ACTRN12624000712505招募中Unknown
Safety and Effectiveness of the Omnipod 5 SmartAdjust 2.0 System in Individuals with Type 1 and Type 2 Diabetes
niversity of Otago, Christchurch.0 个研究点目标入组 48 人开始时间: 2024年6月7日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 2 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Age at time of consent 2-70 years
- •2. Diabetes diagnosis, based on Investigator's clinical judgement, and meets the following:
- •-Type 1 diabetes: 2-70 years old with HbA1c <11%. Diagnosed for at least 6 months for participants aged 2-<7 years or at least 1 year for participants aged 7-70 years.
- •-Type 2 diabetes: 16-70 years old, diagnosed with T2D and on current insulin regimen for at least 3 months. Includes basal-bolus, pre-mix, or basal only users. For basal-bolus and premix users, must have HbA1c <12%. For basal only users must have HbA1c >=7.0% and <12%.
- •3. Living with a parent or guardian if < 16 years old
- •4. Currently using U-100 rapid-acting insulin analogs with insulin pump or basal-bolus, pre-mix, or basal only users suitable for conversion to pump therapy for at least 3 months prior to study start
- •5. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novorapid, or their generic equivalents
- •6. Deemed appropriate for pump therapy per Investigator’s assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other
- •comorbidities
- •7. Stable doses over the preceding 4 weeks of other glucose lowering medications, as determined by Investigator, including within class dose equivalent medication
- •8. Stable doses over the preceding 4 weeks of weight loss medications that may affect glycemic control directly and/or indirectly, as determined by Investigator
- •9. Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
- •10. Willing to wear the system, including Pods, continuously throughout the study
- •11. If female of childbearing potential, willing and able to have pregnancy testing
排除标准
- •1. Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk
- •2. 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
- •3. Any planned surgery during the study which could be considered major in the opinion of the Investigator
- •4. Severe retinopathy based on retinal screening performed within the last 24 months
- •5. History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered consciousness, and
- •requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions
- •6. History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure
- •7. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
- •8. 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
- •9. Plans to receive blood transfusion over the course of the study
- •10. 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)
- •11. Participation in another clinical study using an investigational drug or device within 30-days or intends to participate in any other study during this study period
- •12. 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
- •13. Participant is an employee of Insulet, an Investigator or Investigator’s study team, or immediate family member of any of the aforementioned
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