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.

Study Timeline

• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Study First Posted: 2025-06-26
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-24
• Primary Completion: 2027-04
• Study Completion: 2027-04-01

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

Name	Time	Method
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

Name	Time	Method
Percentage of patients with < 1% TBR Very Low	Up 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 glucose	Up 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% TIR	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
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-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
Percentage of patients with < 4% TBR Low	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 (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 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 QoL
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 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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