Diabetes, Type 1 Diabetes, Diabetes Mellitus
Conditions
Keywords
Omnipod, Automated Insulin Delivery, Post-market Registry
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.
Interventions
DEVICEOmnipod 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.
Sponsors
Insulet Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the percentage of time in the 70 - 180 mg/dL range | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with ≥ 70% | Up to 12-months following first initiation of automated mode | Assess the achievement of CGM-based consensus targets |
| Percentage of time in the 70 - 180 mg/dL range | Up to 12-months following first initiation of automated mode | Glucose metric from continuous glucose monitoring system to assess glucose control |
| Percentage of time in the 70 - 140 mg/dL range | Up to 12-months following first initiation of automated mode | Glucose metric from continuous glucose monitoring system to assess glucose control |
| Percentage of time below 54 mg/dL | Up to 12-months following first initiation of automated mode | Glucose metric from continuous glucose monitoring system to assess glucose control |
| Percentage of time below 70 mg/dL | Up to 12-months following first initiation of automated mode | Glucose metric from continuous glucose monitoring system to assess glucose control |
| Percentage of time above 180 mg/dL | Up to 12-months following first initiation of automated mode | Glucose metric from continuous glucose monitoring system to assess glucose control |
| Percentage of time above 250 mg/dL | Up to 12-months following first initiation of automated mode | Glucose metric from continuous glucose monitoring system to assess glucose control |
| Glucose Management Indicator (GMI) | Up to 12-months following first initiation of automated mode | Glucose metric from continuous glucose monitoring system to assess glucose control |
| Glycemic Risk Index (GRI) | Up to 12-months following first initiation of automated mode | Glucose metric from continuous glucose monitoring system to assess glucose control |
| Coefficient of variation (CV) | Up to 12-months following first initiation of automated mode | Glucose metric from continuous glucose monitoring system to assess glucose control |
| Mean glucose | Up to 12-months following first initiation of automated mode | Glucose metric from continuous glucose monitoring system to assess glucose control |
| Percentage of patients with < 4% | Up to 12-months following first initiation of automated mode | Assess the achievement of CGM-based consensus targets |
| Percentage of patients with < 1% | Up to 12-months following first initiation of automated mode | Assess the achievement of CGM-based consensus targets |
| Percentage of patients with GMI ≤ 7% | Up to 12-months following first initiation of automated mode | Assess the achievement of CGM-based consensus targets |
| Percentage of patients with CV ≤ 36% | Up to 12-months following first initiation of automated mode | Assess the achievement of CGM-based consensus targets |
| Percentage of patients achieving combinations of previous CGM-based consensus targets | Up to 12-months following first initiation of automated mode | Assess the achievement of CGM-based consensus targets |
| EuroQoL 5-dimension 5-level questionnaire | At inclusion and 6 and 12 months following first initiation of automated mode | Assess patients' general quality of life |
| Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory | At inclusion and 6 and 12 months following first initiation of automated mode | Assess patients' diabetes-specific quality of life |
| HbA1c Level (if available) | Up to 12-months following first initiation of automated mode | Blood test to assess glucose control |
| Insulin Delivery System Rating Questionnaire (IDSRQ) interference sub-score | 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 |
| Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire, status version(DTSQs) | At inclusion and 6 and 12 months following first initiation of automated mode | Assess patients' satisfaction with the Omnipod 5 System |
| 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 | Assess patients' satisfaction with the Omnipod 5 System |
| 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 | Assess patients' satisfaction with the Omnipod 5 System |
| Pediatric quality of life questionnaire (animated emoji scale - ad hoc) | At inclusion and 6 and 12 months following first initiation of automated mode | Assess pediatric patients' quality of life with the Omnipod 5 System |
| Percentage of time using the System in automated mode | 12 months following first initiation of automated mode | Describe System use |
| Percentage of time using the System in manual mode | 12 months following first initiation of automated mode | Describe System use |
| Percentage of time using Activity feature | 12 months following first initiation of automated mode | Describe System use |
| Total daily dose of insulin | 12 months following first initiation of automated mode | Describe System use |
| Number of boluses per day | 12 months following first initiation of automated mode | Describe System use |
| Targets used by patients | 12 months following first initiation of automated mode | Describe System use |
| Bolus/Basal distribution | 12 months following first initiation of automated mode | Describe System use |
| Incidence of severe hypoglycemia | 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 |
| Incidence of diabetic ketoacidosis | 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 |
| 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 | Assess the incidence and type of acute metabolic complications |
| Percentage of patients still using the Omnipod 5 System at the end of study follow-up | 12 months following first initiation of automated mode | Assess the rate at which patients stop using the Omnipod 5 system |
| Reasons for having stopped using the Omnipod 5 System | 12 months following first initiation of automated mode | Assess the rate at which patients stop using the Omnipod 5 system |
| 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 | Assess patients' diabetes-specific quality of life |
Countries
France
Contacts
Primary ContactTrang Ly, MBBS, PhD
Backup ContactBonnie Dumais
Outcome results
None listed