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NCT Number: NCT07317102

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 1 Diabetes

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OmniPod 5

Device

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 outcomes

  1. 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

    Glucose metric from continuous glucose monitoring system to assess glucose control

Secondary outcomes

  1. Percentage of time in the 70 - 180 mg/dL range

    Time frame: Up to 12-months following first initiation of automated mode

    Glucose metric from continuous glucose monitoring system to assess glucose control

  2. Percentage of time in the 70 - 140 mg/dL range

    Time frame: Up to 12-months following first initiation of automated mode

    Glucose metric from continuous glucose monitoring system to assess glucose control

  3. Percentage of time below 54 mg/dL

    Time frame: Up to 12-months following first initiation of automated mode

    Glucose metric from continuous glucose monitoring system to assess glucose control

  4. Percentage of time below 70 mg/dL

    Time frame: Up to 12-months following first initiation of automated mode

    Glucose metric from continuous glucose monitoring system to assess glucose control

  5. Percentage of time above 180 mg/dL

    Time frame: Up to 12-months following first initiation of automated mode

    Glucose metric from continuous glucose monitoring system to assess glucose control

  6. Percentage of time above 250 mg/dL

    Time frame: Up to 12-months following first initiation of automated mode

    Glucose metric from continuous glucose monitoring system to assess glucose control

  7. Glucose Management Indicator (GMI)

    Time frame: Up to 12-months following first initiation of automated mode

    Glucose metric from continuous glucose monitoring system to assess glucose control

  8. Glycemic Risk Index (GRI)

    Time frame: Up to 12-months following first initiation of automated mode

    Glucose metric from continuous glucose monitoring system to assess glucose control

  9. Coefficient of variation (CV)

    Time frame: Up to 12-months following first initiation of automated mode

    Glucose metric from continuous glucose monitoring system to assess glucose control

  10. Mean glucose

    Time frame: Up to 12-months following first initiation of automated mode

    Glucose metric from continuous glucose monitoring system to assess glucose control

  11. HbA1c Level (if available)

    Time frame: Up to 12-months following first initiation of automated mode

    Blood test to assess glucose control

  12. Percentage of patients with ≥ 70%

    Time frame: Up to 12-months following first initiation of automated mode

    Assess the achievement of CGM-based consensus targets

  13. Percentage of patients with < 4%

    Time frame: Up to 12-months following first initiation of automated mode

    Assess the achievement of CGM-based consensus targets

  14. Percentage of patients with < 1%

    Time frame: Up to 12-months following first initiation of automated mode

    Assess the achievement of CGM-based consensus targets

  15. Percentage of patients with GMI ≤ 7%

    Time frame: Up to 12-months following first initiation of automated mode

    Assess the achievement of CGM-based consensus targets

  16. Percentage of patients with CV ≤ 36%

    Time frame: Up to 12-months following first initiation of automated mode

    Assess the achievement of CGM-based consensus targets

  17. Percentage of patients achieving combinations of previous CGM-based consensus targets

    Time frame: Up to 12-months following first initiation of automated mode

    Assess the achievement of CGM-based consensus targets

  18. EuroQoL 5-dimension 5-level questionnaire

    Time frame: At inclusion and 6 and 12 months following first initiation of automated mode

    Assess patients' general quality of life

  19. Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL)

    Time frame: At inclusion and 6 and 12 months following first initiation of automated mode

    Assess patients' diabetes-specific quality of life on a scale of very satisfied to very dissatisfied

  20. Patients aged 10-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)

    Time frame: At inclusion and 6 and 12 months following first initiation of automated mode

    Assess patients' diabetes-specific quality of life on a scale of 0 (never) to 4 (all the time)

  21. Insulin Delivery System Rating Questionnaire (IDSRQ) interference sub-score

    Time frame: At inclusion and 6 and 12 months following first initiation of automated mode

    Assess the interference of the Omnipod 5 System with patients' daily lives

  22. Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs)

    Time frame: At inclusion and 6 and 12 months following first initiation of automated mode

    Assess patients' satisfaction with the Omnipod 5 System on a scale of 0 (very dissatisfied) to 6 (very satisfied)

  23. Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire, status version -Teens (DTSQs - Teen)

    Time frame: At inclusion and 6 and 12 months following first initiation of automated mode

    Assess patients' satisfaction with the Omnipod 5 System on a scale of 0 (very dissatisfied) to 6 (very satisfied)

  24. Patients aged 2-12 years: Diabetes Treatment Satisfaction Questionnaire, status version -Parent (DTSQs - Parent)

    Time frame: At inclusion and 6 and 12 months following first initiation of automated mode

    Assess satisfaction with the Omnipod 5 System on a scale of 0 (very dissatisfied) to 6 (very satisfied)

  25. Pediatric quality of life questionnaire

    Time frame: At inclusion and 6 and 12 months following first initiation of automated mode

    Assess pediatric patients' quality of life with the Omnipod 5 System

  26. Percentage of time using the System in automated mode

    Time frame: 12 months following first initiation of automated mode

    Describe System use

  27. Percentage of time using the System in manual mode

    Time frame: 12 months following first initiation of automated mode

    Describe System use

  28. Percentage of time using "Activity" feature

    Time frame: 12 months following first initiation of automated mode

    Describe System use

  29. Total daily dose of insulin

    Time frame: 12 months following first initiation of automated mode

    Describe System use

  30. Number of boluses per day

    Time frame: 12 months following first initiation of automated mode

    Describe System use

  31. Targets used by patients

    Time frame: 12 months following first initiation of automated mode

    Describe System use

  32. Bolus/Basal distribution

    Time frame: 12 months following first initiation of automated mode

    Describe System use

  33. Incidence of severe hypoglycemia

    Time frame: 6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode

    Assess the incidence and type of acute metabolic complications

  34. Incidence of diabetic ketoacidosis

    Time frame: 6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode

    Assess the incidence and type of acute metabolic complications

  35. Unscheduled hospitalizations for diabetes or diabetes complications

    Time frame: 6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode

    Assess the incidence and type of acute metabolic complications

  36. Percentage of patients still using the Omnipod 5 System at the end of study follow-up

    Time frame: 12 months following first initiation of automated mode

    Assess the rate at which patients stop using the Omnipod 5 system

  37. Reasons for having stopped using the Omnipod 5 System

    Time frame: 12 months following first initiation of automated mode

    Assess the rate at which patients stop using the Omnipod 5 system

Study contacts

Contact information is provided by the study sponsor or research team.

Bonnie Dumais

CONTACT

[email protected]

978-600-7000

Trang Ly, MBBS, PhD

CONTACT

[email protected]

978-600-7000

Sponsors and collaborators

Lead sponsor

Insulet Corporation

Industry

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 5, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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