NCT07039942进行中（未招募）不适用
Omnipod 5 - A French Prospective Multicentric Study in Real World
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 304
- 试验地点
- 46
- 主要终点
- Change in the percentage of time in the 70 - 180 mg/dL range (TIR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Omnipod 5 (Device)
结局指标
主要结局
Change in the percentage of time in the 70 - 180 mg/dL range (TIR)
时间窗: 12 months following first initiation of automated mode
Assess the effectiveness of the Omnipod 5 system in terms of glycemic control
次要结局
- Percentage of patients with < 4% TBR Low(Up to 12-months following first initiation of automated mode)
- Percentage of patients with < 1% TBR Very Low(Up to 12-months following first initiation of automated mode)
- Percentage of time in the 70 - 180 mg/dL range (TIR)(Up to 12-months following first initiation of automated mode)
- Percentage of time in the 70 - 140 mg/dL range (TIR Tight)(Up to 12-months following first initiation of automated mode)
- Percentage of time below 54 mg/dL (TBR Very Low)(Up to 12-months following first initiation of automated mode)
- Percentage of time below 70 mg/dL (TBR Low)(Up to 12-months following first initiation of automated mode)
- Percentage of time above 180 mg/dL (TAR High)(Up to 12-months following first initiation of automated mode)
- Percentage of time above 250 mg/dL (TAR Very High)(Up to 12-months following first initiation of automated mode)
- Glucose Management Indicator (GMI)(Up to 12-months following first initiation of automated mode)
- Glycemic Risk Index (GRI)(Up to 12-months following first initiation of automated mode)
- Coefficient of variation (CV)(Up to 12-months following first initiation of automated mode)
- Mean glucose(Up to 12-months following first initiation of automated mode)
- Laboratory HbA1c levels (if available)(Up to 12-months following first initiation of automated mode)
- Percentage of patients with ≥ 70% TIR(Up to 12-months following first initiation of automated mode)
- Percentage of patients with GMI ≤ 7%(Up to 12-months following first initiation of automated mode)
- Percentage of patients with CV ≤ 36%(Up to 12-months following first initiation of automated mode)
- Percentage of patients achieving combinations of previous CGM-based consensus targets(Up to 12-months following first initiation of automated mode)
- EuroQoL 5-dimension 5-level questionnaire(At inclusion and 6 and 12 months following first initiation of automated mode)
- Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory(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)(At inclusion and 6 and 12 months following first initiation of automated mode)
- Insulin Delivery System Rating Questionnaire (IDSRQ) interference sub-score(At inclusion and 6 and 12 months following first initiation of automated mode)
- Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs)(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)(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)(At inclusion and 6 and 12 months following first initiation of automated mode)
- Pediatric quality of life questionnaire (animated emoji scale - ad hoc)(At inclusion and 6 and 12 months following first initiation of automated mode)
- Percentage of time using the System in automated mode(12 months following first initiation of automated mode)
- Percentage of time using the System in manual mode(12 months following first initiation of automated mode)
- Percentage of time using "Activity" feature(12 months following first initiation of automated mode)
- Total daily dose of insulin(12 months following first initiation of automated mode)
- Number of boluses per day(12 months following first initiation of automated mode)
- Targets used by patients(12 months following first initiation of automated mode)
- Bolus/Basal distribution(12 months following first initiation of automated mode)
- Incidence of severe hypoglycemia(6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode)
- Incidence of diabetic ketoacidosis(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.(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.(12 months following first initiation of automated mode)
- Reasons for having stopped using the Omnipod 5 System(12 months following first initiation of automated mode)
研究者
研究点 (46)
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