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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the percentage of time in the 70 - 180 mg/dL range | Glucose metric from continuous glucose monitoring system to assess glucose control | Change in percentage of time in specified range between Baseline and 12-months following first initiation of automated mode |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time in the 70 - 180 mg/dL range | Glucose metric from continuous glucose monitoring system to assess glucose control | Up to 12-months following first initiation of automated mode |
| Percentage of time in the 70 - 140 mg/dL range |
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Inclusion Criteria:
Exclusion Criteria:
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The study population contains patients (age ≥ 2 years) with T1DM initiating a commercially available configuration of the Omnipod 5 System using a FreeStyle Libre 2Plus in France.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trang Ly, MBBS, PhD | Contact | 978-600-7000 | APClinical@insulet.com | |
| Bonnie Dumais | Contact | 978-600-7000 | APClinical@insulet.com |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Pierre Riveline, MD, PhD | Centre Universitaire du Diabète et ses complications Hôpital Lariboisière | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Recruiting | Angers | 49100 | France |
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|
Glucose metric from continuous glucose monitoring system to assess glucose control
| Up to 12-months following first initiation of automated mode |
| Percentage of time below 54 mg/dL | Glucose metric from continuous glucose monitoring system to assess glucose control | Up to 12-months following first initiation of automated mode |
| Percentage of time below 70 mg/dL | Glucose metric from continuous glucose monitoring system to assess glucose control | Up to 12-months following first initiation of automated mode |
| Percentage of time above 180 mg/dL | Glucose metric from continuous glucose monitoring system to assess glucose control | Up to 12-months following first initiation of automated mode |
| Percentage of time above 250 mg/dL | Glucose metric from continuous glucose monitoring system to assess glucose control | Up to 12-months following first initiation of automated mode |
| Glucose Management Indicator (GMI) | Glucose metric from continuous glucose monitoring system to assess glucose control | Up to 12-months following first initiation of automated mode |
| Glycemic Risk Index (GRI) | Glucose metric from continuous glucose monitoring system to assess glucose control | Up to 12-months following first initiation of automated mode |
| Coefficient of variation (CV) | Glucose metric from continuous glucose monitoring system to assess glucose control | Up to 12-months following first initiation of automated mode |
| Mean glucose | Glucose metric from continuous glucose monitoring system to assess glucose control | Up to 12-months following first initiation of automated mode |
| HbA1c Level (if available) | Blood test to assess glucose control | Up to 12-months following first initiation of automated mode |
| Percentage of patients with ≥ 70% | Assess the achievement of CGM-based consensus targets | Up to 12-months following first initiation of automated mode |
| Percentage of patients with < 4% | Assess the achievement of CGM-based consensus targets | Up to 12-months following first initiation of automated mode |
| Percentage of patients with < 1% | Assess the achievement of CGM-based consensus targets | Up to 12-months following first initiation of automated mode |
| Percentage of patients with GMI ≤ 7% | Assess the achievement of CGM-based consensus targets | Up to 12-months following first initiation of automated mode |
| Percentage of patients with CV ≤ 36% | Assess the achievement of CGM-based consensus targets | Up to 12-months following first initiation of automated mode |
| Percentage of patients achieving combinations of previous CGM-based consensus targets | Assess the achievement of CGM-based consensus targets | Up to 12-months following first initiation of automated mode |
| EuroQoL 5-dimension 5-level questionnaire | Assess patients' general quality of life | 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) | Assess patients' diabetes-specific quality of life on a scale of very satisfied to very dissatisfied | At inclusion and 6 and 12 months following first initiation of automated mode |
| Patients aged 10-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF) | Assess patients' diabetes-specific quality of life on a scale of 0 (never) to 4 (all the time) | At inclusion and 6 and 12 months following first initiation of automated mode |
| Insulin Delivery System Rating Questionnaire (IDSRQ) interference sub-score | Assess the interference of the Omnipod 5 System with patients' daily lives | At inclusion and 6 and 12 months following first initiation of automated mode |
| Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs) | Assess patients' satisfaction with the Omnipod 5 System on a scale of 0 (very dissatisfied) to 6 (very satisfied) | 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) | Assess patients' satisfaction with the Omnipod 5 System on a scale of 0 (very dissatisfied) to 6 (very satisfied) | 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) | Assess satisfaction with the Omnipod 5 System on a scale of 0 (very dissatisfied) to 6 (very satisfied) | At inclusion and 6 and 12 months following first initiation of automated mode |
| Pediatric quality of life questionnaire | Assess pediatric patients' quality of life with the Omnipod 5 System | At inclusion and 6 and 12 months following first initiation of automated mode |
| Percentage of time using the System in automated mode | Describe System use | 12 months following first initiation of automated mode |
| Percentage of time using the System in manual mode | Describe System use | 12 months following first initiation of automated mode |
| Percentage of time using "Activity" feature | Describe System use | 12 months following first initiation of automated mode |
| Total daily dose of insulin | Describe System use | 12 months following first initiation of automated mode |
| Number of boluses per day | Describe System use | 12 months following first initiation of automated mode |
| Targets used by patients | Describe System use | 12 months following first initiation of automated mode |
| Bolus/Basal distribution | Describe System use | 12 months following first initiation of automated mode |
| Incidence of severe hypoglycemia | Assess the incidence and type of acute metabolic complications | 6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode |
| Incidence of diabetic ketoacidosis | Assess the incidence and type of acute metabolic complications | 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 | Assess the incidence and type of acute metabolic 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 | Assess the rate at which patients stop using the Omnipod 5 system | 12 months following first initiation of automated mode |
| Reasons for having stopped using the Omnipod 5 System | Assess the rate at which patients stop using the Omnipod 5 system | 12 months following first initiation of automated mode |
| CHU Besançon - Hôpital de Jean Minjoz | Recruiting | Besançon | 25000 | France |
|
| APHP Hopital Avicenne | Not yet recruiting | Bobigny | 93000 | France |
|
| CHU Bordeaux - Hôpital Pellegrin | Recruiting | Bordeaux | 33000 | France |
|
| CHU Bordeaux - Hôpital St-André | Recruiting | Bordeaux | 33000 | France |
|
| CHU Brest - Hôpital de la Cavale Blanche | Recruiting | Brest | 29200 | France |
|
| Hôpital Femme Mère Enfant | Recruiting | Bron | 39500 | France |
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| Centre Hospitalier Sud Francilien | Recruiting | Corbeil-Essonnes | 91100 | France |
|
| CIRDIA | Recruiting | Dijon | 21000 | France |
|
| CHU Dijon - Hôpital François Mitterrand | Recruiting | Dijon | France |
|
| GH La Rochelle-Ré-Aunis - Hôpital Saint Louis | Recruiting | La Rochelle | 17019 | France |
|
| APHP Hôpital Bicêtre | Not yet recruiting | Le Kremlin-Bicêtre | 94270 | France |
|
| Institut de Diabétologie et de Nutrition du Centre | Recruiting | Mainvilliers | 28300 | France |
|
| Fondation Ambroise Paré - Hôpital Européen de Marseille | Recruiting | Marseille | France |
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| CHU Montpellier - Hôpital Lapeyronie | Recruiting | Montpellier | 34090 | France |
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| CHU Nantes | Recruiting | Nantes | France |
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| Institut Saint Pierre | Recruiting | Palavas-les-Flots | 34250 | France |
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| APHP Hôpital Lariboisière | Not yet recruiting | Paris | 75010 | France |
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| APHP Hopital Robert Debré | Not yet recruiting | Paris | 75019 | France |
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| APHP Hôpital Saint-Antoine | Recruiting | Paris | France |
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| CH Périgueux | Recruiting | Périgueux | 24000 | France |
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| Clinique Saint Jean de Védas | Recruiting | Saint-Jean-de-Védas | 34430 | France |
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| CHRU Strasbourg | Recruiting | Strasbourg | 67098 | France |
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| CHU Tours | Recruiting | Tours | 37000 | France |
|
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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