianship, curatorship or tutorship.
• Adult otherwise deprived of liberty.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Device: Omnipod 5; The Omnipod 5 Automated Insulin Delivery System (Omnipod 5 System) is a tubeless insulin pump with a mono-hormonal insulin delivery system designed to deliver U-100 insulin subcutaneously for the management of type 1 diabetes in people aged 2 years and older who require insulin. The Omnipod 5 System is intended to function as an automated insulin delivery system when used with compatible Continuous Glucose Monitoring (CGM) systems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the percentage of time in the 70 - 180 mg/dL range	Glucose metric from continuous glucose monitoring system to assess glucose control	Change in percentage of time in specified range between Baseline and 12-months following first initiation of automated mode

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with GMI ≤ 7%	Assess the achievement of CGM-based consensus targets	Up to 12-months following first initiation of automated mode
Percentage of patients with CV ≤ 36%	Assess the achievement of CGM-based consensus targets	Up to 12-months following first initiation of automated mode
Percentage of patients achieving combinations of previous CGM-based consensus targets	Assess the achievement of CGM-based consensus targets	Up to 12-months following first initiation of automated mode
Insulin Delivery System Rating Questionnaire (IDSRQ) interference sub-score	Assess the interference of the Omnipod 5 System with patients' daily lives	At inclusion and 6 and 12 months following first initiation of automated mode
Percentage of time using the System in automated mode	Describe System use	12 months following first initiation of automated mode
Percentage of time using the System in manual mode	Describe System use	12 months following first initiation of automated mode
Percentage of time using "Activity" feature	Describe System use	12 months following first initiation of automated mode
Total daily dose of insulin	Describe System use	12 months following first initiation of automated mode
Number of boluses per day	Describe System use	12 months following first initiation of automated mode
Targets used by patients	Describe System use	12 months following first initiation of automated mode
Bolus/Basal distribution	Describe System use	12 months following first initiation of automated mode
Incidence of severe hypoglycemia	Assess the incidence and type of acute metabolic complications	6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode
Incidence of diabetic ketoacidosis	Assess the incidence and type of acute metabolic complications	6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode
Reasons for having stopped using the Omnipod 5 System	Assess the rate at which patients stop using the Omnipod 5 system	12 months following first initiation of automated mode
Percentage of time in the 70 - 180 mg/dL range	Glucose metric from continuous glucose monitoring system to assess glucose control	Up to 12-months following first initiation of automated mode
Percentage of time in the 70 - 140 mg/dL range	Glucose metric from continuous glucose monitoring system to assess glucose control	Up to 12-months following first initiation of automated mode
Percentage of time below 54 mg/dL	Glucose metric from continuous glucose monitoring system to assess glucose control	Up to 12-months following first initiation of automated mode
Percentage of time below 70 mg/dL	Glucose metric from continuous glucose monitoring system to assess glucose control	Up to 12-months following first initiation of automated mode
Percentage of time above 180 mg/dL	Glucose metric from continuous glucose monitoring system to assess glucose control	Up to 12-months following first initiation of automated mode
Percentage of time above 250 mg/dL	Glucose metric from continuous glucose monitoring system to assess glucose control	Up to 12-months following first initiation of automated mode
Glucose Management Indicator (GMI)	Glucose metric from continuous glucose monitoring system to assess glucose control	Up to 12-months following first initiation of automated mode
Glycemic Risk Index (GRI)	Glucose metric from continuous glucose monitoring system to assess glucose control	Up to 12-months following first initiation of automated mode
Coefficient of variation (CV)	Glucose metric from continuous glucose monitoring system to assess glucose control	Up to 12-months following first initiation of automated mode
Mean glucose	Glucose metric from continuous glucose monitoring system to assess glucose control	Up to 12-months following first initiation of automated mode
HbA1c Level (if available)	Blood test to assess glucose control	Up to 12-months following first initiation of automated mode
Percentage of patients with ≥ 70%	Assess the achievement of CGM-based consensus targets	Up to 12-months following first initiation of automated mode
Percentage of patients with < 4%	Assess the achievement of CGM-based consensus targets	Up to 12-months following first initiation of automated mode
Percentage of patients with < 1%	Assess the achievement of CGM-based consensus targets	Up to 12-months following first initiation of automated mode
EuroQoL 5-dimension 5-level questionnaire	Assess patients' general quality of life	At inclusion and 6 and 12 months following first initiation of automated mode
Unscheduled hospitalizations for diabetes or diabetes complications	Assess the incidence and type of acute metabolic complications	6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode
Percentage of patients still using the Omnipod 5 System at the end of study follow-up	Assess the rate at which patients stop using the Omnipod 5 system	12 months following first initiation of automated mode
Pediatric quality of life questionnaire	Assess pediatric patients' quality of life with the Omnipod 5 System	At inclusion and 6 and 12 months following first initiation of automated mode
Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL)	Assess patients' diabetes-specific quality of life on a scale of very satisfied to very dissatisfied	At inclusion and 6 and 12 months following first initiation of automated mode
Patients aged 10-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)	Assess patients' diabetes-specific quality of life on a scale of 0 (never) to 4 (all the time)	At inclusion and 6 and 12 months following first initiation of automated mode
Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs)	Assess patients' satisfaction with the Omnipod 5 System on a scale of 0 (very dissatisfied) to 6 (very satisfied)	At inclusion and 6 and 12 months following first initiation of automated mode
Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire, status version -Teens (DTSQs - Teen)	Assess patients' satisfaction with the Omnipod 5 System on a scale of 0 (very dissatisfied) to 6 (very satisfied)	At inclusion and 6 and 12 months following first initiation of automated mode
Patients aged 2-12 years: Diabetes Treatment Satisfaction Questionnaire, status version -Parent (DTSQs - Parent)	Assess satisfaction with the Omnipod 5 System on a scale of 0 (very dissatisfied) to 6 (very satisfied)	At inclusion and 6 and 12 months following first initiation of automated mode

Collaborators and Investigators

• Sponsor: Insulet Corporation
• Investigators: Principal Investigator: Jean-Pierre Riveline, MD, PhD, Centre Universitaire du Diabète et ses complications Hôpital Lariboisière

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Automated Insulin Delivery; Omnipod; Post-market Registry
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: Optimal-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes