NCT07039942

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Jul 2025

Typical duration for all trials

Geographic Reach
1 country

24 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Jul 2025Jul 2027

First Submitted

Initial submission to the registry

June 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

July 23, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

June 18, 2025

Last Update Submit

July 31, 2026

Conditions

DiabetesDiabetes MellitusType 1 Diabetes

Keywords

Type 1 DiabetesOmnipodAutomated Insulin DeliveryRegistry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (37)

  • Percentage of time in the 70 - 180 mg/dL range (TIR)

    Up to 12-months following first initiation of automated mode

  • Percentage of time in the 70 - 140 mg/dL range (TIR Tight)

    Up to 12-months following first initiation of automated mode

  • Percentage of time below 54 mg/dL (TBR Very Low)

    Up to 12-months following first initiation of automated mode

  • Percentage of time below 70 mg/dL (TBR Low)

    Up to 12-months following first initiation of automated mode

  • Percentage of time above 180 mg/dL (TAR High)

    Up to 12-months following first initiation of automated mode

  • +32 more secondary outcomes

Study Arms (1)

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

Interventions

Omnipod 5DEVICE

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.

Omnipod 5 User

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

CHU Angers

Angers, 49100, France

Location

CHU Besançon - Hôpital de Jean Minjoz

Besançon, France

Location

APHP Hopital Avicenne

Bobigny, 93000, France

Location

CHU Bordeaux - Hôpital Pellegrin

Bordeaux, 33000, France

Location

CHU Bordeaux - Hôpital St-André

Bordeaux, 33000, France

Location

CHU BresCHU Brest - Hôpital de la Cavale Blanchet - Hôpital de la Cavale Blanche

Brest, 29200, France

Location

Hôpital Femme Mère Enfant

Bron, 39500, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91100, France

Location

CHU Dijon - Hôpital François MitterrandCHU Dijon - Hôpital François Mitterrand

Dijon, France

Location

GH La Rochelle-Ré-Aunis - Hôpital Saint Louis

La Rochelle, 17019, France

Location

APHP Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Diab-eCare

Lyon, 69008, France

Location

Institut de Diabétologie et de Nutrition du Centre

Mainvilliers, 28300, France

Location

Fondation Ambroise Paré - Hôpital Européen de Marseille

Marseille, France

Location

CHU Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34090, France

Location

CHU Montpellier - Hôpital Lapeyronie

Montpellier, 34090, France

Location

CHU Orléans

Orléans, 45100, France

Location

APHP Hôpital Lariboisière

Paris, 75010, France

Location

APHP La Pitié Salpêtrière

Paris, 75013, France

Location

Hôpital NECKER

Paris, 75015, France

Location

APHP Hopital Robert Debré

Paris, 75019, France

Location

CH Périgueux

Périgueux, 24000, France

Location

Cabinet Médical Saint-Cyr sur Loire

Saint-Cyr-sur-Loire, 37540, France

Location

CHRU Strasbourg

Strasbourg, 67200, France

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jean-Pierre RIVELINE, MD, PhD

    Centre Universitaire du Diabète et ses complications Hôpital Lariboisière

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 26, 2025

Study Start

July 23, 2025

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Last Updated

August 3, 2026

Record last verified: 2026-07

Locations

FR(24)