NCT07317102招募中不适用
Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 29
- 主要终点
- Change in the percentage of time in the 70 - 180 mg/dL range
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 the commercially available FreeStyle Libre 2 Plus configuration of the Omnipod 5 Automated Insulin Delivery System in France.
OPTIMAL-B 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, less than a year ago, a commercially available confi guration of the Omnipod 5 System using a FreeStyle Libre 2 Plus sensor.
- •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.
- •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
时间窗: Change in percentage of time in specified range between Baseline and 12-months following first initiation of automated mode
Glucose metric from continuous glucose monitoring system to assess glucose control
次要结局
- Pediatric quality of life questionnaire(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 ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL)(At inclusion and 6 and 12 months following first initiation of automated mode)
- Percentage of time in the 70 - 180 mg/dL range(Up to 12-months following first initiation of automated mode)
- Percentage of time in the 70 - 140 mg/dL range(Up to 12-months following first initiation of automated mode)
- Percentage of time below 54 mg/dL(Up to 12-months following first initiation of automated mode)
- Percentage of time below 70 mg/dL(Up to 12-months following first initiation of automated mode)
- Percentage of time above 180 mg/dL(Up to 12-months following first initiation of automated mode)
- Percentage of time above 250 mg/dL(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)
- HbA1c Level (if available)(Up to 12-months following first initiation of automated mode)
- Percentage of patients with ≥ 70%(Up to 12-months following first initiation of automated mode)
- Percentage of patients with < 4%(Up to 12-months following first initiation of automated mode)
- Percentage of patients with < 1%(Up to 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)
- 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)
- Insulin Delivery System Rating Questionnaire (IDSRQ) interference sub-score(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)
- Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire, status version(DTSQs)(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 (29)
Loading locations...
相似试验
已完成
不适用
An Evaluation of the Omnipod® M System in Adults With Type 2 DiabetesType 2 Diabetes MellitusNCT07276776Insulet Corporation40
招募中
2 期
GALOP : Oral glibenclamide in hyperglycaemia of the premature infant2024-512230-15-00Assistance Publique Hopitaux De Paris35
招募中
4 期
A phase 1 glucose clamp trial investigating the bioequivalence of CVC-001 cartridge and vial formulations vs U.S.-Licensed Lantus® in healthy male volunteers2024-516472-15-00Civica Inc.96
进行中（未招募）
3 期
一项在饮食和运动血糖控制不佳的中国 2 型糖尿病患者中评价 BGM0504 注射液单药治疗有效性和安全性的随机、双盲、安慰剂平行对照的Ⅲ期临床研究CTR20244494207
尚未招募
不适用
CGM-Based Glycemic Analysis After ESISpinal StenosisHyperglycemiaIntervertebral Disc HerniationNCT07280780Korea University Anam Hospital36