Menu
Recruiting NCT07317102

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

— Observational Diabetes Type 1 Diabetes Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Omnipod 5.
Who it may be relevant to
Registry conditions: Diabetes, Type 1 Diabetes, Diabetes Mellitus. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Change in the percentage of time in the 70 - 180 mg/dL range [Time frame: Change in percentage of time in specified range between Baseline and 12-months following first initiation of automated mode]
Secondary outcome measures (12)
  • Percentage of time in the 70 - 180 mg/dL range [Time frame: Up to 12-months following first initiation of automated mode]
  • Percentage of time in the 70 - 140 mg/dL range [Time frame: Up to 12-months following first initiation of automated mode]
  • Percentage of time below 54 mg/dL [Time frame: Up to 12-months following first initiation of automated mode]
  • Percentage of time below 70 mg/dL [Time frame: Up to 12-months following first initiation of automated mode]
  • Percentage of time above 180 mg/dL [Time frame: Up to 12-months following first initiation of automated mode]
  • Percentage of time above 250 mg/dL [Time frame: Up to 12-months following first initiation of automated mode]
  • Glucose Management Indicator (GMI) [Time frame: Up to 12-months following first initiation of automated mode]
  • Glycemic Risk Index (GRI) [Time frame: Up to 12-months following first initiation of automated mode]
  • Coefficient of variation (CV) [Time frame: Up to 12-months following first initiation of automated mode]
  • Mean glucose [Time frame: Up to 12-months following first initiation of automated mode]
  • HbA1c Level (if available) [Time frame: Up to 12-months following first initiation of automated mode]
  • Percentage of patients with ≥ 70% [Time frame: Up to 12-months following first initiation of automated mode]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 24 centers
  • CHU Angers — Angers
  • CHU Besançon - Hôpital de Jean Minjoz — Besançon
  • APHP Hopital Avicenne — Bobigny
  • CHU Bordeaux - Hôpital Pellegrin — Bordeaux
  • CHU Bordeaux - Hôpital St-André — Bordeaux
  • CHU Brest - Hôpital de la Cavale Blanche — Brest
  • Hôpital Femme Mère Enfant — Bron
  • Centre Hospitalier Sud Francilien — Corbeil-Essonnes
  • … and 16 more centers

Identifiers

NCT: NCT07317102 · Optimal-B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗