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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 one of the Dexcom (Dexcom G6 or G7) configurations commercially available of the Omnipod 5 Automated Insulin Delivery System in France.
OPTIMAL-A 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 (TIR) | Assess the effectiveness of the Omnipod 5 system in terms of glycemic control | 12 months following first initiation of automated mode |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time in the 70 - 180 mg/dL range (TIR) | Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control | Up to 12-months following first initiation of automated mode |
| Percentage of time in the 70 - 140 mg/dL range (TIR Tight) |
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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 Dexcom sensor (Dexcom G6 or Dexcom G7) in France.
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| 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 | Angers | 49100 | France | |||
| CHU Besançon - Hôpital de Jean Minjoz |
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Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control |
| Up to 12-months following first initiation of automated mode |
| Percentage of time below 54 mg/dL (TBR Very Low) | Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control | Up to 12-months following first initiation of automated mode |
| Percentage of time below 70 mg/dL (TBR Low) | Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control | Up to 12-months following first initiation of automated mode |
| Percentage of time above 180 mg/dL (TAR High) | Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control | Up to 12-months following first initiation of automated mode |
| Percentage of time above 250 mg/dL (TAR Very High) | Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control | Up to 12-months following first initiation of automated mode |
| Glucose Management Indicator (GMI) | Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control | Up to 12-months following first initiation of automated mode |
| Glycemic Risk Index (GRI) | Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control | Up to 12-months following first initiation of automated mode |
| Coefficient of variation (CV) | Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control | Up to 12-months following first initiation of automated mode |
| Mean glucose | Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control | Up to 12-months following first initiation of automated mode |
| Laboratory HbA1c levels (if available) | Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control | Up to 12-months following first initiation of automated mode |
| Percentage of patients with ≥ 70% TIR | Assess the achievement of CGM-based consensus targets | Up to 12-months following first initiation of automated mode |
| Percentage of patients with < 4% TBR Low | Assess the achievement of CGM-based consensus targets | Up to 12-months following first initiation of automated mode |
| Percentage of patients with < 1% TBR Very Low | 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 QoL | At inclusion and 6 and 12 months following first initiation of automated mode |
| Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory | Assess patients' diabetes-specific QoL | 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 QoL | 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 | 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 | 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 patients' satisfaction with the Omnipod 5 System | At inclusion and 6 and 12 months following first initiation of automated mode |
| Pediatric quality of life questionnaire (animated emoji scale - ad hoc) | 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 |
| Besançon |
| France |
| APHP Hopital Avicenne | Bobigny | 93000 | France |
| CHU Bordeaux - Hôpital Pellegrin | Bordeaux | 33000 | France |
| CHU Bordeaux - Hôpital St-André | Bordeaux | 33000 | France |
| CHU BresCHU Brest - Hôpital de la Cavale Blanchet - Hôpital de la Cavale Blanche | Brest | 29200 | France |
| Hôpital Femme Mère Enfant | Bron | 39500 | France |
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | 91100 | France |
| CHU Dijon - Hôpital François MitterrandCHU Dijon - Hôpital François Mitterrand | Dijon | France |
| GH La Rochelle-Ré-Aunis - Hôpital Saint Louis | La Rochelle | 17019 | France |
| APHP Hôpital Bicêtre | Le Kremlin-Bicêtre | 94270 | France |
| Diab-eCare | Lyon | 69008 | France |
| Institut de Diabétologie et de Nutrition du Centre | Mainvilliers | 28300 | France |
| Fondation Ambroise Paré - Hôpital Européen de Marseille | Marseille | France |
| CHU Montpellier - Hôpital Arnaud de Villeneuve | Montpellier | 34090 | France |
| CHU Montpellier - Hôpital Lapeyronie | Montpellier | 34090 | France |
| CHU Orléans | Orléans | 45100 | France |
| APHP Hôpital Lariboisière | Paris | 75010 | France |
| APHP La Pitié Salpêtrière | Paris | 75013 | France |
| Hôpital NECKER | Paris | 75015 | France |
| APHP Hopital Robert Debré | Paris | 75019 | France |
| CH Périgueux | Périgueux | 24000 | France |
| Cabinet Médical Saint-Cyr sur Loire | Saint-Cyr-sur-Loire | 37540 | France |
| CHRU Strasbourg | Strasbourg | 67200 | 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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