NCT06181721已完成不适用
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and 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
- 20
- 试验地点
- 1
- 主要终点
- Percentage of time in hypoglycemic range (defined as < 3.9 mmol/L (<70 mg/dL))
研究概览
简要总结
To assess the safety and effectiveness of a next-generation automated insulin delivery algorithm in participants aged 16+ years with type 1 or type 2 diabetes.
详细描述
This study is a single-arm, observational clinical study that will enroll a maximum of 72 participants.
Participants between the ages of 16+ years with type 1 or type 2 diabetes currently using an insulin pump or receiving basal and bolus multiple daily injections (MDI), with an A1C between 7.5-11.0% at screening, will be recruited for the study.
Two participant groups will be recruited and will participate in up to 4 Phases:
- Group A (Participants with type 1 diabetes) will participate in Phase 1, Phase 2, Phase 3, and Phase 4
- Group B (Participants with type 2 diabetes) will participate in Phase 1, and Phase 4
Phase 1 (Group A and B) will include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all the following criteria to be included in the study:
- •Age at time of consent 16+ years
- •Individuals must be diagnosed with type 1 diabetes based on investigator's clinical judgment for at least 1 year. Individuals diagnosed with type 2 diabetes must be on basal and bolus insulin therapy, with no specified duration.
- •A1C between 7.5-11.0% at screening
- •Currently using U-100 rapid-acting insulin analogs with insulin pump or receiving multiple daily injections suitable for conversion to pump therapy for at least 3 months prior to study start
- •Willing to use a Dexcom G6 CGM for the duration of the study
- •Willing to use the Omnipod® 5 Automated Insulin Delivery System during the study
- •Willing to perform all fingerstick BG testing with their personal blood glucose meter at the frequency specified in the study protocol or per investigator discretion
- •Willing to participate in at least 45 minutes of exercise and meal challenges during the 3 day hotel stay (Group A only)
- •Willing to use carbohydrate counting for determination of meal boluses
- •Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF.
排除标准
- •Participants who meet any of the following criteria will be excluded from the study:
- •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
- •Blood disorder or dyscrasia within 3 months prior to screening, including the use of hydroxyurea, which in the investigator's opinion could interfere with determination of HbA1C.
- •History of severe hypoglycemia within the past 6 months
- •History of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome in the past 6 months, unrelated to an intercurrent illness or infusion set failure
- •History of moderate to severe preproliferative or proliferative retinopathy based on screening within the last 12 months.
- •Planning to start a non-insulin anti-diabetic medication during the study. If on non-insulin medication, dose must be stable in the previous 30 days.
- •Planning to start a weight-loss agent during the study. If on a weight-loss medication, dose must be stable in the previous 30 days.
- •Currently on a low carbohydrate diet of < 60 grams of carbohydrates per day
- •Pregnant, 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 sterilisation such as tubal ligation or hysterectomy, or vasectomised partner)
- •Dermatological conditions at the proposed sensor/pump wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor
- •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 previous 12 months.
- •Currently on systemic steroids or intends to receive systemic steroid treatment in the next 6 months, including stable treatment for adrenal insufficiency. Inhaled, ophthalmic, topical, joint injection, and other locally applied steroids are allowed.
- •Currently participating in another clinical study using an investigational drug or device
- •Recent (within the preceding 30 days) participation in a clinical study using an investigational drug
- •Unable to follow the clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment
研究组 & 干预措施
Group A with Type 1 Diabetes
Experimental
Participants with Type 1 Diabetes
干预措施: Omnipod 5 Automated Glucose Control System (Device)
Group B with Type 2 Diabetes
Experimental
Participants with Type 2 Diabetes
干预措施: Omnipod 5 Automated Glucose Control System (Device)
结局指标
主要结局
Percentage of time in hypoglycemic range (defined as < 3.9 mmol/L (<70 mg/dL))
时间窗: At the end of Phase 3 and Phase 4 to compare to baseline values
Glucose metric from CGM
Percentage of time in hyperglycemic range (defined as > 13.9 mmol/L (>250 mg/dL))
时间窗: measured during the 9 week study phase
Glucose metric from CGM
次要结局
- Percentage of time > 16.7 mmol/L (>300 mg/dL)(Measured during the 9 week study phase)
- Average number of hypoglycemic treatments when CGM is less than 3.9mmol/L(Measured during the 9 week study phase)
- Percentage of time > 10.0 mmol/L (>180 mg/dL)(Measured during the 9 week study phase)
- Standard deviation and coefficient of variation(Measured during the 9 week study phase)
- Average total daily insulin (TDI)(Measured during the 9 week study phase)
- Average TDI/kg(Measured during the 9 week study phase)
- Percentage of time between 3.9-10.0 mmol/L (70-180 mg/dL)(Measured during the 9 week study phase)
- Average number of manual boluses/day(Measured during the 9 week study phase)
- Average dose of insulin delivered by manual bolus/day(Measured during the 9 week study phase)
- Mean glucose value of all participants(Measured during the 9 week study phase)
- Percentage of time < 3.0 mmol/L (<54 mg/dL)(Measured during the 9 week study phase)
研究者
研究点 (1)
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