NCT05815342已完成不适用
Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 343
- 试验地点
- 40
- 主要终点
- Change in HbA1c
研究概览
简要总结
This is a single arm, multi-center, prospective study that will evaluate the safety and efficacy of the Omnipod 5 Automated Insulin Delivery System in adults with type 2 diabetes requiring insulin therapy.
详细描述
This outpatient study consists of 2 phases.
Phase 1 is a 14-day period to collect baseline glucose and insulin data. Participants will manage their diabetes as an outpatient per their usual routine. During this time participants will wear a blinded continuous glucose monitor to collect baseline glycemic information.
Phase 2 is a 13 week treatment period during which participants will use the Omnipod 5 System consisting of the Omnipod 5 pod, Omnipod 5 app as well as a Dexcom G6 continuous glucose monitor. Participants will do in-clinic or virtual visits at least monthly for a total of 8 visits. During the treatment period all participants will undergo supervised exercise and meal challenges.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at time of consent 18-75 years
- •Diagnosed with type 2 diabetes, on current insulin regimen for at least 3 months prior to screening (i.e. Basal-bolus, basal only or pre-mix)
- •Basal bolus (long-acting insulin and rapid acting analog) or pre-mix users with A1C <12.0% OR basal users on long or intermediate acting insulin only with A1C > 7.0% and < 12.0%
- •Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog
- •Participant agrees to provide their own insulin for the duration of the study
- •Stable doses over the preceding 4 weeks of other glucose-lowering medications as determined by Investigator
- •Stable doses of weight loss medications over the preceding 4 weeks and throughout the study that may affect glycemic control directly and/or indirectly, except for a dose reduction or discontinuation, as determined by Investigator
- •Willing to wear the system continuously throughout the study
- •Deemed appropriate for pump therapy per investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
- •Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol
- •Able to read and understand English or Spanish
- •Willing and able to sign the Informed Consent Form (ICF)
- •If female of childbearing potential, willing and able to have pregnancy testing
排除标准
- •Use of an AID pump in automated mode within 3 months prior to screening
- •Any medical condition which in the opinion of the investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and/or eating disorders (i.e. anorexia/bulimia)
- •Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening
- •Any planned surgery during the study which could be considered major in the opinion of the investigator
- •History of more than 1 severe hypoglycemic event in the 6 months prior to screening
- •History of more than 1 episode of diabetic ketoacidosis (DKA) or Hyperosmolar hyperglycemic syndrome (HHS) in the 6 months prior to screening; unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis
- •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
- •Plans to receive blood transfusion over the course of the study
- •Has taken oral or injectable steroids within 8 weeks prior to screening or plans to take oral or injectable steroids during the study
- •Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement
- •Pregnant or lactating, planning to become pregnant during the study, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD, or implant); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal)
- •Participation in another clinical study using an investigational drug or device other than the Omnipod 5 in the 30 days prior to screening or intends to participate during the 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 (spouse, biological or legal guardian, child, sibling, parent) of any of the aforementioned
研究组 & 干预措施
Treatment
Experimental
All subjects wearing the Omnipod 5 Automated Glucose Monitoring System
干预措施: Omnipod 5 Automated Glucose Control System (Device)
结局指标
主要结局
Change in HbA1c
时间窗: Comparing the change in HbA1c during the 13 weeks study phase
The change in HbA1c at 13 weeks from baseline
次要结局
- % Meeting MCID for HCS(Baseline compared to end week 13 visit)
- Percent of Time in Range 70-140 mg/dL(Measured during 13 weeks study phase)
- Percent of Time ≥ 300 mg/dL(Measured during 13 weeks study phase)
- Percent of Time > 250 mg/dL(Measured during 13 weeks study phase)
- Percent of Time >180 mg/dL(Measured during 13 weeks study phase)
- % Meeting MCID for Pittsburgh Sleep Quality Index(Baseline compared to end of week 13 visit)
- Mean Glucose(Measuring mean glucose during the 13 weeks study phase)
- Mean Glucose(Measuring mean glucose during the 13 weeks study phase)
- Percentage of Time in Range 70-180 mg/dL(Measured during 13 weeks study phase)
- Percent of Time in Range 70-140 mg/dL(Measured during 13 weeks study phase)
- Percent of Time ≥ 300 mg/dL(Measured during 13 weeks study phase)
- Percent of Time > 250 mg/dL(Measured during 13 weeks study phase)
- Percent of Time >180 mg/dL(Measured during 13 weeks study phase)
- Percent of Time < 70 mg/dL [Non-inferiority; Non-inferiority Limit 2.0%](Measured during 13 weeks study phase)
- Percent of Time < 54 mg/dL [Non-inferiority; Non-inferiority Limit 0.5%](Measured during 13 weeks study phase)
- Change From Baseline in T2-DDAS Total Score(Baseline compared to end of week 13 visit)
- Percentage Meeting MCID for T2-DDAS(Baseline compared to end week 13 visit)
- Change From Baseline in Pittsburgh Sleep Quality Index Total Score(Baseline compared to end of week 13 visit)
- % Meeting MCID for Pittsburgh Sleep Quality Index(Baseline compared to end of week 13 visit)
- Change From Baseline in HCS Total Score(Baseline compared to end week 13 visit)
- % Meeting MCID for HCS(Baseline compared to end week 13 visit)
- Percentage of Time <70 mg/dL (Superiority)(Measured during 13 weeks study phase)
- Percentage of Time <54 mg/dL (Superiority)(Measured during 13 weeks study phase)
- Coefficient of Variation(Measured during 13 weeks study phase and compared to standard therapy)
研究者
研究点 (40)
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