MedPath

French Prospective Multicentric Study in Real World

Not yet recruiting
Conditions
Diabetes
Diabetes Mellitus
Type 1 Diabetes
Registration Number
NCT07039942
Lead Sponsor
Insulet Corporation
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 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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
304
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in the percentage of time in the 70 - 180 mg/dL range (TIR)12 months following first initiation of automated mode

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

Secondary Outcome Measures
NameTimeMethod
Percentage of patients with < 1% TBR Very LowUp to 12-months following first initiation of automated mode

Assess the achievement of CGM-based consensus targets

Percentage of time below 54 mg/dL (TBR Very Low)Up to 12-months following first initiation of automated mode

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

Percentage of time above 180 mg/dL (TAR High)Up to 12-months following first initiation of automated mode

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

Percentage of time above 250 mg/dL (TAR Very High)Up to 12-months following first initiation of automated mode

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

Glucose Management Indicator (GMI)Up to 12-months following first initiation of automated mode

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

Glycemic Risk Index (GRI)Up to 12-months following first initiation of automated mode

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

Coefficient of variation (CV)Up to 12-months following first initiation of automated mode

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

Mean glucoseUp to 12-months following first initiation of automated mode

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

Laboratory HbA1c levels (if available)Up to 12-months following first initiation of automated mode

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

Percentage of patients with ≥ 70% TIRUp 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

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 QoL

Insulin Delivery System Rating Questionnaire (IDSRQ) interference sub-scoreAt 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 mode12 months following first initiation of automated mode

Describe System use

Percentage of time using the System in manual mode12 months following first initiation of automated mode

Describe System use

Percentage of time using "Activity" feature12 months following first initiation of automated mode

Describe System use

Total daily dose of insulin12 months following first initiation of automated mode

Describe System use

Number of boluses per day12 months following first initiation of automated mode

Describe System use

Targets used by patients12 months following first initiation of automated mode

Describe System use

Bolus/Basal distribution12 months following first initiation of automated mode

Describe System use

Incidence of severe hypoglycemia6 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 ketoacidosis6 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 System12 months following first initiation of automated mode

Assess the rate at which patients stop using the Omnipod 5 system

Percentage of patients with < 4% TBR LowUp 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 (TIR)Up to 12-months following first initiation of automated mode

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

Percentage of time in the 70 - 140 mg/dL range (TIR Tight)Up to 12-months following first initiation of automated mode

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

Percentage of time below 70 mg/dL (TBR Low)Up to 12-months following first initiation of automated mode

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

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 targetsUp to 12-months following first initiation of automated mode

Assess the achievement of CGM-based consensus targets

EuroQoL 5-dimension 5-level questionnaireAt inclusion and 6 and 12 months following first initiation of automated mode

Assess patients' general QoL

Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical InventoryAt inclusion and 6 and 12 months following first initiation of automated mode

Assess patients' diabetes-specific QoL

Trial Locations

Locations (22)

CHU Angers

🇫🇷

Angers, France

CHU Besançon - Hôpital de Jean Minjoz

🇫🇷

Besançon, France

APHP Hopital Avicenne

🇫🇷

Bobigny, France

CHU Bordeaux - Hôpital Pellegrin

🇫🇷

Bordeaux, France

CHU Bordeaux - Hôpital St-André

🇫🇷

Bordeaux, France

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

🇫🇷

Brest, France

Hôpital Femme Mère Enfant

🇫🇷

Bron, France

Centre Hospitalier Sud Francilien

🇫🇷

Corbeil-Essonnes, France

CHU Dijon - Hôpital François MitterrandCHU Dijon - Hôpital François Mitterrand

🇫🇷

Dijon, France

GH La Rochelle-Ré-Aunis - Hôpital Saint Louis

🇫🇷

La Rochelle, France

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CHU Angers
🇫🇷Angers, France
Lucie DUFOUR
Contact
Regis COUTANT
Principal Investigator

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