NCT07070830已完成不适用
Feasibility of Simplified Onboarding in Adults With Type 2 Diabetes Using Automated Insulin Delivery
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
- 56
- 试验地点
- 11
- 主要终点
- Percent of time >180 mg/dL
研究概览
简要总结
This is an outpatient study testing different starting doses of insulin in participants with type 2 diabetes. Participants will manage their diabetes using the Omnipod M System. The system is comprised of an Omnipod M Pod, an Omnipod M Controller, and will be used with a Dexcom G6 continuous glucose monitoring sensor (CGM). The main objectives of the study are to evaluate the safety and tolerability of different starting doses of insulin using the Omnipod M System.
There is a precursory evaluation before the main, randomized trial. Participation in the precursory evaluation could last up to 12 weeks and participation in the randomized trial could last up to 6 weeks. During both the evaluation and the randomized trial, participants will manage their diabetes using the Omnipod M System in Automated Mode.
An optional 12-weeks of continued Omnipod M System use is available upon completion of the randomized trial.
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 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 (non-AID pump & MDI), pre-mix, or basal only users suitable for conversion to AID pump therapy for at least 3 months prior to screening. For basal-bolus and premix users, they must have A1c <14%. For basal only users must have A1c >7% and <14%.
- •Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, or their generic equivalents.
- •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 plans to maintain 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
- •Participant agrees to provide their own compatible smartphone for use with the Dexcom G6 CGM
- •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
- •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 up to 90 days 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)
- •Arrhythmias or other cardiac conditions confirmed by ECG (within past 30 days) which in the opinion of the Investigator, would put the participant at an unacceptable safety risk
- •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 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, which in the Investigator's opinion could interfere with determination of HbA1c
- •Use of hydroxyurea
- •Has taken systemic steroids (oral or injectable) within 4 weeks or has had a local steroid injection (intraarticular, epidural) within 1 week 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)
- •Planned international travel during the study
- •Participation in another clinical study using an investigational drug or device other than the Omnipod 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
Omnipod M System with lower starting dose
Active Comparator
干预措施: Active Comparator: Omnipod M System with lower starting dose (Device)
Omnipod M System with higher starting dose
Active Comparator
干预措施: Active Comparator: Omnipod M System with higher starting dose (Device)
结局指标
主要结局
Percent of time >180 mg/dL
时间窗: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Glucose metric from study continuous glucose monitoring system
Percent of time <70 mg/dL
时间窗: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Glucose metric from study continuous glucose monitoring system
次要结局
- Percent of time in range (TIR) 70-180 mg/dL(Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.)
- Percent of time above range (TAR) >250 mg/dL(Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.)
- Percent of time below range (TBR) <54 mg/dL(Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.)
- Total daily insulin (TDI)(Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.)
- Total daily insulin/kg(Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.)
- Perception questionnaire(Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.)
- Weight(Comparing baseline to end of continuation phase in the randomized trial.)
- HbA1c(Comparing baseline to end of continuation phase in the randomized trial.)
研究者
研究点 (11)
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