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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 343
- 试验地点
- 41
- 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
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 (41)
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