French Prospective Multicentric Study in Real World

Insulet Corporation304 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

304

Conditions

Diabetes Diabetes Mellitus Type 1 Diabetes

Interventions

Omnipod 5DEVICE

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.

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with T1D aged ≥ 2 years. * Patient prescribed a commercially available configuration of the Omnipod 5 System using a Dexcom sensor (Dexcom G6 or Dexcom G7). * 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. * Patient or legal guardian (for minors) is not able to understand and complete electronic questionnaires. * Adult under guardianship, curatorship or tutorship. * Adult otherwise deprived of liberty.

Locations (24)

CHU Angers

Angers, France

Outcomes

Primary Outcomes

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

Time frame: 12 months following first initiation of automated mode

Secondary Outcomes

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

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

Percentage of time in the 70 - 140 mg/dL range (TIR Tight)

Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Central Contacts

Trang Ly, MBBS, PhD

CONTACT

978-600-7000 APClinical@insulet.com

Bonnie Dumais Dumais, RN

CONTACT

978-600-7000 APClinical@insulet.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

CHU Besançon - Hôpital de Jean Minjoz

Besançon, France

RECRUITING

APHP Hopital Avicenne

Bobigny, France

RECRUITING

CHU Bordeaux - Hôpital Pellegrin

Bordeaux, France

RECRUITING

CHU Bordeaux - Hôpital St-André

Bordeaux, France

RECRUITING

CHU BresCHU Brest - Hôpital de la Cavale Blanchet - Hôpital de la Cavale Blanche

Brest, France

RECRUITING

Hôpital Femme Mère Enfant

Bron, France

RECRUITING

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

RECRUITING

CHU Dijon - Hôpital François MitterrandCHU Dijon - Hôpital François Mitterrand

Dijon, France

RECRUITING

GH La Rochelle-Ré-Aunis - Hôpital Saint Louis

La Rochelle, France

RECRUITING

...and 14 more locations

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

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

Percentage of patients with ≥ 70% TIR

Assess the achievement of CGM-based consensus targets

Time frame: 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

Time frame: 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

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

Percentage of patients with GMI ≤ 7%

Assess the achievement of CGM-based consensus targets

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

Percentage of patients with CV ≤ 36%

Assess the achievement of CGM-based consensus targets

Time frame: 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

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

EuroQoL 5-dimension 5-level questionnaire

Assess patients' general QoL

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 12 months following first initiation of automated mode

Percentage of time using the System in manual mode

Describe System use

Time frame: 12 months following first initiation of automated mode

Percentage of time using "Activity" feature

Describe System use

Time frame: 12 months following first initiation of automated mode

Total daily dose of insulin

Describe System use

Time frame: 12 months following first initiation of automated mode

Number of boluses per day

Describe System use

Time frame: 12 months following first initiation of automated mode

Targets used by patients

Describe System use

Time frame: 12 months following first initiation of automated mode

Bolus/Basal distribution

Describe System use

Time frame: 12 months following first initiation of automated mode

Incidence of severe hypoglycemia

Assess the incidence and type of acute metabolic complications

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 12 months following first initiation of automated mode