NCT07317102RecruitingNot Applicable
Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Insulet Corporation
- Enrollment
- 152
- Locations
- 29
- Primary Endpoint
- Change in the percentage of time in the 70 - 180 mg/dL range
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: Omnipod 5 (Device)
Outcomes
Primary Outcomes
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
- Pediatric quality of life questionnaire(At inclusion and 6 and 12 months following first initiation of automated mode)
- Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs)(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)(At inclusion and 6 and 12 months following first initiation of automated mode)
- Percentage of time in the 70 - 180 mg/dL range(Up to 12-months following first initiation of automated mode)
- Percentage of time in the 70 - 140 mg/dL range(Up to 12-months following first initiation of automated mode)
- Percentage of time below 54 mg/dL(Up to 12-months following first initiation of automated mode)
- Percentage of time below 70 mg/dL(Up to 12-months following first initiation of automated mode)
- Percentage of time above 180 mg/dL(Up to 12-months following first initiation of automated mode)
- Percentage of time above 250 mg/dL(Up to 12-months following first initiation of automated mode)
- Glucose Management Indicator (GMI)(Up to 12-months following first initiation of automated mode)
- Glycemic Risk Index (GRI)(Up to 12-months following first initiation of automated mode)
- Coefficient of variation (CV)(Up to 12-months following first initiation of automated mode)
- Mean glucose(Up to 12-months following first initiation of automated mode)
- HbA1c Level (if available)(Up to 12-months following first initiation of automated mode)
- Percentage of patients with ≥ 70%(Up to 12-months following first initiation of automated mode)
- Percentage of patients with < 4%(Up to 12-months following first initiation of automated mode)
- Percentage of patients with < 1%(Up to 12-months following first initiation of automated mode)
- Patients aged 10-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)(At inclusion and 6 and 12 months following first initiation of automated mode)
- Percentage of patients with GMI ≤ 7%(Up to 12-months following first initiation of automated mode)
- Percentage of patients with CV ≤ 36%(Up to 12-months following first initiation of automated mode)
- Percentage of patients achieving combinations of previous CGM-based consensus targets(Up to 12-months following first initiation of automated mode)
- EuroQoL 5-dimension 5-level questionnaire(At inclusion and 6 and 12 months following first initiation of automated mode)
- Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory(At inclusion and 6 and 12 months following first initiation of automated mode)
- Insulin Delivery System Rating Questionnaire (IDSRQ) interference sub-score(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)(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)(At inclusion and 6 and 12 months following first initiation of automated mode)
- Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire, status version(DTSQs)(At inclusion and 6 and 12 months following first initiation of automated mode)
- Pediatric quality of life questionnaire (animated emoji scale - ad hoc)(At inclusion and 6 and 12 months following first initiation of automated mode)
- Percentage of time using the System in automated mode(12 months following first initiation of automated mode)
- Percentage of time using the System in manual mode(12 months following first initiation of automated mode)
- Percentage of time using "Activity" feature(12 months following first initiation of automated mode)
- Total daily dose of insulin(12 months following first initiation of automated mode)
- Number of boluses per day(12 months following first initiation of automated mode)
- Targets used by patients(12 months following first initiation of automated mode)
- Bolus/Basal distribution(12 months following first initiation of automated mode)
- Incidence of severe hypoglycemia(6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode)
- Incidence of diabetic ketoacidosis(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(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(12 months following first initiation of automated mode)
- Reasons for having stopped using the Omnipod 5 System(12 months following first initiation of automated mode)
Investigators
Study Sites (29)
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