French Prospective Multicentric Study in Real World (OPTIMAL-A)

Omnipod 5 - A French Prospective Multicentric Study in Real World

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: Active, not 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 one of the Dexcom (Dexcom G6 or G7) configurations commercially available of the Omnipod 5 Automated Insulin Delivery System in France.

OPTIMAL-A 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): 304

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • CHU Angers
  • Besançon, France
    • CHU Besançon - Hôpital de Jean Minjoz
  • Bobigny, France, 93000
    • APHP Hopital Avicenne
  • Bordeaux, France, 33000
    • CHU bordeaux - Hopital Pellegrin
  • Bordeaux, France, 33000
    • CHU Bordeaux - Hôpital St-André
  • Brest, France, 29200
    • CHU BresCHU Brest - Hôpital de la Cavale Blanchet - Hôpital de la Cavale Blanche
  • Bron, France, 39500
    • Hopital Femme Mere Enfant
  • Corbeil-Essonnes, France, 91100
    • Centre Hospitalier Sud Francilien
  • Dijon, France
    • CHU Dijon - Hôpital François MitterrandCHU Dijon - Hôpital François Mitterrand
  • La Rochelle, France, 17019
    • GH La Rochelle-Ré-Aunis - Hôpital Saint Louis
  • Le Kremlin-Bicêtre, France, 94270
    • APHP Hôpital Bicêtre
  • Lyon, France, 69008
    • Diab-eCare
  • Mainvilliers, France, 28300
    • Institut de Diabétologie et de Nutrition du Centre
  • Marseille, France
    • Fondation Ambroise Paré - Hôpital Européen de Marseille
  • Montpellier, France, 34090
    • CHU Montpellier - Hôpital Lapeyronie
  • Montpellier, France, 34090
    • CHU Montpellier - Hôpital Arnaud de Villeneuve
  • Orléans, France, 45100
    • Chu Orleans
  • Paris, France, 75015
    • Hopital Necker
  • Paris, France, 75013
    • APHP La Pitié Salpêtrière
  • Paris, France, 75010
    • APHP Hôpital Lariboisière
  • Paris, France, 75019
    • APHP Hopital Robert Debre
  • Périgueux, France, 24000
    • CH Périgueux
  • Saint-Cyr-sur-Loire, France, 37540
    • Cabinet Médical Saint-Cyr sur Loire
  • Strasbourg, France, 67200
    • CHRU Strasbourg

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 Dexcom sensor (Dexcom G6 or Dexcom G7) in France.

Description

Inclusion Criteria:

• 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.

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.
• Patient or legal guardian (for minors) is not able to understand and complete electronic questionnaires.
• 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 (TIR)	Assess the effectiveness of the Omnipod 5 system in terms of glycemic control	12 months following first initiation of automated mode

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time in the 70 - 180 mg/dL range (TIR)	Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control	Up to 12-months following first initiation of automated mode
Percentage of time in the 70 - 140 mg/dL range (TIR Tight)	Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control	Up to 12-months following first initiation of automated mode
Percentage of time below 54 mg/dL (TBR Very Low)	Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control	Up to 12-months following first initiation of automated mode
Percentage of time below 70 mg/dL (TBR Low)	Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control	Up to 12-months following first initiation of automated mode
Percentage of time above 180 mg/dL (TAR High)	Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control	Up to 12-months following first initiation of automated mode
Percentage of time above 250 mg/dL (TAR Very High)	Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control	Up to 12-months following first initiation of automated mode
Glucose Management Indicator (GMI)	Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control	Up to 12-months following first initiation of automated mode
Glycemic Risk Index (GRI)	Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control	Up to 12-months following first initiation of automated mode
Coefficient of variation (CV)	Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control	Up to 12-months following first initiation of automated mode
Mean glucose	Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control	Up to 12-months following first initiation of automated mode
Laboratory HbA1c levels (if available)	Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control	Up to 12-months following first initiation of automated mode
Percentage of patients with ≥ 70% TIR	Assess the achievement of CGM-based consensus targets	Up to 12-months following first initiation of automated mode
Percentage of patients with < 4% TBR Low	Assess the achievement of CGM-based consensus targets	Up to 12-months following first initiation of automated mode
Percentage of patients with < 1% TBR Very Low	Assess the achievement of CGM-based consensus targets	Up to 12-months following first initiation of automated mode
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
EuroQoL 5-dimension 5-level questionnaire	Assess patients' general QoL	At inclusion and 6 and 12 months following first initiation of automated mode
Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory	Assess patients' diabetes-specific QoL	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 QoL	At inclusion and 6 and 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
Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs)	Assess patients' satisfaction with the Omnipod 5 System	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	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 patients' satisfaction with the Omnipod 5 System	At inclusion and 6 and 12 months following first initiation of automated mode
Pediatric quality of life questionnaire (animated emoji scale - ad hoc)	Assess pediatric patients' quality of life with the Omnipod 5 System	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
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
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

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): July 23, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: June 18, 2025
• First Submitted That Met QC Criteria: June 18, 2025
• First Posted (Actual): June 26, 2025

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 31, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Registry; Type 1 Diabetes; Automated Insulin Delivery; Omnipod
• 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-A

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