Efficacy and Safety of the Omnipod 5 System Compared to Pump Therapy in the Treatment of Type 1 Diabetes: a Randomized, Parallel-group Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 28
- 主要终点
- Percent of Time in Range 70-180 mg/dL
研究概览
简要总结
Subject will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 90-day outpatient phase where subjects will either use the Omnipod 5 system or continue to use their personal insulin pump with the study provided continuous glucose monitoring system.
Participants in France will be offered an optional extension of 12 months of Omnipod 5 System use.
详细描述
This is an outpatient study that consists of two phases, Phase 1 and Phase 2. There will be approximately 8 study visits conducted in person or via telehealth.
Phase 1 is a 14-day period to collect baseline sensor and insulin data where subjects will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system.
Phase 2 is a 90-day period where subjects will be randomized into one of two groups. One group will use the Omnipod 5 system and the other group will continue to use their personal insulin pump with the study continuous glucose monitoring system.
Following the 90-day outpatient phase, participants in France will be offered the option to transition to use the CE-marked commercial Omnipod 5 System for an additional 12 months with the French interface.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at time of consent 18-70 years of age
- •Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment.
- •On pump therapy for ≥ 3 months prior to screening and familiar with pump therapy concepts such as basal and bolus insulin delivery, and carbohydrate counting. Participants using automated insulin delivery (AID) devices, including devices with predictive low glucose suspend (PLGS), in the 3 months prior to screening, will be excluded from participating.
- •A1C 7.0-11.0% by point-of-care taken at screening visit
- •Willing to use and obtain U-100 insulin: (either insulin aspart (Novolog, NovoRapid), or insulin lispro (Humalog, Admelog)), as the primary insulin treatment
- •Must have a smartphone that supports the Dexcom app download and participants must be willing to use the app throughout the study
- •Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol
- •Willing to wear the system continuously throughout the study
- •Willing and able to sign the Informed Consent Form (ICF)
排除标准
- •Any medical condition, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal failure, eating disorders, or other conditions which in the opinion of the investigator, would put the participant at an unacceptable safety risk
- •History of severe hypoglycemia in the past 6 months
- •History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness or infusion set failure
- •Blood disorder or dyscrasia within 3 months prior to screening, including use of hydroxyurea, which in the investigator's opinion could interfere with determination of HbA1C.
- •Currently on systemic steroids or intends to receive systemic steroid treatment during study participation, including stable treatment for adrenal insufficiency. Inhaled, ophthalmic, topical, joint injection, and other locally applied steroids are allowed.
- •Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
- •Use of non-insulin anti-hyperglycemic medication other than metformin, in the 12 weeks prior to the Baseline Visit. Participants taking metformin should remain on a steady dose during study participation.
- •Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner)
- •Participation in another clinical study using an investigational drug or device within 30-days or 5 half-lives (whichever is longer) prior to screening, or intends to participate in any other study during this study period
- •Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment
- •Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned
结局指标
主要结局
Percent of Time in Range 70-180 mg/dL
时间窗: Comparing intervention group with control group during the 13-week study phase
Glucose metric from study continuous glucose monitoring system
次要结局
- Percent of Time <54 mg/dL (Non-inferiority)(Comparing intervention group with control group at the end of the 13-week study phase)
- Percent of Time >180 mg/dL(Comparing intervention group with control group at the end of the 13-week study phase)
- Mean Glucose(Comparing intervention group with control group at the end of the 13-week study phase)
- Change in HbA1c(Baseline compared to end of study visit (Day -30 to Day 90))
- Percent of Time <70 mg/dL(Comparing intervention group with control group at the end of the 13-week study phase)
- Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) Total Score(Baseline compared to end of study visit (Day -14 to Day 90))
- Change in Hypoglycemic Confidence Scale (HCS) Total Score(Baseline compared to end of study visit (Day -14 to Day 90))
- Change in Diabetes Quality of Life (DQOL)-Brief Total Score(Baseline compared to end of study visit (Day -14 to Day 90))
- Proportion of Participants With T1-DDS MCID After 13 Weeks(Comparing intervention group with control group at the end of the 13-week study phase)
- Proportion of Participants With DQOL-brief Clinically Meaningful Improvement After 13 Weeks(Comparing intervention group with control group at the end of the 13-week study phase)
- Proportion of Participants With HCS Mean Score ≥ 3 After 13 Weeks(Comparing intervention group with control group at the end of the 13-week study phase)